Ignite Creation Date:
2024-05-06 @ 5:42 PM
Last Modification Date:
2024-10-26 @ 2:34 PM
Study NCT ID:
NCT05401838
Status:
RECRUITING
Last Update Posted:
2023-12-05
First Post:
2022-05-24
Brief Title:
The Group Risk Reduction Intervention Therapy GRRIT Project
Sponsor:
University of North Carolina Charlotte
Organization:
University of North Carolina Charlotte
Study Overview
Official Title:
Piloting a Brief Cognitive-Behavioral Therapy BCBT Group Intervention for Suicidal Behavior Among Active Duty Military Personnel
Status:
RECRUITING
Status Verified Date:
2023-11
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:
ProjectGRRIT
Brief Summary:
Investigators will evaluate a group format adaptation of Brief Cognitive-Behavioral Therapy for Suicide ie G-BCBT on suicide ideation Aim 1 ability to use coping strategies Aim 2 and overall mental health exploratory analysis The combination of tailored means safety counseling and training in evidence-based emotion regulation and cognitive flexibility skills delivered via a 12-session group therapy treatment will decrease service members overall suicide risk The group format will provide opportunities to learn and practice skills thereby enhancing self-efficacy G-BCBT outcomes are expected to be no worse than Dialectical Behavior Therapy DBT group skills training an existing gold standard intervention that is twice the length of time as G-BCBT
Detailed Description:
Background The suicide rate among active duty service members is more than double the civilian population in the United States Also approximately 1 in 20 service members report suicidal ideation each year and 1 in 100 service members report a non-fatal suicide attempt annually Suicidal behavior rates are compounded by a number of mental health services access barriers such as clinician shortages The purpose of this randomized controlled trial RCT is to demonstrate that a new group therapy intervention protocol Group Brief Cognitive-Behavioral Therapy G-BCBT for Suicide will positively impact suicidal behavior mental health and self-regulatory skill outcomes for service members experiencing recent suicidal behavior
HypothesesObjectives The overall objective of the proposal is to evaluate the effects of a G-BCBT protocol on suicidal ideation suicide attempts mental health and self-regulatory skills Investigators expect that G-BCBT will result in improved service member suicidal behavior Aim 1 ability to use coping strategies Aim 2 and overall mental health exploratory analysis The combination of tailored means safety counseling and training in evidence-based emotion regulation and cognitive flexibility skills will improve service members self-control The group format will provide opportunities to learn and practice skills thereby enhancing self-efficacy G-BCBT outcomes are expected to be no worse than Dialectical Behavior Therapy DBT group skills training an existing gold standard intervention that is twice the length of time as G-BCBT Secondary hypotheses are that G-BCBT will a demonstrate non-inferior improvements in self-regulatory skills and b self-regulatory skills will moderate G-BCBTs impact on suicidal ideation
Specific Aims Investigators expect this project will yield mental health and coping skills benefits for service members These expected outcomes will be attained through the following aims Aim 1 Pilot a group format of BCBT for its impact on suicidal behavior among active duty military service members Aim 2 Assess the relationship between G-BCBT and self-regulatory factors
Study Design This study employs a single-site 4-year 2-arm phase III RCT design Data will be collected at Naval Medical Center Portsmouth University of North Carolina at Charlotte will coordinate the study and conduct intervention evaluation The Ohio State University will conduct fidelity monitoring and provide treatment subject matter expertise for both conditions A total of 136 active duty service members will be randomly assigned to one of two conditions 1 G-BCBT or 2 DBT Service members in the G-BCBT condition will complete a 12-week protocol comprising tailored means safety counseling followed by emotion regulation and cognitive flexibility skills training Service members assigned to the DBT condition will complete a 24-week protocol covering mindfulness emotion regulation distress tolerance and interpersonal effectiveness skills training All participants will complete assessments at baseline after each session upon treatment completion and 3- and 6-months post-intervention completion Data will address suicidal behavior mental health self-regulatory skills treatment process factors and demographic and suicide-related covariates
Clinical Impact G-BCBT will be tested as an evidence-based suicide-specific intervention requiring less resources compared to available options This study will result in the following knowledge products that will be distributed to military healthcare system and community stakeholders G-BCBT protocol revised BCBT manual train-the-trainer materials technical report suicide prevention white paper and G-BCBT fidelity assessment materials This study supports in the 2015 Department of Defense DoD Strategy for Suicide Prevention and 2019 Veterans AffairsDoD Clinical Practice Guidelines for the Assessment and Management of Patients at Risk for Suicide G-BCBT lethal means counseling and coping skills training will enhance service member quality of life and operational readiness
This randomized controlled clinical trial will test a new suicide-specific group therapy intervention Group-Brief Cognitive-Behavioral Therapy for Suicide G-BCBT by comparing it to an established gold standard
HypothesesObjectives The overall objective of the proposal is to evaluate the effects of a G-BCBT protocol on suicidal ideation suicide attempts mental health and self-regulatory skills Investigators expect that G-BCBT will result in improved service member suicidal behavior Aim 1 ability to use coping strategies Aim 2 and overall mental health exploratory analysis The combination of tailored means safety counseling and training in evidence-based emotion regulation and cognitive flexibility skills will improve service members self-control The group format will provide opportunities to learn and practice skills thereby enhancing self-efficacy G-BCBT outcomes are expected to be no worse than Dialectical Behavior Therapy DBT group skills training an existing gold standard intervention that is twice the length of time as G-BCBT Secondary hypotheses are that G-BCBT will a demonstrate non-inferior improvements in self-regulatory skills and b self-regulatory skills will moderate G-BCBTs impact on suicidal ideation
Specific Aims Investigators expect this project will yield mental health and coping skills benefits for service members These expected outcomes will be attained through the following aims Aim 1 Pilot a group format of BCBT for its impact on suicidal behavior among active duty military service members Aim 2 Assess the relationship between G-BCBT and self-regulatory factors
Study Design This study employs a single-site 4-year 2-arm phase III RCT design Data will be collected at Naval Medical Center Portsmouth University of North Carolina at Charlotte will coordinate the study and conduct intervention evaluation The Ohio State University will conduct fidelity monitoring and provide treatment subject matter expertise for both conditions A total of 136 active duty service members will be randomly assigned to one of two conditions 1 G-BCBT or 2 DBT Service members in the G-BCBT condition will complete a 12-week protocol comprising tailored means safety counseling followed by emotion regulation and cognitive flexibility skills training Service members assigned to the DBT condition will complete a 24-week protocol covering mindfulness emotion regulation distress tolerance and interpersonal effectiveness skills training All participants will complete assessments at baseline after each session upon treatment completion and 3- and 6-months post-intervention completion Data will address suicidal behavior mental health self-regulatory skills treatment process factors and demographic and suicide-related covariates
Clinical Impact G-BCBT will be tested as an evidence-based suicide-specific intervention requiring less resources compared to available options This study will result in the following knowledge products that will be distributed to military healthcare system and community stakeholders G-BCBT protocol revised BCBT manual train-the-trainer materials technical report suicide prevention white paper and G-BCBT fidelity assessment materials This study supports in the 2015 Department of Defense DoD Strategy for Suicide Prevention and 2019 Veterans AffairsDoD Clinical Practice Guidelines for the Assessment and Management of Patients at Risk for Suicide G-BCBT lethal means counseling and coping skills training will enhance service member quality of life and operational readiness
This randomized controlled clinical trial will test a new suicide-specific group therapy intervention Group-Brief Cognitive-Behavioral Therapy for Suicide G-BCBT by comparing it to an established gold standard
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?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDMRP-PR210136 | OTHER_GRANT | Department of Defense | None |