Suicide, AttemptedNCT03769259
Brief Cognitive Behavioral Therapy Replication Trial
A study testing Brief Cognitive Behavioral Therapy (BCBT), Present-Centered Therapy (PCT) and Treatment as Usual (TAU) in people with Suicide, Attempted and Suicidal Ideation, run by University of Utah at 3 sites in United States.
Trial summary
The overall goal for the proposed project is to test the effectiveness of BCBT for the prevention of suicide attempts in a sample of treatment-seeking U.S. military personnel and veterans. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Suicide, Attempted, Suicidal Ideation
- What is being tested?
- Brief Cognitive Behavioral Therapy (BCBT), Present-Centered Therapy (PCT) and Treatment as Usual (TAU)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 3 sitesUnited States
- Study dates
- 22 Jan 2020to Aug 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Current or past service in the U.S. military
- 18 years of age or older
- Reporting current suicide ideation with intent to die and/or a suicide attempt within the past two weeks
- Ability to understand and speak the English language; and ability to complete the informed consent process.
Who cannot join
- Psychiatric or medical condition that precludes the ability to provide informed consent or participation in outpatient treatment (e.g., psychosis, mania, acute intoxication).
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites
Lowcountry Center for Veterans Research
Charleston, South Carolina, 29403
The Ohio State University
Columbus, Ohio, 43210
Naval Medical Center Camp Lejeune
Jacksonville, North Carolina, 28547
About this study
The overall goal for the proposed project is to test the effectiveness of BCBT for the prevention of suicide attempts in a sample of treatment-seeking U.S. military personnel and veterans. The standard null hypothesis will involve tests conducted comparing improvement following BCBT (treatment duration of 12 weeks) to Person-Centered Therapy (PCT). The primary outcome comparisons will include direct markers of suicidality (i.e. suicide, suicide attempts). Secondary outcomes will be suicide ideation and indicators of psychiatric distress (e.g., depression, hopelessness). We also aim to assess several hypothesized psychological and neurocognitive mediators of treatment effects (e.g., wish to live, attentional bias, emotion regulation). Participants will be followed for 2 years posttreatment by independent evaluators blind to treatment condition.
Read the detailed description
The number of suicides by military personnel and veterans has steadily increased during the past few decades and remains elevated. Previous research conducted with active duty Army personnel supports the superiority of BCBT and its components over treatment as usual for the reduction of suicide attempts. Additional research is needed to determine if these effects are generalizable to military personnel and veterans more broadly and to confirm hypothesized mechanisms of action. Reference to "active duty" refers to U.S. military service members that have been activated and deployed as a part of Operation Iraqi Freedom/Operation Enduring Freedom (OIF/OEF) in accordance with federal orders under Title 10 or 32, United States Code. Reference to "veteran" refers to any person who has served in the U.S. military at any time, regardless of Branch, Component, era, or discharge status.
Specific Aim 1:To replicate previous findings supporting the efficacy of BCBT for the prevention of suicide attempts among military personnel and veterans (regardless of Axis I or II diagnosis). The standard null hypothesis will involve tests conducted comparing improvement following BCBT to Present-Centered Therapy (PCT)
Specific Aim 2: To identify cognitive-affective mediators of BCBT's effects on risk for suicide attempt.
- Conditions
- Suicide, Attempted, Suicidal Ideation
- Being tested
- Brief Cognitive Behavioral Therapy (BCBT), Present-Centered Therapy (PCT), Treatment as Usual (TAU)
- Keywords
- suicide, suicidal ideation, ambivalence, suicide ambivalence, reasons for living, reasons for dying, military, clinical trial, cognitive behavioral therapy, psychotherapy, crisis, Crisis Response Plan (CRP), Present Centered Therapy (PCT), Brief Cognitive-Behavioral Therapy (BCBT)
- Medical subject headings
- Suicide, Attempted, Suicidal Ideation, Suicide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief Cognitive Behavioral Therapy (BCBT)Behavioural
Also called Cognitive Therapy
Participants in BCBT receive 12 outpatient individual psychotherapy sessions scheduled on a weekly or biweekly basis, with the first session lasting 90 minutes and subsequent sessions lasting 60 minutes. BCBT was is delivered in three sequential phases. In phase I (5 sessions), the therapist identifies patient-specific factors that contribute to and maintain suicidal behaviors, provides a cognitive-behavioral conceptualization, collaboratively develops a crisis response plan, and teaches basic emotion regulation skills. In phase II (5 sessions), the therapist applies cognitive strategies to reduce beliefs and assumptions that serve as vulnerabilities to suicidal behavior. In phase III (2 sessions), a relapse prevention task is conducted.
