Brief Cognitive Behavioral Therapy for Military Populations

Suicide Clinical Trial

Official title:

Brief Cognitive Behavioral Therapy for Military Populations

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02038075
• Other study ID #: W81XWH-09-1-0569
• Secondary ID: W81XWH-09-1-0569
• Status: Completed
• Phase: N/A
• Start date: January 2011
• Est. completion date: September 2014

Study information

• Verified date: November 2023
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 152
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Suicidal Ideation
• Suicide

Intervention

Behavioral:
• Brief Cognitive Behavioral Therapy (BCBT)

• Treatment As Usual (TAU)

Locations

Country	Name	City	State
United States	Fort Carson	Colorado Springs	Colorado

Sponsors (3)

Lead Sponsor	Collaborator
University of Utah	The University of Texas Health Science Center at San Antonio, University of Memphis

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Structured Clinical Interview for DSM-IV, Axis I and II (SCID)	The SCID (patient version with psychotic screen) is a diagnostic instrument based on DSM-IV diagnostic criteria for Axis I disorders.	Intake
Other	Suicide Intent Scale	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.	24 months
Other	Interpersonal Needs Questionnaire (INQ)	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).	24 months
Other	Suicide Cognitions Scale (SCS)	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).	24 months
Other	Post Treatment Health Interview (PTHI)	Frequency, intensity, and location of each patient's accessing of medical services will be assessed via medical record review.	24 months
Primary	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	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.	24 months
Secondary	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.	24 months
Secondary	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.	24 months
Secondary	Beck Anxiety Inventory	The BAI is a 21-item scale that measures the severity of anxiety in adults and adolescents.	24 months

External Links

•   National Center for Veterans Studies