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

NCT03681288 | Completed Results

• 2 other identifiers: D2893-P1I21RX002893-01A1
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Substance Use Disorder; Post-traumatic Stress Disorder; Moral Injury

Keywords

PTSD; substance use disorder; moral injury; self-compassion; mindfulness; Veterans

Outcome Measures

Primary Outcomes (6)

• Self-Compassion Scale (SCS); Change From Baseline in Self-Compassion at Post-treatment

  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.

  Post-Tx (8-10 weeks post baseline)

• Self-Compassion Scale (SCS); Change From Baseline in Self-Compassion at 1 Month Follow-up

  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.

  1-Month Follow-up (12-14 weeks post baseline)

• Trauma-Related Guilt Inventory (TRGI) - Distress Scale; Change From Baseline in Trauma-related Guilt Distress at Post-treatment

  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.

  Post-Tx (8-10 weeks post baseline)

• Trauma-Related Guilt Inventory (TRGI) - Distress Scale; Change From Baseline in Trauma-related Guilt at 1-Month Follow-up

  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.

  1-Month Follow-up (12-14 weeks post baseline)

• Trauma-Related Shame Inventory (TRSI); Change From Baseline in Trauma-related Shame at Post-treatment Follow-up

  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.

  Post-Tx (8-10 weeks post baseline)

• Trauma Related Shame Inventory (TRSI); Change From Baseline in Trauma-related Shame at 1-Month Follow-up

  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.

  1-Month Follow-up (12-14 weeks post baseline)

Secondary Outcomes (4)

• Clinician Administered PTSD Scale for Diagnostic and Statistical Manual-5 (DSM-5); Change From Baseline in PTSD Symptoms at Post-Treatment

  Post-Tx (8-10 weeks post baseline)

• Clinician Administered PTSD Scale (CAPS-5); Change From Baseline in PTSD Symptoms at 1-Month Follow-up

  1-Month Follow-up (12-14 weeks post baseline)

• Timeline Follow-back; Change From Baseline in Days Used Alcohol (Past 90 Days) at Post-treatment

  Post-Tx (8-10 weeks)

• Timeline Follow-Back (TLFB); Change From Baseline in Days Used Alcohol (Past 90 Days) at 1 Month Follow Up

  1-Month Follow-up (12-14 weeks post baseline)

Study Arms (1)

Mindful Self-Compassion

EXPERIMENTAL

Mindful Self-Compassion Intervention

Behavioral: Mindful Self-Compassion

Interventions

Mindful Self-Compassion BEHAVIORAL

Mindful Self-Compassion Intervention

Mindful Self-Compassion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• moral injury as captured by at least one "strongly agree" response on the Moral Injury Events Scale
• diagnosis of PTSD (within the last 30 days) confirmed by the Clinician Administered PTSD Scale (CAPS) with a total symptom score of 22 or more
• diagnosis of a substance use disorder confirmed by the Structured Clinical Interview for Diagnostic and Statistical Manual-5 (DSM-5) Section E (SCID-E) within the last year
• willing and able to provide informed consent
• not currently receiving trauma-focused treatment

You may not qualify if:

• individuals with an acute psychotic disorder or acute psychotic symptoms are not eligible if their symptoms are unstable and if they are not well connected with appropriate mental health services
• patients with a psychiatric hospitalization or suicide attempt within the past month will be excluded
• currently receiving trauma-focused treatment, e.g., (Prolonged Exposure (PE), Cognitive Processing Therapy (CPT), Cognitive Behavioral Therapy (CBT) for PTSD)
• Patients currently enrolled in trauma-focused treatment may be enrolled when they have completed the treatment if they remain interested and continue to have PTSD
• individuals with life-threatening or unstable medical illness. Diagnoses of mild cognitive impairment (e.g. mTBI) and other anxiety and depressive disorders will not be excluded because of their high comorbidity with PTSD and SUD

Sponsors & Collaborators

• VA Office of Research and Development: lead
• Providence VA Medical Center: collaborator

Study Sites (1)

Providence VA Medical Center, Providence, RI

Providence, Rhode Island, 02908, United States

Location

Related Publications (1)

• Eaton E, Capone C, Reese S, Shea MT, Serpa JG, Germer C. Mindful Self-Compassion for Veterans with Morally Injurious Experiences and Co-Occurring Posttraumatic Stress Disorder and Substance Use Disorder: A Feasibility Study. J Dual Diagn. 2025 Apr;21(2):87-98. doi: 10.1080/15504263.2025.2474953. Epub 2025 Apr 1.

  PMID: 40168188 DERIVED

MeSH Terms

Conditions

Substance-Related Disorders; Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders

Limitations and Caveats

1\) Sample size was small and consisted solely of male veterans. Future research should include more diverse samples to examine cultural and gender differences in treatment engagement and tolerability of MSC. 2) The current study lacks the experimental rigor associated with a randomized controlled trial. Findings regarding clinically meaningful change should be viewed as preliminary and in need of further study within the context of a larger efficacy trial.

Results Point of Contact

• Title: Erica Eaton, Ph.D.
• Organization: PROVIDENCE VAMC/ BROWN UNIVERSITY

erica_eaton@brown.edu

14012737100

Study Officials

• Erica M. Eaton, PhD

  Providence VA Medical Center, Providence, RI

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2018
• First Posted: September 24, 2018
• Study Start: July 8, 2019
• Primary Completion: February 26, 2021
• Study Completion: March 31, 2021
• Last Updated: June 21, 2024
• Results First Posted: June 21, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 6 months post publication
• Access Criteria: 6 months post publication

Locations

US (1)