Treatment of Prolonged Grief Disorder in Combat Veterans



Status:Recruiting
Healthy:No
Age Range:21 - Any
Updated:1/5/2019
Start Date:December 1, 2014
End Date:September 30, 2019
Contact:Ron E Acierno, PhD MS BA
Email:Ron.Acierno@va.gov
Phone:(843) 789-7246

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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.

The 'dual burden' of (a) loss of a fellow service member in the context of (b) experiencing
repeated extreme life threat is unique to military combat personnel and a core characteristic
of combat-related Prolonged Grief Disorder (PGD), a disorder as prevalent as Post-traumatic
stress disorder and associated with functional impairment, disability, and suicidality.
Effective treatments for depression and PTSD have proven less than adequate in treating PGD
when each is offered in isolation; and simply combining these 12-16 week treatment regimens
into a 24-36 week treatments is not a viable approach, particularly with a population
predisposed to avoiding extended mental health care. This project addresses the need for a
Veteran/ military specific treatment of PGD, and uses technology to deliver this treatment in
a format that is far more likely to be accepted by military personnel and Veterans. This
study will impact clinical practice by providing the first evidence for effective treatment
of PGD in Veterans.

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.
We found this trial at
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sites
Charleston, South Carolina 29401
Principal Investigator: Ron E. Acierno, PhD MS BA
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Phone: 843-789-6519
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