Trial Outcomes & Findings for Psychosocial Rehabilitation After Moral Injury and Loss With Adaptive Disclosure (NCT NCT03056157)
NCT ID: NCT03056157
Last Updated: 2024-07-03
Results Overview
The Sheehan Disability Scale (SDS; Sheehan, 1983; Sheehan et al., 1996) is a composite of three self-rated items regarding the degree to which symptoms disrupted work/school, social life, and family life/responsibilities on an 11-point scale ranging from "Not at all" to "Extremely," with an option for "Not applicable". The possible range of scores is 0 to 30. Higher scores indicate greater disability.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
174 participants
Primary outcome timeframe
Assessments occurred at baseline, every treatment session, post treatment, and approximately 3 and 6 months after post treatment.
Results posted on
2024-07-03
Participant Flow
Participants were recruited through clinician referral at four VA locations: San Francisco, San Diego, Minneapolis, and Central Texas between January 2018 and November 2021. The first participant was enrolled on January 3rd, 2018 and the last on November 19th, 2021.
304 participants were recruited for the study. 96 did not meet inclusion/exclusion criteria, 20 declined to participate, and 14 were excluded for other reasons (e.g., difficult to contact). A total of 174 were randomized.
Participant milestones
| Measure |
Adaptive Disclosure for Moral Injury and Loss
AD-MIL is a manualized, 12-session individual psychotherapy designed to improve functioning and to reduce PTSD symptoms by facilitating Veterans doing corrective things in their life to heal and repair traumatic loss and moral injuries. The change agents are: (1) emotional-processing of traumatic loss and moral injuries and motivating a healing and action plan by writing therapeutic letters (e.g., to a lost unit member, to victims of personal transgressions, to people who transgressed); (2) skills training and behavioral contracting to improve functioning and targeting moral injury- and traumatic loss-related psychological and behavioral obstacles to positive and potentially habilitative engagements in occupational, relationship, and family roles; and (3) teaching self- and other-compassion and mindfulness. The goal is to redress the functional impact of moral emotions (anger, shame).
|
Present Centered Therapy
Participants randomized to the PCT arm received 12 sessions of therapy focused on improving day-to-day functioning (with no focus on trauma or re-visiting past experiences). PCT is a manualized evidenced-based PTSD treatment used in several large-scale PTSD trials that focuses on improving functioning. It incorporates the essential therapeutic elements common to different types of psychotherapies, including supportive empathic listening and unconditional positive regard. The therapist plays an active role, but does not impart any systematic training. The focus is to create an understanding of how the symptoms of PTSD are related to day-to-day difficulties and to help patients develop new, more adaptive functional responses to these stressors with a problem-focused and problem- solving approach. In prior trials, PCT showed equivalent change to active therapies at the last follow-up. The VA offers PCT as an evidence-based therapy for PTSD.
|
|---|---|---|
|
Overall Study
STARTED
|
89
|
85
|
|
Overall Study
Started Treatment (Attended at Least One Therapy Session)
|
80
|
83
|
|
Overall Study
Completed Treatment
|
59
|
52
|
|
Overall Study
Completed 12 Sessions
|
56
|
50
|
|
Overall Study
Completed 3-month Follow up
|
54
|
62
|
|
Overall Study
Completed 6-month Follow up
|
43
|
41
|
|
Overall Study
COVID-19 Cohort
|
21
|
22
|
|
Overall Study
COMPLETED
|
59
|
52
|
|
Overall Study
NOT COMPLETED
|
30
|
33
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Some participants did not complete or had missing values in this baseline assessment, so the number analyzed is lower than that of the total group.
Baseline characteristics by cohort
| Measure |
Adaptive Disclosure for Moral Injury and Loss
n=89 Participants
AD-MIL is a manualized, 12-session individual psychotherapy designed to improve functioning and to reduce PTSD symptoms by facilitating Veterans doing corrective things in their life to heal and repair traumatic loss and moral injuries. The change agents are: (1) emotional-processing of traumatic loss and moral injuries and motivating a healing and action plan by writing therapeutic letters (e.g., to a lost unit member, to victims of personal transgressions, to people who transgressed); (2) skills training and behavioral contracting to improve functioning and targeting moral injury- and traumatic loss-related psychological and behavioral obstacles to positive and potentially habilitative engagements in occupational, relationship, and family roles; and (3) teaching self- and other-compassion and mindfulness. The goal is to redress the functional impact of moral emotions (anger, shame).
|
Present Centered Therapy
n=85 Participants
Participants randomized to the PCT arm received 12 sessions of therapy focused on improving day-to-day functioning (with no focus on trauma or re-visiting past experiences). PCT is a manualized evidenced-based PTSD treatment used in several large-scale PTSD trials that focuses on improving functioning. It incorporates the essential therapeutic elements common to different types of psychotherapies, including supportive empathic listening and unconditional positive regard. The therapist plays an active role, but does not impart any systematic training. The focus is to create an understanding of how the symptoms of PTSD are related to day-to-day difficulties and to help patients develop new, more adaptive functional responses to these stressors with a problem-focused and problem- solving approach. In prior trials, PCT showed equivalent change to active therapies at the last follow-up. The VA offers PCT as an evidence-based therapy for PTSD.
|
Total
n=174 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=89 Participants
|
0 Participants
n=85 Participants
|
0 Participants
n=174 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
89 Participants
n=89 Participants
|
85 Participants
n=85 Participants
|
174 Participants
n=174 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=89 Participants
|
0 Participants
n=85 Participants
|
0 Participants
n=174 Participants
|
|
Age, Continuous
|
38.82 years
STANDARD_DEVIATION 8.61 • n=89 Participants
|
39.24 years
STANDARD_DEVIATION 8.61 • n=85 Participants
|
39.02 years
STANDARD_DEVIATION 8.61 • n=174 Participants
|
|
Sex/Gender, Customized
Gender · Male
|
69 Participants
n=89 Participants
|
66 Participants
n=85 Participants
|
135 Participants
n=174 Participants
|
|
Sex/Gender, Customized
Gender · Female
|
19 Participants
n=89 Participants
|
18 Participants
n=85 Participants
|
37 Participants
n=174 Participants
|
|
Sex/Gender, Customized
Gender · Transgender
|
0 Participants
n=89 Participants
|
1 Participants
n=85 Participants
|
1 Participants
n=174 Participants
|
|
Sex/Gender, Customized
Gender · Prefer not to answer
|
1 Participants
n=89 Participants
|
0 Participants
n=85 Participants
|
1 Participants
n=174 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
19 Participants
n=89 Participants
|
21 Participants
n=85 Participants
|
40 Participants
n=174 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
66 Participants
n=89 Participants
|
58 Participants
n=85 Participants
|
124 Participants
n=174 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=89 Participants
|
6 Participants
n=85 Participants
|
10 Participants
n=174 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=89 Participants
|
0 Participants
n=85 Participants
|
1 Participants
n=174 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=89 Participants
|
5 Participants
n=85 Participants
|
9 Participants
n=174 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
3 Participants
n=89 Participants
|
2 Participants
n=85 Participants
|
5 Participants
n=174 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=89 Participants
|
9 Participants
n=85 Participants
|
19 Participants
n=174 Participants
|
|
Race (NIH/OMB)
White
|
54 Participants
n=89 Participants
|
50 Participants
n=85 Participants
|
104 Participants
n=174 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=89 Participants
|
12 Participants
n=85 Participants
|
17 Participants
n=174 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
12 Participants
n=89 Participants
|
7 Participants
n=85 Participants
|
19 Participants
n=174 Participants
|
|
Region of Enrollment
United States
|
89 Participants
n=89 Participants
|
85 Participants
n=85 Participants
|
174 Participants
n=174 Participants
|
|
Sheehan Disability Scale (SDS)
|
20.52 Score on a scale
STANDARD_DEVIATION 5.14 • n=82 Participants • Some participants did not complete or had missing values in this baseline assessment, so the number analyzed is lower than that of the total group.
|
20.43 Score on a scale
STANDARD_DEVIATION 5.10 • n=84 Participants • Some participants did not complete or had missing values in this baseline assessment, so the number analyzed is lower than that of the total group.
|
20.48 Score on a scale
STANDARD_DEVIATION 5.10 • n=166 Participants • Some participants did not complete or had missing values in this baseline assessment, so the number analyzed is lower than that of the total group.
|
|
Brief Inventory of Psychosocial Functioning (B-IPF)
|
59.37 Percentage of total possible score
STANDARD_DEVIATION 22.14 • n=85 Participants • Some participants did not complete or had missing values in this baseline assessment, so the number analyzed is lower than that of the total group.
|
61.06 Percentage of total possible score
STANDARD_DEVIATION 19.39 • n=82 Participants • Some participants did not complete or had missing values in this baseline assessment, so the number analyzed is lower than that of the total group.
|
60.20 Percentage of total possible score
STANDARD_DEVIATION 20.79 • n=167 Participants • Some participants did not complete or had missing values in this baseline assessment, so the number analyzed is lower than that of the total group.
|
|
COVID-19 Aim: Sheehan Disability Scale (SDS)
|
21.78 Score on a scale
STANDARD_DEVIATION 4.52 • n=18 Participants • This analysis is just of participants who started the study after December 1, 2020 (COVID-19 cohort). Additionally, some participants did not complete or had missing values in this baseline assessment, so the number analyzed is lower than that of the total group.
|
19.82 Score on a scale
STANDARD_DEVIATION 5.83 • n=22 Participants • This analysis is just of participants who started the study after December 1, 2020 (COVID-19 cohort). Additionally, some participants did not complete or had missing values in this baseline assessment, so the number analyzed is lower than that of the total group.
|
20.70 Score on a scale
STANDARD_DEVIATION 5.31 • n=40 Participants • This analysis is just of participants who started the study after December 1, 2020 (COVID-19 cohort). Additionally, some participants did not complete or had missing values in this baseline assessment, so the number analyzed is lower than that of the total group.
|
|
COVID-19 Aim: PTSD Checklist for DSM-5 (PCL-5)
|
48.53 Score on a scale
STANDARD_DEVIATION 8.84 • n=20 Participants • This analysis is just of participants who started the study after December 1, 2020 (COVID-19 cohort). Additionally, some participants did not complete or had missing values in this baseline assessment, so the number analyzed is lower than that of the total group.
|
50.62 Score on a scale
STANDARD_DEVIATION 11.57 • n=20 Participants • This analysis is just of participants who started the study after December 1, 2020 (COVID-19 cohort). Additionally, some participants did not complete or had missing values in this baseline assessment, so the number analyzed is lower than that of the total group.
|
49.73 Score on a scale
STANDARD_DEVIATION 10.40 • n=40 Participants • This analysis is just of participants who started the study after December 1, 2020 (COVID-19 cohort). Additionally, some participants did not complete or had missing values in this baseline assessment, so the number analyzed is lower than that of the total group.
|
|
COVID-19 Aim: Clinician-administered PTSD scale for DSM-5 (CAPS-5)
|
39.76 Score on a scale
STANDARD_DEVIATION 8.89 • n=21 Participants • This analysis is just of participants who started the study after December 1, 2020 (COVID-19 cohort).
|
40.86 Score on a scale
STANDARD_DEVIATION 9.15 • n=22 Participants • This analysis is just of participants who started the study after December 1, 2020 (COVID-19 cohort).
|
40.33 Score on a scale
STANDARD_DEVIATION 8.93 • n=43 Participants • This analysis is just of participants who started the study after December 1, 2020 (COVID-19 cohort).
|
|
COVID-19 Aim: Patient Health Questionnaire-9 (PHQ-9)
|
17.31 Score on a scale
STANDARD_DEVIATION 5.38 • n=17 Participants • This analysis is just of participants who started the study after December 1, 2020 (COVID-19 cohort). Additionally, some participants did not complete or had missing values in this baseline assessment, so the number analyzed is lower than that of the total group.
|
14.95 Score on a scale
STANDARD_DEVIATION 6.14 • n=20 Participants • This analysis is just of participants who started the study after December 1, 2020 (COVID-19 cohort). Additionally, some participants did not complete or had missing values in this baseline assessment, so the number analyzed is lower than that of the total group.
|
15.88 Score on a scale
STANDARD_DEVIATION 5.88 • n=37 Participants • This analysis is just of participants who started the study after December 1, 2020 (COVID-19 cohort). Additionally, some participants did not complete or had missing values in this baseline assessment, so the number analyzed is lower than that of the total group.
|
|
PTSD Checklist for DSM-5 (PCL-5)
|
49.26 Score on a scale
STANDARD_DEVIATION 11.43 • n=83 Participants • Some participants did not complete or had missing values in this baseline assessment, so the number analyzed is lower than that of the total group.
|
51.66 Score on a scale
STANDARD_DEVIATION 10.85 • n=83 Participants • Some participants did not complete or had missing values in this baseline assessment, so the number analyzed is lower than that of the total group.
|
50.46 Score on a scale
STANDARD_DEVIATION 11.17 • n=166 Participants • Some participants did not complete or had missing values in this baseline assessment, so the number analyzed is lower than that of the total group.
|
|
Clinician-administered PTSD scale for DSM-5 (CAPS-5)
|
36.08 Score on a scale
STANDARD_DEVIATION 11.88 • n=89 Participants • Some participants did not complete or had missing values in this baseline assessment, so the number analyzed is lower than that of the total group.
|
35.69 Score on a scale
STANDARD_DEVIATION 13.60 • n=85 Participants • Some participants did not complete or had missing values in this baseline assessment, so the number analyzed is lower than that of the total group.
|
35.89 Score on a scale
STANDARD_DEVIATION 12.71 • n=174 Participants • Some participants did not complete or had missing values in this baseline assessment, so the number analyzed is lower than that of the total group.
|
|
Patient Health Questionnaire-9 (PHQ-9)
|
16.88 Score on a scale
STANDARD_DEVIATION 5.43 • n=79 Participants • Some participants did not complete or had missing values in this baseline assessment, so the number analyzed is lower than that of the total group.
|
16.62 Score on a scale
STANDARD_DEVIATION 5.50 • n=82 Participants • Some participants did not complete or had missing values in this baseline assessment, so the number analyzed is lower than that of the total group.
|
16.75 Score on a scale
STANDARD_DEVIATION 5.45 • n=161 Participants • Some participants did not complete or had missing values in this baseline assessment, so the number analyzed is lower than that of the total group.
|
|
(Lack of) Justification Subscale of the Brief Trauma Related Guilt Inventory (TRGI-Brief).
|
1.88 Score on a scale
STANDARD_DEVIATION 0.98 • n=81 Participants • Measure Analysis Population Description: Some participants did not complete or had missing values in this baseline assessment, so the number analyzed is lower than that of the total group
|
2.00 Score on a scale
STANDARD_DEVIATION 0.96 • n=80 Participants • Measure Analysis Population Description: Some participants did not complete or had missing values in this baseline assessment, so the number analyzed is lower than that of the total group
|
1.94 Score on a scale
STANDARD_DEVIATION 0.97 • n=161 Participants • Measure Analysis Population Description: Some participants did not complete or had missing values in this baseline assessment, so the number analyzed is lower than that of the total group
|
|
Hindsight-Bias Subscale of the Brief Trauma Related Guilt Inventory (TRGI-Brief)
|
1.66 Score on a scale
STANDARD_DEVIATION 1.06 • n=81 Participants • Some participants did not complete or had missing values in this baseline assessment, so the number analyzed is lower than that of the total group.
|
1.68 Score on a scale
STANDARD_DEVIATION 1.04 • n=80 Participants • Some participants did not complete or had missing values in this baseline assessment, so the number analyzed is lower than that of the total group.
|
1.67 Score on a scale
STANDARD_DEVIATION 1.05 • n=161 Participants • Some participants did not complete or had missing values in this baseline assessment, so the number analyzed is lower than that of the total group.
|
|
Wrongdoing Subscale of the Brief Trauma Related Guilt Inventory (TRGI-Brief)
|
1.71 Score on a scale
STANDARD_DEVIATION 1.00 • n=84 Participants • Some participants did not complete or had missing values in this baseline assessment, so the number analyzed is lower than that of the total group.
|
1.74 Score on a scale
STANDARD_DEVIATION 1.01 • n=81 Participants • Some participants did not complete or had missing values in this baseline assessment, so the number analyzed is lower than that of the total group.
|
1.72 Score on a scale
STANDARD_DEVIATION 1.00 • n=165 Participants • Some participants did not complete or had missing values in this baseline assessment, so the number analyzed is lower than that of the total group.
|
|
Internal Shame Subscale of the Trauma-Related Shame Inventory (TRSI)
|
12.74 Score on a scale
STANDARD_DEVIATION 7.94 • n=82 Participants • Some participants did not complete or had missing values in this baseline assessment, so the number analyzed is lower than that of the total group
|
14.23 Score on a scale
STANDARD_DEVIATION 9.46 • n=80 Participants • Some participants did not complete or had missing values in this baseline assessment, so the number analyzed is lower than that of the total group
|
13.48 Score on a scale
STANDARD_DEVIATION 8.73 • n=162 Participants • Some participants did not complete or had missing values in this baseline assessment, so the number analyzed is lower than that of the total group
|
|
Schwartz Outcome Scale-10 (SOS-10)
|
24.94 Score on a scale
STANDARD_DEVIATION 9.87 • n=85 Participants • Some participants did not complete or had missing values in this baseline assessment, so the number analyzed is lower than that of the total group.
|
25.43 Score on a scale
STANDARD_DEVIATION 8.38 • n=82 Participants • Some participants did not complete or had missing values in this baseline assessment, so the number analyzed is lower than that of the total group.
|
25.18 Score on a scale
STANDARD_DEVIATION 9.14 • n=167 Participants • Some participants did not complete or had missing values in this baseline assessment, so the number analyzed is lower than that of the total group.
