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临床试验/NCT01894841
NCT01894841已完成不适用

Veterans Coping Long-Term With Suicide

VA Office of Research and Development2 个研究点 分布在 1 个国家目标入组 107 人开始时间: 2014年2月24日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
107
试验地点
2
主要终点
Changes in Columbia Suicide Severity Rating Scale (C-SSRS) - Behavior

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

结局指标

主要结局

Changes in Columbia Suicide Severity Rating Scale (C-SSRS) - Behavior

时间窗: baseline, 3, 6, 9, & 12 month post-hospitalization

Items measuring attempt behavior (number of Actual Attempts, number of Aborted Attempts, number of Interrupted Attempts) From the Columbia Suicide Severity Rating Scale were summed to create a composite variable indexing attempt behavior. Higher scores indicate more attempt behavior. We log transformed this variable at all time points to meet assumptions of normality.

次要结局

  • Brief Symptom Inventory(Baseline, 3, 6, 9, & 12 month follow up)
  • Changes in Beck Hopelessness Scale(Baseline, 3, 6, 9, & 12 month follow up)
  • World Health Organization Disability Assessment Schedule (WHODAS) II(Baseline, 3, 6, 9, & 12 month follow ups)
  • Treatment History Interview(3, 6, 9, & 12 month follow up)
  • Changes in Columbia Suicide Severity Rating Scale (C-SSRS) - Ideation Severity(baseline, 3, 6, 9, & 12 month post-hospitalization)

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (2)

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