Clinical trial NCT03681288: Mindful Self Compassion for Combat Deployed Veterans With Moral Injury and Co-occurring PTSD-SUD
Official title: Mindful Self Compassion for Combat Deployed Veterans With Moral Injury and Co-occurring PTSD-SUD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Substance Use Disorder
Post-traumatic Stress Disorder
Moral Injury
Keywords: PTSD
substance use disorder
moral injury
self-compassion
mindfulness
Veterans
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: Providence VA Medical Center
First posted: 2018-09-24
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: PTSD-SUD is particularly common following combat exposure, affecting a rapidly increasing number of U.S. military Veterans. The co-occurrence of these disorders presents added challenges to the VA treatment delivery system, presently in need of effective integrated treatments. Veterans with PTSD-SUD experience more severe symptomatology, increased risk of suicidality, poorer quality of life, and poorer response to existing treatments than Veterans with either disorder alone. Furthermore, PTSD-SUD prevents Veterans from reintegrating into society and is associated with occupational and social dysfunction. These findings underscore the need to effectively and efficiently address comorbidity and the complex array of problems with which Veterans present to treatment.

One approach is to develop interventions that target mechanisms thought to underlie multiple highly prevalent disorders, such as guilt related to traumatic experiences. 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. Veterans who negatively appraise their actions or inaction during combat may experience guilt, a common posttraumatic reaction. Moral injury suggests the inability to contextualize or justify actions and the unsuccessful accommodation of those morally challenging experiences into pre-existing moral schemas, resulting in guilt and shame. Posttraumatic guilt has been implicated as a risk factor for the development and maintenance of several forms of psychopathology including PTSD, SUD, depression, and suicidality. However, to date, treatments for posttraumatic psychological health issues have been primarily disorder specific, with a focus largely on symptom reduction. Therefore, greater understanding of modifiable factors that influence functional impairment and PTSD-SUD is needed to enhance treatment efforts.

Mindful Self Compassion (MSC) combines the skills of mindfulness and self-compassion, providing self-soothing skills to respond to difficult thoughts and feelings (including guilt) via meditation. Self-compassion (SC) emphasizes kindness towards one's self, a feeling of connectedness with others, and mindful awareness of distressing experiences. Furthermore, because SC is negatively associated with self-criticism, rumination, thought suppression, anxiety, and depression, and positively associated with healthy psychological functioning, it is well suited to addressing posttraumatic psychopathology, shame, and guilt.

This proposal will begin to address a gap in the field's knowledge about MSC, and its role in the treatment of co-occurring disorders in Veterans with moral injury. The investigators will evaluate changes in self-compassion, post-traumatic guilt, shame, PTSD and substance use symptom severity. In addition to symptom reduction, the investigators will focus on functional outcomes (e.g., quality of life, suicidality). Participants will complete assessments at baseline, post-treatment, and 1-month follow-up. This project will allow us to 1) determine the feasibility of recruitment, 2) determine the acceptability of MSC, 3) provide preliminary evidence of the effects of MSC, and 4) refine study procedures and make adaptations to MSC based upon experience gained in the pilot in preparation for a fully powered randomized control trial (RCT) to test the effectiveness of MSC.

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

Primary outcomes:
measure: Self-Compassion Scale (SCS); Change From Baseline in Self-Compassion at Post-treatment
timeFrame: Post-Tx (8-10 weeks post baseline)
measure: 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)
measure: 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)
measure: 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)
measure: 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)
measure: 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)
Secondary outcomes:
measure: Clinician Administered PTSD Scale for Diagnostic and Statistical Manual-5 (DSM-5); Change From Baseline in PTSD Symptoms at Post-Treatment
timeFrame: Post-Tx (8-10 weeks post baseline)
measure: Clinician Administered PTSD Scale (CAPS-5); Change From Baseline in PTSD Symptoms at 1-Month Follow-up
timeFrame: 1-Month Follow-up (12-14 weeks post baseline)
measure: Timeline Follow-back; Change From Baseline in Days Used Alcohol (Past 90 Days) at Post-treatment
timeFrame: Post-Tx (8-10 weeks)
measure: Timeline Follow-Back (TLFB); Change From Baseline in Days Used Alcohol (Past 90 Days) at 1 Month Follow Up
timeFrame: 1-Month Follow-up (12-14 weeks post baseline)
Other outcomes:
Locations:
city: Providence
country: United States
facility: Providence VA Medical Center, Providence, RI
state: Rhode Island
Study officials:
affiliation: Providence VA Medical Center, Providence, RI
name: Erica M. Eaton, PhD
role: PRINCIPAL_INVESTIGATOR
References: