CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 155 enrolled
Drug / intervention
BATE-G +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02283333
NCT02283333N/ACompleted

Treatment of Prolonged Grief Disorder in Combat Veterans

VA Office of Research and Development·interventional·Posted Nov 5, 2014·Updated Feb 18, 2021

In Brief

A clinical study evaluating BATE-G and Standard Treatment for Prolonged Grief Disorder. Completed, enrolled 155 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedNov 5, 2014
Enrollment StartDec 1, 2014
Primary CompletionFeb 28, 2020
Study CompletionAug 31, 2020
TodayJul 2, 2026
Enrollment to primary: 5.2 yearsPosted 11.7 years ago

Interventions

BATE-Gbehavioral

Behavioral Activation and Therapeutic Exposure - Grief therapy is delivered in 7 weekly sessions to the participant.

Standard Treatmentbehavioral

Cognitive Restructuring and Supportive Grief Counseling is delivered in 7 weekly sessions to the participant.