NCT02038075

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
152

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

January 14, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 16, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

May 30, 2016

Completed
Last Updated

December 12, 2023

Status Verified

November 1, 2023

Enrollment Period

3.7 years

First QC Date

January 14, 2014

Results QC Date

May 2, 2015

Last Update Submit

November 27, 2023

Conditions

SuicideSuicidal Ideation

Keywords

suicidesuicidal ideationmilitaryveterancognitive behavioral therapybehavioral therapypsychotherapyBrief Cognitive Behavioral Therapy (BCBT)Treatement As Usual (TAU)

Outcome Measures

Primary Outcomes (1)

  • Estimated Percentage of Participants Making Suicide Attempt During 24-month Follow-up

    The SASII is a clinician-administered interview designed to assess the factors involved in nonfatal suicide attempts and intentional self-injury. The SASII assesses variables related to method, reliability, lethality, impulsivity, likelihood of rescue, suicidal intent, consequences, and habitual self-injury. Interrater reliabilities for each item range from .87-.98, with the correlation for rater classification of behavior (i.e., suicide attempt or non-suicidal self-injury) being .92. The SASII demonstrates very high agreement in identifying and classifying suicide-related events when compared to clinician therapy notes, patient diary cards, and medical records (for events requiring medical attention).

    24 months

Secondary Outcomes (4)

  • Scale for Suicide Ideation (SSI)

    24 months

  • Beck Depression Inventory, Second Edition (BDI-II)

    24 months

  • Beck Hopelessness Scale (BHS)

    24 months

  • Beck Anxiety Inventory

    24 months

Other Outcomes (5)

  • Structured Clinical Interview for DSM-IV, Axis I and II (SCID)

    Intake

  • Suicide Intent Scale

    24 months

  • Interpersonal Needs Questionnaire (INQ)

    24 months

  • +2 more other outcomes

Study Arms (2)

Brief Cognitive Behavioral Therapy (BCBT)

EXPERIMENTAL

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.

Behavioral: Brief Cognitive Behavioral Therapy (BCBT)

Treatment As Usual (TAU)

ACTIVE COMPARATOR

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.

Behavioral: Treatment As Usual (TAU)

Interventions

Brief Cognitive Behavioral Therapy (BCBT)BEHAVIORAL
Also known as: Cognitive Therapy
Brief Cognitive Behavioral Therapy (BCBT)
Treatment As Usual (TAU)BEHAVIORAL
Also known as: Usual Care, Enhanced Treatment As Usual, Enhanced Care, Enhanced Care As Usual
Treatment As Usual (TAU)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fort Carson

Colorado Springs, Colorado, 84105, United States

Location

Related Publications (4)

  • 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.

    PMID: 22858207BACKGROUND

  • 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.

    PMID: 22464944BACKGROUND

  • 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.

    PMID: 25677353RESULT

  • 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.

    PMID: 33884617DERIVED

Related Links

MeSH Terms

Conditions

SuicideSuicidal Ideation

Interventions

Cognitive Behavioral TherapyTherapeutics

Condition Hierarchy (Ancestors)

Self-Injurious BehaviorBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Results Point of Contact

Title
Dr. Craig Bryan
Organization
University of Utah
craig.bryan@utah.edu
8015877978

Study Officials

  • Michael D Rudd, PhD, ABPP

    National Center for Veterans Studies & The University of Utah

    PRINCIPAL INVESTIGATOR

  • Craig J Bryan, PsyD, ABPP

    National Center for Veterans Studies & The University of Utah

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Executive Director, National Center for Veterans Studies

Study Record Dates

First Submitted

January 14, 2014

First Posted

January 16, 2014

Study Start

January 1, 2011

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

December 12, 2023

Results First Posted

May 30, 2016

Record last verified: 2023-11

Locations

US(1)