Trial Outcomes & Findings for Mindful Self Compassion for Combat Deployed Veterans With Moral Injury and Co-occurring PTSD-SUD (NCT NCT03681288)
NCT ID: NCT03681288
Last Updated: 2024-06-21
Results Overview
The Self-Compassion Scale (SCS) is a 26-item self-report questionnaire that measures the cognitions and emotions associated with compassionate and uncompassionate responses to feelings of personal inadequacy and general life difficulties. Scores for negative items representing uncompassionate self-responding are reverse-coded to indicate their absence. Responses are given on a 5-point scale from "1-Almost Never" to "5-Almost Always." A total mean score is generated with higher scores corresponding to higher levels of self-compassion. Consider scores 1.0-2.49 to be low, between 2.5-3.5 to be moderate, and 3.51-5.0 to be high.
COMPLETED
NA
34 participants
Post-Tx (8-10 weeks post baseline)
2024-06-21
Participant Flow
During a 18-month period, the investigators enrolled 34 patients who were referred or self-referred themselves to the Mindful Self-Compassion (MSC) program at the Providence VA Medical Center. 76.5% (n=26) of eligible participants who completed the baseline assessment enrolled in MSC by attending the first session.
Participant milestones
| Measure |
Mindful Self-Compassion (MSC)
Mindful Self-Compassion Intervention
|
|---|---|
|
Overall Study
STARTED
|
26
|
|
Overall Study
COMPLETED
|
18
|
|
Overall Study
NOT COMPLETED
|
8
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Mindful Self Compassion for Combat Deployed Veterans With Moral Injury and Co-occurring PTSD-SUD
Baseline characteristics by cohort
| Measure |
Mindful Self-Compassion (MSC)
n=26 Participants
Mindful Self-Compassion Intervention
|
|---|---|
|
Age, Continuous
|
50.92 years
STANDARD_DEVIATION 15.59 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino · Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino · Not Hispanic or Latino
|
26 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino · Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
26 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Education Level
High School Grad/GED
|
6 Participants
n=5 Participants
|
|
Education Level
Some College/Technical School
|
13 Participants
n=5 Participants
|
|
Education Level
College Graduate
|
2 Participants
n=5 Participants
|
|
Education Level
Post-Graduate/Professional Degree
|
5 Participants
n=5 Participants
|
|
Relationship Status
Single
|
5 Participants
n=5 Participants
|
|
Relationship Status
Married or in a committed relationship (living together)
|
15 Participants
n=5 Participants
|
|
Relationship Status
Separated
|
1 Participants
n=5 Participants
|
|
Relationship Status
Divorced
|
5 Participants
n=5 Participants
|
|
Clinician Administered PTSD Scale (CAPS-5)
|
41.33 units on a scale
STANDARD_DEVIATION 8.98 • n=5 Participants
|
|
PTSD Checklist (PCL-5)
|
57.67 units on a scale
STANDARD_DEVIATION 17.01 • n=5 Participants
|
|
Trauma Related Guilt Inventory (TRGI) - Distress Subscale
|
3.05 units on a scale
STANDARD_DEVIATION .93 • n=5 Participants
|
|
Trauma Related Guilt Inventory (TRGI) - Global Guilt Subscale
|
1.83 units on a scale
STANDARD_DEVIATION .61 • n=5 Participants
|
|
Trauma Related Guilt Inventory (TRGI) - Guilt Cognitions Subscale
|
1.58 units on a scale
STANDARD_DEVIATION .84 • n=5 Participants
|
|
Trauma Related Shame Inventory (TRSI)
|
26.84 units on a scale
STANDARD_DEVIATION 20.09 • n=5 Participants
|
|
Self-Compassion Scale (SCS)
|
2.27 units on a scale
STANDARD_DEVIATION .64 • n=5 Participants
|
PRIMARY outcome
Timeframe: Post-Tx (8-10 weeks post baseline)Population: The investigators examined clinically meaningful change among treatment completers with complete pre- and post-treatment data using the standard error of measurement (SEM) for the total self-compassion score on the SCS. The investigators defined meaningful change as a reduction in scores by at least one SEM. The mean difference from baseline to post-treatment was calculated.
