Post-traumatic Stress Disorder Clinical Trial
Official title:
Mindful Self Compassion for Combat Deployed Veterans With Moral Injury and Co-occurring PTSD-SUD
Verified date | April 2021 |
Source | VA Office of Research and Development |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 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., (PE, CPT, 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 |
Country | Name | City | State |
---|---|---|---|
United States | Providence VA Medical Center, Providence, RI | Providence | Rhode Island |
Lead Sponsor | Collaborator |
---|---|
VA Office of Research and Development | Providence VA Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Beck Scale for Suicidal Ideation; Change from baseline in suicidal risk at post-treatment (2 mo) and follow up (3mo) | Beck Scale for Suicidal Ideation (BSSI): This scale is a 19-items instrument that evaluates the presence and intensity of suicidal thoughts in a week before evaluation (19). Each item is scored based on an ordinal scale from 0 to 2 and the total score is 0 to 38 with higher score indicating more risk for suicide. | Baseline, 8-10 weeks, 12-14 weeks | |
Primary | Self-Compassion Scale (SCS); Change from baseline in Self-Compassion at post-treatment (2 mo) and follow up (3mo) | The SCS is a 26-item self-report questionnaire in which respondents describe how they relate to themselves during times of distress. The SCS includes the 5 item Self-Kindness subscale (ranging from 5-25; higher scores reflect more self-kindness), the 5-item Self-Judgment subscale (ranging from 5-25; higher scores reflect more self-judgment), the 4-item Common Humanity subscale (ranging from 4-20; higher scores reflect higher levels of common humanity), the 4-item Isolation subscale (ranging from 4-20; higher scores indicate higher levels of isolation), the 4-item Mindfulness subscale (ranging from 4-20; higher scores reflect higher levels of mindfulness) and the 4-item Over-Identification subscale (ranging from 4-20). Responses are given on a 5-point scale from "1-Almost Never" to "5-Almost Always." Mean scores on the six subscales are then averaged to create an overall self-compassion score ranging from 26 to 130. Higher scores correspond to higher levels of self-compassion. | Baseline, 8-10 weeks, 12-14 weeks | |
Primary | Trauma-Related Guilt Inventory (TRGI); Change from baseline in trauma-related guilt at post-treatment (2 mo) and follow up (3mo) | The TRGI is a 32-item validated self-report measure assessing traumatic guilt. The TRGI has three scales - Guilt Severity, Distress, and Guilt Cognitions. In all 32 items the answers are recorded on 5-point scale (ranging from 0 - not at all true to 4 - extremely true). Eight items are reverse-scored. We will use the TRGI as one of our eligibility criteria and to monitor changes in guilt and related cognitions over time. | Baseline, 8-10 weeks, 12-14 weeks | |
Primary | Internalized Shame Scale (ISS); Change from baseline in shame at post-treatment (2 mo) and follow up (3mo) | The ISS is a 30-item self-report measure assessing shame proneness scored on a 5-point Likert scale ranging from 0 = "never" to 4 = "almost always". The ISS yields sum scores for two subscales, self-esteem (6 items; range = 0-24 with higher scores reflecting higher levels of self-esteem) and internalized shame (24 items; range = 0-96 with higher scores reflecting higher levels of shame) and has been well-validated with research and clinical populations. The self-esteem items are interspersed to counteract a negative response set. | Baseline, 8-10 weeks, 12-14 weeks | |
Secondary | Clinician Administered PTSD Scale for DSM-5; Change from baseline in PTSD symptoms at post-treatment (2 mo) and follow up (3mo) | The CAPS is a semi-structured interview used to assess PTSD diagnostic criteria and severity. Respondents select up to three of the most traumatic events they have experienced, and those events are used as the basis for assessing PTSD symptoms. 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 = 0-40). 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). | Baseline, 8-10 weeks, 12-14 weeks | |
Secondary | Quality Of Life Enjoyment & Satisfaction Questionnaire (WHO-QOL-BREF); Change from baseline in quality of life at post-treatment (2 mo) and follow up (3mo) | The WHO-QOL BREF is a 26-item validated self-report measure that that assesses quality of life across four domains: physical (7 items, range 1-5), psychological (6 items, range 1-5), social relationships (3 items, range 1-5), and environment (8 items, range 1-5). The four domain scores denote an individual's perception of quality of life in each particular domain. The mean score of items within each domain is used to calculate the domain score. Domain scores are scaled in a positive direction (i.e. higher scores denote higher quality of life). There are also two items that are examined separately: question 1 asks about an individual's overall perception of quality of life on a scale of 1 - "very poor" to 5 - "very good". Question 2 asks about an individual's overall perception of their health on a scale of 1 - "very dissatisfied" to 5 - "very satisfied". The WHO-QOL-BREF has excellent internal validity and test-retest reliability. |
Baseline, 8-10 weeks, 12-14 weeks | |
Secondary | Timeline Follow-back; Change from baseline in frequency of substance use at post-treatment (2 mo) and follow up (3mo) | The Alcohol TLFB is a drinking assessment method that obtains estimates of daily drinking. The TLFB will be employed at all three assessment points to evaluate alcohol and other substance use during the 90 days preceding each interview. Using a calendar, people provide retrospective estimates of their daily drinking over a specified time period. The TLFB will be used at each follow-up to establish: percentage days heavy drinking, percent days abstinent, length of initial abstinence, length of use episodes, severity of relapse and current alcohol/drug use pattern. The Alcohol TLFB has been shown to have good psychometric characteristics with a variety of groups, and can generate variables that provide a wide range of information about an individual's use (e.g., pattern, variability, and magnitude of use). | Baseline, 8-10 weeks, 12-14 weeks |
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