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Veterans Coping Long-term With Active Suicide (CLASP-VA)

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ClinicalTrials.gov Identifier: NCT01894841
Recruitment Status : Active, not recruiting
First Posted : July 10, 2013
Last Update Posted : May 10, 2018
Sponsor:
Collaborator:
Butler Hospital
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Suicide Behavioral: Coping Long Term with Active Suicide Not Applicable

Detailed Description:

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Veterans Coping Long-Term With Suicide
Actual Study Start Date : February 24, 2014
Actual Primary Completion Date : March 30, 2018
Estimated Study Completion Date : August 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Suicide
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 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.
Behavioral: Coping Long Term with Active Suicide
an intervention to reduce suicide behavior in Veterans recently hospitalized for suicide attempt or ideation with intent.
Safety Assessment and follow up Evaluation
Treatment as usual plus enhanced monitoring.
Behavioral: Coping Long Term with Active Suicide
an intervention to reduce suicide behavior in Veterans recently hospitalized for suicide attempt or ideation with intent.



Primary Outcome Measures :
  1. Changes in Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: baseline, 3, 6, 9, & 12 month post-hospitalization ]
    Changes in suicidal behavior and severity from baseline levels. Includes suicidal ideation and attempt.


Secondary Outcome Measures :
  1. Changes in Beck Hopelessness Scale [ Time Frame: Baseline, 3, 6, 9, & 12 month follow up ]
    Change in severity of hopelessness from baseline

  2. Brief Symptom Inventory [ Time Frame: Baseline, 3, 6, 9, & 12 month follow up ]
    Change in psychiatric symptoms from baseline

  3. World Health Organization Disability Assessment Schedule (WHODAS) II [ Time Frame: Baseline, 3, 6, 9, & 12 month follow ups ]
    Changes in overall functioning from baseline.

  4. Treatment history interview [ Time Frame: 3, 6, 9, & 12 month follow up ]
    assesses treatment utilization



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01894841


Locations
United States, Rhode Island
Providence VA Medical Center, Providence, RI
Providence, Rhode Island, United States, 02908
Sponsors and Collaborators
VA Office of Research and Development
Butler Hospital
Investigators
Principal Investigator: Jennifer Marie Primack, PhD MA Providence VA Medical Center, Providence, RI

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01894841     History of Changes
Other Study ID Numbers: IIR 13-026
First Posted: July 10, 2013    Key Record Dates
Last Update Posted: May 10, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by VA Office of Research and Development:
depression
prevention
Veterans health

Additional relevant MeSH terms:
Suicide
Self-Injurious Behavior
Behavioral Symptoms