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

August 9, 2017 updated by: Craig Bryan, University of Utah

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

97

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Colorado Springs, Colorado, United States
        • Fort Carson

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Treatment As Usual (TAU)

TAU includes the following intervention components:

  1. suicide risk assessment
  2. supportive listening
  3. provision of professional and crisis contact information
  4. referral to mental health treatment and community resources
  5. verbal contract for safety
Behavioral: Treatment As Usual (TAU)
Other Names:
  • Usual Care
  • Enhanced Care
  • Enhanced Care As Usual
Experimental: Standard Crisis Response Plan (S-CRP)

CRP includes the following intervention components:

  1. suicide risk assessment
  2. supportive listening
  3. identify personal warning signs
  4. identify self-management skills
  5. identify social support contacts
  6. provision of professional and crisis contact information
  7. referral to mental health treatment and community resources
Behavioral: Standard Crisis Response Plan (S-CRP)
Other Names:
  • Safety Plan
Behavioral: Enhanced Crisis Response Plan (E-CRP)
Other Names:
  • Safety Plan
Experimental: Enhanced Crisis Response Plan (E-CRP)

The E-CRP includes the following intervention components:

  1. suicide risk assessment
  2. supportive listening
  3. identify personal warning signs
  4. identify self-management skills
  5. identify reasons for living
  6. identify social support contacts
  7. provision of professional and crisis contact information
  8. referral to mental health treatment and community resources
Behavioral: Enhanced Crisis Response Plan (E-CRP)
Other Names:
  • Safety Plan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Estimated Proportion of Participants With Suicide Attempt
Time Frame: 6 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Beck Scale for Suicide Ideation (BSSI)
Time Frame: 1 month, 3 months, and 6 months
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
Inpatient Psychiatric Hospitalization Days
Time Frame: 6 months
Mean number of days of inpatient psychiatric hospitalization
6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Who Were Admitted for Psychiatric Hospitalization Immediately Post-intervention by a Blinded Clinician
Time Frame: Immediately post-intervention
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Utah

Collaborators

The University of Texas Health Science Center at San Antonio

Investigators

  • Study Director: Tracy A Clemans, PsyD, National Center for Veterans Studies & The University of Utah

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

January 17, 2014

First Submitted That Met QC Criteria

January 21, 2014

First Posted (Estimate)

January 22, 2014

Study Record Updates

Last Update Posted (Actual)

August 11, 2017

Last Update Submitted That Met QC Criteria

August 9, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01481
  • W81XWH-10-2-0181 (Department of Defense)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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