Mindful Self Compassion for Combat Deployed Veterans With Moral Injury and Co-occurring PTSD-SUD (NCT03681288) | Clinical Trial Compass
CompletedNot Applicable
Mindful Self Compassion for Combat Deployed Veterans With Moral Injury and Co-occurring PTSD-SUD
United States34 participantsStarted 2019-07-08
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Self-Compassion Scale (SCS); Change From Baseline in Self-Compassion at Post-treatment
Timeframe: Post-Tx (8-10 weeks post baseline)
2
Self-Compassion Scale (SCS); Change From Baseline in Self-Compassion at 1 Month Follow-up
Timeframe: 1-Month Follow-up (12-14 weeks post baseline)
3
Trauma-Related Guilt Inventory (TRGI) - Distress Scale; Change From Baseline in Trauma-related Guilt Distress at Post-treatment
Timeframe: Post-Tx (8-10 weeks post baseline)
4
Trauma-Related Guilt Inventory (TRGI) - Distress Scale; Change From Baseline in Trauma-related Guilt at 1-Month Follow-up
Timeframe: 1-Month Follow-up (12-14 weeks post baseline)
5
Trauma-Related Shame Inventory (TRSI); Change From Baseline in Trauma-related Shame at Post-treatment Follow-up
Timeframe: Post-Tx (8-10 weeks post baseline)
6
Trauma Related Shame Inventory (TRSI); Change From Baseline in Trauma-related Shame at 1-Month Follow-up
Timeframe: 1-Month Follow-up (12-14 weeks post baseline)