Ignite Creation Date:
2024-05-06 @ 3:24 AM
Last Modification Date:
2024-10-26 @ 11:33 AM
Study NCT ID:
NCT02283333
Status:
COMPLETED
Last Update Posted:
2021-02-18
First Post:
2014-10-23
Brief Title:
Treatment of Prolonged Grief Disorder in Combat Veterans
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Treatment of Prolonged Grief Disorder in Combat Veterans
Status:
COMPLETED
Status Verified Date:
2021-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PGD
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 Veterans 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 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 Veterans 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CX001102 | OTHER_GRANT | VA CSRD | None |