|
|
Self-Compassion Scale (SCS)
|
2.66 Score on a scale
STANDARD_DEVIATION 0.57 • n=82 Participants • Some participants did not complete or had missing values in this baseline assessment, so the number analyzed is lower than that of the total group.
|
2.49 Score on a scale
STANDARD_DEVIATION 0.56 • n=81 Participants • Some participants did not complete or had missing values in this baseline assessment, so the number analyzed is lower than that of the total group.
|
2.58 Score on a scale
STANDARD_DEVIATION 0.57 • n=163 Participants • Some participants did not complete or had missing values in this baseline assessment, so the number analyzed is lower than that of the total group.
|
|
Dimensions of Anger Reactions (DAR)
|
30.27 Score on a scale
STANDARD_DEVIATION 12.90 • n=85 Participants • Some participants did not complete or had missing values in this baseline assessment, so the number analyzed is lower than that of the total group.
|
32.32 Score on a scale
STANDARD_DEVIATION 12.06 • n=81 Participants • Some participants did not complete or had missing values in this baseline assessment, so the number analyzed is lower than that of the total group.
|
31.27 Score on a scale
STANDARD_DEVIATION 12.50 • n=166 Participants • Some participants did not complete or had missing values in this baseline assessment, so the number analyzed is lower than that of the total group.
|
|
Psychological Aggression Subscale of the Revised Conflict Tactics Scale (CTS2)
|
28.94 Score on a scale
STANDARD_DEVIATION 31.45 • n=85 Participants • Some participants did not complete or had missing values in this baseline assessment, so the number analyzed is lower than that of the total group.
|
26.41 Score on a scale
STANDARD_DEVIATION 27.87 • n=82 Participants • Some participants did not complete or had missing values in this baseline assessment, so the number analyzed is lower than that of the total group.
|
27.70 Score on a scale
STANDARD_DEVIATION 29.68 • n=167 Participants • Some participants did not complete or had missing values in this baseline assessment, so the number analyzed is lower than that of the total group.
|
|
Physical Assault Subscale on the Revised Conflict Tactics Scale (CTS2)
|
5.25 Score on a scale
STANDARD_DEVIATION 30.27 • n=85 Participants • Some participants did not complete or had missing values in this baseline assessment, so the number analyzed is lower than that of the total group.
|
0.96 Score on a scale
STANDARD_DEVIATION 3.31 • n=82 Participants • Some participants did not complete or had missing values in this baseline assessment, so the number analyzed is lower than that of the total group.
|
3.31 Score on a scale
STANDARD_DEVIATION 21.76 • n=167 Participants • Some participants did not complete or had missing values in this baseline assessment, so the number analyzed is lower than that of the total group.
|
|
Depressive Symptoms Index - Suicidality Subscale (DSI-SS)
|
1.14 Score on a scale
STANDARD_DEVIATION 1.62 • n=81 Participants • Some participants did not complete or had missing values in this baseline assessment, so the number analyzed is lower than that of the total group.
|
0.93 Score on a scale
STANDARD_DEVIATION 1.65 • n=82 Participants • Some participants did not complete or had missing values in this baseline assessment, so the number analyzed is lower than that of the total group.
|
1.03 Score on a scale
STANDARD_DEVIATION 1.64 • n=163 Participants • Some participants did not complete or had missing values in this baseline assessment, so the number analyzed is lower than that of the total group.
|
|
Quick Drinking Screen (QDS)
|
1.92 Drinks per week
STANDARD_DEVIATION 3.17 • n=85 Participants • Some participants did not complete or had missing values in this baseline assessment, so the number analyzed is lower than that of the total group.
|
1.97 Drinks per week
STANDARD_DEVIATION 2.82 • n=82 Participants • Some participants did not complete or had missing values in this baseline assessment, so the number analyzed is lower than that of the total group.
|
1.94 Drinks per week
STANDARD_DEVIATION 2.99 • n=167 Participants • Some participants did not complete or had missing values in this baseline assessment, so the number analyzed is lower than that of the total group.
|
|
Social Connectedness Scale (SCS)
|
23.89 Score on a scale
STANDARD_DEVIATION 9.69 • n=85 Participants • Some participants did not complete or had missing values in this baseline assessment, so the number analyzed is lower than that of the total group.
|
23.57 Score on a scale
STANDARD_DEVIATION 8.22 • n=82 Participants • Some participants did not complete or had missing values in this baseline assessment, so the number analyzed is lower than that of the total group.
|
23.73 Score on a scale
STANDARD_DEVIATION 8.97 • n=167 Participants • Some participants did not complete or had missing values in this baseline assessment, so the number analyzed is lower than that of the total group.
|
|
Santa Clara Brief Compassion Scale (SCBSC)
|
4.84 Score on a scale
STANDARD_DEVIATION 1.76 • n=85 Participants • Some participants did not complete or had missing values in this baseline assessment, so the number analyzed is lower than that of the total group
|
5.00 Score on a scale
STANDARD_DEVIATION 1.64 • n=82 Participants • Some participants did not complete or had missing values in this baseline assessment, so the number analyzed is lower than that of the total group
|
4.92 Score on a scale
STANDARD_DEVIATION 1.70 • n=167 Participants • Some participants did not complete or had missing values in this baseline assessment, so the number analyzed is lower than that of the total group
|
|
Valued Living Questionnaire (VLQ)
|
37.39 Composite score on a scale
STANDARD_DEVIATION 19.42 • n=79 Participants • Some participants did not complete or had missing values in this baseline assessment, so the number analyzed is lower than that of the total group.
|
40.72 Composite score on a scale
STANDARD_DEVIATION 16.89 • n=81 Participants • Some participants did not complete or had missing values in this baseline assessment, so the number analyzed is lower than that of the total group.
|
39.08 Composite score on a scale
STANDARD_DEVIATION 18.20 • n=160 Participants • Some participants did not complete or had missing values in this baseline assessment, so the number analyzed is lower than that of the total group.
|
PRIMARY outcome
Timeframe: Assessments occurred at baseline, every treatment session, post treatment, and approximately 3 and 6 months after post treatment.Population: The number of participants analyzed differs at the timepoints due to some participants either: 1) not filling out the measure at a given time point due to clinician error; 2) not being present for one of the timepoints; or 3) leaving the study before a given timepoint.
The Sheehan Disability Scale (SDS; Sheehan, 1983; Sheehan et al., 1996) is a composite of three self-rated items regarding the degree to which symptoms disrupted work/school, social life, and family life/responsibilities on an 11-point scale ranging from "Not at all" to "Extremely," with an option for "Not applicable". The possible range of scores is 0 to 30. Higher scores indicate greater disability.
Outcome measures
| Measure |
Adaptive Disclosure for Moral Injury and Loss
n=89 Participants
AD-MIL is a manualized, 12-session individual psychotherapy designed to improve functioning and to reduce PTSD symptoms by facilitating Veterans doing corrective things in their life to heal and repair traumatic loss and moral injuries. The change agents are: (1) emotional-processing of traumatic loss and moral injuries and motivating a healing and action plan by writing therapeutic letters (e.g., to a lost unit member, to victims of personal transgressions, to people who transgressed); (2) skills training and behavioral contracting to improve functioning and targeting moral injury- and traumatic loss-related psychological and behavioral obstacles to positive and potentially habilitative engagements in occupational, relationship, and family roles; and (3) teaching self- and other-compassion and mindfulness. The goal is to redress the functional impact of moral emotions (anger, shame).
|
Present Centered Therapy
n=85 Participants
Participants randomized to the PCT arm received 12 sessions of therapy focused on improving day-to-day functioning (with no focus on trauma or re-visiting past experiences). Participants randomized to the PCT arm received 12 sessions of therapy focused on improving day-to-day functioning (with no focus on trauma or re-visiting past experiences). PCT is a manualized evidenced-based PTSD treatment used in several large-scale PTSD trials that focuses on improving functioning. It incorporates the essential therapeutic elements common to different types of psychotherapies, including supportive empathic listening and unconditional positive regard. The therapist plays an active role but does not impart any systematic training. The focus is to create an understanding of how the symptoms of PTSD are related to day-to-day difficulties and to help patients develop new, more adaptive functional responses to these stressors with a problem-focused and problem- solving approach. In prior trials, PCT showed equivalent change to active therapies at the last follow-up. The VA offers PCT as an evidence-based therapy for PTSD.
|
|---|---|---|
|
Change in Functional Impairment Assessed Through the Sheehan Disability Scale (SDS)
Baseline
|
20.52 Score on a scale
Standard Deviation 5.14
|
20.43 Score on a scale
Standard Deviation 5.10
|
|
Change in Functional Impairment Assessed Through the Sheehan Disability Scale (SDS)
Session 1
|
17.39 Score on a scale
Standard Deviation 5.67
|
18.04 Score on a scale
Standard Deviation 5.49
|
|
Change in Functional Impairment Assessed Through the Sheehan Disability Scale (SDS)
Session 2
|
16.93 Score on a scale
Standard Deviation 6.12
|
18.25 Score on a scale
Standard Deviation 6.47
|
|
Change in Functional Impairment Assessed Through the Sheehan Disability Scale (SDS)
Session 3
|
16.16 Score on a scale
Standard Deviation 6.45
|
17.36 Score on a scale
Standard Deviation 6.46
|
|
Change in Functional Impairment Assessed Through the Sheehan Disability Scale (SDS)
Session 4
|
16.16 Score on a scale
Standard Deviation 7.00
|
17.50 Score on a scale
Standard Deviation 6.00
|
|
Change in Functional Impairment Assessed Through the Sheehan Disability Scale (SDS)
Session 5
|
14.58 Score on a scale
Standard Deviation 6.73
|
16.02 Score on a scale
Standard Deviation 6.97
|
|
Change in Functional Impairment Assessed Through the Sheehan Disability Scale (SDS)
Session 6
|
14.86 Score on a scale
Standard Deviation 7.27
|
16.16 Score on a scale
Standard Deviation 7.39
|
|
Change in Functional Impairment Assessed Through the Sheehan Disability Scale (SDS)
Session 7
|
14.33 Score on a scale
Standard Deviation 6.76
|
15.32 Score on a scale
Standard Deviation 7.42
|
|
Change in Functional Impairment Assessed Through the Sheehan Disability Scale (SDS)
Session 8
|
12.57 Score on a scale
Standard Deviation 6.83
|
15.21 Score on a scale
Standard Deviation 7.03
|
|
Change in Functional Impairment Assessed Through the Sheehan Disability Scale (SDS)
Session 9
|
11.90 Score on a scale
Standard Deviation 6.54
|
14.16 Score on a scale
Standard Deviation 7.85
|
|
Change in Functional Impairment Assessed Through the Sheehan Disability Scale (SDS)
Session 10
|
11.51 Score on a scale
Standard Deviation 6.41
|
13.65 Score on a scale
Standard Deviation 7.66
|
|
Change in Functional Impairment Assessed Through the Sheehan Disability Scale (SDS)
Session 11
|
11.02 Score on a scale
Standard Deviation 6.34
|
13.88 Score on a scale
Standard Deviation 7.42
|
|
Change in Functional Impairment Assessed Through the Sheehan Disability Scale (SDS)
Session 12
|
9.76 Score on a scale
Standard Deviation 6.44
|
14.04 Score on a scale
Standard Deviation 7.91
|
|
Change in Functional Impairment Assessed Through the Sheehan Disability Scale (SDS)
3 month follow-up
|
13.21 Score on a scale
Standard Deviation 7.83
|
15.38 Score on a scale
Standard Deviation 7.71
|
|
Change in Functional Impairment Assessed Through the Sheehan Disability Scale (SDS)
6 month follow-up
|
11.22 Score on a scale
Standard Deviation 6.87
|
15.66 Score on a scale
Standard Deviation 7.39
|
PRIMARY outcome
Timeframe: Baseline and post-treatment.Population: The participants analyzed here are participants who had a complete SDS baseline assessment, and a complete SDS post-treatment assessment.
The investigators used the Jacobson and Truax methodology to index individual participant clinically significant change in functional impairment, assessed through the Sheehan Disability Scale (SDS). Individuals were classified as experiencing probable recovery if they passed the Criterion Cutoff and the RCI criteria; improved if they passed the RCI criterion, but their post-treatment or follow-up score did not pass the Criterion Cutoff; unchanged if they failed to pass the RCI; or deteriorated if they passed the RCI criterion but symptom scores increased.
Outcome measures
| Measure |
Adaptive Disclosure for Moral Injury and Loss
n=51 Participants
AD-MIL is a manualized, 12-session individual psychotherapy designed to improve functioning and to reduce PTSD symptoms by facilitating Veterans doing corrective things in their life to heal and repair traumatic loss and moral injuries. The change agents are: (1) emotional-processing of traumatic loss and moral injuries and motivating a healing and action plan by writing therapeutic letters (e.g., to a lost unit member, to victims of personal transgressions, to people who transgressed); (2) skills training and behavioral contracting to improve functioning and targeting moral injury- and traumatic loss-related psychological and behavioral obstacles to positive and potentially habilitative engagements in occupational, relationship, and family roles; and (3) teaching self- and other-compassion and mindfulness. The goal is to redress the functional impact of moral emotions (anger, shame).
|
Present Centered Therapy
n=56 Participants
Participants randomized to the PCT arm received 12 sessions of therapy focused on improving day-to-day functioning (with no focus on trauma or re-visiting past experiences). Participants randomized to the PCT arm received 12 sessions of therapy focused on improving day-to-day functioning (with no focus on trauma or re-visiting past experiences). PCT is a manualized evidenced-based PTSD treatment used in several large-scale PTSD trials that focuses on improving functioning. It incorporates the essential therapeutic elements common to different types of psychotherapies, including supportive empathic listening and unconditional positive regard. The therapist plays an active role but does not impart any systematic training. The focus is to create an understanding of how the symptoms of PTSD are related to day-to-day difficulties and to help patients develop new, more adaptive functional responses to these stressors with a problem-focused and problem- solving approach. In prior trials, PCT showed equivalent change to active therapies at the last follow-up. The VA offers PCT as an evidence-based therapy for PTSD.
|
|---|---|---|
|
Pre-to-Post-Treatment Clinically Significant Change (CSC) in Functional Impairment Assessed Through the Sheehan Disability Scale (SDS)
Probable Recovery
|
56.86 Percentage of participants
|
35.71 Percentage of participants
|
|
Pre-to-Post-Treatment Clinically Significant Change (CSC) in Functional Impairment Assessed Through the Sheehan Disability Scale (SDS)
Improved
|
0 Percentage of participants
|
12.50 Percentage of participants
|
|
Pre-to-Post-Treatment Clinically Significant Change (CSC) in Functional Impairment Assessed Through the Sheehan Disability Scale (SDS)
Unchanged
|
43.14 Percentage of participants
|
48.21 Percentage of participants
|
|
Pre-to-Post-Treatment Clinically Significant Change (CSC) in Functional Impairment Assessed Through the Sheehan Disability Scale (SDS)
Deteriorated
|
0 Percentage of participants
|
3.57 Percentage of participants
|
PRIMARY outcome
Timeframe: Assessments occurred at baseline, post treatment, and approximately 3 and 6 months after post treatment.Population: The number of participants analyzed differs at the timepoints due to some participants either: 1) not filling out the measure at a given time point due to clinician error; 2) not being present for one of the timepoints; or 3) leaving the study before a given timepoint.
The Brief Inventory of Psychosocial Functioning (B-IPF; Marx, 2013) was used to assess functional gains. It is a 7-item scale indexing overall level of functioning in seven life domains: romantic relationship, relationship with children, family relationships, friendships and socializing, work, training and education, and activities of daily living. The investigators used a prorated total percentage for the dimensional ratings, such that Veterans who were not in romantic relationships, had no children, or were not in employed or in school did not have those domains included in their percentage. Possible scores on the B-IPF range from 0% to 100%, with higher scores indicating more issues in psychosocial functioning.
Outcome measures
| Measure |
Adaptive Disclosure for Moral Injury and Loss
n=89 Participants
AD-MIL is a manualized, 12-session individual psychotherapy designed to improve functioning and to reduce PTSD symptoms by facilitating Veterans doing corrective things in their life to heal and repair traumatic loss and moral injuries. The change agents are: (1) emotional-processing of traumatic loss and moral injuries and motivating a healing and action plan by writing therapeutic letters (e.g., to a lost unit member, to victims of personal transgressions, to people who transgressed); (2) skills training and behavioral contracting to improve functioning and targeting moral injury- and traumatic loss-related psychological and behavioral obstacles to positive and potentially habilitative engagements in occupational, relationship, and family roles; and (3) teaching self- and other-compassion and mindfulness. The goal is to redress the functional impact of moral emotions (anger, shame).
|
Present Centered Therapy
n=85 Participants
Participants randomized to the PCT arm received 12 sessions of therapy focused on improving day-to-day functioning (with no focus on trauma or re-visiting past experiences). Participants randomized to the PCT arm received 12 sessions of therapy focused on improving day-to-day functioning (with no focus on trauma or re-visiting past experiences). PCT is a manualized evidenced-based PTSD treatment used in several large-scale PTSD trials that focuses on improving functioning. It incorporates the essential therapeutic elements common to different types of psychotherapies, including supportive empathic listening and unconditional positive regard. The therapist plays an active role but does not impart any systematic training. The focus is to create an understanding of how the symptoms of PTSD are related to day-to-day difficulties and to help patients develop new, more adaptive functional responses to these stressors with a problem-focused and problem- solving approach. In prior trials, PCT showed equivalent change to active therapies at the last follow-up. The VA offers PCT as an evidence-based therapy for PTSD.
|
|---|---|---|
|
Change in Psychosocial Functioning Assessed Through the Brief Inventory of Psychosocial Functioning (B-IPF)
Baseline
|
59.37 Units on a scale
Standard Deviation 22.14
|
61.06 Units on a scale
Standard Deviation 19.38
|
|
Change in Psychosocial Functioning Assessed Through the Brief Inventory of Psychosocial Functioning (B-IPF)
Post treatment
|
52.68 Units on a scale
Standard Deviation 25.96
|
55.97 Units on a scale
Standard Deviation 24.77
|
|
Change in Psychosocial Functioning Assessed Through the Brief Inventory of Psychosocial Functioning (B-IPF)
3 month follow-up
|
43.47 Units on a scale
Standard Deviation 26.98
|
52.87 Units on a scale
Standard Deviation 28.44
|
|
Change in Psychosocial Functioning Assessed Through the Brief Inventory of Psychosocial Functioning (B-IPF)
6 month follow-up
|
41.12 Units on a scale
Standard Deviation 25.95
|
51.73 Units on a scale
Standard Deviation 25.31
|
PRIMARY outcome
Timeframe: Assessments occurred at baseline, every treatment session, and approximately 3 and 6 months after post treatment.Population: The number of participants analyzed differs at the timepoints due to some participants either: 1) not filling out the measure at a given time point due to clinician error; 2) not being present for one of the timepoints; or 3) leaving the study before a given timepoint.
