Clinical trial NCT01894841: Veterans Coping Long-term With Active Suicide
Official title: Veterans Coping Long-Term With Suicide
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Suicide
Keywords: depression
prevention
Veterans health
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: Butler Hospital
First posted: 2013-07-10
Enrollment: 107
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility 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)

Primary outcomes:
measure: Changes in Columbia Suicide Severity Rating Scale (C-SSRS) - Behavior
timeFrame: baseline, 3, 6, 9, & 12 month post-hospitalization
Secondary outcomes:
measure: Changes in Beck Hopelessness Scale
timeFrame: Baseline, 3, 6, 9, & 12 month follow up
measure: Brief Symptom Inventory
timeFrame: Baseline, 3, 6, 9, & 12 month follow up
measure: World Health Organization Disability Assessment Schedule (WHODAS) II
timeFrame: Baseline, 3, 6, 9, & 12 month follow ups
measure: Treatment History Interview
timeFrame: 3, 6, 9, & 12 month follow up
measure: Changes in Columbia Suicide Severity Rating Scale (C-SSRS) - Ideation Severity
timeFrame: baseline, 3, 6, 9, & 12 month post-hospitalization
Other outcomes:
Locations:
city: Providence
country: United States
facility: Providence VA Medical Center, Providence, RI
state: Rhode Island
Study officials:
affiliation: Providence VA Medical Center, Providence, RI
name: Jennifer Marie Primack, PhD MA
role: PRINCIPAL_INVESTIGATOR
References: