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Brief Cognitive Behavioral Therapy Replication Trial

Primary Purpose

Suicide, Attempted, Suicidal Ideation

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Brief Cognitive Behavioral Therapy (BCBT)
Present-Centered Therapy (PCT)
Treatment as Usual (TAU)
Sponsored by
University of Utah
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Suicide, Attempted focused on measuring 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)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Active duty Marine
  • 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).

Sites / Locations

  • Naval Medical Center Camp Lejeune

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Brief Cognitive Behavioral Therapy

Present-Centered Therapy

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
November 1, 2018
Last Updated
October 5, 2022
Sponsor
University of Utah
Collaborators
United States Department of Defense
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1. Study Identification

Unique Protocol Identification Number
NCT03769259
Brief Title
Brief Cognitive Behavioral Therapy Replication Trial
Official Title
Brief Cognitive Behavioral Therapy Replication Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
January 22, 2020 (Actual)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
August 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Utah
Collaborators
United States Department of Defense

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 Marines. 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 has steadily increased since 2004, especially in the U.S. Marine Corps (USMC), and has remained high despite a relative decline during 2014. 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 the U.S. Marine Corps 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. Specific Aim 1:To replicate previous findings supporting the efficacy of BCBT for the prevention of suicide attempts among active duty Marines (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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Brief Cognitive Behavioral Therapy
Arm Type
Experimental
Arm Title
Present-Centered Therapy
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Brief Cognitive Behavioral Therapy (BCBT)
Other Intervention Name(s)
Cognitive Therapy
Intervention Description
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
Intervention Name(s)
Present-Centered Therapy (PCT)
Intervention Description
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
Intervention Name(s)
Treatment as Usual (TAU)
Intervention Description
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 via the Marine Intercept Program (MIP) Psychotropic medication, group therapy, substance abuse counseling, and other mental health interventions provided routinely as a part of treatment as usual
Primary Outcome Measure Information:
Title
Change in number of suicide attempts from baseline
Description
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.
Time Frame
Assessed every 3 months through study completion (average of 2 years)
Secondary Outcome Measure Information:
Title
Change in suicidal ideation scores from baseline
Description
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.
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Active duty Marine 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Craig J Bryan, PsyD, ABPP
Organizational Affiliation
National Center for Veterans Studies & the University of Utah
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
LT Justin Baker, PhD
Organizational Affiliation
Naval Medical Center Camp Lejeune
Official's Role
Principal Investigator
Facility Information:
Facility Name
Naval Medical Center Camp Lejeune
City
Jacksonville
State/Province
North Carolina
ZIP/Postal Code
28547
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22858207
Citation
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.
Results Reference
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PubMed Identifier
22464944
Citation
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.
Results Reference
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PubMed Identifier
25677353
Citation
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.
Results Reference
background
PubMed Identifier
28142085
Citation
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.
Results Reference
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Links:
URL
http://veterans.utah.edu
Description
National Center for Veterans Studies

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Brief Cognitive Behavioral Therapy Replication Trial

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