Veterans Coping Long-term With Active Suicide

NCT ID: NCT01894841

Last Updated: 2020-02-10

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

107 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-24

Study Completion Date

2018-08-29

Brief Summary

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The proposed study seeks to test the efficacy of an intervention to reduce suicide behaviors in Veterans. The Veterans Coping Long Term with Active Suicide Program (CLASP-VA) is an innovative, telephone-based intervention that combines elements of individual therapy, case management, and significant other/family therapy and is designed to be integrated into a VA system.

Detailed Description

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Suicide is a leading cause of death for military personnel, and for the first time in recorded history, rates of military suicides are exceeding civilian rates. Despite public and patient health costs associated with suicidal ideation and behavior, existing efforts haven't appreciably reduced rates of suicidal behavior in the military. Consequently, finding novel, efficacious, and acceptable methods to reduce suicide behaviors is imperative. The Veteran's Coping Long Term with Active Suicide Program (CLASP-VA) is a unique suicide reduction intervention that directly targets high-risk patients at the time of hospital discharge. It is one of the few empirically-developed and promising interventions (e.g., strong pilot data) for individuals hospitalized for suicide behavior.

The primary objective of this study is to test the efficacy of the CLASP intervention compared to a treatment as usual plus Safety Assessment and Follow-up Evaluation (SAFE) control condition. Efficacy will be determined by primary outcomes including: number of attempts, number of re-hospitalizations, severity, and chronicity of suicidal ideation. A secondary objective is identifying the types of patients who receive the most benefit from the CLASP-VA intervention.

Conditions

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Suicide

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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CLASP Intervention

A 6 month adjunctive intervention consisting of 3 individual meetings, one family session, and 11 brief phone contacts with patient and identified significant other.

Group Type EXPERIMENTAL

Coping Long Term with Active Suicide (CLASP)

Intervention Type BEHAVIORAL

6 month behavioral telephone-based intervention. Calls assess risk, problem solve any immediate issues, and case management

Safety Assessment and Follow Up Evaluation

Intervention Type OTHER

enhanced risk monitoring with full assessment protocol at 3, 6, 9, and 12 month follow up. Results sent as a note to the patient's VA mental health provider

Safety Assessment and follow up Evaluation

Treatment as usual plus enhanced monitoring.

Group Type OTHER

Safety Assessment and Follow Up Evaluation

Intervention Type OTHER

enhanced risk monitoring with full assessment protocol at 3, 6, 9, and 12 month follow up. Results sent as a note to the patient's VA mental health provider

Interventions

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Coping Long Term with Active Suicide (CLASP)

6 month behavioral telephone-based intervention. Calls assess risk, problem solve any immediate issues, and case management

Intervention Type BEHAVIORAL

Safety Assessment and Follow Up Evaluation

enhanced risk monitoring with full assessment protocol at 3, 6, 9, and 12 month follow up. Results sent as a note to the patient's VA mental health provider

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* suicide attempt or suicidal ideation with any methods, plan, and/or intent to make a suicide attempt within 1 week of hospitalization
* age greater than 18
* have a telephone
* ability to speak, read, and understand spoken English sufficiently well to complete the procedures of the study

Exclusion Criteria

* long-term psychiatric disorder
* diagnosis of borderline personality disorder
* cognitive impairment which would interfere with adequate participation in the project (MMSE \<20)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Butler Hospital

OTHER

Sponsor Role collaborator

VA Office of Research and Development

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jennifer Marie Primack, PhD MA

Role: PRINCIPAL_INVESTIGATOR

Providence VA Medical Center, Providence, RI

Locations

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Providence VA Medical Center, Providence, RI

Providence, Rhode Island, United States

Site Status

Countries

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United States

References

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Primack JM, Thompson MF, Peters A, Quinn M, Kelsey M, Miller IW, Bozzay M. Suicide Characteristics of Veterans Hospitalized for Suicide Ideation or Attempt. Mil Med. 2023 Nov 3;188(11-12):e3371-e3376. doi: 10.1093/milmed/usad196.

Reference Type DERIVED
PMID: 37294816 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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IIR 13-026

Identifier Type: -

Identifier Source: org_study_id

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