NCT02283333: PGD

Treatment of Prolonged Grief Disorder in Combat Veterans

Completed NA Results posted Last updated 18 February 2021

What this trial tests

NA trial testing BATE-G in Prolonged Grief Disorder in 155 participants. Completed in 31 August 2020.

Timeline

1 December 2014

Primary endpoint
28 February 2020

31 August 2020

Quick facts

Lead sponsor	VA Office of Research and Development
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	155
Start date	1 December 2014
Primary completion	28 February 2020
Estimated completion	31 August 2020
Sites	2 locations across United States

Drugs / interventions tested

• BATE-G
• Standard Treatment

Conditions studied

• Prolonged Grief Disorder — all drugs for Prolonged Grief Disorder →

Sponsor

VA Office of Research and Development — full company profile →

Who can join

21 and older, any sex, with Prolonged Grief Disorder. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Inventory of Complicated Grief - Revised (ICG-R) Primary · Baseline

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.

Group	Value	95% CI
BATE-G	93.15	± 19.79
Standard Treatment	93.10	± 21.59

Inventory of Complicated Grief - Revised (ICG-R) Primary · 8 weeks

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.

Group	Value	95% CI
BATE-G	78.8	± 19.4
Standard Treatment	78.6	± 21.2

Inventory of Complicated Grief - Revised (ICG-R) Primary · 3 months

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.

Group	Value	95% CI
BATE-G	79.4	± 22.7
Standard Treatment	81.4	± 22.8

Inventory of Complicated Grief - Revised (ICG-R) Primary · 6 months

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.

Group	Value	95% CI
BATE-G	78.6	± 22.9
Standard Treatment	80.0	± 21.4

Beck Depression Inventory - II (BDI-II) Secondary · Baseline

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.

Group	Value	95% CI
BATE-G	28.5	± 11.8
Standard Treatment	28.8	± 14.0

PTSD Checklist for DSM-5 (PCL 5) Secondary · Baseline

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.

Group	Value	95% CI
BATE-G	48.0	± 15.1
Standard Treatment	46.2	± 16.5

Beck Depression Inventory - II (BDI-II) Secondary · 8 weeks

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.

Group	Value	95% CI
BATE-G	23.0	± 11.6
Standard Treatment	22.1	± 10.9

Beck Depression Inventory - II (BDI-II) Secondary · 3 months

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.

Group	Value	95% CI
BATE-G	22.0	± 10.5
Standard Treatment	22.2	± 11.2

Beck Depression Inventory - II (BDI-II) Secondary · 6 months

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.

Group	Value	95% CI
BATE-G	21.1	± 11.2
Standard Treatment	23.4	± 11.3

PTSD Checklist for DSM-5 (PCL 5) Secondary · 8 weeks

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.

Group	Value	95% CI
BATE-G	34.5	± 15.8
Standard Treatment	33.9	± 16.5

PTSD Checklist for DSM-5 (PCL 5) Secondary · 3 months

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.

Group	Value	95% CI
BATE-G	35.3	± 16.8
Standard Treatment	37.6	± 16.3

PTSD Checklist for DSM-5 (PCL 5) Secondary · 6 months

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.

Group	Value	95% CI
BATE-G	33.3	± 16.7
Standard Treatment	36.0	± 14.6

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse event data was collected for a period of 5 years, 1 month.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

BATE-G

Serious: 0/77 (0%)

Deaths: 0/77

Standard Treatment

Serious: 1/78 (1%)

Deaths: 0/78

Serious adverse events (1 terms)

Reaction	System	BATE-G	Standard Treatment
Serious Adverse Event	Psychiatric disorders	—	—

Most-reported serious reactions: Serious Adverse Event.

Data from ClinicalTrials.gov NCT02283333 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.