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 range18 Years

SexALL

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

What they're measuring

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

Timeframe: Post-Tx (8-10 weeks post baseline)

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)

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)

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)

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)

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)

Trial details

NCT IDNCT03681288

SponsorVA Office of Research and Development

Sponsor typeFED

Study typeINTERVENTIONAL

Primary completion2021-02-26

Results submitted2022-06-01

View on ClinicalTrials.gov More Substance Use Disorder trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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

Timeframe: Post-Tx (8-10 weeks post baseline)

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)

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)

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)

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)

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)