The Sheehan Disability Scale (SDS; Sheehan, 1983; Sheehan et al., 1996) is a composite of three self-rated items regarding the degree to which symptoms disrupted work/school, social life, and family life/responsibilities on an 11-point scale ranging from "Not at all" to "Extremely," with an option for "Not applicable". The investigators used a prorated total mean score for the dimensional ratings such that only social and family ratings will be included for Veterans who were not employed or attending school at the time. The possible range of scores is 0 to 30. Higher scores indicate greater disability.
Outcome measures
| Measure |
Adaptive Disclosure for Moral Injury and Loss
n=21 Participants
AD-MIL is a manualized, 12-session individual psychotherapy designed to improve functioning and to reduce PTSD symptoms by facilitating Veterans doing corrective things in their life to heal and repair traumatic loss and moral injuries. The change agents are: (1) emotional-processing of traumatic loss and moral injuries and motivating a healing and action plan by writing therapeutic letters (e.g., to a lost unit member, to victims of personal transgressions, to people who transgressed); (2) skills training and behavioral contracting to improve functioning and targeting moral injury- and traumatic loss-related psychological and behavioral obstacles to positive and potentially habilitative engagements in occupational, relationship, and family roles; and (3) teaching self- and other-compassion and mindfulness. The goal is to redress the functional impact of moral emotions (anger, shame).
|
Present Centered Therapy
n=22 Participants
Participants randomized to the PCT arm received 12 sessions of therapy focused on improving day-to-day functioning (with no focus on trauma or re-visiting past experiences). Participants randomized to the PCT arm received 12 sessions of therapy focused on improving day-to-day functioning (with no focus on trauma or re-visiting past experiences). PCT is a manualized evidenced-based PTSD treatment used in several large-scale PTSD trials that focuses on improving functioning. It incorporates the essential therapeutic elements common to different types of psychotherapies, including supportive empathic listening and unconditional positive regard. The therapist plays an active role but does not impart any systematic training. The focus is to create an understanding of how the symptoms of PTSD are related to day-to-day difficulties and to help patients develop new, more adaptive functional responses to these stressors with a problem-focused and problem- solving approach. In prior trials, PCT showed equivalent change to active therapies at the last follow-up. The VA offers PCT as an evidence-based therapy for PTSD.
|
|---|---|---|
|
Change in Functional Impairment Assessed Through the Sheehan Disability Scale (SDS) for the COVID-19 Cohort
Baseline
|
21.78 Score on a scale
Standard Deviation 4.52
|
19.82 Score on a scale
Standard Deviation 5.83
|
|
Change in Functional Impairment Assessed Through the Sheehan Disability Scale (SDS) for the COVID-19 Cohort
Session 1
|
17.22 Score on a scale
Standard Deviation 5.07
|
18.15 Score on a scale
Standard Deviation 4.66
|
|
Change in Functional Impairment Assessed Through the Sheehan Disability Scale (SDS) for the COVID-19 Cohort
Session 2
|
18.47 Score on a scale
Standard Deviation 5.75
|
19.50 Score on a scale
Standard Deviation 4.63
|
|
Change in Functional Impairment Assessed Through the Sheehan Disability Scale (SDS) for the COVID-19 Cohort
Session 3
|
16.75 Score on a scale
Standard Deviation 5.51
|
17.00 Score on a scale
Standard Deviation 6.56
|
|
Change in Functional Impairment Assessed Through the Sheehan Disability Scale (SDS) for the COVID-19 Cohort
Session 4
|
16.59 Score on a scale
Standard Deviation 6.56
|
18.00 Score on a scale
Standard Deviation 5.58
|
|
Change in Functional Impairment Assessed Through the Sheehan Disability Scale (SDS) for the COVID-19 Cohort
Session 5
|
13.00 Score on a scale
Standard Deviation 5.90
|
14.39 Score on a scale
Standard Deviation 6.32
|
|
Change in Functional Impairment Assessed Through the Sheehan Disability Scale (SDS) for the COVID-19 Cohort
Session 6
|
12.88 Score on a scale
Standard Deviation 4.98
|
16.24 Score on a scale
Standard Deviation 5.27
|
|
Change in Functional Impairment Assessed Through the Sheehan Disability Scale (SDS) for the COVID-19 Cohort
Session 7
|
13.53 Score on a scale
Standard Deviation 5.85
|
14.22 Score on a scale
Standard Deviation 6.32
|
|
Change in Functional Impairment Assessed Through the Sheehan Disability Scale (SDS) for the COVID-19 Cohort
Session 8
|
13.73 Score on a scale
Standard Deviation 5.26
|
14.06 Score on a scale
Standard Deviation 5.40
|
|
Change in Functional Impairment Assessed Through the Sheehan Disability Scale (SDS) for the COVID-19 Cohort
Session 9
|
11.29 Score on a scale
Standard Deviation 5.11
|
12.67 Score on a scale
Standard Deviation 6.64
|
|
Change in Functional Impairment Assessed Through the Sheehan Disability Scale (SDS) for the COVID-19 Cohort
Session 10
|
10.77 Score on a scale
Standard Deviation 4.51
|
13.00 Score on a scale
Standard Deviation 8.06
|
|
Change in Functional Impairment Assessed Through the Sheehan Disability Scale (SDS) for the COVID-19 Cohort
Session 11
|
9.93 Score on a scale
Standard Deviation 5.28
|
11.53 Score on a scale
Standard Deviation 7.21
|
|
Change in Functional Impairment Assessed Through the Sheehan Disability Scale (SDS) for the COVID-19 Cohort
Session 12
|
9.08 Score on a scale
Standard Deviation 5.94
|
13.18 Score on a scale
Standard Deviation 7.99
|
|
Change in Functional Impairment Assessed Through the Sheehan Disability Scale (SDS) for the COVID-19 Cohort
3 month follow-up
|
19.00 Score on a scale
Standard Deviation 5.29
|
15.56 Score on a scale
Standard Deviation 7.06
|
PRIMARY outcome
Timeframe: Assessments occurred at baseline, every treatment session, and approximately 3 and 6 months after post treatment.Population: The number of participants analyzed differs at the timepoints due to some participants either: 1) not filling out the measure at a given time point due to clinician error; 2) not being present for one of the timepoints; or 3) leaving the study before a given timepoint.
The PTSD Checklist for DSM-5 (PCL-5; Weathers et al., 2013) is a 20-item self-report checklist based on the 20 DSM-5 symptoms post-traumatic stress disorder (PTSD). The PCL-5 has been validated as a means of monitoring symptom change during treatment. The 20 items are scored are scored in the past month on a scale from 0 ("not at all") to 4 ("extremely"), generating a total symptom severity score between 0 and 80, with higher scores indicating greater PTSD symptom severity.
Outcome measures
| Measure |
Adaptive Disclosure for Moral Injury and Loss
n=21 Participants
AD-MIL is a manualized, 12-session individual psychotherapy designed to improve functioning and to reduce PTSD symptoms by facilitating Veterans doing corrective things in their life to heal and repair traumatic loss and moral injuries. The change agents are: (1) emotional-processing of traumatic loss and moral injuries and motivating a healing and action plan by writing therapeutic letters (e.g., to a lost unit member, to victims of personal transgressions, to people who transgressed); (2) skills training and behavioral contracting to improve functioning and targeting moral injury- and traumatic loss-related psychological and behavioral obstacles to positive and potentially habilitative engagements in occupational, relationship, and family roles; and (3) teaching self- and other-compassion and mindfulness. The goal is to redress the functional impact of moral emotions (anger, shame).
|
Present Centered Therapy
n=22 Participants
Participants randomized to the PCT arm received 12 sessions of therapy focused on improving day-to-day functioning (with no focus on trauma or re-visiting past experiences). Participants randomized to the PCT arm received 12 sessions of therapy focused on improving day-to-day functioning (with no focus on trauma or re-visiting past experiences). PCT is a manualized evidenced-based PTSD treatment used in several large-scale PTSD trials that focuses on improving functioning. It incorporates the essential therapeutic elements common to different types of psychotherapies, including supportive empathic listening and unconditional positive regard. The therapist plays an active role but does not impart any systematic training. The focus is to create an understanding of how the symptoms of PTSD are related to day-to-day difficulties and to help patients develop new, more adaptive functional responses to these stressors with a problem-focused and problem- solving approach. In prior trials, PCT showed equivalent change to active therapies at the last follow-up. The VA offers PCT as an evidence-based therapy for PTSD.
|
|---|---|---|
|
Change in PTSD Symptom Burden Assessed Through the PTSD Checklist for DSM-5 (PCL-5) for the COVID-19 Cohort
Baseline
|
48.53 Score on a scale
Standard Deviation 8.84
|
50.62 Score on a scale
Standard Deviation 11.57
|
|
Change in PTSD Symptom Burden Assessed Through the PTSD Checklist for DSM-5 (PCL-5) for the COVID-19 Cohort
Session 1
|
47.11 Score on a scale
Standard Deviation 12.07
|
46.48 Score on a scale
Standard Deviation 10.87
|
|
Change in PTSD Symptom Burden Assessed Through the PTSD Checklist for DSM-5 (PCL-5) for the COVID-19 Cohort
Session 2
|
41.65 Score on a scale
Standard Deviation 11.33
|
47.15 Score on a scale
Standard Deviation 12.73
|
|
Change in PTSD Symptom Burden Assessed Through the PTSD Checklist for DSM-5 (PCL-5) for the COVID-19 Cohort
Session 3
|
43.24 Score on a scale
Standard Deviation 13.10
|
45.22 Score on a scale
Standard Deviation 10.11
|
|
Change in PTSD Symptom Burden Assessed Through the PTSD Checklist for DSM-5 (PCL-5) for the COVID-19 Cohort
Session 4
|
42.47 Score on a scale
Standard Deviation 13.68
|
45.89 Score on a scale
Standard Deviation 8.81
|
|
Change in PTSD Symptom Burden Assessed Through the PTSD Checklist for DSM-5 (PCL-5) for the COVID-19 Cohort
Session 5
|
40.50 Score on a scale
Standard Deviation 17.04
|
39.72 Score on a scale
Standard Deviation 12.21
|
|
Change in PTSD Symptom Burden Assessed Through the PTSD Checklist for DSM-5 (PCL-5) for the COVID-19 Cohort
Session 6
|
36.75 Score on a scale
Standard Deviation 15.26
|
42.00 Score on a scale
Standard Deviation 10.81
|
|
Change in PTSD Symptom Burden Assessed Through the PTSD Checklist for DSM-5 (PCL-5) for the COVID-19 Cohort
Session 7
|
36.40 Score on a scale
Standard Deviation 12.20
|
37.78 Score on a scale
Standard Deviation 12.83
|
|
Change in PTSD Symptom Burden Assessed Through the PTSD Checklist for DSM-5 (PCL-5) for the COVID-19 Cohort
Session 8
|
33.67 Score on a scale
Standard Deviation 12.11
|
37.47 Score on a scale
Standard Deviation 14.69
|
|
Change in PTSD Symptom Burden Assessed Through the PTSD Checklist for DSM-5 (PCL-5) for the COVID-19 Cohort
Session 9
|
30.50 Score on a scale
Standard Deviation 13.14
|
37.44 Score on a scale
Standard Deviation 13.43
|
|
Change in PTSD Symptom Burden Assessed Through the PTSD Checklist for DSM-5 (PCL-5) for the COVID-19 Cohort
Session 10
|
31.69 Score on a scale
Standard Deviation 14.29
|
35.53 Score on a scale
Standard Deviation 14.89
|
|
Change in PTSD Symptom Burden Assessed Through the PTSD Checklist for DSM-5 (PCL-5) for the COVID-19 Cohort
Session 11
|
30.14 Score on a scale
Standard Deviation 14.72
|
35.29 Score on a scale
Standard Deviation 14.55
|
|
Change in PTSD Symptom Burden Assessed Through the PTSD Checklist for DSM-5 (PCL-5) for the COVID-19 Cohort
Session 12
|
29.15 Score on a scale
Standard Deviation 12.11
|
37.47 Score on a scale
Standard Deviation 14.49
|
|
Change in PTSD Symptom Burden Assessed Through the PTSD Checklist for DSM-5 (PCL-5) for the COVID-19 Cohort
3-month follow-up
|
30.33 Score on a scale
Standard Deviation 11.59
|
40.47 Score on a scale
Standard Deviation 20.46
|
PRIMARY outcome
Timeframe: Assessments occurred at baseline, post treatment, and approximately 3 and 6 months after post treatment.Population: The number of participants analyzed differs at the timepoints due to some participants either: 1) not filling out the measure at a given time point due to clinician error; 2) not being present for one of the timepoints; or 3) leaving the study before a given timepoint.
The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5; Weathers et al., 2013) is closely modeled on the CAPS-IV, a structured diagnostic interview and gold standard for assessing PTSD. It has excellent psychometric properties and diagnostic efficiency (Weathers et al., 2001). The CAPS-5 uses a single 4-point ordinal rating scale to measure symptom severity. These ratings combine information about symptom frequency and intensity obtained by the interviewer. CAPS-5 scores range from 0 to 80, with higher scores indicating greater PTSD symptom severity.
Outcome measures
| Measure |
Adaptive Disclosure for Moral Injury and Loss
n=21 Participants
AD-MIL is a manualized, 12-session individual psychotherapy designed to improve functioning and to reduce PTSD symptoms by facilitating Veterans doing corrective things in their life to heal and repair traumatic loss and moral injuries. The change agents are: (1) emotional-processing of traumatic loss and moral injuries and motivating a healing and action plan by writing therapeutic letters (e.g., to a lost unit member, to victims of personal transgressions, to people who transgressed); (2) skills training and behavioral contracting to improve functioning and targeting moral injury- and traumatic loss-related psychological and behavioral obstacles to positive and potentially habilitative engagements in occupational, relationship, and family roles; and (3) teaching self- and other-compassion and mindfulness. The goal is to redress the functional impact of moral emotions (anger, shame).
|
Present Centered Therapy
n=22 Participants
Participants randomized to the PCT arm received 12 sessions of therapy focused on improving day-to-day functioning (with no focus on trauma or re-visiting past experiences). Participants randomized to the PCT arm received 12 sessions of therapy focused on improving day-to-day functioning (with no focus on trauma or re-visiting past experiences). PCT is a manualized evidenced-based PTSD treatment used in several large-scale PTSD trials that focuses on improving functioning. It incorporates the essential therapeutic elements common to different types of psychotherapies, including supportive empathic listening and unconditional positive regard. The therapist plays an active role but does not impart any systematic training. The focus is to create an understanding of how the symptoms of PTSD are related to day-to-day difficulties and to help patients develop new, more adaptive functional responses to these stressors with a problem-focused and problem- solving approach. In prior trials, PCT showed equivalent change to active therapies at the last follow-up. The VA offers PCT as an evidence-based therapy for PTSD.
|
|---|---|---|
|
Change in PTSD Symptom Severity and Diagnosis Assessed Through the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) for the COVID-19 Cohort
Baseline
|
39.76 Score on a scale
Standard Deviation 8.89
|
40.86 Score on a scale
Standard Deviation 9.15
|
|
Change in PTSD Symptom Severity and Diagnosis Assessed Through the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) for the COVID-19 Cohort
Post treatment
|
24.07 Score on a scale
Standard Deviation 13.51
|
34.79 Score on a scale
Standard Deviation 11.92
|
|
Change in PTSD Symptom Severity and Diagnosis Assessed Through the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) for the COVID-19 Cohort
3 month follow-up
|
35.50 Score on a scale
Standard Deviation 7.82
|
28.33 Score on a scale
Standard Deviation 17.63
|
PRIMARY outcome
Timeframe: Assessments occurred at baseline, every treatment session, and approximately 3 and 6 months after post treatment.Population: The number of participants analyzed differs at the timepoints due to some participants either: 1) not filling out the measure at a given time point due to clinician error; 2) not being present for one of the timepoints; or 3) leaving the study before a given timepoint.
The Patient Health Questionnaire (PHQ-9) is widely used and well-validated measure of symptoms of depression (Kroenke et al., 2001). It scores each of the nine DSM criteria for depression on a scale of 0 ("not at all") to 3 ("nearly every day"). The range of possible scores is 0 to 27. A higher score indicates more frequent depression symptoms.
