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NCT03681288 · ClinicalTrials.gov registry record · NA
Mindful Self Compassion for Combat Deployed Veterans With Moral Injury and Co-occurring PTSD-SUD
A NA study of Post Traumatic Stress Disorder and Substance Use Disorder, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- NA
- Development phase
- 34
- Enrollment target
- 1
- Study location
NCT03681288: Completed NA study of Post Traumatic Stress Disorder and Substance Use Disorder, sponsored by VA Office of Research and Development.
NCT03681288 is a NA study of Post Traumatic Stress Disorder and Substance Use Disorder that has completed, run by VA Office of Research and Development. The registered enrollment target is 34 participants, below the 664-participant average among 262 other Post Traumatic Stress Disorder trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03681288, a NA study of Post Traumatic Stress Disorder and Substance Use Disorder, has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- NA
- Development phase
- 34 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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 correspondi
Conditions Studied
Interventions
- BEHAVIORAL Mindful Self-Compassion
Study Locations (1)
Rhode Island
- Providence VA Medical Center, Providence, RI - Providence
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2019-07-08 |
| Est. Completion | 2021-03-31 |
| Phase | NA |
What the finished NCT03681288 record still lists
NCT03681288 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 664-participant average among 262 other Post Traumatic Stress Disorder trials with a reported enrollment target (95% lower).
The record links to 3 conditions, with Post Traumatic Stress Disorder appearing as the primary indexed condition, and to 1 intervention - of which Mindful Self-Compassion is the first listed.
NCT03681288 reports a single indexed study location in Rhode Island.
Frequently Asked Questions
What is clinical trial NCT03681288 about?
NCT03681288 is a clinical study titled "Mindful Self Compassion for Combat Deployed Veterans With Moral Injury and Co-occurring PTSD-SUD". 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 ...
What is the current status of trial NCT03681288?
This trial is currently completed. It is a NA study. The enrollment target is 34 participants. The study started on 2019-07-08. Estimated completion is 2021-03-31.
What conditions does trial NCT03681288 study?
This clinical trial studies the following conditions: Post Traumatic Stress Disorder, Substance Use Disorder, Moral Injury.
What interventions are being tested in trial NCT03681288?
The interventions under investigation include: Mindful Self-Compassion (BEHAVIORAL).
Who is sponsoring clinical trial NCT03681288?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03681288 being conducted?
This trial has 1 study location across Rhode Island. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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