Treatment of Prolonged Grief Disorder in Combat Veterans
NCT02283333 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 155
Last updated 2021-02-18
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.
Conditions
- Prolonged Grief Disorder
Interventions
- BEHAVIORAL
-
BATE-G
Behavioral Activation and Therapeutic Exposure - Grief therapy is delivered in 7 weekly sessions to the participant.
- BEHAVIORAL
-
Standard Treatment
Cognitive Restructuring and Supportive Grief Counseling is delivered in 7 weekly sessions to the participant.
Sponsors & Collaborators
-
VA Office of Research and Development
lead FED
Principal Investigators
-
Ron E. Acierno, PhD MS BA · Ralph H. Johnson VA Medical Center, Charleston, SC
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 21 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-12-01
- Primary Completion
- 2020-02-28
- Completion
- 2020-08-31
Countries
- United States
Study Locations
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