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Brief Cognitive Behavioral Therapy for Military Populations

Primary Purpose

Suicide, Suicidal Ideation

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Brief Cognitive Behavioral Therapy (BCBT)
Treatment As Usual (TAU)
Sponsored by
University of Utah
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Suicide focused on measuring suicide, suicidal ideation, military, veteran, cognitive behavioral therapy, behavioral therapy, psychotherapy, Brief Cognitive Behavioral Therapy (BCBT), Treatement As Usual (TAU)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Fort Carson

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Brief Cognitive Behavioral Therapy (BCBT)

Treatment As Usual (TAU)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Scale for Suicide Ideation (SSI)
The SSI is a 21-item, interviewer-administered scale used to evaluate the current intensity of the patient's specific attitudes, behaviors, and plans to commit suicide. The SSI has moderately high internal consistency and good concurrent and discriminant validity for psychiatric outpatients. Inter-rater reliability has been found to be higher than .98, with good evidence of predictive validity.
Beck Depression Inventory, Second Edition (BDI-II)
The BDI-II is a 21-item self-report instrument developed to measure severity of depression in adults and adolescents. Each of the items consists of four statements reflecting increasing levels of severity for a particular symptom of depression.
Beck Hopelessness Scale (BHS)
The BHS consists of 20 true-false statements designed to assess the extent of positive and negative beliefs about the future.
Beck Anxiety Inventory
The BAI is a 21-item scale that measures the severity of anxiety in adults and adolescents.

Full Information

First Posted
January 14, 2014
Last Updated
May 24, 2016
Sponsor
University of Utah
Collaborators
University of Memphis, The University of Texas Health Science Center at San Antonio
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1. Study Identification

Unique Protocol Identification Number
NCT02038075
Brief Title
Brief Cognitive Behavioral Therapy for Military Populations
Official Title
Brief Cognitive Behavioral Therapy for Military Populations
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Utah
Collaborators
University of Memphis, The University of Texas Health Science Center at San Antonio

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicide, Suicidal Ideation
Keywords
suicide, suicidal ideation, military, veteran, cognitive behavioral therapy, behavioral therapy, psychotherapy, Brief Cognitive Behavioral Therapy (BCBT), Treatement As Usual (TAU)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
152 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Brief Cognitive Behavioral Therapy (BCBT)
Arm Type
Experimental
Arm Description
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.
Arm Title
Treatment As Usual (TAU)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Brief Cognitive Behavioral Therapy (BCBT)
Other Intervention Name(s)
Cognitive Therapy
Intervention Type
Behavioral
Intervention Name(s)
Treatment As Usual (TAU)
Other Intervention Name(s)
Usual Care, Enhanced Treatment As Usual, Enhanced Care, Enhanced Care As Usual
Primary Outcome Measure Information:
Title
Estimated Percentage of Participants Making Suicide Attempt During 24-month Follow-up
Description
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).
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Scale for Suicide Ideation (SSI)
Description
The SSI is a 21-item, interviewer-administered scale used to evaluate the current intensity of the patient's specific attitudes, behaviors, and plans to commit suicide. The SSI has moderately high internal consistency and good concurrent and discriminant validity for psychiatric outpatients. Inter-rater reliability has been found to be higher than .98, with good evidence of predictive validity.
Time Frame
24 months
Title
Beck Depression Inventory, Second Edition (BDI-II)
Description
The BDI-II is a 21-item self-report instrument developed to measure severity of depression in adults and adolescents. Each of the items consists of four statements reflecting increasing levels of severity for a particular symptom of depression.
Time Frame
24 months
Title
Beck Hopelessness Scale (BHS)
Description
The BHS consists of 20 true-false statements designed to assess the extent of positive and negative beliefs about the future.
Time Frame
24 months
Title
Beck Anxiety Inventory
Description
The BAI is a 21-item scale that measures the severity of anxiety in adults and adolescents.
Time Frame
24 months
Other Pre-specified Outcome Measures:
Title
Structured Clinical Interview for DSM-IV, Axis I and II (SCID)
Description
The SCID (patient version with psychotic screen) is a diagnostic instrument based on DSM-IV diagnostic criteria for Axis I disorders.
Time Frame
Intake
Title
Suicide Intent Scale
Description
The SIS is a 15-item, interviewer-administered assessment of the intensity of an individual's intent to die at the time of a suicide attempt. It assesses verbal and nonverbal indicators of suicidal attempt including objective circumstances surrounding the attempt, and the attempters' perceptions of the attempt.
Time Frame
24 months
Title
Interpersonal Needs Questionnaire (INQ)
Description
The INQ is a 10-item self-report questionnaire that measures current beliefs about the extent to which the respondent feels connected to others (i.e., thwarted belongingness), and the extent to which he or she feels like a burden on the people in their lives (i.e., perceived burdensomeness).
Time Frame
24 months
Title
Suicide Cognitions Scale (SCS)
Description
The SCS-R is an 18-item self-report measure that measures two aspects of suicide-specific hopelessness: 1) unlovability (which measures more trait-like aspects of hopelessness), and 2) unbearability (which measures more state-like aspects of hopelessness).
Time Frame
24 months
Title
Post Treatment Health Interview (PTHI)
Description
Frequency, intensity, and location of each patient's accessing of medical services will be assessed via medical record review.
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael D Rudd, PhD, ABPP
Organizational Affiliation
National Center for Veterans Studies & The University of Utah
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Craig J Bryan, PsyD, ABPP
Organizational Affiliation
National Center for Veterans Studies & The University of Utah
Official's Role
Study Director
Facility Information:
Facility Name
Fort Carson
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
84105
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22858207
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.
Results Reference
background
PubMed Identifier
22464944
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.
Results Reference
background
PubMed Identifier
25677353
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.
Results Reference
result
PubMed Identifier
33884617
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.
Results Reference
derived
Links:
URL
http://veterans.utah.edu
Description
National Center for Veterans Studies

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Brief Cognitive Behavioral Therapy for Military Populations

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