Trial Outcomes & Findings for A Novel Posttraumatic Stress Disorder Treatment for Veterans With Moral Injury (NCT NCT03764033)
NCT ID: NCT03764033
Last Updated: 2025-11-20
Results Overview
A widely-validated, 26-item measure on a 5 point scale that assesses functioning in physical health, psychological health, social relationships, and environment, with higher scores indicating greater health in each domain. Each item is scored from 1-5, and a total raw score is calculated by summing all items (26-130). The total score is calculated by transforming the raw score to a 0-100 scale, with higher scores representing better quality of life.
COMPLETED
NA
100 participants
Change from post-treatment (Week 11) to 6 month follow-up (6 months after post-treatment)
2025-11-20
Participant Flow
Veterans were recruited from 8/12/2019 to 11/30/2024 through direct mailings, advertisements, referrals from VA providers and other VA research studies. Screening procedures comprised a brief phone pre-screener, informed consent , and a diagnostic clinical interview. A total of 100 Veterans completed all screening procedures, were eligible for the study, completed a baseline self-report questionnaire of outcome measures, and were randomly assigned to a treatment condition.
Participant milestones
| Measure |
Impact of Killing (IOK)
Participants in this arm will receive 10 sessions (60-90 minutes) of a cognitive-behavioral moral injury treatment called IOK .
Impact of Killing (IOK): Participants in this arm will receive 10 sessions (60-90 minutes) of a cognitive-behavioral moral injury treatment called IOK .
|
Present Centered Therapy
Participants in this arm will receive 10 sessions (60-90 minutes) of a PTSD treatment that does not focus on trauma or cognitive restructuring, but rather the functional impact of trauma called Present Center Therapy (PCT)
Present Centered Therapy: Participants in this arm will receive 10 sessions (60-90 minutes) of a PTSD treatment that does not focus on trauma or cognitive restructuring, but rather the functional impact of trauma called Present Center Therapy (PCT)
|
|---|---|---|
|
Treatment Phase
STARTED
|
49
|
51
|
|
Treatment Phase
COMPLETED
|
41
|
47
|
|
Treatment Phase
NOT COMPLETED
|
8
|
4
|
|
Six Month Follow-Up
STARTED
|
41
|
47
|
|
Six Month Follow-Up
COMPLETED
|
41
|
42
|
|
Six Month Follow-Up
NOT COMPLETED
|
0
|
5
|
Reasons for withdrawal
| Measure |
Impact of Killing (IOK)
Participants in this arm will receive 10 sessions (60-90 minutes) of a cognitive-behavioral moral injury treatment called IOK .
Impact of Killing (IOK): Participants in this arm will receive 10 sessions (60-90 minutes) of a cognitive-behavioral moral injury treatment called IOK .
|
Present Centered Therapy
Participants in this arm will receive 10 sessions (60-90 minutes) of a PTSD treatment that does not focus on trauma or cognitive restructuring, but rather the functional impact of trauma called Present Center Therapy (PCT)
Present Centered Therapy: Participants in this arm will receive 10 sessions (60-90 minutes) of a PTSD treatment that does not focus on trauma or cognitive restructuring, but rather the functional impact of trauma called Present Center Therapy (PCT)
|
|---|---|---|
|
Treatment Phase
Withdrawal by Subject
|
8
|
3
|
|
Treatment Phase
Withdrawn by PI due to frequent no-shows and cancellations of study appointments.
|
0
|
1
|
|
Six Month Follow-Up
Lost to Follow-up
|
0
|
5
|
Baseline Characteristics
A Novel Posttraumatic Stress Disorder Treatment for Veterans With Moral Injury
Baseline characteristics by cohort
| Measure |
Impact of Killing (IOK)
n=49 Participants
Participants in this arm will receive 10 sessions (60-90 minutes) of a cognitive-behavioral moral injury treatment called IOK .
Impact of Killing (IOK): Participants in this arm will receive 10 sessions (60-90 minutes) of a cognitive-behavioral moral injury treatment called IOK .
|
Present Centered Therapy
n=51 Participants
Participants in this arm will receive 10 sessions (60-90 minutes) of a PTSD treatment that does not focus on trauma or cognitive restructuring, but rather the functional impact of trauma called Present Center Therapy (PCT)
Present Centered Therapy: Participants in this arm will receive 10 sessions (60-90 minutes) of a PTSD treatment that does not focus on trauma or cognitive restructuring, but rather the functional impact of trauma called Present Center Therapy (PCT)
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50.0 years
STANDARD_DEVIATION 14.5
|
46.8 years
STANDARD_DEVIATION 12.9 • n=4 Participants
|
48.4 years
STANDARD_DEVIATION 13.7 • n=8 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
48 Participants
|
50 Participants
n=4 Participants
|
98 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
|
11 Participants
n=4 Participants
|
19 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
41 Participants
|
40 Participants
n=4 Participants
|
81 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
12 Participants
|
13 Participants
n=4 Participants
|
25 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
34 Participants
|
34 Participants
n=4 Participants
|
68 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Change from baseline (Week 0) and post-treatment (Week 11)A widely-validated, 26-item measure on a 5 point scale that assesses functioning in physical health, psychological health, social relationships, and environment, with higher scores indicating greater health in each domain. Each item is scored from 1-5, and a total raw score is calculated by summing all items (26-130). The total score is calculated by transforming the raw score to a 0-100 scale, with higher scores representing better quality of life.