The Self-Compassion Scale (SCS) is a 26-item self-report questionnaire that measures the cognitions and emotions associated with compassionate and uncompassionate responses to feelings of personal inadequacy and general life difficulties. Scores for negative items representing uncompassionate self-responding are reverse-coded to indicate their absence. Responses are given on a 5-point scale from "1-Almost Never" to "5-Almost Always." A total mean score is generated with higher scores corresponding to higher levels of self-compassion. Consider scores 1.0-2.49 to be low, between 2.5-3.5 to be moderate, and 3.51-5.0 to be high.
Outcome measures
| Measure |
Mindful Self-Compassion (MSC)
n=14 Participants
Mindful Self-Compassion Intervention
|
|---|---|
|
Self-Compassion Scale (SCS); Change From Baseline in Self-Compassion at Post-treatment
|
0.45 score on a scale
Standard Error 0.21
|
PRIMARY outcome
Timeframe: 1-Month Follow-up (12-14 weeks post baseline)Population: The investigators examined clinically meaningful change among treatment completers with complete pre- and post-treatment data using the standard error of measurement for the total self-compassion score on the SCS. The investigators defined meaningful change as a reduction in scores by at least one SEM. The mean difference from baseline to one-month follow-up was calculated.
The Self-Compassion Scale (SCS) is a 26-item self-report questionnaire that measures the cognitions and emotions associated with compassionate and uncompassionate responses to feelings of personal inadequacy and general life difficulties. Scores for negative items representing uncompassionate self-responding are reverse-coded to indicate their absence. Responses are given on a 5-point scale from "1-Almost Never" to "5-Almost Always." A total mean score is generated with higher scores corresponding to higher levels of self-compassion. Consider scores 1.0-2.49 to be low, between 2.5-3.5 to be moderate, and 3.51-5.0 to be high.
Outcome measures
| Measure |
Mindful Self-Compassion (MSC)
n=14 Participants
Mindful Self-Compassion Intervention
|
|---|---|
|
Self-Compassion Scale (SCS); Change From Baseline in Self-Compassion at 1 Month Follow-up
|
1.26 score on a scale
Standard Error 0.21
|
PRIMARY outcome
Timeframe: Post-Tx (8-10 weeks post baseline)Population: The investigators examined clinically meaningful change among treatment completers with complete pre- and post-treatment data using the standard error of measurement for the Distress subscale on the TRGI. The investigators defined meaningful change as a reduction in scores by at least one SEM. The mean difference from baseline to post-treatment was calculated.
The TRGI distress subscale is made up of 6 items (e.g., "I experience severe emotional distress when I think about what happened"). Respondents rate each statement using a 5-point Likert scale to indicate the degree to which they believe the statement is true about themselves (i.e., Extremely True=4, Very True=3, Somewhat True=2, Slightly True=1, or Never True=0). The items are summed and divided by 6 to create an average score raging from 0-4 with higher scores reflecting higher levels of distress.
Outcome measures
| Measure |
Mindful Self-Compassion (MSC)
n=14 Participants
Mindful Self-Compassion Intervention
|
|---|---|
|
Trauma-Related Guilt Inventory (TRGI) - Distress Scale; Change From Baseline in Trauma-related Guilt Distress at Post-treatment
|
-0.28 score on a scale
Standard Error 0.34
|
PRIMARY outcome
Timeframe: 1-Month Follow-up (12-14 weeks post baseline)Population: The investigators examined clinically meaningful change among treatment completers with complete pre- and post-treatment data using the standard error of measurement for the Distress subscale on the TRGI. The investigators defined meaningful change as a reduction in scores by at least one SEM. The mean difference from baseline to 1-month follow-up was calculated.
The TRGI distress subscale is made up of 6 items (e.g., "I experience severe emotional distress when I think about what happened"). Respondents rate each statement using a 5-point Likert scale to indicate the degree to which they believe the statement is true about themselves (i.e., Extremely True=4, Very True=3, Somewhat True=2, Slightly True=1, or Never True=0). The items are summed and divided by 6 to create an average score raging from 0-4 with higher scores reflecting higher levels of distress.
