- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03769259
Brief Cognitive Behavioral Therapy Replication Trial
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
North Carolina
-
Jacksonville, North Carolina, United States, 28547
- Naval Medical Center Camp Lejeune
-
-
Ohio
-
Columbus, Ohio, United States, 43210
- The Ohio State University
-
-
South Carolina
-
Charleston, South Carolina, United States, 29403
- Lowcountry Center for Veterans Research
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Brief Cognitive Behavioral Therapy
|
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 Names:
All participants will receive the following interventions or procedures, regardless of treatment assignment:
|
Active Comparator: Present-Centered Therapy
|
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.
All participants will receive the following interventions or procedures, regardless of treatment assignment:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Assessed every 3 months through study completion (average of 2 years)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Assessed once per week until completion of treatment (average of 12 weeks) and at every 3 months through study completion (average of 2 years)
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Craig J Bryan, PsyD, ABPP, Ohio State University
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NMCCL.2018.0009
- W81XWH1820022 (Other Grant/Funding Number: U.S. Army Medical Research Acquisition Activity)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Suicidal Ideation
-
University of WashingtonUnited States Department of Defense; Military Suicide Research ConsortiumCompletedSuicidal and Self-injurious Behavior | Suicidal Ideation ActiveUnited States
-
The Catholic University of AmericaUniversity of Washington; VA Office of Research and DevelopmentCompletedSuicidal and Self-injurious Behavior | Suicidal Ideation Active
-
Emory UniversityGeorgia Institute of TechnologyCompletedSuicide, Suicidal IdeationUnited States
-
Henry M. Jackson Foundation for the Advancement...University of Pennsylvania; University of Michigan; Duke University; US Department... and other collaboratorsUnknownSuicide, Attempted | Suicidal Ideation ActiveUnited States
-
Technische Universität DresdenUnknownDepression | Suicidal Ideation/BehaviorGermany
-
International Islamic University, IslamabadRecruitingImpulsivity | Suicidal Ideation and BehaviorPakistan
-
VA Office of Research and DevelopmentCentral Texas Veterans Health Care SystemRecruitingHealth | Reintegration Difficulties | Suicidal Ideation and Behaviors | ConnectednessUnited States
-
Children's Hospital Medical Center, CincinnatiCompleted
-
Eisenhower Army Medical CenterAugusta University; The Geneva Foundation; Congressionally Directed Medical Research...CompletedSuicidal Ideation | Suicide | Suicidal Intention | Suicidal Impulses | Suicidal and Self-Injurious Behavior | Suicidal DepressionUnited States
-
Rhode Island HospitalNational Institute of Mental Health (NIMH)Enrolling by invitation
Clinical Trials on Brief Cognitive Behavioral Therapy (BCBT)
-
San Diego State UniversityNational Institute of Mental Health (NIMH); University of Pittsburgh; Kaiser...CompletedDepression | AnxietyUnited States
-
The University of Texas Health Science Center at...Massachusetts General Hospital; 59th Medical Wing; Uniformed Services University... and other collaboratorsRecruitingChronic PainUnited States
-
University of North Carolina, CharlotteOhio State University; United States Naval Medical Center, PortsmouthRecruitingDepression | PTSD | Anxiety | Suicidal Ideation | Suicide, Attempted | Coping SkillsUnited States
-
VA Office of Research and DevelopmentActive, not recruiting
-
VA Office of Research and DevelopmentNot yet recruiting
-
Ohio State UniversityActive, not recruitingSuicidal Ideation | Suicide | Suicide AttemptUnited States
-
The University of Texas Health Science Center at...59th Medical Wing; Brooke Army Medical Center; South Texas Veterans Health Care...CompletedCombat Disorders | Post-Traumatic Stress Disorders | Stress DisordersUnited States
-
Ohio State UniversityUnited States Department of DefenseRecruitingSuicidal IdeationUnited States
-
University of MinnesotaCompleted
-
Massachusetts General HospitalNational Cancer Institute (NCI)CompletedDepression | Cancer | Anxiety | Unspecified Adult Solid Tumor, Protocol Specific | Cognitive Behavioral TherapyUnited States