The Group Risk Reduction Intervention Therapy (GRRIT) Project
- Conditions
- AnxietyCoping SkillsDepressionSuicidal IdeationSuicide, AttemptedPTSD
- Interventions
- Behavioral: Group Brief Cognitive-Behavioral Therapy (G-BCBT)Behavioral: Dialectical Behavior Therapy (DBT) Skills Group
- Registration Number
- NCT05401838
- Lead Sponsor
- University of North Carolina, Charlotte
- Brief Summary
Investigators will evaluate a group format adaptation of Brief Cognitive-Behavioral Therapy for Suicide (i.e., 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.
Hypotheses/Objectives: 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-BCBT's 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 Affairs/DoD 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 141
- (1) Be an active duty service member.
- (2) Be 18 years-of-age or older.
- (3) Be of treatment-seeking status in outpatient mental health or substance abuse rehabilitation clinics, and/or inpatient psychiatry discharge.
- (4) Report current suicide ideation within the last week and/or a suicide attempt within the past month.
- (5) Be able to understand and speak English.
- (6) Possess ability to complete the informed consent process.
- (1) Have a psychiatric or medical condition that precludes the ability to provide informed consent or participation in outpatient treatment (e.g., psychosis, mania, acute intoxication).
- (2) Retired service members and family/dependents.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description G-BCBT Group Brief Cognitive-Behavioral Therapy (G-BCBT) 68 active duty service member participants assigned to G-BCBT will undergo 12 group therapy sessions scheduled on a weekly basis. DBT Dialectical Behavior Therapy (DBT) Skills Group 68 active duty service member participants in the DBT condition will receive 24 weekly group therapy sessions each lasting 90 minutes.
- Primary Outcome Measures
Name Time Method Change in Beck Scale for Suicidal Ideation score From pre-intervention baseline to 3- and 6-months post-treatment completion. Suicidal ideation will be measured with the Beck Scale for Suicide Ideation (BSSI). The BSSI contains 19 self-report items assessing of suicidal ideation. With a score range of 0 to 38, higher scores reflect worse ideation. The BSSI demonstrates strong reliability and associations with suicide measures when used with military personnel.
- Secondary Outcome Measures
Name Time Method Change in Patient Health Questionnaire-9 score From pre-intervention baseline to 3- and 6-months post-treatment completion. Depression will be quantified with the Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 contains nine self-report items measuring of depression symptom severity. With a score range of 0 to 27, higher scores reflect worse depressive symptoms. The PHQ-9 has demonstrated high internal consistency among treatment-seeking service members, and construct validity in a clinical sample.
Frequency of suicide attempts From pre-intervention baseline to 3- and 6-months post-treatment completion. Suicide attempts will be defined as intentional self-injurious behavior for which there is evidence of intent to die. We will measure suicide attempts using the Self-Injurious Thoughts and Behaviors Interview-Revised (SITBI-R), a structured clinician-administered interview that assesses features of suicide attempts and other self-injurious behaviors. The SITBI-R will be converted to self-report format. The full version will be administered at baseline. Only the suicide attempt question will be administered at follow-up time-points. Also, question time frames will be reworded to reflect last point of contact (e.g., since last therapy session). The SITBI-R has demonstrated good construct validity. Review of the U.S. military's Behavioral Health Data Portal (BHDP) medical records will additionally be conducted to identify suicide attempts that might have been missed during SITBI-R administrations (e.g., participants who drop out early or miss follow-up assessments).
Trial Locations
- Locations (1)
Naval Medical Center Portsmouth
🇺🇸Portsmouth, Virginia, United States