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Brief Cognitive Behavioral Therapy for Military Populations

NCT ID: NCT02038075

Last Updated: 2023-12-12

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

152 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2014-09-30

Brief Summary

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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

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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.

Conditions

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Suicide Suicidal Ideation

Keywords

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suicide suicidal ideation military veteran cognitive behavioral therapy behavioral therapy psychotherapy Brief Cognitive Behavioral Therapy (BCBT) Treatement As Usual (TAU)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Brief Cognitive Behavioral Therapy (BCBT)

In addition to TAU, 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.

Group Type EXPERIMENTAL

Brief Cognitive Behavioral Therapy (BCBT)

Intervention Type BEHAVIORAL

Treatment As Usual (TAU)

Participants in TAU receive usual care from military clinicians as well as non-military clinicians from the local community, as determined by participants' primary mental health care provider. All mental health, substance abuse, and medical treatment are provided within the military health care system at no cost to participants.

Group Type ACTIVE_COMPARATOR

Treatment As Usual (TAU)

Intervention Type BEHAVIORAL

Interventions

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Brief Cognitive Behavioral Therapy (BCBT)

Intervention Type BEHAVIORAL

Treatment As Usual (TAU)

Intervention Type BEHAVIORAL

Other Intervention Names

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Cognitive Therapy Usual Care Enhanced Treatment As Usual Enhanced Care Enhanced Care As Usual

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Memphis

OTHER

Sponsor Role collaborator

The University of Texas Health Science Center at San Antonio

OTHER

Sponsor Role collaborator

University of Utah

OTHER

Sponsor Role lead

Responsible Party

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Craig Bryan

Executive Director, National Center for Veterans Studies

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michael D Rudd, PhD, ABPP

Role: PRINCIPAL_INVESTIGATOR

National Center for Veterans Studies & The University of Utah

Craig J Bryan, PsyD, ABPP

Role: STUDY_DIRECTOR

National Center for Veterans Studies & The University of Utah

Locations

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Fort Carson

Colorado Springs, Colorado, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 22858207 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22464944 (View on PubMed)

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.

Reference Type RESULT
PMID: 25677353 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33884617 (View on PubMed)

Related Links

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http://veterans.utah.edu

National Center for Veterans Studies

Other Identifiers

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W81XWH-09-1-0569

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

W81XWH-09-1-0569

Identifier Type: -

Identifier Source: org_study_id