Refinement of Suicide Risk Management Intervention

NCT ID: NCT04888845

Last Updated: 2024-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-22

Study Completion Date

2026-07-30

Brief Summary

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Participants will be randomly assigned to 1 of the 4 interventions using a sequential stratified randomization procedure. We will use sex (M, F) and history of suicide attempts (never, 1, and multiple) as our randomization strata. Participants will be assessed before and after the intervention to study the potential effects of each approach on suicide-related clinical outcomes.

Detailed Description

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Conditions

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Structured Interview Narrative Assessment Safety Plan Crisis Response Plan

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Structured interview and Safety Plan

In the structured interview approach, clinicians ask a series of predetermined questions and/or assess a specified set of risk and protective factors, typically using a checklist-based approach. The safety plan is a written, prioritized list of coping strategies and resources for reducing suicide risk.

Group Type ACTIVE_COMPARATOR

Safety Plan

Intervention Type BEHAVIORAL

The safety plan is a written, prioritized list of coping strategies and resources for reducing suicide risk.

Structured interview

Intervention Type BEHAVIORAL

In the structured interview approach, clinicians ask a series of predetermined questions and/or assess a specified set of risk and protective factors, typically using a checklist-based approach.

Structured interview and Crisis Response Plan

In the structured interview approach, clinicians ask a series of predetermined questions and/or assess a specified set of risk and protective factors, typically using a checklist-based approach. Crisis response planning intervention teaches a range of coping strategies and provides support that can reduce suicide attempts and ideation.

Group Type ACTIVE_COMPARATOR

Crisis Response Plan

Intervention Type BEHAVIORAL

Crisis response planning intervention teaches a range of coping strategies and provides support that can reduce suicide attempts and ideation.

Structured interview

Intervention Type BEHAVIORAL

In the structured interview approach, clinicians ask a series of predetermined questions and/or assess a specified set of risk and protective factors, typically using a checklist-based approach.

Narrative assessment and Safety Plan

In the narrative assessment approach, clinicians ask patients to "tell the story" of their suicidal crisis. The safety plan is a written, prioritized list of coping strategies and resources for reducing suicide risk.

Group Type ACTIVE_COMPARATOR

Safety Plan

Intervention Type BEHAVIORAL

The safety plan is a written, prioritized list of coping strategies and resources for reducing suicide risk.

Narrative Assessment

Intervention Type BEHAVIORAL

In the narrative assessment approach, clinicians ask patients to "tell the story" of their suicidal crisis.

Narrative assessment and Crisis Response Plan

In the narrative assessment approach, clinicians ask patients to "tell the story" of their suicidal crisis. Crisis response planning intervention teaches a range of coping strategies and provides support that can reduce suicide attempts and ideation.

Group Type ACTIVE_COMPARATOR

Crisis Response Plan

Intervention Type BEHAVIORAL

Crisis response planning intervention teaches a range of coping strategies and provides support that can reduce suicide attempts and ideation.

Narrative Assessment

Intervention Type BEHAVIORAL

In the narrative assessment approach, clinicians ask patients to "tell the story" of their suicidal crisis.

Interventions

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Safety Plan

The safety plan is a written, prioritized list of coping strategies and resources for reducing suicide risk.

Intervention Type BEHAVIORAL

Crisis Response Plan

Crisis response planning intervention teaches a range of coping strategies and provides support that can reduce suicide attempts and ideation.

Intervention Type BEHAVIORAL

Structured interview

In the structured interview approach, clinicians ask a series of predetermined questions and/or assess a specified set of risk and protective factors, typically using a checklist-based approach.

Intervention Type BEHAVIORAL

Narrative Assessment

In the narrative assessment approach, clinicians ask patients to "tell the story" of their suicidal crisis.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Clinical diagnosis of suicide Ideation
* History of suicide attempts

Exclusion Criteria

* Geographic location outside the U.S.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ohio State University

OTHER

Sponsor Role collaborator

University of Utah

OTHER

Sponsor Role lead

Responsible Party

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Monika Lohani

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Monika Lohani, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Utah

Locations

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The Ohio State

Columbus, Ohio, United States

Site Status

University of Utah

Salt Lake City, Utah, United States

Site Status

Countries

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United States

References

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Lohani M, Baker JC, Elsey JS, Dutton S, Findley SP, Langenecker SA, Do AS, Bryan CJ. Suicide prevention via telemental health services: insights from a randomized control trial of crisis response plan and self-guided safety planning approaches. BMC Health Serv Res. 2024 Nov 12;24(1):1389. doi: 10.1186/s12913-024-11739-w.

Reference Type DERIVED
PMID: 39533271 (View on PubMed)

Other Identifiers

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IRB_00135355

Identifier Type: -

Identifier Source: org_study_id