Brief Interventions for Short-Term Suicide Risk Reduction in Military Populations

Suicide Clinical Trial

— BISSR  

Official title:

Brief Interventions for Short-Term Suicide Risk Reduction in Military Populations

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02042131
• Other study ID #: R01481
• Secondary ID: W81XWH-10-2-0181
• Status: Completed
• Phase: N/A
• First received: January 17, 2014
• Last updated: August 9, 2017
• Start date: January 2013
• Est. completion date: September 2016

Study information

• Verified date: August 2017
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the proposed study is to identify the most effective brief interventions for reducing short-term risk for suicide attempts in "real world" military triage settings, and to identify potential mechanisms of change underlying the interventions' impact on subsequent suicide attempts. We will randomize 360 patients to one of three commonly-used crisis interventions delivered as routine care in the mental health triage system: (1) Treatment As Usual (TAU); (2) Standard Crisis Response Plan (S-CRP); or (3) Enhanced Crisis Response Plan with Reasons For Living (E-CRP). The following hypotheses will be tested:

1. The enhanced crisis response plan (E-CRP) intervention will contribute to significantly decreased risk for suicide attempts and hospitalization during follow-up relative to the standard crisis response plan alone (S-CRP) and treatment as usual (TAU).

2. The standard crisis response plan (S-CRP) intervention will contribute to significantly decreased risk for suicide attempts and hospitalization during follow-up relative to treatment as usual (TAU).

3. Greater ambivalence about suicide and faster recall of reasons for living will mediate the relationship between intervention and reduced risk for suicide attempt during follow-up.

Description:

The CRP has been proposed as an alternative to TAU for the short-term management of suicidal patients and is now in widespread use, but has never been empirically tested. The CRP is purported to reduce suicide risk via unique mechanisms that directly suicide risk, notably suicidal ambivalence (i.e., the relative balance between the wish to live and the wish to die) and problem solving. Because suicidal ambivalence has gained support as an active mechanism for reducing suicide risk, the present study will also seek to augment this underlying mechanism by directly engaging the suicidal patient in a discussion about their reasons for living, thereby potentially increasing the potency of the CRP.

The present study therefore entails a component analysis of crisis interventions. As such, we anticipate ordered effects, whereby the S-CRP and E-CRP conditions will show significantly better outcomes than TAU, and E-CRP will demonstrate significantly better outcomes than the standard CRP condition.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Active duty

• 18 years of age or older

• Reporting current suicidal ideation with intent to die, or a suicide attempt within the past two weeks

• Able to speak and understand the English language

• Able to complete the informed consent process

Exclusion Criteria:

• Severe psychiatric or medical conditions that preclude the ability to provide informed consent or participation in outpatient treatment

Related Conditions & MeSH terms

• Suicidal Ideation
• Suicide

Intervention

Behavioral:
• Treatment As Usual (TAU)

• Standard Crisis Response Plan (S-CRP)

• Enhanced Crisis Response Plan (E-CRP)

Locations

Country	Name	City	State
United States	Fort Carson	Colorado Springs	Colorado

Sponsors (2)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Participants Who Were Admitted for Psychiatric Hospitalization Immediately Post-intervention by a Blinded Clinician	Doctoral-level clinicians (i.e., physicians or psychologists) who were blind to treatment condition made a determination regarding psychiatric inpatient admission (either admit or not admit) immediately following the intervention.	Immediately post-intervention
Primary	Estimated Proportion of Participants With Suicide Attempt	Suicide attempts were assessed using the Suicide Attempt Self Injury Interview (SASII; Linehan et al., 2006). The SASII is a valid and reliable clinician-administered interview for categorizing suicide-related and self-injurious behaviors. Suicide attempt was defined as behavior that is self-directed and deliberately results in injury or the potential for injury to oneself for which there is evidence, whether implicit or explicit, of suicidal intent	6 months
Secondary	Beck Scale for Suicide Ideation (BSSI)	The BSSI is used to evaluate the intensity of the patient's specific attitudes, behaviors, and plans to make a suicide attempt. BSSI total score was used as the outcome measure. Total scores range from 0 to 38, with higher scores indicating more severe suicide ideation.	1 month, 3 months, and 6 months
Secondary	Inpatient Psychiatric Hospitalization Days	Mean number of days of inpatient psychiatric hospitalization	6 months

External Links

•   National Center for Veterans Studies