Outcome measures
| Measure |
Adaptive Disclosure for Moral Injury and Loss
n=21 Participants
AD-MIL is a manualized, 12-session individual psychotherapy designed to improve functioning and to reduce PTSD symptoms by facilitating Veterans doing corrective things in their life to heal and repair traumatic loss and moral injuries. The change agents are: (1) emotional-processing of traumatic loss and moral injuries and motivating a healing and action plan by writing therapeutic letters (e.g., to a lost unit member, to victims of personal transgressions, to people who transgressed); (2) skills training and behavioral contracting to improve functioning and targeting moral injury- and traumatic loss-related psychological and behavioral obstacles to positive and potentially habilitative engagements in occupational, relationship, and family roles; and (3) teaching self- and other-compassion and mindfulness. The goal is to redress the functional impact of moral emotions (anger, shame).
|
Present Centered Therapy
n=22 Participants
Participants randomized to the PCT arm received 12 sessions of therapy focused on improving day-to-day functioning (with no focus on trauma or re-visiting past experiences). Participants randomized to the PCT arm received 12 sessions of therapy focused on improving day-to-day functioning (with no focus on trauma or re-visiting past experiences). PCT is a manualized evidenced-based PTSD treatment used in several large-scale PTSD trials that focuses on improving functioning. It incorporates the essential therapeutic elements common to different types of psychotherapies, including supportive empathic listening and unconditional positive regard. The therapist plays an active role but does not impart any systematic training. The focus is to create an understanding of how the symptoms of PTSD are related to day-to-day difficulties and to help patients develop new, more adaptive functional responses to these stressors with a problem-focused and problem- solving approach. In prior trials, PCT showed equivalent change to active therapies at the last follow-up. The VA offers PCT as an evidence-based therapy for PTSD.
|
|---|---|---|
|
Change in Symptoms of Depression Assessed Through the Patient Health Questionnaire (PHQ-9) for the COVID-19 Cohort
3 month follow-up
|
18.00 Score on a scale
Standard Deviation 7.55
|
14.10 Score on a scale
Standard Deviation 6.02
|
|
Change in Symptoms of Depression Assessed Through the Patient Health Questionnaire (PHQ-9) for the COVID-19 Cohort
Session 3
|
13.79 Score on a scale
Standard Deviation 4.95
|
15.56 Score on a scale
Standard Deviation 5.43
|
|
Change in Symptoms of Depression Assessed Through the Patient Health Questionnaire (PHQ-9) for the COVID-19 Cohort
Session 4
|
13.82 Score on a scale
Standard Deviation 5.44
|
14.92 Score on a scale
Standard Deviation 4.08
|
|
Change in Symptoms of Depression Assessed Through the Patient Health Questionnaire (PHQ-9) for the COVID-19 Cohort
Baseline
|
17.31 Score on a scale
Standard Deviation 5.38
|
14.95 Score on a scale
Standard Deviation 6.14
|
|
Change in Symptoms of Depression Assessed Through the Patient Health Questionnaire (PHQ-9) for the COVID-19 Cohort
Session 1
|
15.07 Score on a scale
Standard Deviation 6.37
|
16.14 Score on a scale
Standard Deviation 4.13
|
|
Change in Symptoms of Depression Assessed Through the Patient Health Questionnaire (PHQ-9) for the COVID-19 Cohort
Session 2
|
14.44 Score on a scale
Standard Deviation 5.87
|
16.02 Score on a scale
Standard Deviation 5.08
|
|
Change in Symptoms of Depression Assessed Through the Patient Health Questionnaire (PHQ-9) for the COVID-19 Cohort
Session 5
|
15.10 Score on a scale
Standard Deviation 5.05
|
12.28 Score on a scale
Standard Deviation 4.12
|
|
Change in Symptoms of Depression Assessed Through the Patient Health Questionnaire (PHQ-9) for the COVID-19 Cohort
Session 6
|
12.60 Score on a scale
Standard Deviation 6.08
|
12.37 Score on a scale
Standard Deviation 3.47
|
|
Change in Symptoms of Depression Assessed Through the Patient Health Questionnaire (PHQ-9) for the COVID-19 Cohort
Session 7
|
12.40 Score on a scale
Standard Deviation 6.73
|
11.90 Score on a scale
Standard Deviation 4.56
|
|
Change in Symptoms of Depression Assessed Through the Patient Health Questionnaire (PHQ-9) for the COVID-19 Cohort
Session 8
|
12.27 Score on a scale
Standard Deviation 6.38
|
12.46 Score on a scale
Standard Deviation 4.93
|
|
Change in Symptoms of Depression Assessed Through the Patient Health Questionnaire (PHQ-9) for the COVID-19 Cohort
Session 9
|
11.20 Score on a scale
Standard Deviation 5.45
|
12.78 Score on a scale
Standard Deviation 5.92
|
|
Change in Symptoms of Depression Assessed Through the Patient Health Questionnaire (PHQ-9) for the COVID-19 Cohort
Session 10
|
11.86 Score on a scale
Standard Deviation 7.15
|
12.59 Score on a scale
Standard Deviation 5.42
|
|
Change in Symptoms of Depression Assessed Through the Patient Health Questionnaire (PHQ-9) for the COVID-19 Cohort
Session 11
|
10.56 Score on a scale
Standard Deviation 5.77
|
11.84 Score on a scale
Standard Deviation 4.69
|
|
Change in Symptoms of Depression Assessed Through the Patient Health Questionnaire (PHQ-9) for the COVID-19 Cohort
Session 12
|
10.47 Score on a scale
Standard Deviation 5.21
|
11.53 Score on a scale
Standard Deviation 4.61
|
SECONDARY outcome
Timeframe: Assessments occurred at baseline, post treatment, and approximately 3 and 6 months after post treatment.Population: The number of participants analyzed differs at the timepoints due to some participants either: 1) not filling out the measure at a given time point due to clinician error; 2) not being present for one of the timepoints; or 3) leaving the study before a given timepoint.
The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5; Weathers et al., 2013) is closely modeled on the CAPS-IV, a structured diagnostic interview and gold standard for assessing PTSD. It has excellent psychometric properties and diagnostic efficiency (Weathers et al., 2001). The CAPS-5 uses a single 4-point ordinal rating scale to measure symptom severity. These ratings combine information about symptom frequency and intensity obtained by the interviewer. CAPS-5 scores range from 0 to 80, with higher scores indicating greater PTSD symptom severity.
Outcome measures
| Measure |
Adaptive Disclosure for Moral Injury and Loss
n=89 Participants
AD-MIL is a manualized, 12-session individual psychotherapy designed to improve functioning and to reduce PTSD symptoms by facilitating Veterans doing corrective things in their life to heal and repair traumatic loss and moral injuries. The change agents are: (1) emotional-processing of traumatic loss and moral injuries and motivating a healing and action plan by writing therapeutic letters (e.g., to a lost unit member, to victims of personal transgressions, to people who transgressed); (2) skills training and behavioral contracting to improve functioning and targeting moral injury- and traumatic loss-related psychological and behavioral obstacles to positive and potentially habilitative engagements in occupational, relationship, and family roles; and (3) teaching self- and other-compassion and mindfulness. The goal is to redress the functional impact of moral emotions (anger, shame).
|
Present Centered Therapy
n=85 Participants
Participants randomized to the PCT arm received 12 sessions of therapy focused on improving day-to-day functioning (with no focus on trauma or re-visiting past experiences). Participants randomized to the PCT arm received 12 sessions of therapy focused on improving day-to-day functioning (with no focus on trauma or re-visiting past experiences). PCT is a manualized evidenced-based PTSD treatment used in several large-scale PTSD trials that focuses on improving functioning. It incorporates the essential therapeutic elements common to different types of psychotherapies, including supportive empathic listening and unconditional positive regard. The therapist plays an active role but does not impart any systematic training. The focus is to create an understanding of how the symptoms of PTSD are related to day-to-day difficulties and to help patients develop new, more adaptive functional responses to these stressors with a problem-focused and problem- solving approach. In prior trials, PCT showed equivalent change to active therapies at the last follow-up. The VA offers PCT as an evidence-based therapy for PTSD.
|
|---|---|---|
|
Change in PTSD Symptom Severity and Diagnosis Assessed Through the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
Baseline
|
36.08 Score on a scale
Standard Deviation 11.88
|
35.69 Score on a scale
Standard Deviation 13.60
|
|
Change in PTSD Symptom Severity and Diagnosis Assessed Through the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
Post treatment
|
21.78 Score on a scale
Standard Deviation 14.92
|
30.74 Score on a scale
Standard Deviation 12.41
|
|
Change in PTSD Symptom Severity and Diagnosis Assessed Through the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
3 month follow-up
|
24.44 Score on a scale
Standard Deviation 14.37
|
29.63 Score on a scale
Standard Deviation 13.68
|
|
Change in PTSD Symptom Severity and Diagnosis Assessed Through the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
6 month follow-up
|
21.16 Score on a scale
Standard Deviation 15.47
|
27.41 Score on a scale
Standard Deviation 13.07
|
SECONDARY outcome
Timeframe: Baseline and post treatment.The investigators used the Jacobson and Truax methodology to index individual participant clinically significant change in PTSD symptom severity and diagnosis, which the investigators assessed through the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5). Individuals were classified as experiencing probable recovery if they passed the Criterion Cutoff and the RCI criteria; improved if they passed the RCI criterion, but their post-treatment or follow-up score did not pass the Criterion Cutoff; unchanged if they failed to pass the RCI; or deteriorated if they passed the RCI criterion but symptom scores increased.
Outcome measures
| Measure |
Adaptive Disclosure for Moral Injury and Loss
n=59 Participants
AD-MIL is a manualized, 12-session individual psychotherapy designed to improve functioning and to reduce PTSD symptoms by facilitating Veterans doing corrective things in their life to heal and repair traumatic loss and moral injuries. The change agents are: (1) emotional-processing of traumatic loss and moral injuries and motivating a healing and action plan by writing therapeutic letters (e.g., to a lost unit member, to victims of personal transgressions, to people who transgressed); (2) skills training and behavioral contracting to improve functioning and targeting moral injury- and traumatic loss-related psychological and behavioral obstacles to positive and potentially habilitative engagements in occupational, relationship, and family roles; and (3) teaching self- and other-compassion and mindfulness. The goal is to redress the functional impact of moral emotions (anger, shame).
|
Present Centered Therapy
n=66 Participants
Participants randomized to the PCT arm received 12 sessions of therapy focused on improving day-to-day functioning (with no focus on trauma or re-visiting past experiences). Participants randomized to the PCT arm received 12 sessions of therapy focused on improving day-to-day functioning (with no focus on trauma or re-visiting past experiences). PCT is a manualized evidenced-based PTSD treatment used in several large-scale PTSD trials that focuses on improving functioning. It incorporates the essential therapeutic elements common to different types of psychotherapies, including supportive empathic listening and unconditional positive regard. The therapist plays an active role but does not impart any systematic training. The focus is to create an understanding of how the symptoms of PTSD are related to day-to-day difficulties and to help patients develop new, more adaptive functional responses to these stressors with a problem-focused and problem- solving approach. In prior trials, PCT showed equivalent change to active therapies at the last follow-up. The VA offers PCT as an evidence-based therapy for PTSD.
|
|---|---|---|
|
Pre- to Post-Treatment Clinically Significant Change (CSC) in PTSD Symptom Severity and Diagnosis Assessed Through the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
Probable Recovery
|
15.25 Percentage of participants
|
3.03 Percentage of participants
|
|
Pre- to Post-Treatment Clinically Significant Change (CSC) in PTSD Symptom Severity and Diagnosis Assessed Through the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
Improved
|
30.51 Percentage of participants
|
25.76 Percentage of participants
|
|
Pre- to Post-Treatment Clinically Significant Change (CSC) in PTSD Symptom Severity and Diagnosis Assessed Through the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
Unchanged
|
52.54 Percentage of participants
|
63.64 Percentage of participants
|
|
Pre- to Post-Treatment Clinically Significant Change (CSC) in PTSD Symptom Severity and Diagnosis Assessed Through the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
Deteriorated
|
1.69 Percentage of participants
|
10.61 Percentage of participants
|
SECONDARY outcome
Timeframe: Assessments occurred at baseline, post treatment, and approximately 3 and 6 months after post treatment.Population: The number of participants analyzed differs at the timepoints due to some participants either 1) not filling out the measure at a given time point due to clinician error or 2) leaving the study before a given timepoint.
The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5; Weathers et al., 2013) is closely modeled on the CAPS-IV, a structured diagnostic interview and gold standard for assessing PTSD. It has excellent psychometric properties and diagnostic efficiency (Weathers et al., 2001). The CAPS-5 uses a single 4-point ordinal rating scale to measure symptom severity. These ratings combine information about symptom frequency and intensity obtained by the interviewer. A patient is determined to have met the DSM-5 criteria for PTSD if they have endorsed at least one symptom from the B cluster, at least one symptom from the C Cluster, and at least two symptoms from the E cluster, along with experiencing the symptoms for at least one month and reporting clinically significant distress or functional impairment.
Outcome measures
| Measure |
Adaptive Disclosure for Moral Injury and Loss
n=89 Participants
AD-MIL is a manualized, 12-session individual psychotherapy designed to improve functioning and to reduce PTSD symptoms by facilitating Veterans doing corrective things in their life to heal and repair traumatic loss and moral injuries. The change agents are: (1) emotional-processing of traumatic loss and moral injuries and motivating a healing and action plan by writing therapeutic letters (e.g., to a lost unit member, to victims of personal transgressions, to people who transgressed); (2) skills training and behavioral contracting to improve functioning and targeting moral injury- and traumatic loss-related psychological and behavioral obstacles to positive and potentially habilitative engagements in occupational, relationship, and family roles; and (3) teaching self- and other-compassion and mindfulness. The goal is to redress the functional impact of moral emotions (anger, shame).
|
Present Centered Therapy
n=85 Participants
Participants randomized to the PCT arm received 12 sessions of therapy focused on improving day-to-day functioning (with no focus on trauma or re-visiting past experiences). Participants randomized to the PCT arm received 12 sessions of therapy focused on improving day-to-day functioning (with no focus on trauma or re-visiting past experiences). PCT is a manualized evidenced-based PTSD treatment used in several large-scale PTSD trials that focuses on improving functioning. It incorporates the essential therapeutic elements common to different types of psychotherapies, including supportive empathic listening and unconditional positive regard. The therapist plays an active role but does not impart any systematic training. The focus is to create an understanding of how the symptoms of PTSD are related to day-to-day difficulties and to help patients develop new, more adaptive functional responses to these stressors with a problem-focused and problem- solving approach. In prior trials, PCT showed equivalent change to active therapies at the last follow-up. The VA offers PCT as an evidence-based therapy for PTSD.
|
|---|---|---|
|
Change in PTSD Caseness Assessed Through PTSD Diagnoses Using the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
Baseline
|
89 Participants
|
85 Participants
|
|
Change in PTSD Caseness Assessed Through PTSD Diagnoses Using the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
Post treatment
|
30 Participants
|
45 Participants
|
|
Change in PTSD Caseness Assessed Through PTSD Diagnoses Using the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
3 month follow-up
|
31 Participants
|
35 Participants
|
|
Change in PTSD Caseness Assessed Through PTSD Diagnoses Using the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
6 month follow-up
|
19 Participants
|
27 Participants
|
SECONDARY outcome
Timeframe: Assessments occurred at baseline, every treatment session, and approximately 3 and 6 months after post treatment.Population: The number of participants analyzed differs at the timepoints due to some participants either: 1) not filling out the measure at a given time point due to clinician error; 2) not being present for one of the timepoints; or 3) leaving the study before a given timepoint.
The PTSD Checklist for DSM-5 (PCL-5; Weathers et al., 2013) is a 20-item self-report checklist based on the 20 DSM-5 symptoms post-traumatic stress disorder (PTSD). The PCL-5 has been validated as a means of monitoring symptom change during treatment. The 20 items are scored are scored in the past month on a scale from 0 ("not at all") to 4 ("extremely"), generating a total symptom severity score between 0 and 80, with higher scores indicating greater PTSD symptom severity.