Outcome measures
| Measure |
Mindful Self-Compassion (MSC)
n=14 Participants
Mindful Self-Compassion Intervention
|
|---|---|
|
Trauma-Related Guilt Inventory (TRGI) - Distress Scale; Change From Baseline in Trauma-related Guilt at 1-Month Follow-up
|
-0.45 score on a scale
Standard Error 0.34
|
PRIMARY outcome
Timeframe: Post-Tx (8-10 weeks post baseline)Population: The investigators examined clinically meaningful change among treatment completers with complete pre- and post-treatment data using the standard error of measurement for the TRSI sum score. The investigators defined meaningful change as a reduction in scores by at least one SEM. The mean difference from baseline to post-treatment was calculated.
The TRSI is a 24-item self-report measure assessing trauma-related shame on a 4-point Likert scale (Not true of me=0, Somewhat true of me=1, Mostly true of me=2, Completely true of me=3). A total shame score is summed ranging from 0-72 which higher scores reflecting a greater level of trauma-related shame.
Outcome measures
| Measure |
Mindful Self-Compassion (MSC)
n=14 Participants
Mindful Self-Compassion Intervention
|
|---|---|
|
Trauma-Related Shame Inventory (TRSI); Change From Baseline in Trauma-related Shame at Post-treatment Follow-up
|
-5.94 score on a scale
Standard Error 3.04
|
PRIMARY outcome
Timeframe: 1-Month Follow-up (12-14 weeks post baseline)Population: The investigators examined clinically meaningful change among treatment completers with complete pre- and post-treatment data using the standard error of measurement for the TRSI sum score. The investigators defined meaningful change as a reduction in scores by at least one SEM. The mean difference from baseline to one-month follow-up was calculated.
The TRSI is a 24-item self-report measure assessing trauma-related shame on a 4-point Likert scale (Not true of me=0, Somewhat true of me=1, Mostly true of me=2, Completely true of me=3). A total shame score is summed ranging from 0-72 which higher scores reflecting a greater level of trauma-related shame.
Outcome measures
| Measure |
Mindful Self-Compassion (MSC)
n=14 Participants
Mindful Self-Compassion Intervention
|
|---|---|
|
Trauma Related Shame Inventory (TRSI); Change From Baseline in Trauma-related Shame at 1-Month Follow-up
|
-8.46 score on a scale
Standard Error 3.04
|
SECONDARY outcome
Timeframe: Post-Tx (8-10 weeks post baseline)Population: Clinically meaningful change among treatment completers with complete pre- and post-treatment data was examined using the standard error of measurement for the CAPS total severity sum score. The investigators defined meaningful change as a reduction in scores by at least one SEM. The mean difference from baseline to post-treatment for the CAPS total severity sum score was calculated.
The Clinician Administered PTSD Scale for DSM-5 (CAPS-5) is a semi-structured interview used to assess PTSD diagnostic criteria and severity. The CAPS assesses each of the 20 items from the DSM-5 criteria B, C, D, and E. The assessor combines information about frequency and intensity of an item into a single severity rating (0=Absent; 1=Mild/subthreshold; 2=Moderate/threshold; 3=Severe/markedly elevated; 4=Extreme/incapacitating). CAPS-5 total symptom severity score is calculated by summing severity scores for the 20 DSM-5 PTSD symptoms (range = 0-80). Similarly, CAPS-5 symptom cluster severity scores are calculated by summing the individual item severity scores for symptoms corresponding to a given DSM-5 cluster: Criterion B (items 1-5); Criterion C (items 6-7); Criterion D (items 8-14); and, Criterion E (items 15-20). Higher scores indicate worse PTSD symptoms.
Outcome measures
| Measure |
Mindful Self-Compassion (MSC)
n=14 Participants
Mindful Self-Compassion Intervention
|
|---|---|
|
Clinician Administered PTSD Scale for Diagnostic and Statistical Manual-5 (DSM-5); Change From Baseline in PTSD Symptoms at Post-Treatment
|
-5.86 score on a scale
Standard Error 4.28
|
SECONDARY outcome
Timeframe: 1-Month Follow-up (12-14 weeks post baseline)Population: Clinically meaningful change among treatment completers with complete pre- and post-treatment data was examined using the standard error of measurement for the CAPS total severity sum score. We defined meaningful change as a reduction in scores by at least one SEM. The mean difference from baseline to one-month post-treatment for the CAPS total severity sum score was calculated.
