Treatment of Prolonged Grief Disorder in Combat Veterans

NCT02283333 | Completed Results

• 2 other identifiers: CLNA-001-14SCX001102
• Study Type: interventional
• Target: 155
• Locations: 1 country
• Sites: 2

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.

Conditions

Prolonged Grief Disorder

Keywords

Behavioral Activation; Therapeutic Exposure; Mental Health; Veterans; Complicated Grief; Military; Treatment; Cognitive Therapy; Bereavement; Complicated Bereavement

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (8)

• Beck Depression Inventory - II (BDI-II)

  Baseline

• PTSD Checklist for DSM-5 (PCL 5)

  Baseline

• Beck Depression Inventory - II (BDI-II)

  8 weeks

• Beck Depression Inventory - II (BDI-II)

  3 months

• Beck Depression Inventory - II (BDI-II)

  6 months

Study Arms (2)

BATE-G

EXPERIMENTAL

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

Behavioral: BATE-G

Standard Treatment

ACTIVE COMPARATOR

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

Behavioral: Standard Treatment

Interventions

BATE-G BEHAVIORAL

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

BATE-G

Standard Treatment BEHAVIORAL

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

Standard Treatment

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (2)

Ralph H. Johnson VA Medical Center, Charleston, SC

Charleston, South Carolina, 29401-5799, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29401, United States

Location

MeSH Terms

Conditions

Prolonged Grief Disorder; Psychological Well-Being

Condition Hierarchy (Ancestors)

Trauma and Stressor Related Disorders; Mental Disorders; Personal Satisfaction; Behavior

Results Point of Contact

• Title: Dr. Ron Acierno, PI
• Organization: Ralph H. Johnson VA Medical Center

ron.acierno@va.gov

843-364-1667

Study Officials

• Ron E. Acierno, PhD MS BA

  Ralph H. Johnson VA Medical Center, Charleston, SC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2014
• First Posted: November 5, 2014
• Study Start: December 1, 2014
• Primary Completion: February 28, 2020
• Study Completion: August 31, 2020
• Last Updated: February 18, 2021
• Results First Posted: February 18, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)