Outcome measures
| Measure |
Adaptive Disclosure for Moral Injury and Loss
n=89 Participants
AD-MIL is a manualized, 12-session individual psychotherapy designed to improve functioning and to reduce PTSD symptoms by facilitating Veterans doing corrective things in their life to heal and repair traumatic loss and moral injuries. The change agents are: (1) emotional-processing of traumatic loss and moral injuries and motivating a healing and action plan by writing therapeutic letters (e.g., to a lost unit member, to victims of personal transgressions, to people who transgressed); (2) skills training and behavioral contracting to improve functioning and targeting moral injury- and traumatic loss-related psychological and behavioral obstacles to positive and potentially habilitative engagements in occupational, relationship, and family roles; and (3) teaching self- and other-compassion and mindfulness. The goal is to redress the functional impact of moral emotions (anger, shame).
|
Present Centered Therapy
n=85 Participants
Participants randomized to the PCT arm received 12 sessions of therapy focused on improving day-to-day functioning (with no focus on trauma or re-visiting past experiences). Participants randomized to the PCT arm received 12 sessions of therapy focused on improving day-to-day functioning (with no focus on trauma or re-visiting past experiences). PCT is a manualized evidenced-based PTSD treatment used in several large-scale PTSD trials that focuses on improving functioning. It incorporates the essential therapeutic elements common to different types of psychotherapies, including supportive empathic listening and unconditional positive regard. The therapist plays an active role but does not impart any systematic training. The focus is to create an understanding of how the symptoms of PTSD are related to day-to-day difficulties and to help patients develop new, more adaptive functional responses to these stressors with a problem-focused and problem- solving approach. In prior trials, PCT showed equivalent change to active therapies at the last follow-up. The VA offers PCT as an evidence-based therapy for PTSD.
|
|---|---|---|
|
Change in PTSD Symptom Burden Assessed Through the PTSD Checklist for DSM-5 (PCL-5)
Baseline
|
49.26 Score on a scale
Standard Deviation 11.43
|
51.66 Score on a scale
Standard Deviation 10.85
|
|
Change in PTSD Symptom Burden Assessed Through the PTSD Checklist for DSM-5 (PCL-5)
Session 1
|
45.79 Score on a scale
Standard Deviation 13.24
|
45.60 Score on a scale
Standard Deviation 12.72
|
|
Change in PTSD Symptom Burden Assessed Through the PTSD Checklist for DSM-5 (PCL-5)
Session 2
|
42.49 Score on a scale
Standard Deviation 13.91
|
44.01 Score on a scale
Standard Deviation 13.60
|
|
Change in PTSD Symptom Burden Assessed Through the PTSD Checklist for DSM-5 (PCL-5)
Session 3
|
42.46 Score on a scale
Standard Deviation 13.88
|
42.81 Score on a scale
Standard Deviation 13.76
|
|
Change in PTSD Symptom Burden Assessed Through the PTSD Checklist for DSM-5 (PCL-5)
Session 4
|
42.06 Score on a scale
Standard Deviation 14.36
|
42.68 Score on a scale
Standard Deviation 12.83
|
|
Change in PTSD Symptom Burden Assessed Through the PTSD Checklist for DSM-5 (PCL-5)
Session 5
|
41.08 Score on a scale
Standard Deviation 16.14
|
40.23 Score on a scale
Standard Deviation 14.53
|
|
Change in PTSD Symptom Burden Assessed Through the PTSD Checklist for DSM-5 (PCL-5)
Session 6
|
38.42 Score on a scale
Standard Deviation 15.40
|
38.72 Score on a scale
Standard Deviation 14.34
|
|
Change in PTSD Symptom Burden Assessed Through the PTSD Checklist for DSM-5 (PCL-5)
Session 7
|
36.64 Score on a scale
Standard Deviation 15.21
|
38.43 Score on a scale
Standard Deviation 14.06
|
|
Change in PTSD Symptom Burden Assessed Through the PTSD Checklist for DSM-5 (PCL-5)
Session 8
|
33.48 Score on a scale
Standard Deviation 15.67
|
37.76 Score on a scale
Standard Deviation 15.83
|
|
Change in PTSD Symptom Burden Assessed Through the PTSD Checklist for DSM-5 (PCL-5)
Session 9
|
31.83 Score on a scale
Standard Deviation 16.63
|
35.40 Score on a scale
Standard Deviation 15.53
|
|
Change in PTSD Symptom Burden Assessed Through the PTSD Checklist for DSM-5 (PCL-5)
Session 10
|
30.51 Score on a scale
Standard Deviation 16.80
|
34.32 Score on a scale
Standard Deviation 15.25
|
|
Change in PTSD Symptom Burden Assessed Through the PTSD Checklist for DSM-5 (PCL-5)
Session 11
|
29.37 Score on a scale
Standard Deviation 16.44
|
34.82 Score on a scale
Standard Deviation 15.51
|
|
Change in PTSD Symptom Burden Assessed Through the PTSD Checklist for DSM-5 (PCL-5)
Session 12
|
27.33 Score on a scale
Standard Deviation 15.78
|
35.48 Score on a scale
Standard Deviation 15.72
|
|
Change in PTSD Symptom Burden Assessed Through the PTSD Checklist for DSM-5 (PCL-5)
3 month follow-up
|
29.88 Score on a scale
Standard Deviation 18.61
|
38.40 Score on a scale
Standard Deviation 15.63
|
|
Change in PTSD Symptom Burden Assessed Through the PTSD Checklist for DSM-5 (PCL-5)
6 month follow-up
|
31.43 Score on a scale
Standard Deviation 18.80
|
35.79 Score on a scale
Standard Deviation 15.90
|
SECONDARY outcome
Timeframe: Baseline and post treatment.The investigators used the Jacobson and Truax methodology to index individual participant clinically significant change in PTSD symptom burden, which the investigators assessed through the PTSD Checklist for DSM-5 (PCL-5). Individuals were classified as experiencing probable recovery if they passed the Criterion Cutoff and the RCI criteria; improved if they passed the RCI criterion, but their post-treatment or follow-up score did not pass the Criterion Cutoff; unchanged if they failed to pass the RCI; or deteriorated if they passed the RCI criterion but symptom scores increased.
Outcome measures
| Measure |
Adaptive Disclosure for Moral Injury and Loss
n=56 Participants
AD-MIL is a manualized, 12-session individual psychotherapy designed to improve functioning and to reduce PTSD symptoms by facilitating Veterans doing corrective things in their life to heal and repair traumatic loss and moral injuries. The change agents are: (1) emotional-processing of traumatic loss and moral injuries and motivating a healing and action plan by writing therapeutic letters (e.g., to a lost unit member, to victims of personal transgressions, to people who transgressed); (2) skills training and behavioral contracting to improve functioning and targeting moral injury- and traumatic loss-related psychological and behavioral obstacles to positive and potentially habilitative engagements in occupational, relationship, and family roles; and (3) teaching self- and other-compassion and mindfulness. The goal is to redress the functional impact of moral emotions (anger, shame).
|
Present Centered Therapy
n=55 Participants
Participants randomized to the PCT arm received 12 sessions of therapy focused on improving day-to-day functioning (with no focus on trauma or re-visiting past experiences). Participants randomized to the PCT arm received 12 sessions of therapy focused on improving day-to-day functioning (with no focus on trauma or re-visiting past experiences). PCT is a manualized evidenced-based PTSD treatment used in several large-scale PTSD trials that focuses on improving functioning. It incorporates the essential therapeutic elements common to different types of psychotherapies, including supportive empathic listening and unconditional positive regard. The therapist plays an active role but does not impart any systematic training. The focus is to create an understanding of how the symptoms of PTSD are related to day-to-day difficulties and to help patients develop new, more adaptive functional responses to these stressors with a problem-focused and problem- solving approach. In prior trials, PCT showed equivalent change to active therapies at the last follow-up. The VA offers PCT as an evidence-based therapy for PTSD.
|
|---|---|---|
|
Pre- to Post-Treatment Clinically Significant Change (CSC) in PTSD Symptom Burden Assessed Through the PTSD Checklist for DSM-5 (PCL-5)
Probable Recovery
|
42.86 Percentage of participants
|
25.45 Percentage of participants
|
|
Pre- to Post-Treatment Clinically Significant Change (CSC) in PTSD Symptom Burden Assessed Through the PTSD Checklist for DSM-5 (PCL-5)
Improved
|
17.86 Percentage of participants
|
23.64 Percentage of participants
|
|
Pre- to Post-Treatment Clinically Significant Change (CSC) in PTSD Symptom Burden Assessed Through the PTSD Checklist for DSM-5 (PCL-5)
Unchanged
|
37.50 Percentage of participants
|
50.91 Percentage of participants
|
|
Pre- to Post-Treatment Clinically Significant Change (CSC) in PTSD Symptom Burden Assessed Through the PTSD Checklist for DSM-5 (PCL-5)
Deteriorated
|
1.79 Percentage of participants
|
0 Percentage of participants
|
SECONDARY outcome
Timeframe: Assessments occurred at baseline, every treatment session, and approximately 3 and 6 months after post treatment.Population: The number of participants analyzed differs at the timepoints due to some participants either: 1) not filling out the measure at a given time point due to clinician error; 2) not being present for one of the timepoints; or 3) leaving the study before a given timepoint.
The Patient Health Questionnaire (PHQ-9) is widely used and well-validated measure of symptoms of depression (Kroenke et al., 2001). It scores each of the nine DSM criteria for depression on a scale of 0 ("not at all") to 3 ("nearly every day"). The range of possible scores is 0 to 27. A higher score indicates more frequent depression symptoms.
Outcome measures
| Measure |
Adaptive Disclosure for Moral Injury and Loss
n=89 Participants
AD-MIL is a manualized, 12-session individual psychotherapy designed to improve functioning and to reduce PTSD symptoms by facilitating Veterans doing corrective things in their life to heal and repair traumatic loss and moral injuries. The change agents are: (1) emotional-processing of traumatic loss and moral injuries and motivating a healing and action plan by writing therapeutic letters (e.g., to a lost unit member, to victims of personal transgressions, to people who transgressed); (2) skills training and behavioral contracting to improve functioning and targeting moral injury- and traumatic loss-related psychological and behavioral obstacles to positive and potentially habilitative engagements in occupational, relationship, and family roles; and (3) teaching self- and other-compassion and mindfulness. The goal is to redress the functional impact of moral emotions (anger, shame).
|
Present Centered Therapy
n=85 Participants
Participants randomized to the PCT arm received 12 sessions of therapy focused on improving day-to-day functioning (with no focus on trauma or re-visiting past experiences). Participants randomized to the PCT arm received 12 sessions of therapy focused on improving day-to-day functioning (with no focus on trauma or re-visiting past experiences). PCT is a manualized evidenced-based PTSD treatment used in several large-scale PTSD trials that focuses on improving functioning. It incorporates the essential therapeutic elements common to different types of psychotherapies, including supportive empathic listening and unconditional positive regard. The therapist plays an active role but does not impart any systematic training. The focus is to create an understanding of how the symptoms of PTSD are related to day-to-day difficulties and to help patients develop new, more adaptive functional responses to these stressors with a problem-focused and problem- solving approach. In prior trials, PCT showed equivalent change to active therapies at the last follow-up. The VA offers PCT as an evidence-based therapy for PTSD.
|
|---|---|---|
|
Change in Symptoms of Depression Assessed Through the Patient Health Questionnaire (PHQ-9)
Baseline
|
16.88 Score on a scale
Standard Deviation 5.43
|
16.62 Score on a scale
Standard Deviation 5.50
|
|
Change in Symptoms of Depression Assessed Through the Patient Health Questionnaire (PHQ-9)
Session 1
|
15.92 Score on a scale
Standard Deviation 6.05
|
15.70 Score on a scale
Standard Deviation 5.44
|
|
Change in Symptoms of Depression Assessed Through the Patient Health Questionnaire (PHQ-9)
Session 2
|
14.80 Score on a scale
Standard Deviation 5.60
|
15.81 Score on a scale
Standard Deviation 5.55
|
|
Change in Symptoms of Depression Assessed Through the Patient Health Questionnaire (PHQ-9)
Session 3
|
14.56 Score on a scale
Standard Deviation 5.43
|
15.14 Score on a scale
Standard Deviation 5.83
|
|
Change in Symptoms of Depression Assessed Through the Patient Health Questionnaire (PHQ-9)
Session 4
|
14.47 Score on a scale
Standard Deviation 5.54
|
14.95 Score on a scale
Standard Deviation 5.03
|
|
Change in Symptoms of Depression Assessed Through the Patient Health Questionnaire (PHQ-9)
Session 5
|
14.53 Score on a scale
Standard Deviation 5.74
|
14.30 Score on a scale
Standard Deviation 5.87
|
|
Change in Symptoms of Depression Assessed Through the Patient Health Questionnaire (PHQ-9)
Session 6
|
13.85 Score on a scale
Standard Deviation 6.43
|
13.26 Score on a scale
Standard Deviation 5.25
|
|
Change in Symptoms of Depression Assessed Through the Patient Health Questionnaire (PHQ-9)
Session 7
|
12.89 Score on a scale
Standard Deviation 6.20
|
13.19 Score on a scale
Standard Deviation 5.73
|
|
Change in Symptoms of Depression Assessed Through the Patient Health Questionnaire (PHQ-9)
Session 8
|
12.34 Score on a scale
Standard Deviation 6.91
|
13.32 Score on a scale
Standard Deviation 5.99
|
|
Change in Symptoms of Depression Assessed Through the Patient Health Questionnaire (PHQ-9)
Session 9
|
11.47 Score on a scale
Standard Deviation 6.18
|
12.67 Score on a scale
Standard Deviation 6.11
|
|
Change in Symptoms of Depression Assessed Through the Patient Health Questionnaire (PHQ-9)
Session 10
|
11.26 Score on a scale
Standard Deviation 6.92
|
12.05 Score on a scale
Standard Deviation 5.90
|
|
Change in Symptoms of Depression Assessed Through the Patient Health Questionnaire (PHQ-9)
Session 11
|
11.17 Score on a scale
Standard Deviation 6.22
|
12.29 Score on a scale
Standard Deviation 6.07
|
|
Change in Symptoms of Depression Assessed Through the Patient Health Questionnaire (PHQ-9)
Session 12
|
9.99 Score on a scale
Standard Deviation 6.30
|
11.56 Score on a scale
Standard Deviation 5.75
|
|
Change in Symptoms of Depression Assessed Through the Patient Health Questionnaire (PHQ-9)
3 month follow-up
|
12.22 Score on a scale
Standard Deviation 7.61
|
14.17 Score on a scale
Standard Deviation 6.29
|
|
Change in Symptoms of Depression Assessed Through the Patient Health Questionnaire (PHQ-9)
6 month follow-up
|
11.84 Score on a scale
Standard Deviation 7.14
|
13.15 Score on a scale
Standard Deviation 7.28
|
SECONDARY outcome
Timeframe: Assessments occurred at baseline, post treatment, and approximately 3 and 6 months after post treatment.Population: The number of participants analyzed differs at the timepoints due to some participants either: 1) not filling out the measure at a given time point due to clinician error; 2) not being present for one of the timepoints; or 3) leaving the study before a given timepoint.
The (lack of) Justification subscale of the Brief Trauma Related Guilt Inventory (TRGI-Brief; Kubany et al., 1996) is a 4-item measure that assesses guilty thoughts about the justification of one's actions related to a specific traumatic event. Possible scores range from 0 to 4, with higher scores indicating increased guilt.
Outcome measures
| Measure |
Adaptive Disclosure for Moral Injury and Loss
n=89 Participants
AD-MIL is a manualized, 12-session individual psychotherapy designed to improve functioning and to reduce PTSD symptoms by facilitating Veterans doing corrective things in their life to heal and repair traumatic loss and moral injuries. The change agents are: (1) emotional-processing of traumatic loss and moral injuries and motivating a healing and action plan by writing therapeutic letters (e.g., to a lost unit member, to victims of personal transgressions, to people who transgressed); (2) skills training and behavioral contracting to improve functioning and targeting moral injury- and traumatic loss-related psychological and behavioral obstacles to positive and potentially habilitative engagements in occupational, relationship, and family roles; and (3) teaching self- and other-compassion and mindfulness. The goal is to redress the functional impact of moral emotions (anger, shame).
|
Present Centered Therapy
n=85 Participants
Participants randomized to the PCT arm received 12 sessions of therapy focused on improving day-to-day functioning (with no focus on trauma or re-visiting past experiences). Participants randomized to the PCT arm received 12 sessions of therapy focused on improving day-to-day functioning (with no focus on trauma or re-visiting past experiences). PCT is a manualized evidenced-based PTSD treatment used in several large-scale PTSD trials that focuses on improving functioning. It incorporates the essential therapeutic elements common to different types of psychotherapies, including supportive empathic listening and unconditional positive regard. The therapist plays an active role but does not impart any systematic training. The focus is to create an understanding of how the symptoms of PTSD are related to day-to-day difficulties and to help patients develop new, more adaptive functional responses to these stressors with a problem-focused and problem- solving approach. In prior trials, PCT showed equivalent change to active therapies at the last follow-up. The VA offers PCT as an evidence-based therapy for PTSD.
|
|---|---|---|
|
Change in Guilt Cognitions About a Specific Warzone Event Assessed Through the (Lack of) Justification Subscale of the Brief Trauma Related Guilt Inventory (TRGI-Brief)
Baseline
|
1.88 Score on a scale
Standard Deviation 0.98
|
2.00 Score on a scale
Standard Deviation 0.96
|
|
Change in Guilt Cognitions About a Specific Warzone Event Assessed Through the (Lack of) Justification Subscale of the Brief Trauma Related Guilt Inventory (TRGI-Brief)
Post treatment
|
1.59 Score on a scale
Standard Deviation 0.92
|
1.86 Score on a scale
Standard Deviation 1.10
|
|
Change in Guilt Cognitions About a Specific Warzone Event Assessed Through the (Lack of) Justification Subscale of the Brief Trauma Related Guilt Inventory (TRGI-Brief)
3 month follow-up
|
1.70 Score on a scale
Standard Deviation 1.06
|
2.08 Score on a scale
Standard Deviation 1.12
|
|
Change in Guilt Cognitions About a Specific Warzone Event Assessed Through the (Lack of) Justification Subscale of the Brief Trauma Related Guilt Inventory (TRGI-Brief)
6 month follow-up
|
1.87 Score on a scale
Standard Deviation 1.26
|
1.78 Score on a scale
Standard Deviation 1.21
|
SECONDARY outcome
Timeframe: Assessments occurred at baseline, post treatment, and approximately 3 and 6 months after post treatment.Population: The number of participants analyzed differs at the timepoints due to some participants either: 1) not filling out the measure at a given time point due to clinician error; 2) not being present for one of the timepoints; or 3) leaving the study before a given timepoint.
The Hindsight-Bias subscale of the Brief Trauma Related Guilt Inventory (TRGI-Brief; Kubany et al., 1996) is a 7-item measure that assesses guilty thoughts about the preventability and responsibility of a traumatic event. Possible scores range from 0 to 4, with higher scores indicating increased guilt.
