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Completed

NCT Number: NCT02042131

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

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.

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Key information

Conditions

Suicide Behavior Behavioral Symptoms Self-Injurious Behavior Suicidal Ideation

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fort Carson

Colorado Springs, Colorado, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Treatment as Usual (TAU)

Behavioral

Other names: Usual Care, Enhanced Care, Enhanced Care As Usual

Standard Crisis Response Plan (S-CRP)

Behavioral

Other names: Safety Plan

Enhanced Crisis Response Plan (E-CRP)

Behavioral

Other names: Safety Plan

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. Inpatient Psychiatric Hospitalization Days

    Time frame: 6 months

    Mean number of days of inpatient psychiatric hospitalization

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Collaborators

  • The University of Texas Health Science Center at San Antonio

Registry information

Acronym: BISSR

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Jan 22, 2014
Registry last updated
Aug 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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