Present-Centered Therapy (PCT)Behavioural
Participants in PCT will receive will include 12 outpatient individual psychotherapy sessions scheduled on a weekly or biweekly basis, with the first session lasting 90 minutes and subsequent sessions lasting 60 minutes. PCT consists of (1) psychoeducation about the typical symptoms and features associated with suicidal thoughts and behaviors among military personnel; (2) normalization of symptoms; (3) experience of receipt of support and feedback from a licensed professional; and (4) positive interpersonal interactions.
Treatment as Usual (TAU)Behavioural
All participants will receive the following interventions or procedures, regardless of treatment assignment:
- Suicide risk assessment using the Columbia Suicide Severity Rating Scale
- VA's safety planning intervention, which include Military Crisis Line contact information and lethal means access reduction
- Caring contacts and outreach
- Psychotropic medication, group therapy, substance abuse counseling, and other mental health interventions provided routinely as a part of treatment as usual
| Study group | Role | What they receive |
|---|---|---|
| Brief Cognitive Behavioral Therapy | Experimental | Not described Receives: Behavioral: Brief Cognitive Behavioral Therapy (BCBT); Behavioral: Treatment as Usual (TAU) |
| Present-Centered Therapy | Active comparator | Not described Receives: Behavioral: Present-Centered Therapy (PCT); Behavioral: Treatment as Usual (TAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in number of suicide attempts from baseline
The change in number of suicide attempts from baseline will be assessed through review of participants' medical records and through participants' responses to the Self-Injurious Thoughts and Behaviors Interview. The Self-Injurious Thoughts and Behaviors Interview is a structured interview assessing history of suicidal thoughts and behaviors, including suicide attempt history (dates, methods, and severity (e.g., need for medical attention) of previous suicide attempts). An increased number of suicide attempts at any assessment is considered a worse outcome.
Measured: Assessed every 3 months through study completion (average of 2 years)
Secondary outcomes (1)
Change in suicidal ideation scores from baseline
The Beck Scale for Suicide Ideation is a 21-item self-report measure of the severity of current suicidal ideation. Items 1-19 measure current suicidal ideation, with summed total scores for these items ranging from 0-38. Higher scores are associated with more severe suicidal ideation and are considered a worse outcome.
Measured: Assessed once per week until completion of treatment (average of 12 weeks) and at every 3 months through study completion (average of 2 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2018
- Study start22 Jan 2020
- Primary completionAug 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Suicide, AttemptedStudies 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense, Ohio State University, Lowcountry Center for Veterans Research, Medical University of South Carolina
- Responsible party
- Principal investigator, Craig Bryan, Ohio State University
- Investigators
- Craig J Bryan, PsyD, ABPP, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03769259
- Sponsor's protocol ID
- NMCCL.2018.0009
- Other IDs
- W81XWH1820022
- Status last verified
- Dec 2024
- First submitted
- 1 Nov 2018
- Last updated
- 10 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bryan CJ, Rudd MD, Wertenberger E. Reasons for suicide attempts in a clinical sample of active duty soldiers. J Affect Disord. 2013 Jan 10;144(1-2):148-52. doi: 10.1016/j.jad.2012.06.030. Epub 2012 Aug 1.
PubMed 22858207Bryan CJ, Rudd MD. Life stressors, emotional distress, and trauma-related thoughts occurring in the 24 h preceding active duty U.S. soldiers' suicide attempts. J Psychiatr Res. 2012 Jul;46(7):843-8. doi: 10.1016/j.jpsychires.2012.03.012. Epub 2012 Apr 1.
PubMed 22464944Rudd 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 25677353Bryan CJ, Mintz J, Clemans TA, Leeson B, Burch TS, Williams SR, Maney E, Rudd MD. Effect of crisis response planning vs. contracts for safety on suicide risk in U.S. Army Soldiers: A randomized clinical trial. J Affect Disord. 2017 Apr 1;212:64-72. doi: 10.1016/j.jad.2017.01.028. Epub 2017 Jan 23.
PubMed 28142085Bryan CJ, Khazem LR, Baker JC, Brown LA, Taylor DJ, Pruiksma KE, Acierno R, Larick JG, Baucom BRW, Garland EL, Rudd MD. Brief Cognitive Behavioral Therapy for Suicidal Military Personnel and Veterans: The Military Suicide Prevention Intervention Research (MSPIRE) Randomized Clinical Trial. JAMA Psychiatry. 2025 Dec 1;82(12):1169-1176. doi: 10.1001/jamapsychiatry.2025.2850.