Outcome measures
| Measure |
Adaptive Disclosure for Moral Injury and Loss
n=89 Participants
AD-MIL is a manualized, 12-session individual psychotherapy designed to improve functioning and to reduce PTSD symptoms by facilitating Veterans doing corrective things in their life to heal and repair traumatic loss and moral injuries. The change agents are: (1) emotional-processing of traumatic loss and moral injuries and motivating a healing and action plan by writing therapeutic letters (e.g., to a lost unit member, to victims of personal transgressions, to people who transgressed); (2) skills training and behavioral contracting to improve functioning and targeting moral injury- and traumatic loss-related psychological and behavioral obstacles to positive and potentially habilitative engagements in occupational, relationship, and family roles; and (3) teaching self- and other-compassion and mindfulness. The goal is to redress the functional impact of moral emotions (anger, shame).
|
Present Centered Therapy
n=85 Participants
Participants randomized to the PCT arm received 12 sessions of therapy focused on improving day-to-day functioning (with no focus on trauma or re-visiting past experiences). Participants randomized to the PCT arm received 12 sessions of therapy focused on improving day-to-day functioning (with no focus on trauma or re-visiting past experiences). PCT is a manualized evidenced-based PTSD treatment used in several large-scale PTSD trials that focuses on improving functioning. It incorporates the essential therapeutic elements common to different types of psychotherapies, including supportive empathic listening and unconditional positive regard. The therapist plays an active role but does not impart any systematic training. The focus is to create an understanding of how the symptoms of PTSD are related to day-to-day difficulties and to help patients develop new, more adaptive functional responses to these stressors with a problem-focused and problem- solving approach. In prior trials, PCT showed equivalent change to active therapies at the last follow-up. The VA offers PCT as an evidence-based therapy for PTSD.
|
|---|---|---|
|
Change in Guilt Cognitions About a Specific Warzone Event Assessed Through the Hindsight-Bias Subscale of the Brief Trauma Related Guilt Inventory (TRGI-Brief)
Baseline
|
1.66 Score on a scale
Standard Deviation 1.06
|
1.68 Score on a scale
Standard Deviation 1.04
|
|
Change in Guilt Cognitions About a Specific Warzone Event Assessed Through the Hindsight-Bias Subscale of the Brief Trauma Related Guilt Inventory (TRGI-Brief)
Post treatment
|
0.93 Score on a scale
Standard Deviation 0.95
|
1.51 Score on a scale
Standard Deviation 1.05
|
|
Change in Guilt Cognitions About a Specific Warzone Event Assessed Through the Hindsight-Bias Subscale of the Brief Trauma Related Guilt Inventory (TRGI-Brief)
3 month follow-up
|
0.98 Score on a scale
Standard Deviation 1.08
|
1.31 Score on a scale
Standard Deviation 1.15
|
|
Change in Guilt Cognitions About a Specific Warzone Event Assessed Through the Hindsight-Bias Subscale of the Brief Trauma Related Guilt Inventory (TRGI-Brief)
6 month follow-up
|
1.13 Score on a scale
Standard Deviation 1.24
|
1.09 Score on a scale
Standard Deviation 0.83
|
SECONDARY outcome
Timeframe: Assessments occurred at baseline, post treatment, and approximately 3 and 6 months after post treatment.Population: The number of participants analyzed differs at the timepoints due to some participants either: 1) not filling out the measure at a given time point due to clinician error; 2) not being present for one of the timepoints; or 3) leaving the study before a given timepoint.
The Wrongdoing subscale of the Brief Trauma Related Guilt Inventory (TRGI-Brief; Kubany et al., 1996) is a 5-item measure that assesses guilty thoughts about wrongdoing tied to a specific traumatic event. Possible scores range from 0 to 4, with higher scores indicating increased guilt.
Outcome measures
| Measure |
Adaptive Disclosure for Moral Injury and Loss
n=89 Participants
AD-MIL is a manualized, 12-session individual psychotherapy designed to improve functioning and to reduce PTSD symptoms by facilitating Veterans doing corrective things in their life to heal and repair traumatic loss and moral injuries. The change agents are: (1) emotional-processing of traumatic loss and moral injuries and motivating a healing and action plan by writing therapeutic letters (e.g., to a lost unit member, to victims of personal transgressions, to people who transgressed); (2) skills training and behavioral contracting to improve functioning and targeting moral injury- and traumatic loss-related psychological and behavioral obstacles to positive and potentially habilitative engagements in occupational, relationship, and family roles; and (3) teaching self- and other-compassion and mindfulness. The goal is to redress the functional impact of moral emotions (anger, shame).
|
Present Centered Therapy
n=85 Participants
Participants randomized to the PCT arm received 12 sessions of therapy focused on improving day-to-day functioning (with no focus on trauma or re-visiting past experiences). Participants randomized to the PCT arm received 12 sessions of therapy focused on improving day-to-day functioning (with no focus on trauma or re-visiting past experiences). PCT is a manualized evidenced-based PTSD treatment used in several large-scale PTSD trials that focuses on improving functioning. It incorporates the essential therapeutic elements common to different types of psychotherapies, including supportive empathic listening and unconditional positive regard. The therapist plays an active role but does not impart any systematic training. The focus is to create an understanding of how the symptoms of PTSD are related to day-to-day difficulties and to help patients develop new, more adaptive functional responses to these stressors with a problem-focused and problem- solving approach. In prior trials, PCT showed equivalent change to active therapies at the last follow-up. The VA offers PCT as an evidence-based therapy for PTSD.
|
|---|---|---|
|
Change in Guilt Cognitions About a Specific Warzone Event Assessed Through the Wrongdoing Subscale of the Brief Trauma Related Guilt Inventory (TRGI-Brief)
Baseline
|
1.71 Score on a scale
Standard Deviation 1.00
|
1.74 Score on a scale
Standard Deviation 1.01
|
|
Change in Guilt Cognitions About a Specific Warzone Event Assessed Through the Wrongdoing Subscale of the Brief Trauma Related Guilt Inventory (TRGI-Brief)
Post treatment
|
1.34 Score on a scale
Standard Deviation 0.95
|
1.65 Score on a scale
Standard Deviation 1.03
|
|
Change in Guilt Cognitions About a Specific Warzone Event Assessed Through the Wrongdoing Subscale of the Brief Trauma Related Guilt Inventory (TRGI-Brief)
3 month follow-up
|
1.33 Score on a scale
Standard Deviation 0.97
|
1.51 Score on a scale
Standard Deviation 1.04
|
|
Change in Guilt Cognitions About a Specific Warzone Event Assessed Through the Wrongdoing Subscale of the Brief Trauma Related Guilt Inventory (TRGI-Brief)
6 month follow-up
|
1.42 Score on a scale
Standard Deviation 1.06
|
1.29 Score on a scale
Standard Deviation 0.93
|
SECONDARY outcome
Timeframe: Assessments occurred at baseline, post treatment, and approximately 3 and 6 months after post treatment.Population: The number of participants analyzed differs at the timepoints due to some participants either: 1) not filling out the measure at a given time point due to clinician error; 2) not being present for one of the timepoints; or 3) leaving the study before a given timepoint.
The Internal Shame Subscale of the Trauma-Related Shame Inventory (TRSI; Øktedalen et al., 2014) is a 12-item self-report instrument designed to assess individuals' negative self-evaluations in the context of their traumatic experiences. Possible scores range from 0 to 36, with higher scores indicating more negative self-evaluations. The measure has demonstrated good construct validity (Øktedalen et al., 2014).
Outcome measures
| Measure |
Adaptive Disclosure for Moral Injury and Loss
n=89 Participants
AD-MIL is a manualized, 12-session individual psychotherapy designed to improve functioning and to reduce PTSD symptoms by facilitating Veterans doing corrective things in their life to heal and repair traumatic loss and moral injuries. The change agents are: (1) emotional-processing of traumatic loss and moral injuries and motivating a healing and action plan by writing therapeutic letters (e.g., to a lost unit member, to victims of personal transgressions, to people who transgressed); (2) skills training and behavioral contracting to improve functioning and targeting moral injury- and traumatic loss-related psychological and behavioral obstacles to positive and potentially habilitative engagements in occupational, relationship, and family roles; and (3) teaching self- and other-compassion and mindfulness. The goal is to redress the functional impact of moral emotions (anger, shame).
|
Present Centered Therapy
n=85 Participants
Participants randomized to the PCT arm received 12 sessions of therapy focused on improving day-to-day functioning (with no focus on trauma or re-visiting past experiences). Participants randomized to the PCT arm received 12 sessions of therapy focused on improving day-to-day functioning (with no focus on trauma or re-visiting past experiences). PCT is a manualized evidenced-based PTSD treatment used in several large-scale PTSD trials that focuses on improving functioning. It incorporates the essential therapeutic elements common to different types of psychotherapies, including supportive empathic listening and unconditional positive regard. The therapist plays an active role but does not impart any systematic training. The focus is to create an understanding of how the symptoms of PTSD are related to day-to-day difficulties and to help patients develop new, more adaptive functional responses to these stressors with a problem-focused and problem- solving approach. In prior trials, PCT showed equivalent change to active therapies at the last follow-up. The VA offers PCT as an evidence-based therapy for PTSD.
|
|---|---|---|
|
Change in Shame Tied to a Specific Warzone Event Assessed Through the Internal Shame Subscale of the Trauma-Related Shame Inventory (TRSI)
Baseline
|
12.74 Score on a scale
Standard Deviation 7.94
|
14.23 Score on a scale
Standard Deviation 9.46
|
|
Change in Shame Tied to a Specific Warzone Event Assessed Through the Internal Shame Subscale of the Trauma-Related Shame Inventory (TRSI)
Post treatment
|
11.71 Score on a scale
Standard Deviation 8.66
|
12.76 Score on a scale
Standard Deviation 8.31
|
|
Change in Shame Tied to a Specific Warzone Event Assessed Through the Internal Shame Subscale of the Trauma-Related Shame Inventory (TRSI)
3 month follow-up
|
10.59 Score on a scale
Standard Deviation 8.36
|
12.00 Score on a scale
Standard Deviation 8.68
|
|
Change in Shame Tied to a Specific Warzone Event Assessed Through the Internal Shame Subscale of the Trauma-Related Shame Inventory (TRSI)
6 month follow-up
|
10.56 Score on a scale
Standard Deviation 6.69
|
11.69 Score on a scale
Standard Deviation 6.70
|
SECONDARY outcome
Timeframe: Assessments occurred at baseline, post treatment, and approximately 3 and 6 months after post treatment.Population: The number of participants analyzed differs at the timepoints due to some participants either: 1) not filling out the measure at a given time point due to clinician error; 2) not being present for one of the timepoints; or 3) leaving the study before a given timepoint.
The Schwartz Outcome Scale-10 (SOS-10; Blais et al., 1999) is a 10-item general mental health outcome measure meant to capture psychological health and distress. Possible scores range from 0 to 60 with higher scores indicating better psychological health and lower distress. The SOS-10 has demonstrated good psychometric properties (Blais et al., 1999).
Outcome measures
| Measure |
Adaptive Disclosure for Moral Injury and Loss
n=89 Participants
AD-MIL is a manualized, 12-session individual psychotherapy designed to improve functioning and to reduce PTSD symptoms by facilitating Veterans doing corrective things in their life to heal and repair traumatic loss and moral injuries. The change agents are: (1) emotional-processing of traumatic loss and moral injuries and motivating a healing and action plan by writing therapeutic letters (e.g., to a lost unit member, to victims of personal transgressions, to people who transgressed); (2) skills training and behavioral contracting to improve functioning and targeting moral injury- and traumatic loss-related psychological and behavioral obstacles to positive and potentially habilitative engagements in occupational, relationship, and family roles; and (3) teaching self- and other-compassion and mindfulness. The goal is to redress the functional impact of moral emotions (anger, shame).
|
Present Centered Therapy
n=85 Participants
Participants randomized to the PCT arm received 12 sessions of therapy focused on improving day-to-day functioning (with no focus on trauma or re-visiting past experiences). Participants randomized to the PCT arm received 12 sessions of therapy focused on improving day-to-day functioning (with no focus on trauma or re-visiting past experiences). PCT is a manualized evidenced-based PTSD treatment used in several large-scale PTSD trials that focuses on improving functioning. It incorporates the essential therapeutic elements common to different types of psychotherapies, including supportive empathic listening and unconditional positive regard. The therapist plays an active role but does not impart any systematic training. The focus is to create an understanding of how the symptoms of PTSD are related to day-to-day difficulties and to help patients develop new, more adaptive functional responses to these stressors with a problem-focused and problem- solving approach. In prior trials, PCT showed equivalent change to active therapies at the last follow-up. The VA offers PCT as an evidence-based therapy for PTSD.
|
|---|---|---|
|
Change in Psychological Health and Distress Assessed Through the Schwartz Outcome Scale-10 (SOS-10)
Baseline
|
24.94 Score on a scale
Standard Deviation 9.87
|
25.43 Score on a scale
Standard Deviation 8.38
|
|
Change in Psychological Health and Distress Assessed Through the Schwartz Outcome Scale-10 (SOS-10)
Post treatment
|
32.16 Score on a scale
Standard Deviation 12.72
|
29.53 Score on a scale
Standard Deviation 11.18
|
|
Change in Psychological Health and Distress Assessed Through the Schwartz Outcome Scale-10 (SOS-10)
3 month follow-up
|
32.43 Score on a scale
Standard Deviation 13.23
|
26.78 Score on a scale
Standard Deviation 10.75
|
|
Change in Psychological Health and Distress Assessed Through the Schwartz Outcome Scale-10 (SOS-10)
6 month follow-up
|
31.98 Score on a scale
Standard Deviation 13.37
|
28.85 Score on a scale
Standard Deviation 11.60
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Assessments occurred at baseline, post treatment, and approximately 3 and 6 months after post treatment.Population: The number of participants analyzed differs at the timepoints due to some participants either: 1) not filling out the measure at a given time point due to clinician error; 2) not being present for one of the timepoints; or 3) leaving the study before a given timepoint.
The Self Compassion Scale (SCS; Neff, 2003) is a 26-item measure that includes 6 subscales (including Self-Kindness, Self-Judgment, Common Humanity, Isolation, Mindfulness, and Over-Identification) and measures overall self-compassion. The possible range of scores is 1 to 5, with higher scores indicating higher self-compassion. The SCS has shown good internal consistency reliability as well as good test-retest reliability (Neff, 2003).
Outcome measures
| Measure |
Adaptive Disclosure for Moral Injury and Loss
n=89 Participants
AD-MIL is a manualized, 12-session individual psychotherapy designed to improve functioning and to reduce PTSD symptoms by facilitating Veterans doing corrective things in their life to heal and repair traumatic loss and moral injuries. The change agents are: (1) emotional-processing of traumatic loss and moral injuries and motivating a healing and action plan by writing therapeutic letters (e.g., to a lost unit member, to victims of personal transgressions, to people who transgressed); (2) skills training and behavioral contracting to improve functioning and targeting moral injury- and traumatic loss-related psychological and behavioral obstacles to positive and potentially habilitative engagements in occupational, relationship, and family roles; and (3) teaching self- and other-compassion and mindfulness. The goal is to redress the functional impact of moral emotions (anger, shame).
|
Present Centered Therapy
n=85 Participants
Participants randomized to the PCT arm received 12 sessions of therapy focused on improving day-to-day functioning (with no focus on trauma or re-visiting past experiences). Participants randomized to the PCT arm received 12 sessions of therapy focused on improving day-to-day functioning (with no focus on trauma or re-visiting past experiences). PCT is a manualized evidenced-based PTSD treatment used in several large-scale PTSD trials that focuses on improving functioning. It incorporates the essential therapeutic elements common to different types of psychotherapies, including supportive empathic listening and unconditional positive regard. The therapist plays an active role but does not impart any systematic training. The focus is to create an understanding of how the symptoms of PTSD are related to day-to-day difficulties and to help patients develop new, more adaptive functional responses to these stressors with a problem-focused and problem- solving approach. In prior trials, PCT showed equivalent change to active therapies at the last follow-up. The VA offers PCT as an evidence-based therapy for PTSD.
|
|---|---|---|
|
Change in Overall Self-Compassion Assessed Through the Self Compassion Scale (SCS)
Baseline
|
2.66 Score on a scale
Standard Deviation 0.57
|
2.49 Score on a scale
Standard Deviation 0.56
|
|
Change in Overall Self-Compassion Assessed Through the Self Compassion Scale (SCS)
Post treatment
|
2.97 Score on a scale
Standard Deviation 0.76
|
2.61 Score on a scale
Standard Deviation 0.64
|
|
Change in Overall Self-Compassion Assessed Through the Self Compassion Scale (SCS)
3 month follow-up
|
3.01 Score on a scale
Standard Deviation 0.78
|
2.57 Score on a scale
Standard Deviation 0.68
|
|
Change in Overall Self-Compassion Assessed Through the Self Compassion Scale (SCS)
6 month follow-up
|
3.13 Score on a scale
Standard Deviation 0.78
|
2.67 Score on a scale
Standard Deviation 0.61
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Assessments occurred at baseline, post treatment, and approximately 3 and 6 months after post treatment.Population: The number of participants analyzed differs at the timepoints due to some participants either: 1) not filling out the measure at a given time point due to clinician error; 2) not being present for one of the timepoints; or 3) leaving the study before a given timepoint.
The Dimensions of Anger Reactions (DAR; Forbes et al., 2004) is a widely used measure of state anger. The measure consists of a 7-item inventory intended to capture anger disposition. Possible scores range from 0 to 56, with higher scores indicating higher state anger.
