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Brief Cognitive Behavioral Therapy Replication Trial

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ClinicalTrials.gov Identifier: NCT03769259
Recruitment Status : Not yet recruiting
First Posted : December 7, 2018
Last Update Posted : December 7, 2018
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
Craig Bryan, University of Utah

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.

Condition or disease Intervention/treatment Phase
Suicide, Attempted Suicidal Ideation Behavioral: Brief Cognitive Behavioral Therapy (BCBT) Behavioral: Present-Centered Therapy (PCT) Behavioral: Treatment as Usual (TAU) Not Applicable

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 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Brief Cognitive Behavioral Therapy Replication Trial
Estimated Study Start Date : May 2019
Estimated Primary Completion Date : August 2023
Estimated Study Completion Date : August 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Suicide

Arm Intervention/treatment
Experimental: Brief Cognitive Behavioral Therapy Behavioral: 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.
Other Name: Cognitive Therapy

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 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

Active Comparator: Present-Centered Therapy 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.

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 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 Measures :
  1. 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 Outcome Measures :
  1. Change in suicidal ideation scores from baseline [ 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) ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03769259


Contacts
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Contact: Craig J Bryan, PsyD, ABPP 801-587-7978 craig.bryan@utah.edu
Contact: Lauren R Khazem, PhD 801-213-1040 lauren.khazem@utah.edu

Locations
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United States, North Carolina
Naval Medical Center Camp Lejeune Not yet recruiting
Jacksonville, North Carolina, United States, 28547
Contact: LT Justin Baker, PhD         
Sponsors and Collaborators
University of Utah
United States Department of Defense
Investigators
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Principal Investigator: Craig J Bryan, PsyD, ABPP National Center for Veterans Studies & the University of Utah
Principal Investigator: LT Justin Baker, PhD Naval Medical Center Camp Lejeune

Additional Information:
Publications:
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Responsible Party: Craig Bryan, Executive Director, National Center for Veterans Studies, University of Utah
ClinicalTrials.gov Identifier: NCT03769259     History of Changes
Other Study ID Numbers: NMCCL.2018.0009
W81XWH1820022 ( Other Grant/Funding Number: U.S. Army Medical Research Acquisition Activity )
First Posted: December 7, 2018    Key Record Dates
Last Update Posted: December 7, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Craig Bryan, University of Utah:
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)

Additional relevant MeSH terms:
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Suicide
Suicidal Ideation
Suicide, Attempted
Self-Injurious Behavior
Behavioral Symptoms