Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2015 by Department of Veterans Affairs
Sponsor:
Collaborator:
Butler Hospital
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01894841
First received: July 3, 2013
Last updated: February 2, 2015
Last verified: January 2015
  Purpose

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 Intervention Phase
Suicide
Behavioral: Coping Long Term with Active Suicide
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Veterans Coping Long-Term With Suicide

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: baseline, 3, 6, 9, & 12 month post-hospitalization ] [ Designated as safety issue: No ]
    A measure of suicidal behavior and severity. Includes suicidal ideation and attempt.


Secondary Outcome Measures:
  • Beck Hopelessness Scale [ Time Frame: Baseline, discharge, 3, 6, 9, & 12 month follow up ] [ Designated as safety issue: No ]
  • Brief Symptom Inventory [ Time Frame: Baseline, 3, 6, 9, & 12 month follow up ] [ Designated as safety issue: No ]
    psychiatric symptoms

  • WHODAS II [ Time Frame: Baseline, 3, 6, 9, & 12 month follow ups ] [ Designated as safety issue: No ]
    Assesses overall functioning

  • Treatment history interview [ Time Frame: 3, 6, 9, & 12 month follow up ] [ Designated as safety issue: No ]
    assesses treatment utilization


Estimated Enrollment: 300
Study Start Date: February 2014
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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 SAFE (Safety Assessment and Follow-up Evaluation) 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • suicide attempt or suicidal ideation with intent to make a suicide attempt within 1 week of inpatient 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01894841

Contacts
Contact: Jennifer M Primack, PhD MA (857) 472-3044 Jennifer.Primack@va.gov
Contact: Traci Shea, PhD tracie.shea@va.gov

Locations
United States, Rhode Island
Providence VA Medical Center, Providence, RI Recruiting
Providence, Rhode Island, United States, 02908
Contact: Jennifer M Primack, PhD MA    (857) 472-3044    Jennifer.Primack@va.gov   
Contact: Debra D'Allesandro    (401) 273-7100 ext 6238    Debra.D'Allesandro@va.gov   
Principal Investigator: Jennifer Marie Primack, PhD MA         
Sponsors and Collaborators
Butler Hospital
Investigators
Principal Investigator: Jennifer Marie Primack, PhD MA Providence VA Medical Center, Providence, RI
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01894841     History of Changes
Other Study ID Numbers: IIR 13-026
Study First Received: July 3, 2013
Last Updated: February 2, 2015
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
depression
prevention
veterans health

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

ClinicalTrials.gov processed this record on March 03, 2015