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

Post-traumatic Stress Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03681288
• Other study ID #: D2893-P
• Secondary ID: 1I21RX002893-01A
• Status: Completed
• Phase: N/A
• Start date: July 8, 2019
• Est. completion date: March 31, 2021

Study information

• Verified date: February 2024
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: March 31, 2021
• Est. primary completion date: February 26, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Moral Injury
• Post-traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic
• Substance Use Disorder
• Substance-Related Disorders
• Wounds and Injuries

Intervention

Behavioral:
• Mindful Self-Compassion
Mindful Self-Compassion Intervention

Locations

Country	Name	City	State
United States	Providence VA Medical Center, Providence, RI	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
VA Office of Research and Development	Providence VA Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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	Clinician Administered PTSD Scale for Diagnostic and Statistical Manual-5 (DSM-5); Change From Baseline in PTSD Symptoms at Post-Treatment	The Clinician Administered PTSD Scale for DSM-5 (CAPS-5) is a semi-structured interview used to assess PTSD diagnostic criteria and severity. The CAPS assesses each of the 20 items from the DSM-5 criteria B, C, D, and E. The assessor combines information about frequency and intensity of an item into a single severity rating (0=Absent; 1=Mild/subthreshold; 2=Moderate/threshold; 3=Severe/markedly elevated; 4=Extreme/incapacitating). CAPS-5 total symptom severity score is calculated by summing severity scores for the 20 DSM-5 PTSD symptoms (range = 0-80). Similarly, CAPS-5 symptom cluster severity scores are calculated by summing the individual item severity scores for symptoms corresponding to a given DSM-5 cluster: Criterion B (items 1-5); Criterion C (items 6-7); Criterion D (items 8-14); and, Criterion E (items 15-20). Higher scores indicate worse PTSD symptoms.	Post-Tx (8-10 weeks post baseline)
Secondary	Clinician Administered PTSD Scale (CAPS-5); Change From Baseline in PTSD Symptoms at 1-Month Follow-up	The Clinician Administered PTSD Scale for DSM-5 (CAPS-5) is a semi-structured interview used to assess PTSD diagnostic criteria and severity. The CAPS assesses each of the 20 items from the DSM-5 criteria B, C, D, and E. The assessor combines information about frequency and intensity of an item into a single severity rating (0=Absent; 1=Mild/subthreshold; 2=Moderate/threshold; 3=Severe/markedly elevated; 4=Extreme/incapacitating). CAPS-5 total symptom severity score is calculated by summing severity scores for the 20 DSM-5 PTSD symptoms (range = 0-80). Similarly, CAPS-5 symptom cluster severity scores are calculated by summing the individual item severity scores for symptoms corresponding to a given DSM-5 cluster: Criterion B (items 1-5); Criterion C (items 6-7); Criterion D (items 8-14); and, Criterion E (items 15-20). Higher scores indicate worse PTSD symptoms.	1-Month Follow-up (12-14 weeks post baseline)
Secondary	Timeline Follow-back; Change From Baseline in Days Used Alcohol (Past 90 Days) at Post-treatment	The Timeline Follow-back (TLFB) is a drinking assessment method that obtains estimates of daily drinking. The TLFB evaluates alcohol and other substance use during the previous 90 days. Using a calendar, people provide retrospective estimates of their daily drinking over a specified time period. The TLFB was used to establish: days respondents used alcohol.	Post-Tx (8-10 weeks)
Secondary	Timeline Follow-Back (TLFB); Change From Baseline in Days Used Alcohol (Past 90 Days) at 1 Month Follow Up	The Timeline Follow-back (TLFB) is a drinking assessment method that obtains estimates of daily drinking. The TLFB evaluates alcohol and other substance use during the previous 90 days. Using a calendar, people provide retrospective estimates of their daily drinking over a specified time period. The TLFB was used to establish: number of days respondents used alcohol.	1-Month Follow-up (12-14 weeks post baseline)