Suicidal IdeationProjectGRRITNCT05401838
The Group Risk Reduction Intervention Therapy (GRRIT) Project
A study testing Group Brief Cognitive-Behavioral Therapy (G-BCBT) and Dialectical Behavior Therapy (DBT) Skills Group in people with Suicidal Ideation and Suicide, Attempted, run by University of North Carolina, Charlotte at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Suicidal Ideation, Suicide, Attempted, Coping Skills
- What is being tested?
- Group Brief Cognitive-Behavioral Therapy (G-BCBT) and Dialectical Behavior Therapy (DBT) Skills Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 141 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2023to 30 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (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.
Who cannot join
- (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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Naval Medical Center Portsmouth
Portsmouth, Virginia, 23708
About this study
Official title: Piloting a Brief Cognitive-Behavioral Therapy (BCBT) Group Intervention for Suicidal Behavior Among Active Duty Military Personnel
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.
Read the 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.
- Conditions
- Suicidal Ideation, Suicide, Attempted, Coping Skills, Depression, Anxiety, PTSD
- Being tested
- Group Brief Cognitive-Behavioral Therapy (G-BCBT), Dialectical Behavior Therapy (DBT) Skills Group
- Keywords
- Randomized controlled trial, Group therapy, Military
- Medical subject headings
- Suicidal Ideation, Suicide, Attempted, Depression, Anxiety Disorders, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group Brief Cognitive-Behavioral Therapy (G-BCBT)Behavioural
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.
Dialectical Behavior Therapy (DBT) Skills GroupBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| G-BCBT | Experimental | 68 active duty service member participants assigned to G-BCBT will undergo 12 group therapy sessions scheduled on a weekly basis. Receives: Behavioral: Group Brief Cognitive-Behavioral Therapy (G-BCBT) |
| DBT | Active comparator | 68 active duty service member participants in the DBT condition will receive 24 weekly group therapy sessions each lasting 90 minutes. Receives: Behavioral: Dialectical Behavior Therapy (DBT) Skills Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From pre-intervention baseline to 3- and 6-months post-treatment completion.
Secondary outcomes (2)
Frequency of suicide attempts
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).
Measured: From pre-intervention baseline to 3- and 6-months post-treatment completion.
Change in Patient Health Questionnaire-9 score
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.
Measured: From pre-intervention baseline to 3- and 6-months post-treatment completion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2022
- Study start1 Jun 2023
- Primary completion28 Mar 2026
- Study completion30 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Suicidal IdeationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Investigators will conduct parallel 2-arm randomized controlled trial of G-BCBT compared to a DBT skills group. G-BCBT is a new adaptation of the existing BCBT protocol administered in a group format. Because DBT's efficacy in a group format is already supported and investigators anticipate G-BCBT to be at least as equally effective, investigators propose a 2-arm non-inferiority design.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Charlotte
- Sponsor type
- University, hospital or other
- Collaborators
- Ohio State University, United States Naval Medical Center, Portsmouth
- Responsible party
- Principal investigator, Robert J. Cramer, PhD, University of North Carolina, Charlotte
- Investigators
- Robert J Cramer, PhD, Principal investigator, UNC Charlotte
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05401838
- Sponsor's protocol ID
- W81XWH2210234
- Other IDs
- CDMRP-PR210136
- Acronym
- ProjectGRRIT
- Status last verified
- Apr 2026
- First submitted
- 24 May 2022
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 25677353Cramer 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.
PubMed 32369420Baker 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.
PubMed 38053122
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Piloting a Brief Cognitive-Behavioral Therapy (BCBT) Group Intervention for Suicidal Behavior Among Active Duty Military Personnel
- ClinicalTrials.gov ID
- NCT05401838
- Acronym / sponsor ID
- ProjectGRRIT / W81XWH2210234
- Conditions
- Suicidal Ideation, Suicide, Attempted, Coping Skills, Depression, Anxiety, PTSD
- Keywords
- Randomized controlled trial, Group therapy, Military
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 141 participants (actual)
- Lead sponsor
- University of North Carolina, CharlotteUniversity, hospital or other
- Collaborators
- Ohio State University, United States Naval Medical Center, Portsmouth
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 28 Mar 2026 (actual)
- Study completion
- 30 Jan 2027 (estimated)
- First posted
- 2 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Investigators will conduct parallel 2-arm randomized controlled trial of G-BCBT compared to a DBT skills group. G-BCBT is a new adaptation of the existing BCBT protocol administered in a group format. Because DBT's efficacy in a group format is already supported and investigators anticipate G-BCBT to be at least as equally effective, investigators propose a 2-arm non-inferiority design.
| Arm | Type | Receives |
|---|---|---|
| G-BCBT | Experimental | Behavioral: 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 | Active comparator | Behavioral: Dialectical Behavior Therapy (DBT) Skills Group68 active duty service member participants in the DBT condition will receive 24 weekly group therapy sessions each lasting 90 minutes. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- (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.
Key exclusion criteria (2 listed)
- (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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group Brief Cognitive-Behavioral Therapy (G-BCBT)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. | Behavioural | G-BCBT |
| Dialectical Behavior Therapy (DBT) Skills GroupDBT 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. | Behavioural | DBT |
Primary outcome
Change in Beck Scale for Suicidal Ideation score
Time frame: 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.
2 secondary outcomes
Frequency of suicide attempts
Time frame: From pre-intervention baseline to 3- and 6-months post-treatment completion.
Change in Patient Health Questionnaire-9 score
Time frame: From pre-intervention baseline to 3- and 6-months post-treatment completion.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- Results publication: PubMed 25677353Rudd 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.
- Results publication: PubMed 32369420Cramer 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.
- Derived from this study: PubMed 38053122Baker 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert J Cramer, PhD principal investigator
UNC Charlotte
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group Brief Cognitive-Behavioral Therapy (G-BCBT) and Dialectical Behavior Therapy (DBT) Skills Group in people with Suicidal Ideation and Suicide, Attempted, run by University of North Carolina, Charlotte at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Beck Scale for Suicidal Ideation score (time frame: From pre-intervention baseline to 3- and 6-months post-treatment completion.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05401838, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.