Outcome measures
| Measure |
Impact of Killing (IOK)
n=49 Participants
Participants in this arm will receive 10 sessions (60-90 minutes) of a cognitive-behavioral moral injury treatment called IOK .
Impact of Killing (IOK): Participants in this arm will receive 10 sessions (60-90 minutes) of a cognitive-behavioral moral injury treatment called IOK .
|
Present Centered Therapy
n=51 Participants
Participants in this arm will receive 10 sessions (60-90 minutes) of a PTSD treatment that does not focus on trauma or cognitive restructuring, but rather the functional impact of trauma called Present Center Therapy (PCT)
Present Centered Therapy: Participants in this arm will receive 10 sessions (60-90 minutes) of a PTSD treatment that does not focus on trauma or cognitive restructuring, but rather the functional impact of trauma called Present Center Therapy (PCT)
|
|---|---|---|
|
World Health Organization Quality of Life-BREF
|
53.35 score on a scale
Standard Error 2.03
|
52.39 score on a scale
Standard Error 1.94
|
PRIMARY outcome
Timeframe: Change from post-treatment (Week 11) to 6 month follow-up (6 months after post-treatment)A widely-validated, 26-item measure on a 5 point scale that assesses functioning in physical health, psychological health, social relationships, and environment, with higher scores indicating greater health in each domain. Each item is scored from 1-5, and a total raw score is calculated by summing all items (26-130). The total score is calculated by transforming the raw score to a 0-100 scale, with higher scores representing better quality of life.
Outcome measures
| Measure |
Impact of Killing (IOK)
n=41 Participants
Participants in this arm will receive 10 sessions (60-90 minutes) of a cognitive-behavioral moral injury treatment called IOK .
Impact of Killing (IOK): Participants in this arm will receive 10 sessions (60-90 minutes) of a cognitive-behavioral moral injury treatment called IOK .
|
Present Centered Therapy
n=42 Participants
Participants in this arm will receive 10 sessions (60-90 minutes) of a PTSD treatment that does not focus on trauma or cognitive restructuring, but rather the functional impact of trauma called Present Center Therapy (PCT)
Present Centered Therapy: Participants in this arm will receive 10 sessions (60-90 minutes) of a PTSD treatment that does not focus on trauma or cognitive restructuring, but rather the functional impact of trauma called Present Center Therapy (PCT)
|
|---|---|---|
|
World Health Organization Quality of Life-BREF
|
50.86 score on a scale
Standard Error 2.03
|
50.62 score on a scale
Standard Error 1.99
|
SECONDARY outcome
Timeframe: Change from baseline (Week 0) and post-treatment (Week 11)This measure is used to identify DSM-5 criteria for PTSD. CAPS-5 provides both a dimensional and categorical measure of current PTSD and the frequency and intensity of PTSD-related symptoms. Score range from 0-80 with lower score representing fewer PTSD symptoms.
Outcome measures
| Measure |
Impact of Killing (IOK)
n=49 Participants
Participants in this arm will receive 10 sessions (60-90 minutes) of a cognitive-behavioral moral injury treatment called IOK .
Impact of Killing (IOK): Participants in this arm will receive 10 sessions (60-90 minutes) of a cognitive-behavioral moral injury treatment called IOK .
|
Present Centered Therapy
n=51 Participants
Participants in this arm will receive 10 sessions (60-90 minutes) of a PTSD treatment that does not focus on trauma or cognitive restructuring, but rather the functional impact of trauma called Present Center Therapy (PCT)
Present Centered Therapy: Participants in this arm will receive 10 sessions (60-90 minutes) of a PTSD treatment that does not focus on trauma or cognitive restructuring, but rather the functional impact of trauma called Present Center Therapy (PCT)
|
|---|---|---|
|
Clinician Administered PTSD Scale for DSM-5 (CAPS-5)
|
25.79 score on a scale
Standard Error 1.82
|
26.03 score on a scale
Standard Error 1.73
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Change from baseline (Week 0) and post-treatment (Week 11)A 20-item measure that assesses PTSD symptom severity using a 5-point rating scale. The PCL-5 items correspond to the DSM-5 symptoms for PTSD. Total severity can range from 0 to 80. Higher scores indicate greater severity of PTSD symptoms.
Outcome measures
| Measure |
Impact of Killing (IOK)
n=49 Participants
Participants in this arm will receive 10 sessions (60-90 minutes) of a cognitive-behavioral moral injury treatment called IOK .
Impact of Killing (IOK): Participants in this arm will receive 10 sessions (60-90 minutes) of a cognitive-behavioral moral injury treatment called IOK .
|
Present Centered Therapy
n=51 Participants
Participants in this arm will receive 10 sessions (60-90 minutes) of a PTSD treatment that does not focus on trauma or cognitive restructuring, but rather the functional impact of trauma called Present Center Therapy (PCT)
Present Centered Therapy: Participants in this arm will receive 10 sessions (60-90 minutes) of a PTSD treatment that does not focus on trauma or cognitive restructuring, but rather the functional impact of trauma called Present Center Therapy (PCT)
|
|---|---|---|
|
PTSD Checklist for DSM-5 (PCL-5)
|
37.31 score on a scale
Standard Error 2.23
|
42.9 score on a scale
Standard Error 2.14
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Change from post-treatment (Week 11) to 6 month follow-up (6 months after post-treatment)A 20-item measure that assesses PTSD symptom severity using a 5-point rating scale. The PCL-5 items correspond to the DSM-5 symptoms for PTSD. Total severity can range from 0 to 80. Higher scores indicate greater severity of PTSD symptoms.
Outcome measures
| Measure |
Impact of Killing (IOK)
n=41 Participants
Participants in this arm will receive 10 sessions (60-90 minutes) of a cognitive-behavioral moral injury treatment called IOK .
Impact of Killing (IOK): Participants in this arm will receive 10 sessions (60-90 minutes) of a cognitive-behavioral moral injury treatment called IOK .
|
Present Centered Therapy
n=42 Participants
Participants in this arm will receive 10 sessions (60-90 minutes) of a PTSD treatment that does not focus on trauma or cognitive restructuring, but rather the functional impact of trauma called Present Center Therapy (PCT)
Present Centered Therapy: Participants in this arm will receive 10 sessions (60-90 minutes) of a PTSD treatment that does not focus on trauma or cognitive restructuring, but rather the functional impact of trauma called Present Center Therapy (PCT)
|
|---|---|---|
|
PTSD Checklist for DSM-5 (PCL-5)
|
36.77 score on a scale
Standard Error 2.23
|
42.35 score on a scale
Standard Error 2.19
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Change from baseline (Week 0) and post-treatment (Week 11)A 53-item measure, using a 5-point Likert scale, in which participants rate the extent to which they have been bothered in the past week by various mental health symptoms (e.g., depression, anxiety, hostility, psychoticism, paranoid ideation, etc.). The BSI measures global psychological distress, with scores ranging from 0-53. Higher scores represent more severe psychiatric symptoms.
Outcome measures
| Measure |
Impact of Killing (IOK)
n=49 Participants
Participants in this arm will receive 10 sessions (60-90 minutes) of a cognitive-behavioral moral injury treatment called IOK .
Impact of Killing (IOK): Participants in this arm will receive 10 sessions (60-90 minutes) of a cognitive-behavioral moral injury treatment called IOK .
|
Present Centered Therapy
n=51 Participants
Participants in this arm will receive 10 sessions (60-90 minutes) of a PTSD treatment that does not focus on trauma or cognitive restructuring, but rather the functional impact of trauma called Present Center Therapy (PCT)
Present Centered Therapy: Participants in this arm will receive 10 sessions (60-90 minutes) of a PTSD treatment that does not focus on trauma or cognitive restructuring, but rather the functional impact of trauma called Present Center Therapy (PCT)
|
|---|---|---|
|
Brief Symptom Inventory (BSI)
|
1.11 score on a scale
Standard Error 0.11
|
1.35 score on a scale
Standard Error 0.10
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Change from baseline (Week 0) and post-treatment (Week 11)A 32-item measure, using a 5-point Likert scale, assessing the emotional and cognitive aspects of guilt associated with a specified traumatic event (e.g., combat experience, car accident, physical or sexual abuse, or sudden death of a loved one). The TRGI has main scales representing guilt, distress and guilt cognitions. Scores represent the average for items in the scale and range from 0-4, with higher scores representing greater guilt/distress.
Outcome measures
| Measure |
Impact of Killing (IOK)
n=49 Participants
Participants in this arm will receive 10 sessions (60-90 minutes) of a cognitive-behavioral moral injury treatment called IOK .
