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

NCT02042131 | Completed Results

• 2 other identifiers: R01481W81XWH-10-2-0181
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 1

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:

1. 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. 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. 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.

Conditions

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)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Beck Scale for Suicide Ideation (BSSI)

  1 month, 3 months, and 6 months

• Inpatient Psychiatric Hospitalization Days

  6 months

Other Outcomes (1)

• Number of Participants Who Were Admitted for Psychiatric Hospitalization Immediately Post-intervention by a Blinded Clinician

  Immediately post-intervention

Study Arms (3)

Treatment As Usual (TAU)

ACTIVE COMPARATOR

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)

Standard Crisis Response Plan (S-CRP)

EXPERIMENTAL

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); Behavioral: Enhanced Crisis Response Plan (E-CRP)

Enhanced Crisis Response Plan (E-CRP)

EXPERIMENTAL

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)

Interventions

Treatment As Usual (TAU) BEHAVIORAL

Also known as: Usual Care, Enhanced Care, Enhanced Care As Usual

Treatment As Usual (TAU)

Standard Crisis Response Plan (S-CRP) BEHAVIORAL

Also known as: Safety Plan

Standard Crisis Response Plan (S-CRP)

Enhanced Crisis Response Plan (E-CRP) BEHAVIORAL

Also known as: Safety Plan

Enhanced Crisis Response Plan (E-CRP); Standard Crisis Response Plan (S-CRP)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Active duty
• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Utah: lead
• The University of Texas Health Science Center at San Antonio: collaborator

Study Sites (1)

Fort Carson

Colorado Springs, Colorado, United States

Location

Related Publications (2)

• 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.

  PMID: 28967323 DERIVED

• 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.

  PMID: 28806894 DERIVED

Related Links

• National Center for Veterans Studies

MeSH Terms

Conditions

Suicide; Suicidal Ideation

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Self-Injurious Behavior; Behavioral Symptoms; Behavior

Limitations and Caveats

Staffing changes at the research site resulted in a one year suspension of recruitment by the IRB and the inability to meet planned recruitment goals. In all, 97 participants were enrolled, approximately one-quarter of the original goal (N=360).

Results Point of Contact

• Title: Craig Bryan
• Organization: The University of Utah

craig.bryan@utah.edu

801-587-7978

Study Officials

• Craig J Bryan, PsyD, ABPP

  National Center for Veterans Studies & The University of Utah

  PRINCIPAL INVESTIGATOR

• Tracy A Clemans, PsyD

  National Center for Veterans Studies & The University of Utah

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: January 17, 2014
• First Posted: January 22, 2014
• Study Start: January 1, 2013
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: August 11, 2017
• Results First Posted: August 11, 2017

Record last verified: 2017-08

Locations

US (1)