Brief Cognitive Behavioral Therapy Replication Trial

Part of paid clinical trials in Jacksonville, North Carolina.

Sponsor
University of Utah
Study ID
NCT03769259
Status
Enrolling By Invitation

Conditions

  • Suicidal Ideation
  • Suicide, Attempted

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.
  • 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.
  • 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

Study Details

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.

Key Dates

Start date
Jan 22, 2020
Status verified
Dec 2024
Primary completion
Aug 31, 2025
Completion
Aug 31, 2025

Study Design

Enrollment
300 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Brief Cognitive Behavioral Therapy
  • Active Comparator: Present-Centered Therapy

Primary Outcome Measure

Change in number of suicide attempts from baseline [ Time Frame: Assessed every 3 months through study completion (average of 2 years) ]

Locations (3)

FacilityCityStateZIPSite coordinators
Naval Medical Center Camp LejeuneJacksonvilleNorth Carolina28547-
The Ohio State UniversityColumbusOhio43210-
Lowcountry Center for Veterans ResearchCharlestonSouth Carolina29403-

Find similar trials in Jacksonville, NC

By research site
Naval Medical Center Camp Lejeune· Jacksonville, NCThe Ohio State University· Columbus, OHLowcountry Center for Veterans Research· Charleston, SC

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