Treatment of Prolonged Grief Disorder in Combat Veterans (PGD)

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 Overview

• Status: Completed
• Conditions: Prolonged Grief Disorder
• Intervention / Treatment: Behavioral: BATE-G; Behavioral: Standard Treatment

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.

• Study Type: Interventional
• Enrollment (Actual): 155
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29401-5799
      • Ralph H. Johnson VA Medical Center, Charleston, SC
    • Charleston, South Carolina, United States, 29401
      • Medical University of South Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BATE-G; Behavioral Activation and Therapeutic Exposure - Grief therapy are delivered in 7 weekly sessions to the participant.	Behavioral: BATE-G; Behavioral Activation and Therapeutic Exposure - Grief therapy is delivered in 7 weekly sessions to the participant.
Active Comparator: Standard Treatment; Cognitive Restructuring and Supportive Grief Counseling are 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inventory of Complicated Grief - Revised (ICG-R)	The Inventory of Complicated Grief (ICG) Revised is a self-report instrument that allows for the dimensional assessment of the severity of complicated grief symptoms. It has 34 items with scores ranging from 30 to 150. Min score 50; max score 143 indicated at baseline. Higher scores indicate worse outcomes.	Baseline
Inventory of Complicated Grief - Revised (ICG-R)	The Inventory of Complicated Grief (ICG) is a self-report instrument that allows for the dimensional assessment of the severity of complicated grief symptoms. It has 34 items with scores ranging from 30 to 150. Min score 33.31; max score 133 indicated at post. Higher scores indicate worse outcomes.	8 weeks
Inventory of Complicated Grief - Revised (ICG-R)	The Inventory of Complicated Grief (ICG) is a self-report instrument that allows for the dimensional assessment of the severity of complicated grief symptoms. It has 34 items with scores ranging from 30 to 150. Min score 31.97; max score 150 indicated at 3 month. Higher scores indicate worse outcomes.	3 months
Inventory of Complicated Grief - Revised (ICG-R)	The Inventory of Complicated Grief (ICG) is a self-report instrument that allows for the dimensional assessment of the severity of complicated grief symptoms. It has 34 items with scores ranging from 30 to 150. Min score 30; max score 141 indicated at 6 month. Higher scores indicate worse outcomes.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Beck Depression Inventory - II (BDI-II)	Beck Depression Inventory-II is a 21 item measure of depressive severity with scores ranging from 0 to 63. Min score 0; max score 61 indicated at baseline. Higher scores indicate worse outcomes.	Baseline
PTSD Checklist for DSM-5 (PCL 5)	The PCL-5 is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD with scores ranging from 0 to 80. The PCL-5 has a variety of purposes, including: monitoring symptom change during and after treatment, screening individuals for PTSD, and making a provisional PTSD diagnosis. Min score 2; max score 76 indicated at baseline. Higher scores indicate worse outcomes.	Baseline
Beck Depression Inventory - II (BDI-II)	Beck Depression Inventory-II is a 21 item measure of depressive severity with scores ranging from 0 to 63. Min score 0; max score 58 indicated at post. Higher scores indicate worse outcomes.	8 weeks
Beck Depression Inventory - II (BDI-II)	Beck Depression Inventory-II is a 21 item measure of depressive severity with scores ranging from 0 to 63. Min score 0; max score 52 indicated at 3 month. Higher scores indicate worse outcomes.	3 months
Beck Depression Inventory - II (BDI-II)	Beck Depression Inventory-II is a 21 item measure of depressive severity with scores ranging from 0 to 63. Min score 0; max score 58 indicated at 6 month. Higher scores indicate worse outcomes.	6 months
PTSD Checklist for DSM-5 (PCL 5)	The PCL-5 is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD with scores ranging from 0 to 80. The PCL-5 has a variety of purposes, including: monitoring symptom change during and after treatment, screening individuals for PTSD, and making a provisional PTSD diagnosis. Min score 0; max score 72 indicated at post. Higher scores indicate worse outcomes.	8 weeks
PTSD Checklist for DSM-5 (PCL 5)	The PCL-5 is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD with scores ranging from 0 to 80. The PCL-5 has a variety of purposes, including: monitoring symptom change during and after treatment, screening individuals for PTSD, and making a provisional PTSD diagnosis. Min score 0; max score 76 indicated at 3 month. Higher scores indicate worse outcomes.	3 months
PTSD Checklist for DSM-5 (PCL 5)	The PCL-5 is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD with scores ranging from 0 to 80. The PCL-5 has a variety of purposes, including: monitoring symptom change during and after treatment, screening individuals for PTSD, and making a provisional PTSD diagnosis. Min score 0; max score 76 indicated at 6 month. Higher scores indicate worse outcomes.	6 months

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Ron E. Acierno, PhD MS BA, Ralph H. Johnson VA Medical Center, Charleston, SC

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2014
• Primary Completion (Actual): February 28, 2020
• Study Completion (Actual): August 31, 2020

Study Registration Dates

• First Submitted: October 23, 2014
• First Submitted That Met QC Criteria: October 31, 2014
• First Posted (Estimate): November 5, 2014

Study Record Updates

• Last Update Posted (Actual): February 18, 2021
• Last Update Submitted That Met QC Criteria: January 29, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Behavioral Activation; Treatment; Mental Health; Veterans; Military; Cognitive Therapy; Complicated Grief; Bereavement; Therapeutic Exposure; Complicated Bereavement
• Additional Relevant MeSH Terms: Pathologic Processes; Disease
• Other Study ID Numbers: CLNA-001-14S; CX001102 (Other Grant/Funding Number: VA CSR&D)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No