The Clinician Administered PTSD Scale for DSM-5 (CAPS-5) is a semi-structured interview used to assess PTSD diagnostic criteria and severity. The CAPS assesses each of the 20 items from the DSM-5 criteria B, C, D, and E. The assessor combines information about frequency and intensity of an item into a single severity rating (0=Absent; 1=Mild/subthreshold; 2=Moderate/threshold; 3=Severe/markedly elevated; 4=Extreme/incapacitating). CAPS-5 total symptom severity score is calculated by summing severity scores for the 20 DSM-5 PTSD symptoms (range = 0-80). Similarly, CAPS-5 symptom cluster severity scores are calculated by summing the individual item severity scores for symptoms corresponding to a given DSM-5 cluster: Criterion B (items 1-5); Criterion C (items 6-7); Criterion D (items 8-14); and, Criterion E (items 15-20). Higher scores indicate worse PTSD symptoms.
Outcome measures
| Measure |
Mindful Self-Compassion (MSC)
n=14 Participants
Mindful Self-Compassion Intervention
|
|---|---|
|
Clinician Administered PTSD Scale (CAPS-5); Change From Baseline in PTSD Symptoms at 1-Month Follow-up
|
-8.96 score on a scale
Standard Error 4.28
|
SECONDARY outcome
Timeframe: Post-Tx (8-10 weeks)Population: Clinically meaningful change among treatment completers with complete pre- and post-treatment data was examined using the standard error of measurement for days used alcohol (last 90 days; TLFB). The investigators defined meaningful change as a reduction in scores by at least one SEM. The mean difference from baseline to post-treatment for the days used alcohol was calculated.
The Timeline Follow-back (TLFB) is a drinking assessment method that obtains estimates of daily drinking. The TLFB evaluates alcohol and other substance use during the previous 90 days. Using a calendar, people provide retrospective estimates of their daily drinking over a specified time period. The TLFB was used to establish: days respondents used alcohol.
Outcome measures
| Measure |
Mindful Self-Compassion (MSC)
n=14 Participants
Mindful Self-Compassion Intervention
|
|---|---|
|
Timeline Follow-back; Change From Baseline in Days Used Alcohol (Past 90 Days) at Post-treatment
|
-24.30 days used alcohol
Standard Error 15.8
|
SECONDARY outcome
Timeframe: 1-Month Follow-up (12-14 weeks post baseline)Population: Clinically meaningful change among treatment completers with complete pre- and post-treatment data was examined using the standard error of measurement for days used alcohol (last 90 days; TLFB). The investigators defined meaningful change as a reduction in scores by at least one SEM. The mean difference from baseline to one-month follow-up for the days used alcohol was calculated.
The Timeline Follow-back (TLFB) is a drinking assessment method that obtains estimates of daily drinking. The TLFB evaluates alcohol and other substance use during the previous 90 days. Using a calendar, people provide retrospective estimates of their daily drinking over a specified time period. The TLFB was used to establish: number of days respondents used alcohol.
Outcome measures
| Measure |
Mindful Self-Compassion (MSC)
n=14 Participants
Mindful Self-Compassion Intervention
|
|---|---|
|
Timeline Follow-Back (TLFB); Change From Baseline in Days Used Alcohol (Past 90 Days) at 1 Month Follow Up
|
-26.20 days used alcohol
Standard Error 15.8
|
Adverse Events
Mindful Self-Compassion (MSC)
Serious adverse events
| Measure |
Mindful Self-Compassion (MSC)
n=26 participants at risk
Mindful Self-Compassion Intervention
|
|---|---|
|
General disorders
Hospitalization/Medical
|
3.8%
1/26 • Number of events 1 • Adverse event data were collected from participant enrollment (baseline) through one-month follow-up (approximately 12-14 weeks).
|
Other adverse events
| Measure |
Mindful Self-Compassion (MSC)
n=26 participants at risk
Mindful Self-Compassion Intervention
|
|---|---|
|
Psychiatric disorders
Incarceration
|
3.8%
1/26 • Number of events 1 • Adverse event data were collected from participant enrollment (baseline) through one-month follow-up (approximately 12-14 weeks).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place