Clinical trial NCT02283333: Treatment of Prolonged Grief Disorder in Combat Veterans
Official title: Treatment of Prolonged Grief Disorder in Combat Veterans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prolonged Grief Disorder
Keywords: Behavioral Activation
Therapeutic Exposure
Mental Health
Veterans
Complicated Grief
Military
Treatment
Cognitive Therapy
Bereavement
Complicated Bereavement
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2014-11-05
Enrollment: 155
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

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.

Primary outcomes:
measure: Inventory of Complicated Grief - Revised (ICG-R)
timeFrame: Baseline
measure: Inventory of Complicated Grief - Revised (ICG-R)
timeFrame: 8 weeks
measure: Inventory of Complicated Grief - Revised (ICG-R)
timeFrame: 3 months
measure: Inventory of Complicated Grief - Revised (ICG-R)
timeFrame: 6 months
Secondary outcomes:
measure: Beck Depression Inventory - II (BDI-II)
timeFrame: Baseline
measure: PTSD Checklist for DSM-5 (PCL 5)
timeFrame: Baseline
measure: Beck Depression Inventory - II (BDI-II)
timeFrame: 8 weeks
measure: Beck Depression Inventory - II (BDI-II)
timeFrame: 3 months
measure: Beck Depression Inventory - II (BDI-II)
timeFrame: 6 months
measure: PTSD Checklist for DSM-5 (PCL 5)
timeFrame: 8 weeks
measure: PTSD Checklist for DSM-5 (PCL 5)
timeFrame: 3 months
measure: PTSD Checklist for DSM-5 (PCL 5)
timeFrame: 6 months
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Ralph H. Johnson VA Medical Center, Charleston, SC
state: South Carolina
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Ralph H. Johnson VA Medical Center, Charleston, SC
name: Ron E. Acierno, PhD MS BA
role: PRINCIPAL_INVESTIGATOR
References: