Clinical trial NCT03769259: Brief Cognitive Behavioral Therapy Replication Trial
Official title: Brief Cognitive Behavioral Therapy Replication Trial
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: 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)
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
name: Ohio State University
name: Lowcountry Center for Veterans Research
name: Medical University of South Carolina
First posted: 2018-12-07
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: Change in number of suicide attempts from baseline
timeFrame: Assessed every 3 months through study completion (average of 2 years)
Secondary outcomes:
measure: Change in suicidal ideation scores from baseline
timeFrame: Assessed once per week until completion of treatment (average of 12 weeks) and at every 3 months through study completion (average of 2 years)
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Naval Medical Center Camp Lejeune
state: North Carolina
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: Charleston
country: United States
facility: Lowcountry Center for Veterans Research
state: South Carolina
Study officials:
affiliation: Ohio State University
name: Craig J Bryan, PsyD, ABPP
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.