Outcome measures
| Measure |
Adaptive Disclosure for Moral Injury and Loss
n=89 Participants
AD-MIL is a manualized, 12-session individual psychotherapy designed to improve functioning and to reduce PTSD symptoms by facilitating Veterans doing corrective things in their life to heal and repair traumatic loss and moral injuries. The change agents are: (1) emotional-processing of traumatic loss and moral injuries and motivating a healing and action plan by writing therapeutic letters (e.g., to a lost unit member, to victims of personal transgressions, to people who transgressed); (2) skills training and behavioral contracting to improve functioning and targeting moral injury- and traumatic loss-related psychological and behavioral obstacles to positive and potentially habilitative engagements in occupational, relationship, and family roles; and (3) teaching self- and other-compassion and mindfulness. The goal is to redress the functional impact of moral emotions (anger, shame).
|
Present Centered Therapy
n=85 Participants
Participants randomized to the PCT arm received 12 sessions of therapy focused on improving day-to-day functioning (with no focus on trauma or re-visiting past experiences). Participants randomized to the PCT arm received 12 sessions of therapy focused on improving day-to-day functioning (with no focus on trauma or re-visiting past experiences). PCT is a manualized evidenced-based PTSD treatment used in several large-scale PTSD trials that focuses on improving functioning. It incorporates the essential therapeutic elements common to different types of psychotherapies, including supportive empathic listening and unconditional positive regard. The therapist plays an active role but does not impart any systematic training. The focus is to create an understanding of how the symptoms of PTSD are related to day-to-day difficulties and to help patients develop new, more adaptive functional responses to these stressors with a problem-focused and problem- solving approach. In prior trials, PCT showed equivalent change to active therapies at the last follow-up. The VA offers PCT as an evidence-based therapy for PTSD.
|
|---|---|---|
|
Change in State Anger Assessed Through the Dimensions of Anger Reactions (DAR)
Baseline
|
30.27 Score on a scale
Standard Deviation 12.90
|
32.32 Score on a scale
Standard Deviation 12.06
|
|
Change in State Anger Assessed Through the Dimensions of Anger Reactions (DAR)
Post treatment
|
24.63 Score on a scale
Standard Deviation 13.96
|
29.07 Score on a scale
Standard Deviation 15.17
|
|
Change in State Anger Assessed Through the Dimensions of Anger Reactions (DAR)
3 month follow-up
|
22.52 Score on a scale
Standard Deviation 14.53
|
28.96 Score on a scale
Standard Deviation 15.10
|
|
Change in State Anger Assessed Through the Dimensions of Anger Reactions (DAR)
6 month follow-up
|
20.85 Score on a scale
Standard Deviation 14.28
|
28.51 Score on a scale
Standard Deviation 13.37
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Assessments occurred at baseline, post treatment, and approximately 3 and 6 months after post treatment.Population: The number of participants analyzed differs at the timepoints due to some participants either: 1) not filling out the measure at a given time point due to clinician error; 2) not being present for one of the timepoints; or 3) leaving the study before a given timepoint.
The Psychological Aggression subscale of the Revised Conflict Tactics Scale (CTS2; Straus et al., 1996) was used to measure psychologically aggressive behavior. The subscales consists of 8 items, rated on a scale from 0 ("never") to 6 ("more than 20 times"), with higher scores indicating greater use of aggressive behaviors in the past month. To calculate the annual frequency score, values of 3 though 6 were transformed as follows: 3 = 4, 4 = 8, 5 = 15, 6 = 25. These values were then summed, with higher scores indicating greater frequency.
Outcome measures
| Measure |
Adaptive Disclosure for Moral Injury and Loss
n=89 Participants
AD-MIL is a manualized, 12-session individual psychotherapy designed to improve functioning and to reduce PTSD symptoms by facilitating Veterans doing corrective things in their life to heal and repair traumatic loss and moral injuries. The change agents are: (1) emotional-processing of traumatic loss and moral injuries and motivating a healing and action plan by writing therapeutic letters (e.g., to a lost unit member, to victims of personal transgressions, to people who transgressed); (2) skills training and behavioral contracting to improve functioning and targeting moral injury- and traumatic loss-related psychological and behavioral obstacles to positive and potentially habilitative engagements in occupational, relationship, and family roles; and (3) teaching self- and other-compassion and mindfulness. The goal is to redress the functional impact of moral emotions (anger, shame).
|
Present Centered Therapy
n=85 Participants
Participants randomized to the PCT arm received 12 sessions of therapy focused on improving day-to-day functioning (with no focus on trauma or re-visiting past experiences). Participants randomized to the PCT arm received 12 sessions of therapy focused on improving day-to-day functioning (with no focus on trauma or re-visiting past experiences). PCT is a manualized evidenced-based PTSD treatment used in several large-scale PTSD trials that focuses on improving functioning. It incorporates the essential therapeutic elements common to different types of psychotherapies, including supportive empathic listening and unconditional positive regard. The therapist plays an active role but does not impart any systematic training. The focus is to create an understanding of how the symptoms of PTSD are related to day-to-day difficulties and to help patients develop new, more adaptive functional responses to these stressors with a problem-focused and problem- solving approach. In prior trials, PCT showed equivalent change to active therapies at the last follow-up. The VA offers PCT as an evidence-based therapy for PTSD.
|
|---|---|---|
|
Change in Use of Psychologically Aggressive Behavior Assessed Through the Psychological Aggression Subscale of the Revised Conflict Tactics Scale (CTS2)
Baseline
|
28.94 Score on a scale
Standard Deviation 31.45
|
26.41 Score on a scale
Standard Deviation 27.87
|
|
Change in Use of Psychologically Aggressive Behavior Assessed Through the Psychological Aggression Subscale of the Revised Conflict Tactics Scale (CTS2)
Post treatment
|
16.69 Score on a scale
Standard Deviation 22.19
|
19.47 Score on a scale
Standard Deviation 20.78
|
|
Change in Use of Psychologically Aggressive Behavior Assessed Through the Psychological Aggression Subscale of the Revised Conflict Tactics Scale (CTS2)
3 month follow-up
|
13.86 Score on a scale
Standard Deviation 20.40
|
17.84 Score on a scale
Standard Deviation 20.46
|
|
Change in Use of Psychologically Aggressive Behavior Assessed Through the Psychological Aggression Subscale of the Revised Conflict Tactics Scale (CTS2)
6 month follow-up
|
16.11 Score on a scale
Standard Deviation 23.64
|
17.77 Score on a scale
Standard Deviation 17.96
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Assessments occurred at baseline, post treatment, and approximately 3 and 6 months after post treatment.Population: The number of participants analyzed differs at the timepoints due to some participants either: 1) not filling out the measure at a given time point due to clinician error; 2) not being present for one of the timepoints; or 3) leaving the study before a given timepoint.
The Physical Assault subscale of the Revised Conflict Tactics Scale (CTS2; Straus \& Douglas, 2004; Straus et al., 1996) was used to measure occurrence of physically aggressive behavior. The subscale consists of 12 items, rated on a scale from 0 ("never") to 6 ("more than 20 times"), with higher scores indicating greater use of aggressive behaviors in the past month. To calculate the annual frequency score, values of 3 through 6 were transformed as follows: 3 = 4, 4 = 8, 5 = 15, 6 = 25. These values were then summed, with higher scores indicating greater frequency.
Outcome measures
| Measure |
Adaptive Disclosure for Moral Injury and Loss
n=89 Participants
AD-MIL is a manualized, 12-session individual psychotherapy designed to improve functioning and to reduce PTSD symptoms by facilitating Veterans doing corrective things in their life to heal and repair traumatic loss and moral injuries. The change agents are: (1) emotional-processing of traumatic loss and moral injuries and motivating a healing and action plan by writing therapeutic letters (e.g., to a lost unit member, to victims of personal transgressions, to people who transgressed); (2) skills training and behavioral contracting to improve functioning and targeting moral injury- and traumatic loss-related psychological and behavioral obstacles to positive and potentially habilitative engagements in occupational, relationship, and family roles; and (3) teaching self- and other-compassion and mindfulness. The goal is to redress the functional impact of moral emotions (anger, shame).
|
Present Centered Therapy
n=85 Participants
Participants randomized to the PCT arm received 12 sessions of therapy focused on improving day-to-day functioning (with no focus on trauma or re-visiting past experiences). Participants randomized to the PCT arm received 12 sessions of therapy focused on improving day-to-day functioning (with no focus on trauma or re-visiting past experiences). PCT is a manualized evidenced-based PTSD treatment used in several large-scale PTSD trials that focuses on improving functioning. It incorporates the essential therapeutic elements common to different types of psychotherapies, including supportive empathic listening and unconditional positive regard. The therapist plays an active role but does not impart any systematic training. The focus is to create an understanding of how the symptoms of PTSD are related to day-to-day difficulties and to help patients develop new, more adaptive functional responses to these stressors with a problem-focused and problem- solving approach. In prior trials, PCT showed equivalent change to active therapies at the last follow-up. The VA offers PCT as an evidence-based therapy for PTSD.
|
|---|---|---|
|
Change in Use of Physically Aggressive Behavior Assessed Through the Physical Assault Subscale on the Revised Conflict Tactics Scale (CTS2)
3 month follow up
|
0.30 Score on a scale
Standard Deviation 1.28
|
4.10 Score on a scale
Standard Deviation 24.47
|
|
Change in Use of Physically Aggressive Behavior Assessed Through the Physical Assault Subscale on the Revised Conflict Tactics Scale (CTS2)
6 month follow up
|
0.24 Score on a scale
Standard Deviation 0.91
|
1.69 Score on a scale
Standard Deviation 6.81
|
|
Change in Use of Physically Aggressive Behavior Assessed Through the Physical Assault Subscale on the Revised Conflict Tactics Scale (CTS2)
Baseline
|
5.25 Score on a scale
Standard Deviation 30.27
|
0.96 Score on a scale
Standard Deviation 3.31
|
|
Change in Use of Physically Aggressive Behavior Assessed Through the Physical Assault Subscale on the Revised Conflict Tactics Scale (CTS2)
Post treatment
|
1.12 Score on a scale
Standard Deviation 3.33
|
1.64 Score on a scale
Standard Deviation 5.19
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Assessments occurred at baseline, post treatment, and approximately 3 and 6 months after posttreatment.Population: The number of participants analyzed differs at the timepoints due to some participants either: 1) not filling out the measure at a given time point due to clinician error; 2) not being present for one of the timepoints; or 3) leaving the study before a given timepoint.
The Depressive Symptoms Index - Suicidality Subscale (DSI-SS; Metalsky \& Joiner, 1997) is a 4-item scale that focuses on ideation, plans, perceived control over ideation, and impulses for suicide. A review of measures of suicidal ideation and behaviors found that the DSI-SS had excellent internal consistency and concurrent validity (Batterham et al., 2014). Possible scores range from 0 to 12, with higher scores indicating greater severity of suicidal ideation.
Outcome measures
| Measure |
Adaptive Disclosure for Moral Injury and Loss
n=89 Participants
AD-MIL is a manualized, 12-session individual psychotherapy designed to improve functioning and to reduce PTSD symptoms by facilitating Veterans doing corrective things in their life to heal and repair traumatic loss and moral injuries. The change agents are: (1) emotional-processing of traumatic loss and moral injuries and motivating a healing and action plan by writing therapeutic letters (e.g., to a lost unit member, to victims of personal transgressions, to people who transgressed); (2) skills training and behavioral contracting to improve functioning and targeting moral injury- and traumatic loss-related psychological and behavioral obstacles to positive and potentially habilitative engagements in occupational, relationship, and family roles; and (3) teaching self- and other-compassion and mindfulness. The goal is to redress the functional impact of moral emotions (anger, shame).
|
Present Centered Therapy
n=85 Participants
Participants randomized to the PCT arm received 12 sessions of therapy focused on improving day-to-day functioning (with no focus on trauma or re-visiting past experiences). Participants randomized to the PCT arm received 12 sessions of therapy focused on improving day-to-day functioning (with no focus on trauma or re-visiting past experiences). PCT is a manualized evidenced-based PTSD treatment used in several large-scale PTSD trials that focuses on improving functioning. It incorporates the essential therapeutic elements common to different types of psychotherapies, including supportive empathic listening and unconditional positive regard. The therapist plays an active role but does not impart any systematic training. The focus is to create an understanding of how the symptoms of PTSD are related to day-to-day difficulties and to help patients develop new, more adaptive functional responses to these stressors with a problem-focused and problem- solving approach. In prior trials, PCT showed equivalent change to active therapies at the last follow-up. The VA offers PCT as an evidence-based therapy for PTSD.
|
|---|---|---|
|
Change in Suicidality Across Assessed Through the Depressive Symptoms Index - Suicidality Subscale (DSI-SS)
Baseline
|
1.14 Score on a scale
Standard Deviation 1.62
|
0.93 Score on a scale
Standard Deviation 1.65
|
|
Change in Suicidality Across Assessed Through the Depressive Symptoms Index - Suicidality Subscale (DSI-SS)
Post treatment
|
1.00 Score on a scale
Standard Deviation 1.63
|
0.85 Score on a scale
Standard Deviation 1.55
|
|
Change in Suicidality Across Assessed Through the Depressive Symptoms Index - Suicidality Subscale (DSI-SS)
3 month follow-up
|
0.91 Score on a scale
Standard Deviation 1.61
|
0.94 Score on a scale
Standard Deviation 1.58
|
|
Change in Suicidality Across Assessed Through the Depressive Symptoms Index - Suicidality Subscale (DSI-SS)
6 month follow-up
|
1.15 Score on a scale
Standard Deviation 1.72
|
1.05 Score on a scale
Standard Deviation 1.62
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Assessments occurred at baseline, post treatment, and approximately 3 and 6 months after post treatment.Population: The number of participants analyzed differs at the timepoints due to some participants either: 1) not filling out the measure at a given time point due to clinician error; 2) not being present for one of the timepoints; or 3) leaving the study before a given timepoint.
Alcohol abuse was evaluated with the Quick Drinking Screen (QDS; Sobell et al., 2003), a 4-item probe of frequency and quantity of alcohol consumption in the last month. The QDS has very good psychometric characteristics (Sobell et al., 2003). The outcome for this measure used in this study was average drinks per week, calculated by using items 1 and 2 from the screen.
Outcome measures
| Measure |
Adaptive Disclosure for Moral Injury and Loss
n=89 Participants
AD-MIL is a manualized, 12-session individual psychotherapy designed to improve functioning and to reduce PTSD symptoms by facilitating Veterans doing corrective things in their life to heal and repair traumatic loss and moral injuries. The change agents are: (1) emotional-processing of traumatic loss and moral injuries and motivating a healing and action plan by writing therapeutic letters (e.g., to a lost unit member, to victims of personal transgressions, to people who transgressed); (2) skills training and behavioral contracting to improve functioning and targeting moral injury- and traumatic loss-related psychological and behavioral obstacles to positive and potentially habilitative engagements in occupational, relationship, and family roles; and (3) teaching self- and other-compassion and mindfulness. The goal is to redress the functional impact of moral emotions (anger, shame).
|
Present Centered Therapy
n=85 Participants
Participants randomized to the PCT arm received 12 sessions of therapy focused on improving day-to-day functioning (with no focus on trauma or re-visiting past experiences). Participants randomized to the PCT arm received 12 sessions of therapy focused on improving day-to-day functioning (with no focus on trauma or re-visiting past experiences). PCT is a manualized evidenced-based PTSD treatment used in several large-scale PTSD trials that focuses on improving functioning. It incorporates the essential therapeutic elements common to different types of psychotherapies, including supportive empathic listening and unconditional positive regard. The therapist plays an active role but does not impart any systematic training. The focus is to create an understanding of how the symptoms of PTSD are related to day-to-day difficulties and to help patients develop new, more adaptive functional responses to these stressors with a problem-focused and problem- solving approach. In prior trials, PCT showed equivalent change to active therapies at the last follow-up. The VA offers PCT as an evidence-based therapy for PTSD.
|
|---|---|---|
|
Change in Alcohol Consumption Assessed Through the Quick Drinking Screen (QDS)
Baseline
|
1.92 Estimated drinks per week
Standard Deviation 3.17
|
1.97 Estimated drinks per week
Standard Deviation 2.81
|
|
Change in Alcohol Consumption Assessed Through the Quick Drinking Screen (QDS)
Post treatment
|
0.84 Estimated drinks per week
Standard Deviation 1.58
|
2.16 Estimated drinks per week
Standard Deviation 3.55
|
|
Change in Alcohol Consumption Assessed Through the Quick Drinking Screen (QDS)
3 month follow-up
|
1.27 Estimated drinks per week
Standard Deviation 2.28
|
2.37 Estimated drinks per week
Standard Deviation 4.34
|
|
Change in Alcohol Consumption Assessed Through the Quick Drinking Screen (QDS)
6 month follow-up
|
0.84 Estimated drinks per week
Standard Deviation 1.87
|
2.55 Estimated drinks per week
Standard Deviation 4.81
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Assessments occurred at baseline, post treatment, and approximately 3 and 6 months after post treatment.Population: The number of participants analyzed differs at the timepoints due to some participants either: 1) not filling out the measure at a given time point due to clinician error; 2) not being present for one of the timepoints; or 3) leaving the study before a given timepoint.
The Social Connectedness Scale (SCS; Lee and Robbins, 1995) was used to assess interpersonal closeness. The SCS is an 8-item scale that focuses on individual experiences in a social world (i.e., with peers, friends, and society) and the degree of difficulty in maintaining a sense of closeness. Possible scores range from 8 to 42, with higher scores indicating more social connection.
