N/A
N=26
Mindful Self Compassion for Combat Deployed Veterans With Moral Injury and Co-occurring PTSD-SUD
Substance Use Disorder · Post-traumatic Stress Disorder · Moral Injury
Bottom Line
View on ClinicalTrials.gov: NCT03681288 ↗Enrolled (actual)
26
Serious AEs
3.9%
Results posted
Jun 2024
Primary outcome: Primary: Self-Compassion Scale (SCS); Change From Baseline in Self-Compassion at Post-treatment — 0.45 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Mindful Self-Compassion (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Feb 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Self-Compassion Scale (SCS); Change From Baseline in Self-Compassion at Post-treatment |
0.45 | — |
| PRIMARY Self-Compassion Scale (SCS); Change From Baseline in Self-Compassion at 1 Month Follow-up |
1.26 | — |
| PRIMARY Trauma-Related Guilt Inventory (TRGI) - Distress Scale; Change From Baseline in Trauma-related Guilt Distress at Post-treatment |
-0.28 | — |
| PRIMARY Trauma-Related Guilt Inventory (TRGI) - Distress Scale; Change From Baseline in Trauma-related Guilt at 1-Month Follow-up |
-0.45 | — |
| PRIMARY Trauma-Related Shame Inventory (TRSI); Change From Baseline in Trauma-related Shame at Post-treatment Follow-up |
-5.94 | — |
| PRIMARY Trauma Related Shame Inventory (TRSI); Change From Baseline in Trauma-related Shame at 1-Month Follow-up |
-8.46 | — |
| SECONDARY Clinician Administered PTSD Scale for Diagnostic and Statistical Manual-5 (DSM-5); Change From Baseline in PTSD Symptoms at Post-Treatment |
-5.86 | — |
| SECONDARY Clinician Administered PTSD Scale (CAPS-5); Change From Baseline in PTSD Symptoms at 1-Month Follow-up |
-8.96 | — |
| SECONDARY Timeline Follow-back; Change From Baseline in Days Used Alcohol (Past 90 Days) at Post-treatment |
-24.30 | — |
| SECONDARY Timeline Follow-Back (TLFB); Change From Baseline in Days Used Alcohol (Past 90 Days) at 1 Month Follow Up |
-26.20 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT03681288). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.