PubMed 41060644
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brief Cognitive Behavioral Therapy Replication Trial
- ClinicalTrials.gov ID
- NCT03769259
- Acronym / sponsor ID
- NMCCL.2018.0009
- Conditions
- Suicide, Attempted, Suicidal Ideation
- Keywords
- suicide, suicidal ideation, ambivalence, suicide ambivalence, reasons for living, reasons for dying, military, clinical trial
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- United States Department of Defense, Ohio State University, Lowcountry Center for Veterans Research, Medical University of South Carolina
- Study start
- 22 Jan 2020 (actual)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 7 Dec 2018 (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.
The overall goal for the proposed project is to test the effectiveness of BCBT for the prevention of suicide attempts in a sample of treatment-seeking U.S. military personnel and veterans. The standard null hypothesis will involve tests conducted comparing improvement following BCBT (treatment duration of 12 weeks) to Person-Centered Therapy (PCT). The primary outcome comparisons will include direct markers of suicidality (i.e. suicide, suicide attempts). Secondary outcomes will be suicide ideation and indicators of psychiatric distress (e.g., depression, hopelessness). We also aim to assess several hypothesized psychological and neurocognitive mediators of treatment effects (e.g., wish to live, attentional bias, emotion regulation). Participants will be followed for 2 years posttreatment by independent evaluators blind to treatment condition.
Detailed description
The number of suicides by military personnel and veterans has steadily increased during the past few decades and remains elevated. Previous research conducted with active duty Army personnel supports the superiority of BCBT and its components over treatment as usual for the reduction of suicide attempts. Additional research is needed to determine if these effects are generalizable to military personnel and veterans more broadly and to confirm hypothesized mechanisms of action. Reference to "active duty" refers to U.S. military service members that have been activated and deployed as a part of Operation Iraqi Freedom/Operation Enduring Freedom (OIF/OEF) in accordance with federal orders under Title 10 or 32, United States Code. Reference to "veteran" refers to any person who has served in the U.S. military at any time, regardless of Branch, Component, era, or discharge status.
Specific Aim 1:To replicate previous findings supporting the efficacy of BCBT for the prevention of suicide attempts among military personnel and veterans (regardless of Axis I or II diagnosis). The standard null hypothesis will involve tests conducted comparing improvement following BCBT to Present-Centered Therapy (PCT)
Specific Aim 2: To identify cognitive-affective mediators of BCBT's effects on risk for suicide attempt.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brief Cognitive Behavioral Therapy | Experimental | Behavioral: Brief Cognitive Behavioral Therapy (BCBT), Behavioral: Treatment as Usual (TAU) |
| Present-Centered Therapy | Active comparator | Behavioral: Present-Centered Therapy (PCT), Behavioral: Treatment as Usual (TAU) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Current or past service in the U.S. military
- 18 years of age or older
- Reporting current suicide ideation with intent to die and/or a suicide attempt within the past two weeks
- Ability to understand and speak the English language; and ability to complete the informed consent process.
Key exclusion criteria (1 listed)
- Psychiatric or medical condition that precludes the ability to provide informed consent or participation in outpatient treatment (e.g., psychosis, mania, acute intoxication).
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 |
|---|---|---|
| Brief Cognitive Behavioral Therapy (BCBT)Also: Cognitive TherapyParticipants in BCBT receive 12 outpatient individual psychotherapy sessions scheduled on a weekly or biweekly basis, with the first session lasting 90 minutes and subsequent sessions lasting 60 minutes. BCBT was is delivered in three sequential phases. In phase I (5 sessions), the therapist identifies patient-specific factors that contribute to and maintain suicidal behaviors, provides a cognitive-behavioral conceptualization, collaboratively develops a crisis response plan, and teaches basic emotion regulation skills. In phase II (5 sessions), the therapist applies cognitive strategies to reduce beliefs and assumptions that serve as vulnerabilities to suicidal behavior. In phase III (2 sessions), a relapse prevention task is conducted. | Behavioural | Brief Cognitive Behavioral Therapy |
| Present-Centered Therapy (PCT)Participants in PCT will receive will include 12 outpatient individual psychotherapy sessions scheduled on a weekly or biweekly basis, with the first session lasting 90 minutes and subsequent sessions lasting 60 minutes. PCT consists of (1) psychoeducation about the typical symptoms and features associated with suicidal thoughts and behaviors among military personnel; (2) normalization of symptoms; (3) experience of receipt of support and feedback from a licensed professional; and (4) positive interpersonal interactions. | Behavioural | Present-Centered Therapy |
| Treatment as Usual (TAU)All participants will receive the following interventions or procedures, regardless of treatment assignment: * Suicide risk assessment using the Columbia Suicide Severity Rating Scale * VA's safety planning intervention, which include Military Crisis Line contact information and lethal means access reduction * Caring contacts and outreach * Psychotropic medication, group therapy, substance abuse counseling, and other mental health interventions provided routinely as a part of treatment as usual | Behavioural | Brief Cognitive Behavioral Therapy, Present-Centered Therapy |
Primary outcome
Change in number of suicide attempts from baseline
Time frame: Assessed every 3 months through study completion (average of 2 years)
The change in number of suicide attempts from baseline will be assessed through review of participants' medical records and through participants' responses to the Self-Injurious Thoughts and Behaviors Interview. The Self-Injurious Thoughts and Behaviors Interview is a structured interview assessing history of suicidal thoughts and behaviors, including suicide attempt history (dates, methods, and severity (e.g., need for medical attention) of previous suicide attempts). An increased number of suicide attempts at any assessment is considered a worse outcome.
