Brief Cognitive Behavioral Therapy Replication Trial

NCT ID: NCT03769259

Last Updated: 2024-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-22

Study Completion Date

2025-08-31

Brief Summary

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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

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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

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Suicide, Attempted Suicidal Ideation

Keywords

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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)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Brief Cognitive Behavioral Therapy

Group Type EXPERIMENTAL

Brief Cognitive Behavioral Therapy (BCBT)

Intervention Type BEHAVIORAL

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.

Treatment as Usual (TAU)

Intervention Type BEHAVIORAL

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

Present-Centered Therapy

Group Type ACTIVE_COMPARATOR

Present-Centered Therapy (PCT)

Intervention Type BEHAVIORAL

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)

Intervention Type BEHAVIORAL

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

Interventions

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Brief Cognitive Behavioral Therapy (BCBT)

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.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

Other Intervention Names

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Cognitive Therapy

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* Psychiatric or medical condition that precludes the ability to provide informed consent or participation in outpatient treatment (e.g., psychosis, mania, acute intoxication).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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United States Department of Defense

FED

Sponsor Role collaborator

Ohio State University

OTHER

Sponsor Role collaborator

Lowcountry Center for Veterans Research

UNKNOWN

Sponsor Role collaborator

Medical University of South Carolina

OTHER

Sponsor Role collaborator

University of Utah

OTHER

Sponsor Role lead

Responsible Party

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Craig Bryan

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Craig J Bryan, PsyD, ABPP

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

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Naval Medical Center Camp Lejeune

Jacksonville, North Carolina, United States

Site Status

The Ohio State University

Columbus, Ohio, United States

Site Status

Lowcountry Center for Veterans Research

Charleston, South Carolina, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 22858207 (View on PubMed)

Bryan 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.

Reference Type BACKGROUND
PMID: 22464944 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25677353 (View on PubMed)

Bryan 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.

Reference Type BACKGROUND
PMID: 28142085 (View on PubMed)

Bryan 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 Oct 8:e252850. doi: 10.1001/jamapsychiatry.2025.2850. Online ahead of print.

Reference Type DERIVED
PMID: 41060644 (View on PubMed)

Provided Documents

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Document Type: Informed Consent Form

View Document

Related Links

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http://strive2be.org

Suicide and Trauma Reduction Initiative (STRIVE)

Other Identifiers

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W81XWH1820022

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

NMCCL.2018.0009

Identifier Type: -

Identifier Source: org_study_id