The Group Risk Reduction Intervention Therapy (GRRIT) Project
ProjectGRRIT
Piloting a Brief Cognitive-Behavioral Therapy (BCBT) Group Intervention for Suicidal Behavior Among Active Duty Military Personnel
2 other identifiers
interventional
141
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2023
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 24, 2022
CompletedFirst Posted
Study publicly available on registry
June 2, 2022
CompletedStudy Start
First participant enrolled
June 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 28, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
January 30, 2027
ExpectedApril 28, 2026
April 1, 2026
2.8 years
May 24, 2022
April 27, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Beck Scale for Suicidal Ideation score
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.
From pre-intervention baseline to 3- and 6-months post-treatment completion.
Secondary Outcomes (2)
Frequency of suicide attempts
From pre-intervention baseline to 3- and 6-months post-treatment completion.
Change in Patient Health Questionnaire-9 score
From pre-intervention baseline to 3- and 6-months post-treatment completion.
Study Arms (2)
G-BCBT
EXPERIMENTAL68 active duty service member participants assigned to G-BCBT will undergo 12 group therapy sessions scheduled on a weekly basis.
DBT
ACTIVE COMPARATOR68 active duty service member participants in the DBT condition will receive 24 weekly group therapy sessions each lasting 90 minutes.
Interventions
G-BCBT comprises 12, 90 minute sessions organized in three phases: (1) emotion regulation, (2) cognitive flexibility, and (3) relapse prevention. The first session will be a tailored individual session focusing on person-specific crisis response planning and developing the participant's suicide mode. Sessions 2 through 5 feature treatment goal setting, followed by teaching skills in stimulus control, mindfulness, relaxation, a reasons for living task, and survival kit. Sessions 6 through 10 provide opportunities for improving cognitive flexibility via cognitive-behavioral exercises such as ABC worksheets, challenging questions, patterns of problematic thinking worksheets, coping cards, and activity planning. The third phase of treatment focuses on relapse prevention, and encompasses the last two sessions of treatments where group participants demonstrate mastery of the skills learned in treatment and practice successfully navigating a future stressful situation.
DBT comprises 24 weekly group therapy sessions each lasting 90 minutes. DBT sessions include worksheets and skills practice activities. The DBT protocol entails three phases as follows. Phase I (8 weeks) covers a two-week mindfulness orientation and a six-week distress tolerance module. Distress tolerance skill building includes paired muscle relaxation, distraction, and radical acceptance. Phase II (nine weeks) entails a two-week mindfulness module followed by seven weeks of emotion regulation skill building. Emotion regulation content includes a model of describing emotion and a pleasant events checklist. Phase III (7 weeks) includes two-week mindfulness and orientation module, followed by five weeks of interpersonal effectiveness training. Interpersonal effectiveness training approaches include clarifying goals in interpersonal situations, guidelines for keeping relationships, and self-respect. Mindfulness, cutting across modules, addresses review of concepts such as Wise Mind.
Eligibility Criteria
You may qualify if:
- (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.
You may not qualify if:
- (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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of North Carolina, Charlottelead
- Ohio State Universitycollaborator
- United States Naval Medical Center, Portsmouthcollaborator
Study Sites (1)
Naval Medical Center Portsmouth
Portsmouth, Virginia, 23708, United States
Related Publications (3)
Rudd MD, Bryan CJ, Wertenberger EG, Peterson AL, Young-McCaughan S, Mintz J, Williams SR, Arne KA, Breitbach J, Delano K, Wilkinson E, Bruce TO. Brief cognitive-behavioral therapy effects on post-treatment suicide attempts in a military sample: results of a randomized clinical trial with 2-year follow-up. Am J Psychiatry. 2015 May;172(5):441-9. doi: 10.1176/appi.ajp.2014.14070843. Epub 2015 Feb 13.
PMID: 25677353RESULTCramer RJ, Franks M, Cunningham CA, Bryan CJ. Preferences in Information Processing: Understanding Suicidal Thoughts and Behaviors among Active Duty Military Service Members. Arch Suicide Res. 2022 Jan-Mar;26(1):169-186. doi: 10.1080/13811118.2020.1760156. Epub 2020 May 5.
PMID: 32369420RESULTBaker JC, Grover S, Gunn LH, Charles C, Rikli H, Franks MJ, Khazem LR, Williams S, Ammendola E, Washington C, Bennette M, Starkey A, Schnecke K, Cain S, Bryan CJ, Cramer RJ. Group brief cognitive behavioral therapy for suicide prevention compared to dialectal behavior therapy skills group for military service members: a study protocol of a randomized controlled trial. BMC Psychiatry. 2023 Dec 5;23(1):904. doi: 10.1186/s12888-023-05282-x.
PMID: 38053122DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Robert J Cramer, PhD
UNC Charlotte
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Co-I Gunn (statistician) will be blinded to intervention condition during primary data analyses; the dataset will be cleaned by other project staff and intervention condition will be referred to only as intervention A or B.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Belk Endowed Professor in Health Research
Study Record Dates
First Submitted
May 24, 2022
First Posted
June 2, 2022
Study Start
June 1, 2023
Primary Completion
March 28, 2026
Study Completion (Estimated)
January 30, 2027
Last Updated
April 28, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
- Time Frame
- Data will become available 6 months after the end of the project grant period. Data and supplemental materials identified above will be available in perpetuity.
- Access Criteria
- See above (Data Request Form).
Individual datasets with de-identified complete data with data dictionaries will be available; however, interested parties will need to request specific variables via completion of a Data Request Form (DSF). The DSF contains requestor name, position, affiliation, contact information, summary of research questions and aims, description of the data/code to be requested, an anticipated project timeline, and study team, roles and authorship list for the proposed project. The DSF will be reviewed by the Project Investigator Committee, comprising PI Cramer, Co-PI Baker, Co-Bryan, Co-I Gunn, and Co-I Franks. To be granted, the DSF must (a) be determined to not overlap with study team project aims, or current/planned analyses, and (b) be accepted by majority vote in writing. If the request is denied or deemed pending revision, PI Cramer or Co-PI Baker will provide the requestor a signed copy of the DSF with a short explanation of the determination.