Brief Cognitive Behavioral Therapy Replication Trial

NCT03769259 | Enrolling By Invitation DMC

• 2 other identifiers: NMCCL.2018.0009W81XWH1820022
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 3

Brief 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. 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.

Conditions

Suicide, Attempted; Suicidal Ideation

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)

Outcome Measures

Primary Outcomes (1)

• 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.

  Assessed every 3 months through study completion (average of 2 years)

Secondary Outcomes (1)

• Change in suicidal ideation scores from baseline

  Assessed once per week until completion of treatment (average of 12 weeks) and at every 3 months through study completion (average of 2 years)

Study Arms (2)

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)

Interventions

Brief Cognitive Behavioral Therapy (BCBT) 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.

Also known as: Cognitive Therapy

Brief Cognitive Behavioral Therapy

Present-Centered Therapy (PCT) 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.

Present-Centered Therapy

Treatment as Usual (TAU) 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

Brief Cognitive Behavioral Therapy; Present-Centered Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Current or past service in the U.S. military
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Utah: lead
• United States Department of Defense: collaborator
• Ohio State University: collaborator
• Lowcountry Center for Veterans Research: collaborator
• Medical University of South Carolina: collaborator

Study Sites (3)

Naval Medical Center Camp Lejeune

Jacksonville, North Carolina, 28547, United States

Location

The Ohio State University

Columbus, Ohio, 43210, United States

Location

Lowcountry Center for Veterans Research

Charleston, South Carolina, 29403, United States

Location

Related Publications (5)

• 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.

  PMID: 22858207 BACKGROUND

• 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.

  PMID: 22464944 BACKGROUND

• 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: 25677353 BACKGROUND

• 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.

  PMID: 28142085 BACKGROUND

• 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 Dec 1;82(12):1169-1176. doi: 10.1001/jamapsychiatry.2025.2850.

  PMID: 41060644 DERIVED

Related Links

• Suicide and Trauma Reduction Initiative (STRIVE)

MeSH Terms

Conditions

Suicide, Attempted; Suicidal Ideation; Suicide

Interventions

Cognitive Behavioral Therapy; Therapeutics

Condition Hierarchy (Ancestors)

Self-Injurious Behavior; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Craig J Bryan, PsyD, ABPP

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 1, 2018
• First Posted: December 7, 2018
• Study Start: January 22, 2020
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: December 10, 2024

Record last verified: 2024-12

Locations

US (3)