Impact of Killing (IOK): Participants in this arm will receive 10 sessions (60-90 minutes) of a cognitive-behavioral moral injury treatment called IOK .
|
Present Centered Therapy
n=51 Participants
Participants in this arm will receive 10 sessions (60-90 minutes) of a PTSD treatment that does not focus on trauma or cognitive restructuring, but rather the functional impact of trauma called Present Center Therapy (PCT)
Present Centered Therapy: Participants in this arm will receive 10 sessions (60-90 minutes) of a PTSD treatment that does not focus on trauma or cognitive restructuring, but rather the functional impact of trauma called Present Center Therapy (PCT)
|
|---|---|---|
|
Trauma-related Guilt Inventory (TRGI)
|
2.01 score on a scale
Standard Error 0.15
|
2.18 score on a scale
Standard Error 0.14
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Change from post-treatment (Week 11) to 6 month follow-up (6 months after post-treatment)A 53-item measure, using a 5-point Likert scale, in which participants rate the extent to which they have been bothered in the past week by various mental health symptoms (e.g., depression, anxiety, hostility, psychoticism, paranoid ideation, etc.). The BSI measures global psychological distress, with scores ranging from 0-53. Higher scores represent more severe psychiatric symptoms.
Outcome measures
| Measure |
Impact of Killing (IOK)
n=41 Participants
Participants in this arm will receive 10 sessions (60-90 minutes) of a cognitive-behavioral moral injury treatment called IOK .
Impact of Killing (IOK): Participants in this arm will receive 10 sessions (60-90 minutes) of a cognitive-behavioral moral injury treatment called IOK .
|
Present Centered Therapy
n=42 Participants
Participants in this arm will receive 10 sessions (60-90 minutes) of a PTSD treatment that does not focus on trauma or cognitive restructuring, but rather the functional impact of trauma called Present Center Therapy (PCT)
Present Centered Therapy: Participants in this arm will receive 10 sessions (60-90 minutes) of a PTSD treatment that does not focus on trauma or cognitive restructuring, but rather the functional impact of trauma called Present Center Therapy (PCT)
|
|---|---|---|
|
Brief Symptom Inventory (BSI)
|
1.15 score on a scale
Standard Error 0.11
|
1.45 score on a scale
Standard Error 0.10
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Change from post-treatment (Week 11) to 6 month follow-up (6 months after post-treatment)A 32-item measure, using a 5-point Likert scale, assessing the emotional and cognitive aspects of guilt associated with a specified traumatic event (e.g., combat experience, car accident, physical or sexual abuse, or sudden death of a loved one). The TRGI has main scales representing guilt, distress and guilt cognitions. Scores represent the average for items in the scale and range from 0-4, with higher scores representing more guilt/distress.
Outcome measures
| Measure |
Impact of Killing (IOK)
n=41 Participants
Participants in this arm will receive 10 sessions (60-90 minutes) of a cognitive-behavioral moral injury treatment called IOK .
Impact of Killing (IOK): Participants in this arm will receive 10 sessions (60-90 minutes) of a cognitive-behavioral moral injury treatment called IOK .
|
Present Centered Therapy
n=42 Participants
Participants in this arm will receive 10 sessions (60-90 minutes) of a PTSD treatment that does not focus on trauma or cognitive restructuring, but rather the functional impact of trauma called Present Center Therapy (PCT)
Present Centered Therapy: Participants in this arm will receive 10 sessions (60-90 minutes) of a PTSD treatment that does not focus on trauma or cognitive restructuring, but rather the functional impact of trauma called Present Center Therapy (PCT)
|
|---|---|---|
|
Trauma-related Guilt Inventory (TRGI)
|
1.79 score on a scale
Standard Error 0.15
|
2.00 score on a scale
Standard Error 0.15
|
Adverse Events
Impact of Killing (IOK)
Present Centered Therapy
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Impact of Killing (IOK)
n=49 participants at risk
Participants in this arm will receive 10 sessions (60-90 minutes) of a cognitive-behavioral moral injury treatment called IOK .
Impact of Killing (IOK): Participants in this arm will receive 10 sessions (60-90 minutes) of a cognitive-behavioral moral injury treatment called IOK .
|
Present Centered Therapy
n=51 participants at risk
Participants in this arm will receive 10 sessions (60-90 minutes) of a PTSD treatment that does not focus on trauma or cognitive restructuring, but rather the functional impact of trauma called Present Center Therapy (PCT)
Present Centered Therapy: Participants in this arm will receive 10 sessions (60-90 minutes) of a PTSD treatment that does not focus on trauma or cognitive restructuring, but rather the functional impact of trauma called Present Center Therapy (PCT)
|
|---|---|---|
|
Psychiatric disorders
Drug Relapse
|
0.00%
0/49 • Adverse event data were collected for participants during the treatment phase of the study, from baseline (Week 0) to the post-treatment diagnostic interview (Week 11)
|
2.0%
1/51 • Number of events 1 • Adverse event data were collected for participants during the treatment phase of the study, from baseline (Week 0) to the post-treatment diagnostic interview (Week 11)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place