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

Primary Purpose

Suicide, Suicidal Ideation

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Treatment As Usual (TAU)
Standard Crisis Response Plan (S-CRP)
Enhanced Crisis Response Plan (E-CRP)
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, ambivalence, suicide ambivalence, reasons for living, reasons for dying, military, veteran, clinical trial, cognitive behavioral therapy, psychotherapy, crisis, Treatment As Usual (TAU), Crisis Response Plan (CRP), Enhanced Crisis Response Plan (E-CRP)

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Fort Carson

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Treatment As Usual (TAU)

Standard Crisis Response Plan (S-CRP)

Enhanced Crisis Response Plan (E-CRP)

Arm Description

TAU includes the following intervention components: suicide risk assessment supportive listening provision of professional and crisis contact information referral to mental health treatment and community resources verbal contract for safety

CRP includes the following intervention components: suicide risk assessment supportive listening identify personal warning signs identify self-management skills identify social support contacts provision of professional and crisis contact information referral to mental health treatment and community resources

The E-CRP includes the following intervention components: suicide risk assessment supportive listening identify personal warning signs identify self-management skills identify reasons for living identify social support contacts provision of professional and crisis contact information referral to mental health treatment and community resources

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
Inpatient Psychiatric Hospitalization Days
Mean number of days of inpatient psychiatric hospitalization

Full Information

First Posted
January 17, 2014
Last Updated
August 9, 2017
Sponsor
University of Utah
Collaborators
The University of Texas Health Science Center at San Antonio
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1. Study Identification

Unique Protocol Identification Number
NCT02042131
Brief Title
Brief Interventions for Short-Term Suicide Risk Reduction in Military Populations
Acronym
BISSR
Official Title
Brief Interventions for Short-Term Suicide Risk Reduction in Military Populations
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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: 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). 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). 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.
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.

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, ambivalence, suicide ambivalence, reasons for living, reasons for dying, military, veteran, clinical trial, cognitive behavioral therapy, psychotherapy, crisis, Treatment As Usual (TAU), Crisis Response Plan (CRP), Enhanced Crisis Response Plan (E-CRP)

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Treatment As Usual (TAU)
Arm Type
Active Comparator
Arm Description
TAU includes the following intervention components: suicide risk assessment supportive listening provision of professional and crisis contact information referral to mental health treatment and community resources verbal contract for safety
Arm Title
Standard Crisis Response Plan (S-CRP)
Arm Type
Experimental
Arm Description
CRP includes the following intervention components: suicide risk assessment supportive listening identify personal warning signs identify self-management skills identify social support contacts provision of professional and crisis contact information referral to mental health treatment and community resources
Arm Title
Enhanced Crisis Response Plan (E-CRP)
Arm Type
Experimental
Arm Description
The E-CRP includes the following intervention components: suicide risk assessment supportive listening identify personal warning signs identify self-management skills identify reasons for living identify social support contacts provision of professional and crisis contact information referral to mental health treatment and community resources
Intervention Type
Behavioral
Intervention Name(s)
Treatment As Usual (TAU)
Other Intervention Name(s)
Usual Care, Enhanced Care, Enhanced Care As Usual
Intervention Type
Behavioral
Intervention Name(s)
Standard Crisis Response Plan (S-CRP)
Other Intervention Name(s)
Safety Plan
Intervention Type
Behavioral
Intervention Name(s)
Enhanced Crisis Response Plan (E-CRP)
Other Intervention Name(s)
Safety Plan
Primary Outcome Measure Information:
Title
Estimated Proportion of Participants With Suicide Attempt
Description
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
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Beck Scale for Suicide Ideation (BSSI)
Description
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.
Time Frame
1 month, 3 months, and 6 months
Title
Inpatient Psychiatric Hospitalization Days
Description
Mean number of days of inpatient psychiatric hospitalization
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Number of Participants Who Were Admitted for Psychiatric Hospitalization Immediately Post-intervention by a Blinded Clinician
Description
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.
Time Frame
Immediately post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
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
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tracy A Clemans, PsyD
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
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
28967323
Citation
Bryan CJ, Mintz J, Clemans TA, Burch TS, Leeson B, Williams S, Rudd MD. Effect of Crisis Response Planning on Patient Mood and Clinician Decision Making: A Clinical Trial With Suicidal U.S. Soldiers. Psychiatr Serv. 2018 Jan 1;69(1):108-111. doi: 10.1176/appi.ps.201700157. Epub 2017 Oct 2.
Results Reference
derived
PubMed Identifier
28806894
Citation
Lowder EM, Rade CB, Desmarais SL. Effectiveness of Mental Health Courts in Reducing Recidivism: A Meta-Analysis. Psychiatr Serv. 2018 Jan 1;69(1):15-22. doi: 10.1176/appi.ps.201700107. Epub 2017 Aug 15.
Results Reference
derived
Links:
URL
http://veterans.utah.edu
Description
National Center for Veterans Studies

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

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