Providence VA Medical Center, Providence, RI
Providence, Rhode Island, 02908, United States
NCT Number: NCT03681288
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Providence, Rhode Island, 02908, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Mindful Self-Compassion Intervention
Time frame: Post-Tx (8-10 weeks post baseline)
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.
Time frame: 1-Month Follow-up (12-14 weeks post baseline)
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.
Time frame: Post-Tx (8-10 weeks post baseline)
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.
Time frame: 1-Month Follow-up (12-14 weeks post baseline)
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.
Time frame: Post-Tx (8-10 weeks post baseline)
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.
Time frame: 1-Month Follow-up (12-14 weeks post baseline)
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.
Time frame: Post-Tx (8-10 weeks post baseline)
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.
Time frame: 1-Month Follow-up (12-14 weeks post baseline)
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.
Time frame: Post-Tx (8-10 weeks)
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.
Time frame: 1-Month Follow-up (12-14 weeks post baseline)
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.
VA Office of Research and Development
Fed
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