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NCT02283333 · ClinicalTrials.gov registry record · NA
Treatment of Prolonged Grief Disorder in Combat Veterans
A NA study of Prolonged Grief Disorder, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- NA
- Development phase
- 155
- Enrollment target
- 2
- Study locations
NCT02283333: Completed NA study of Prolonged Grief Disorder, sponsored by VA Office of Research and Development.
NCT02283333 is a NA study of Prolonged Grief Disorder that has completed, run by VA Office of Research and Development. The registered enrollment target is 155 participants, roughly in line with the 160-participant average among 3 other Prolonged Grief Disorder trials with a reported enrollment target. The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02283333, a NA study of Prolonged Grief Disorder, has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- NA
- Development phase
- 155 participants
- Enrollment target
- 2
- Study locations
Study Summary
The purpose of this study is to compare the efficacy of an experimental treatment (termed BATE-G) for Prolonged Grief Disorder (PGD) in Veterans compared to the current, VA-approved standard of care treatment. Currently, treatments for grief in Veterans remain understudied. Our research group has recently completed pilot work on an innovative, technology-leveraged treatment protocol for PGD that combines Behavioral Activation with Therapeutic Exposure (BATE) and appears readily applicable to the Veteran and Military populations. Per the VA / DoD Iraq War Clinician Guide, 2nd ed., the current standard of treatment is Cognitive Restructuring and Supportive Grief Counseling. The study will enroll 140 Veterans, aged 21 years and older, who served in any combat era. All Veterans will meet criteria for PGD. There will be assessments at baseline, 1 week, 3 months, and 6 months post treatment. During the treatment phase, Veterans will undergo 7 weekly sessions of either BATE-G or standard treatment. Sessions 2-6 will be delivered via televideo to the Veteran's home. We hypothesize that BATE-G will be more effective than standard treatment in reducing symptoms of PGD, both at post-treatment and follow-up. Moreover, BATE-G will be more effective in reducing acute emotional distress and preventing long-term emotional distress in terms of general depression and anxiety symptoms. BATE-G will result in increased frequency of completed positively reinforcing, community-based events when compared to Cognitive Restructuring and Supportive Grief Counseling. BATE-G will also result in greater improvements in perceived social support and health. Note: This project is the first evidence-based treatment for PGD in military populations, thus addressing a significant service gap.
Primary Outcome
The Inventory of Complicated Grief (ICG) Revised is a self-report instrument that allows for the dimensional assessment of the severity of complicated grief symptoms. It has 34 items with scores ranging from 30 to 150. Min score 50; max score 143 indicated at baseline. Higher scores indicate worse outcomes.
Conditions Studied
Interventions
- BEHAVIORAL Standard Treatment
- BEHAVIORAL BATE-G
Study Locations (2)
South Carolina
- Ralph H. Johnson VA Medical Center, Charleston, SC - Charleston
- Medical University of South Carolina - Charleston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 155 participants |
| Start Date | 2014-12-01 |
| Est. Completion | 2020-08-31 |
| Phase | NA |
What the finished NCT02283333 record still lists
NCT02283333 is an interventional study that assigns participants to a tested intervention. The registered 155 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 160-participant average among 3 other Prolonged Grief Disorder trials with a reported enrollment target.
The record links to 1 condition, with Prolonged Grief Disorder appearing as the primary indexed condition, and to 2 interventions - of which Standard Treatment is the first listed.
NCT02283333 reports a single indexed study location in South Carolina.
Frequently Asked Questions
What is clinical trial NCT02283333 about?
NCT02283333 is a clinical study titled "Treatment of Prolonged Grief Disorder in Combat Veterans". The purpose of this study is to compare the efficacy of an experimental treatment (termed BATE-G) for Prolonged Grief Disorder (PGD) in Veterans compared to the current, VA-approved standard of care treatment. Currently, treatments for grief in Veterans remain understudied. Our research group has re...
What is the current status of trial NCT02283333?
This trial is currently completed. It is a NA study. The enrollment target is 155 participants. The study started on 2014-12-01. Estimated completion is 2020-08-31.
What conditions does trial NCT02283333 study?
This clinical trial studies the following conditions: Prolonged Grief Disorder.
What interventions are being tested in trial NCT02283333?
The interventions under investigation include: Standard Treatment (BEHAVIORAL), BATE-G (BEHAVIORAL).
Who is sponsoring clinical trial NCT02283333?
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 NCT02283333 being conducted?
This trial has 2 study locations across South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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