Clinical trial NCT02038075: Brief Cognitive Behavioral Therapy for Military Populations
Official title: Brief Cognitive Behavioral Therapy for Military Populations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Suicide
Suicidal Ideation
Keywords: suicide
suicidal ideation
military
veteran
cognitive behavioral therapy
behavioral therapy
psychotherapy
Brief Cognitive Behavioral Therapy (BCBT)
Treatement As Usual (TAU)
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: University of Memphis
name: The University of Texas Health Science Center at San Antonio
First posted: 2014-01-16
Enrollment: 152
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 primary purpose of this study is to compare the effectiveness of brief cognitive-behavioral therapy (B-CBT) for the treatment of suicidality, including suicidal ideation and attempts (regardless of Axis I or II diagnosis) among active duty military personnel. The standard null hypothesis will involve tests conducted comparing improvement following B-CBT (treatment duration of 12 weeks) to treatment as usual (TAU). The primary outcome comparisons will include both direct markers of suicidality (i.e. suicide, suicide attempts) and indirect markers including associated symptomatology (i.e. suicidal ideation, intent, anxiety, depression, hopelessness, substance abuse, and sleep disturbance), along with remission of psychiatric diagnoses. Secondary purposes include the prospective investigation of suicide risk factors and warning signs to explore these variables' ability to predict subsequent suicidal behavior following an index attempt.

Detailed description: The research gap in the treatment of suicidality is considerable, particularly with military populations, including those returning from deployment in support of OIF/OEF. Only one randomized clinical trial targeting suicidality has been conducted with a military sample (Rudd et al., 1996). Although time-limited treatment of suicidality is the primary target of the project, additional elements will be explored including prospective investigation of suicide risk factors and warning signs, as well as development of a centralized software assessment/management tracking system for high-risk suicidal individuals. 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, Unites States Code. This includes individuals on active duty from the National Guard and Reserve forces.

Specific Aim 1: To evaluate the effectiveness of brief cognitive-behavioral therapy (B-CBT) for the treatment of suicidality, including suicidal ideation and attempts (regardless of Axis I or II diagnosis) among active duty military personnel. It is anticipated that a large percentage of those identified for treatment will include military personnel recently returned from OIF/OEF. The standard null hypothesis will involve tests conducted comparing improvement following B-CBT (treatment duration of 12 weeks) to treatment as usual (TAU). The primary outcome comparisons will include both direct markers of suicidality (i.e. suicide, suicide attempts) and indirect markers including associated symptomatology (i.e. suicidal ideation, intent, anxiety, depression, hopelessness, substance abuse, agitation, and sleep disturbance), along with remission of psychiatric diagnoses.

Specific Aim 2: To engage in prospective investigation of suicide risk factors (i.e. psychiatric diagnosis and history, suicidal ideation, intent, anxiety, depression, hopelessness) and warning signs (i.e. agitation, sleep disturbance), exploring their ability to predict subsequent suicidal behavior following onset of suicidality.

Specific Aim 3: To explore the effectiveness of B-CBT (versus TAU) for increasing appropriate utilization of and compliance with medical, mental health, and substance abuse treatment, as well as improving psychological and social functioning.

Specific Aim 4: To develop a risk management software program for the initial risk assessment, ongoing monitoring and clinical management of high-risk suicidal patients. The software program would provide a mechanism for organizing and tracking clinical risk factors and warning signs for suicide, along with appropriate management and clinical intervention strategies during the treatment process.

Eligibility criteria: Inclusion Criteria:

* Active duty military
* 18 years or older
* Current suicidal ideation with intent to die and/or suicide attempt within past month
* Able to complete informed consent procedures

Exclusion Criteria:

* Psychiatric or medical condition that precludes informed consent or outpatient therapy

Primary outcomes:
measure: Estimated Percentage of Participants Making Suicide Attempt During 24-month Follow-up
timeFrame: 24 months
Secondary outcomes:
measure: Scale for Suicide Ideation (SSI)
timeFrame: 24 months
measure: Beck Depression Inventory, Second Edition (BDI-II)
timeFrame: 24 months
measure: Beck Hopelessness Scale (BHS)
timeFrame: 24 months
measure: Beck Anxiety Inventory
timeFrame: 24 months
Other outcomes:
measure: Structured Clinical Interview for DSM-IV, Axis I and II (SCID)
timeFrame: Intake
measure: Suicide Intent Scale
timeFrame: 24 months
measure: Interpersonal Needs Questionnaire (INQ)
timeFrame: 24 months
measure: Suicide Cognitions Scale (SCS)
timeFrame: 24 months
measure: Post Treatment Health Interview (PTHI)
timeFrame: 24 months
Locations:
city: Colorado Springs
country: United States
facility: Fort Carson
state: Colorado
Study officials:
affiliation: National Center for Veterans Studies & The University of Utah
name: Michael D Rudd, PhD, ABPP
role: PRINCIPAL_INVESTIGATOR
affiliation: National Center for Veterans Studies & The University of Utah
name: Craig J Bryan, PsyD, ABPP
role: STUDY_DIRECTOR
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: Witt KG, Hetrick SE, Rajaram G, Hazell P, Taylor Salisbury TL, Townsend E, Hawton K. Psychosocial interventions for self-harm in adults. Cochrane Database Syst Rev. 2021 Apr 22;4(4):CD013668. doi: 10.1002/14651858.CD013668.pub2.