Outcome measures
| Measure |
Adaptive Disclosure for Moral Injury and Loss
n=89 Participants
AD-MIL is a manualized, 12-session individual psychotherapy designed to improve functioning and to reduce PTSD symptoms by facilitating Veterans doing corrective things in their life to heal and repair traumatic loss and moral injuries. The change agents are: (1) emotional-processing of traumatic loss and moral injuries and motivating a healing and action plan by writing therapeutic letters (e.g., to a lost unit member, to victims of personal transgressions, to people who transgressed); (2) skills training and behavioral contracting to improve functioning and targeting moral injury- and traumatic loss-related psychological and behavioral obstacles to positive and potentially habilitative engagements in occupational, relationship, and family roles; and (3) teaching self- and other-compassion and mindfulness. The goal is to redress the functional impact of moral emotions (anger, shame).
|
Present Centered Therapy
n=85 Participants
Participants randomized to the PCT arm received 12 sessions of therapy focused on improving day-to-day functioning (with no focus on trauma or re-visiting past experiences). Participants randomized to the PCT arm received 12 sessions of therapy focused on improving day-to-day functioning (with no focus on trauma or re-visiting past experiences). PCT is a manualized evidenced-based PTSD treatment used in several large-scale PTSD trials that focuses on improving functioning. It incorporates the essential therapeutic elements common to different types of psychotherapies, including supportive empathic listening and unconditional positive regard. The therapist plays an active role but does not impart any systematic training. The focus is to create an understanding of how the symptoms of PTSD are related to day-to-day difficulties and to help patients develop new, more adaptive functional responses to these stressors with a problem-focused and problem- solving approach. In prior trials, PCT showed equivalent change to active therapies at the last follow-up. The VA offers PCT as an evidence-based therapy for PTSD.
|
|---|---|---|
|
Change in Social Connectedness Assessed Through the Social Connectedness Scale (SCS)
Baseline
|
23.89 Score on a scale
Standard Deviation 9.69
|
23.56 Score on a scale
Standard Deviation 8.22
|
|
Change in Social Connectedness Assessed Through the Social Connectedness Scale (SCS)
Post treatment
|
28.08 Score on a scale
Standard Deviation 11.75
|
24.78 Score on a scale
Standard Deviation 9.16
|
|
Change in Social Connectedness Assessed Through the Social Connectedness Scale (SCS)
3 month follow-up
|
29.56 Score on a scale
Standard Deviation 12.11
|
26.41 Score on a scale
Standard Deviation 10.83
|
|
Change in Social Connectedness Assessed Through the Social Connectedness Scale (SCS)
6 month follow-up
|
29.83 Score on a scale
Standard Deviation 12.17
|
27.21 Score on a scale
Standard Deviation 9.10
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Assessments occurred at baseline, post treatment, and approximately 3 and 6 months after post treatment.Population: The number of participants analyzed differs at the timepoints due to some participants either: 1) not filling out the measure at a given time point due to clinician error; 2) not being present for one of the timepoints; or 3) leaving the study before a given timepoint.
The Santa Clara Brief Compassion Scale (SCBSC; Hwang, et al., 2008) is a 5-item short form of the Compassionate Love Scale for Humanity (CLS). Possible scores range from 1 to 7, with higher scores indicating more compassion for humanity.
Outcome measures
| Measure |
Adaptive Disclosure for Moral Injury and Loss
n=89 Participants
AD-MIL is a manualized, 12-session individual psychotherapy designed to improve functioning and to reduce PTSD symptoms by facilitating Veterans doing corrective things in their life to heal and repair traumatic loss and moral injuries. The change agents are: (1) emotional-processing of traumatic loss and moral injuries and motivating a healing and action plan by writing therapeutic letters (e.g., to a lost unit member, to victims of personal transgressions, to people who transgressed); (2) skills training and behavioral contracting to improve functioning and targeting moral injury- and traumatic loss-related psychological and behavioral obstacles to positive and potentially habilitative engagements in occupational, relationship, and family roles; and (3) teaching self- and other-compassion and mindfulness. The goal is to redress the functional impact of moral emotions (anger, shame).
|
Present Centered Therapy
n=85 Participants
Participants randomized to the PCT arm received 12 sessions of therapy focused on improving day-to-day functioning (with no focus on trauma or re-visiting past experiences). Participants randomized to the PCT arm received 12 sessions of therapy focused on improving day-to-day functioning (with no focus on trauma or re-visiting past experiences). PCT is a manualized evidenced-based PTSD treatment used in several large-scale PTSD trials that focuses on improving functioning. It incorporates the essential therapeutic elements common to different types of psychotherapies, including supportive empathic listening and unconditional positive regard. The therapist plays an active role but does not impart any systematic training. The focus is to create an understanding of how the symptoms of PTSD are related to day-to-day difficulties and to help patients develop new, more adaptive functional responses to these stressors with a problem-focused and problem- solving approach. In prior trials, PCT showed equivalent change to active therapies at the last follow-up. The VA offers PCT as an evidence-based therapy for PTSD.
|
|---|---|---|
|
Change in Compassion for Humanity Assessed Through The Santa Clara Brief Compassion Scale (SCBSC)
Baseline
|
4.84 Score on a scale
Standard Deviation 1.76
|
5.00 Score on a scale
Standard Deviation 1.64
|
|
Change in Compassion for Humanity Assessed Through The Santa Clara Brief Compassion Scale (SCBSC)
Post treatment
|
4.93 Score on a scale
Standard Deviation 1.65
|
5.02 Score on a scale
Standard Deviation 1.63
|
|
Change in Compassion for Humanity Assessed Through The Santa Clara Brief Compassion Scale (SCBSC)
3 month follow-up
|
5.12 Score on a scale
Standard Deviation 1.56
|
4.82 Score on a scale
Standard Deviation 1.77
|
|
Change in Compassion for Humanity Assessed Through The Santa Clara Brief Compassion Scale (SCBSC)
6 month follow-up
|
4.97 Score on a scale
Standard Deviation 1.73
|
4.85 Score on a scale
Standard Deviation 1.54
|
POST_HOC outcome
Timeframe: Assessments occurred at baseline, the sixth treatment session, post treatment, and approximately 3 months after post treatment.Population: The number of participants analyzed differs at the timepoints due to some participants either: 1) not filling out the measure at a given time point due to clinician error; 2) not being present for one of the timepoints; or 3) leaving the study before a given timepoint.
The Valued Living Questionnaire (VLQ; Wilson et al., 2010) value and engagement in 10 domains of living. Respondents rate how important each domain is from 1 ("not at all important") to 10 ("extremely important"; Importance subscale) and their engagement in each domain, on a scale from 1 ("not at all consistent with my value") to 10 ("completely consistent with my value"; Consistency subscale). Importance and Consistency scores are multiplied for each domain, added across domains, and then divided by 10 such that possible scores range from 10-100. Higher scores indicate greater valued living.
Outcome measures
| Measure |
Adaptive Disclosure for Moral Injury and Loss
n=89 Participants
AD-MIL is a manualized, 12-session individual psychotherapy designed to improve functioning and to reduce PTSD symptoms by facilitating Veterans doing corrective things in their life to heal and repair traumatic loss and moral injuries. The change agents are: (1) emotional-processing of traumatic loss and moral injuries and motivating a healing and action plan by writing therapeutic letters (e.g., to a lost unit member, to victims of personal transgressions, to people who transgressed); (2) skills training and behavioral contracting to improve functioning and targeting moral injury- and traumatic loss-related psychological and behavioral obstacles to positive and potentially habilitative engagements in occupational, relationship, and family roles; and (3) teaching self- and other-compassion and mindfulness. The goal is to redress the functional impact of moral emotions (anger, shame).
|
Present Centered Therapy
n=85 Participants
Participants randomized to the PCT arm received 12 sessions of therapy focused on improving day-to-day functioning (with no focus on trauma or re-visiting past experiences). Participants randomized to the PCT arm received 12 sessions of therapy focused on improving day-to-day functioning (with no focus on trauma or re-visiting past experiences). PCT is a manualized evidenced-based PTSD treatment used in several large-scale PTSD trials that focuses on improving functioning. It incorporates the essential therapeutic elements common to different types of psychotherapies, including supportive empathic listening and unconditional positive regard. The therapist plays an active role but does not impart any systematic training. The focus is to create an understanding of how the symptoms of PTSD are related to day-to-day difficulties and to help patients develop new, more adaptive functional responses to these stressors with a problem-focused and problem- solving approach. In prior trials, PCT showed equivalent change to active therapies at the last follow-up. The VA offers PCT as an evidence-based therapy for PTSD.
|
|---|---|---|
|
Change in Valued/Mindful Living Assessed Through The Valued Living Questionnaire (VLQ)
Baseline
|
37.39 Score on a composite scale
Standard Deviation 19.42
|
40.72 Score on a composite scale
Standard Deviation 16.89
|
|
Change in Valued/Mindful Living Assessed Through The Valued Living Questionnaire (VLQ)
Session 6
|
42.42 Score on a composite scale
Standard Deviation 18.02
|
40.51 Score on a composite scale
Standard Deviation 16.31
|
|
Change in Valued/Mindful Living Assessed Through The Valued Living Questionnaire (VLQ)
Post treatment
|
47.32 Score on a composite scale
Standard Deviation 19.80
|
43.81 Score on a composite scale
Standard Deviation 18.96
|
|
Change in Valued/Mindful Living Assessed Through The Valued Living Questionnaire (VLQ)
3 month follow up
|
46.24 Score on a composite scale
Standard Deviation 20.72
|
44.10 Score on a composite scale
Standard Deviation 20.33
|
|
Change in Valued/Mindful Living Assessed Through The Valued Living Questionnaire (VLQ)
6 month follow up
|
44.42 Score on a composite scale
Standard Deviation 19.40
|
45.29 Score on a composite scale
Standard Deviation 21.33
|
Adverse Events
Adaptive Disclosure for Moral Injury and Loss
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Present Centered Therapy
Serious events: 2 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Adaptive Disclosure for Moral Injury and Loss
n=89 participants at risk
AD-MIL is a manualized, 12-session individual psychotherapy designed to improve functioning and to reduce PTSD symptoms by facilitating Veterans doing corrective things in their life to heal and repair traumatic loss and moral injuries. The change agents are: (1) emotional-processing of traumatic loss and moral injuries and motivating a healing and action plan by writing therapeutic letters (e.g., to a lost unit member, to victims of personal transgressions, to people who transgressed); (2) skills training and behavioral contracting to improve functioning and targeting moral injury- and traumatic loss-related psychological and behavioral obstacles to positive and potentially habilitative engagements in occupational, relationship, and family roles; and (3) teaching self- and other-compassion and mindfulness. The goal is to redress the functional impact of moral emotions (anger, shame).
|
Present Centered Therapy
n=85 participants at risk
PCT is a manualized evidenced-based PTSD treatment used in several large-scale PTSD trials. It incorporates the essential therapeutic elements common to different types of psychotherapies, including supportive empathic listening and unconditional positive regard. The therapist plays an active role, but does not impart any systematic training. The focus is to create an understanding of how the symptoms of PTSD are related to day-to-day difficulties and to help patients develop new, more adaptive responses to these stressors with a problem-focused and problem-solving approach. In prior trials, PCT showed equivalent change to active therapies at the last follow-up. The VA offers PCT as an evidence-based therapy for PTSD.
Present Centered Therapy: Participants randomized to the PCT arm will receive 12 sessions of therapy focused on problems occurring in the present (with no focus on trauma or re-visiting past experiences).
|
|---|---|---|
|
Cardiac disorders
Hospitalization due to hypertension/elevated heart rate
|
0.00%
0/89 • Adverse event data for a given participant were collected for the entire period that the participant was involved in the study. Adverse events were monitored for from the time consent was collected through the duration of the clinical intervention, which, for participants who completed the entire study, was approximately 9 months. For all participants combined, data were collected for approximately 4 years (January 2018-January 2022).
All adverse events, both serious and non serious, regardless of relationship to the study intervention, were recorded on the VA Boston IRB adverse event log. Adverse event data were collected from the time the informed consent form is signed through the duration of the clinical investigation. Standard medical terminology was used when recording Adverse events.
|
1.2%
1/85 • Number of events 1 • Adverse event data for a given participant were collected for the entire period that the participant was involved in the study. Adverse events were monitored for from the time consent was collected through the duration of the clinical intervention, which, for participants who completed the entire study, was approximately 9 months. For all participants combined, data were collected for approximately 4 years (January 2018-January 2022).
All adverse events, both serious and non serious, regardless of relationship to the study intervention, were recorded on the VA Boston IRB adverse event log. Adverse event data were collected from the time the informed consent form is signed through the duration of the clinical investigation. Standard medical terminology was used when recording Adverse events.
|
|
Psychiatric disorders
Pt relapsed on alcohol and self-admitted to a 30-day rehabilitation program
|
0.00%
0/89 • Adverse event data for a given participant were collected for the entire period that the participant was involved in the study. Adverse events were monitored for from the time consent was collected through the duration of the clinical intervention, which, for participants who completed the entire study, was approximately 9 months. For all participants combined, data were collected for approximately 4 years (January 2018-January 2022).
All adverse events, both serious and non serious, regardless of relationship to the study intervention, were recorded on the VA Boston IRB adverse event log. Adverse event data were collected from the time the informed consent form is signed through the duration of the clinical investigation. Standard medical terminology was used when recording Adverse events.
|
1.2%
1/85 • Number of events 1 • Adverse event data for a given participant were collected for the entire period that the participant was involved in the study. Adverse events were monitored for from the time consent was collected through the duration of the clinical intervention, which, for participants who completed the entire study, was approximately 9 months. For all participants combined, data were collected for approximately 4 years (January 2018-January 2022).
All adverse events, both serious and non serious, regardless of relationship to the study intervention, were recorded on the VA Boston IRB adverse event log. Adverse event data were collected from the time the informed consent form is signed through the duration of the clinical investigation. Standard medical terminology was used when recording Adverse events.
|
|
Infections and infestations
Right small toe was amputated due to an infection
|
1.1%
1/89 • Number of events 1 • Adverse event data for a given participant were collected for the entire period that the participant was involved in the study. Adverse events were monitored for from the time consent was collected through the duration of the clinical intervention, which, for participants who completed the entire study, was approximately 9 months. For all participants combined, data were collected for approximately 4 years (January 2018-January 2022).
All adverse events, both serious and non serious, regardless of relationship to the study intervention, were recorded on the VA Boston IRB adverse event log. Adverse event data were collected from the time the informed consent form is signed through the duration of the clinical investigation. Standard medical terminology was used when recording Adverse events.
|
0.00%
0/85 • Adverse event data for a given participant were collected for the entire period that the participant was involved in the study. Adverse events were monitored for from the time consent was collected through the duration of the clinical intervention, which, for participants who completed the entire study, was approximately 9 months. For all participants combined, data were collected for approximately 4 years (January 2018-January 2022).
All adverse events, both serious and non serious, regardless of relationship to the study intervention, were recorded on the VA Boston IRB adverse event log. Adverse event data were collected from the time the informed consent form is signed through the duration of the clinical investigation. Standard medical terminology was used when recording Adverse events.
|
Other adverse events
| Measure |
Adaptive Disclosure for Moral Injury and Loss
n=89 participants at risk
AD-MIL is a manualized, 12-session individual psychotherapy designed to improve functioning and to reduce PTSD symptoms by facilitating Veterans doing corrective things in their life to heal and repair traumatic loss and moral injuries. The change agents are: (1) emotional-processing of traumatic loss and moral injuries and motivating a healing and action plan by writing therapeutic letters (e.g., to a lost unit member, to victims of personal transgressions, to people who transgressed); (2) skills training and behavioral contracting to improve functioning and targeting moral injury- and traumatic loss-related psychological and behavioral obstacles to positive and potentially habilitative engagements in occupational, relationship, and family roles; and (3) teaching self- and other-compassion and mindfulness. The goal is to redress the functional impact of moral emotions (anger, shame).
|
Present Centered Therapy
n=85 participants at risk
PCT is a manualized evidenced-based PTSD treatment used in several large-scale PTSD trials. It incorporates the essential therapeutic elements common to different types of psychotherapies, including supportive empathic listening and unconditional positive regard. The therapist plays an active role, but does not impart any systematic training. The focus is to create an understanding of how the symptoms of PTSD are related to day-to-day difficulties and to help patients develop new, more adaptive responses to these stressors with a problem-focused and problem-solving approach. In prior trials, PCT showed equivalent change to active therapies at the last follow-up. The VA offers PCT as an evidence-based therapy for PTSD.
Present Centered Therapy: Participants randomized to the PCT arm will receive 12 sessions of therapy focused on problems occurring in the present (with no focus on trauma or re-visiting past experiences).
|
|---|---|---|
|
Psychiatric disorders
Increase in psychiatric symptoms
|
7.9%
7/89 • Number of events 10 • Adverse event data for a given participant were collected for the entire period that the participant was involved in the study. Adverse events were monitored for from the time consent was collected through the duration of the clinical intervention, which, for participants who completed the entire study, was approximately 9 months. For all participants combined, data were collected for approximately 4 years (January 2018-January 2022).
All adverse events, both serious and non serious, regardless of relationship to the study intervention, were recorded on the VA Boston IRB adverse event log. Adverse event data were collected from the time the informed consent form is signed through the duration of the clinical investigation. Standard medical terminology was used when recording Adverse events.
|
11.8%
10/85 • Number of events 11 • Adverse event data for a given participant were collected for the entire period that the participant was involved in the study. Adverse events were monitored for from the time consent was collected through the duration of the clinical intervention, which, for participants who completed the entire study, was approximately 9 months. For all participants combined, data were collected for approximately 4 years (January 2018-January 2022).
All adverse events, both serious and non serious, regardless of relationship to the study intervention, were recorded on the VA Boston IRB adverse event log. Adverse event data were collected from the time the informed consent form is signed through the duration of the clinical investigation. Standard medical terminology was used when recording Adverse events.
|
Additional Information
Dr. Brett Litz
VA Boston Healthcare System
Phone: (617)5849314
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place