1 secondary outcome
Change in suicidal ideation scores from baseline
Time frame: Assessed once per week until completion of treatment (average of 12 weeks) and at every 3 months through study completion (average of 2 years)
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 10 Dec 2024.
- Background: PubMed 22858207Bryan CJ, Rudd MD, Wertenberger E. Reasons for suicide attempts in a clinical sample of active duty soldiers. J Affect Disord. 2013 Jan 10;144(1-2):148-52. doi: 10.1016/j.jad.2012.06.030. Epub 2012 Aug 1.
- Background: PubMed 22464944Bryan CJ, Rudd MD. Life stressors, emotional distress, and trauma-related thoughts occurring in the 24 h preceding active duty U.S. soldiers' suicide attempts. J Psychiatr Res. 2012 Jul;46(7):843-8. doi: 10.1016/j.jpsychires.2012.03.012. Epub 2012 Apr 1.
- Background: 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.
- Background: PubMed 28142085Bryan CJ, Mintz J, Clemans TA, Leeson B, Burch TS, Williams SR, Maney E, Rudd MD. Effect of crisis response planning vs. contracts for safety on suicide risk in U.S. Army Soldiers: A randomized clinical trial. J Affect Disord. 2017 Apr 1;212:64-72. doi: 10.1016/j.jad.2017.01.028. Epub 2017 Jan 23.
- Derived from this study: PubMed 41060644Bryan CJ, Khazem LR, Baker JC, Brown LA, Taylor DJ, Pruiksma KE, Acierno R, Larick JG, Baucom BRW, Garland EL, Rudd MD. Brief Cognitive Behavioral Therapy for Suicidal Military Personnel and Veterans: The Military Suicide Prevention Intervention Research (MSPIRE) Randomized Clinical Trial. JAMA Psychiatry. 2025 Dec 1;82(12):1169-1176. doi: 10.1001/jamapsychiatry.2025.2850.
- Suicide and Trauma Reduction Initiative (STRIVE)Link provided by the sponsor.
Related trials for Suicide, Attempted
Active, not recruiting
Motivational Interviewing to Address Suicidal Ideation for Veterans at High Risk for Suicide
Suicide, Attempted, Suicidal Ideation
Recruiting
Suicide Preventive Psychosocial Treatment for Youths
Suicide Attempt, Suicidal and Self-injurious Behavior
Recruiting
Evaluation of a Multi-Layered Digital Phenotyping, Digital Safety Plan, and Pharmacogenomic Intervention for Suicide Prevention in Adults With Depression
Depressive Disorder, Major Depressive Disorder, Suicidal Ideation
Not yet recruiting
THRIVE: A Recovery-Focused Suicide Prevention Intervention in Crisis Stabilization Centers
Suicide
Active, not recruiting
DBT Skills Groups for Veterans at High Risk for Suicide Attempt
Suicide, Attempted
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.
Craig J Bryan, PsyD, ABPP principal investigator
Ohio State University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief Cognitive Behavioral Therapy (BCBT), Present-Centered Therapy (PCT) and Treatment as Usual (TAU) in people with Suicide, Attempted and Suicidal Ideation, run by University of Utah at 3 sites 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 4 inclusion and 1 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: enrolling by invitation, as of the sponsor's last update on 10 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 number of suicide attempts from baseline (time frame: Assessed every 3 months through study completion (average of 2 years)). 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 NCT03769259, which also lists 5 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 10 Dec 2024.