NCT03681288

Mindful Self Compassion for Combat Deployed Veterans With Moral Injury and Co-occurring PTSD-SUD

Completed NA Results posted Last updated 21 June 2024

What this trial tests

NA trial testing Mindful Self-Compassion in Substance Use Disorder in 34 participants. Completed in 31 March 2021.

Timeline

8 July 2019

Primary endpoint
26 February 2021

31 March 2021

Quick facts

Lead sponsor	VA Office of Research and Development
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	34
Start date	8 July 2019
Primary completion	26 February 2021
Estimated completion	31 March 2021
Sites	1 location across United States

Drugs / interventions tested

• Mindful Self-Compassion

Conditions studied

• Substance Use Disorder — all drugs for Substance Use Disorder →
• Post-traumatic Stress Disorder — all drugs for Post-traumatic Stress Disorder →
• Moral Injury — all drugs for Moral Injury →

Sponsor

VA Office of Research and Development — full company profile →

Who can join

18 and older, any sex, with Substance Use Disorder or Post-traumatic Stress Disorder. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Self-Compassion Scale (SCS); Change From Baseline in Self-Compassion at Post-treatment Primary · Post-Tx (8-10 weeks post baseline)

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 mo

Group	Value	95% CI
Mindful Self-Compassion (MSC)	0.45	± 0.21

Self-Compassion Scale (SCS); Change From Baseline in Self-Compassion at 1 Month Follow-up Primary · 1-Month Follow-up (12-14 weeks post baseline)

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 mo

Group	Value	95% CI
Mindful Self-Compassion Intervention	1.26	± 0.21

Trauma-Related Guilt Inventory (TRGI) - Distress Scale; Change From Baseline in Trauma-related Guilt Distress at Post-treatment Primary · Post-Tx (8-10 weeks post baseline)

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.

Group	Value	95% CI
Mindful Self-Compassion (MSC)	-0.28	± 0.34

Trauma-Related Guilt Inventory (TRGI) - Distress Scale; Change From Baseline in Trauma-related Guilt at 1-Month Follow-up Primary · 1-Month Follow-up (12-14 weeks post baseline)

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.

Group	Value	95% CI
Mindful Self-Compassion Intervention	-0.45	± 0.34

Trauma-Related Shame Inventory (TRSI); Change From Baseline in Trauma-related Shame at Post-treatment Follow-up Primary · Post-Tx (8-10 weeks post baseline)

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.

Group	Value	95% CI
Mindful Self-Compassion Intervention	-5.94	± 3.04

Trauma Related Shame Inventory (TRSI); Change From Baseline in Trauma-related Shame at 1-Month Follow-up Primary · 1-Month Follow-up (12-14 weeks post baseline)

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.

Group	Value	95% CI
Mindful Self-Compassion Intervention	-8.46	± 3.04

Clinician Administered PTSD Scale for Diagnostic and Statistical Manual-5 (DSM-5); Change From Baseline in PTSD Symptoms at Post-Treatment Secondary · Post-Tx (8-10 weeks post baseline)

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 severit

Group	Value	95% CI
Mindful Self-Compassion Intervention	-5.86	± 4.28

Clinician Administered PTSD Scale (CAPS-5); Change From Baseline in PTSD Symptoms at 1-Month Follow-up Secondary · 1-Month Follow-up (12-14 weeks post baseline)

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 severit

Group	Value	95% CI
Mindful Self-Compassion Intervention	-8.96	± 4.28

Timeline Follow-back; Change From Baseline in Days Used Alcohol (Past 90 Days) at Post-treatment Secondary · Post-Tx (8-10 weeks)

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.

Group	Value	95% CI
Mindful Self-Compassion Intervention	-24.30	± 15.8

Timeline Follow-Back (TLFB); Change From Baseline in Days Used Alcohol (Past 90 Days) at 1 Month Follow Up Secondary · 1-Month Follow-up (12-14 weeks post baseline)

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.

Group	Value	95% CI
Mindful Self-Compassion Intervention	-26.20	± 15.8

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse event data were collected from participant enrollment (baseline) through one-month follow-up (approximately 12-14 weeks).. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Mindful Self-Compassion (MSC)

Serious: 1/26 (4%)

Deaths: 2/26

Serious adverse events (1 terms)

Reaction	System	Mindful Self-Compassion (M…
Hospitalization/Medical	General disorders	—

Other adverse events (1 terms — click to expand)

Reaction	System	Mindful Self-Compassion (M…
Incarceration	Psychiatric disorders	—

Most-reported serious reactions: Hospitalization/Medical.

Data from ClinicalTrials.gov NCT03681288 adverse events section.

Sponsor's own description

Veterans with co-occurring Posttraumatic Stress Disorder and Substance Use Disorder (PTSD-SUD) experience more severe symptomatology and poorer response to existing treatments than Veterans with either disorder alone. Guilt is a common posttraumatic reaction and has been implicated as a risk factor for the development and maintenance of PTSD and substance use. Combat Veterans often report experiencing moral injury defined as perpetrating, failing to prevent, or witnessing acts that violate the values they live by in their civilian lives, which can lead to feelings of guilt and shame. Accordingly, reduction in guilt and increase in self-compassion may lead to improved quality of life for Veterans. This project will conduct a pilot study to evaluate changes in self-compassion, guilt, and PTSD-SUD symptom severity in a sample of Veterans after receiving 8 sessions of Mindful Self Compassion treatment (via a telehealth modality during COVID-19 pandemic). Findings will have significant impact on effective treatment options and lead to improvements in Veterans' quality of life and posttraumatic symptoms.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Mindful Self-Compassion for Veterans with Morally Injurious Experiences and Co-Occurring Posttraumatic Stress Disorder and Substance Use Disorder: A Feasibility Study.
   Eaton E, Capone C, Reese S, Shea MT, et al · · 2025 · cited 1× · PMID 40168188 · DOI 10.1080/15504263.2025.2474953