N/A
N=155
Treatment of Prolonged Grief Disorder in Combat Veterans
Prolonged Grief Disorder
Bottom Line
View on ClinicalTrials.gov: NCT02283333 ↗Enrolled (actual)
155
Serious AEs
0.7%
Results posted
Feb 2021
Primary outcome: Primary: Inventory of Complicated Grief - Revised (ICG-R) — 93.15; 93.10 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- BATE-G (Behavioral); Standard Treatment (Behavioral)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Feb 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Inventory of Complicated Grief - Revised (ICG-R) |
78.6; 80.0 | — |
| PRIMARY Inventory of Complicated Grief - Revised (ICG-R) |
78.6; 80.0 | — |
| PRIMARY Inventory of Complicated Grief - Revised (ICG-R) |
78.6; 80.0 | — |
| PRIMARY Inventory of Complicated Grief - Revised (ICG-R) |
78.6; 80.0 | — |
| SECONDARY Beck Depression Inventory - II (BDI-II) |
21.1; 23.4 | — |
| SECONDARY PTSD Checklist for DSM-5 (PCL 5) |
33.3; 36.0 | — |
| SECONDARY Beck Depression Inventory - II (BDI-II) |
21.1; 23.4 | — |
| SECONDARY Beck Depression Inventory - II (BDI-II) |
21.1; 23.4 | — |
| SECONDARY Beck Depression Inventory - II (BDI-II) |
21.1; 23.4 | — |
| SECONDARY PTSD Checklist for DSM-5 (PCL 5) |
33.3; 36.0 | — |
| SECONDARY PTSD Checklist for DSM-5 (PCL 5) |
33.3; 36.0 | — |
| SECONDARY PTSD Checklist for DSM-5 (PCL 5) |
33.3; 36.0 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Participants may be either Active Duty Service Personnel/Veterans of any service era.
- Participants may be male or female,
- age 21 and above,
- with a diagnosis of Prolonged Grief Disorder.
- Veterans starting a new psychotropic medication at baseline will be asked to wait 4 weeks for medication stabilization before starting the study.
Exclusion Criteria
- Actively psychotic or demented persons,
- Individuals with both suicidal ideation and clear intent,
- Individuals with homicidal ideation and or intent,
- Individuals meeting criteria for substance dependence,
- Individuals who cannot or are unwilling to schedule regular weekly appointments (with the exception of Veterans who have medical and/or transportation barriers,
- Individuals who are already enrolled in another trial for PTSD and/or depression will be excluded.
Data sourced from ClinicalTrials.gov (NCT02283333). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.