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Clinical Trials/NCT03769259
NCT03769259
Enrolling by Invitation
N/A

Brief Cognitive Behavioral Therapy Replication Trial

University of Utah3 sites in 1 country300 target enrollmentJanuary 22, 2020

Overview

Phase
N/A
Intervention
Not specified
Conditions
Suicide, Attempted
Sponsor
University of Utah
Enrollment
300
Locations
3
Primary Endpoint
Change in number of suicide attempts from baseline
Status
Enrolling by Invitation
Last Updated
last year

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
January 22, 2020
End Date
August 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Craig Bryan

Professor

Ohio State University

Eligibility Criteria

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).

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • 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 Sites (3)

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