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临床试验/NCT02439762
NCT02439762已完成不适用

Intervening to Reduce Suicide Risk in Veterans With Substance Use Disorders

University of Michigan6 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2015年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
300
试验地点
6
主要终点
Change in frequency and intensity of suicidal thoughts and suicide attempts

研究概览

简要总结

The purpose of this study is to evaluate the impact of a Cognitive Behavioral Therapy (CBT) intervention compared to a Supportive Psycho-educational Control (SPC) condition in reducing the frequency and intensity of suicidal thoughts and behaviors in Veterans with Substance Use Disorders (SUDs) over a two-year follow-up period.

详细描述

The project is a multi-site randomized controlled trial of the CBT intervention versus the SPC condition for 300 suicidal Veterans seen in Veterans Health Administration (VHA) intensive outpatient substance treatment programs (SUD IOP). Participants will be screened for current suicidal ideation and other conditions by completing a self-report survey questionnaire. Eligible participants will complete a baseline assessment which will include a self-report survey questionnaire, a research staff administered interview, and a voluntary urine drug screen. Participants will be randomized to either a Cognitive Behavior Therapy (CBT) or Supportive Psycho-education Control (SPC) condition. Both conditions will involve receipt of 8 one-on-one sessions lasting approximately one hour over a period of approximately 3-4 weeks in addition to their standard SUD IOP treatment of care they may be receiving at the VAMC. The intervention is designed to augment their current treatment, not to take the place of current treatment. Participants will be re-assessed immediately after receiving the study interventions (at 1-month) and then again at 3-, 6- 12-, 18-, and 24-month post-intervention follow-ups by completing a series of self-report surveys, researcher administered interviews, and a voluntary urine drug screen. To ensure adequate monitoring of suicidal ideation, additional telephone follow-up assessments will occur 2-, 4-, and 5-months post-intervention.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

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

  • Must be 18 years of age or older
  • Must be a United States Military Veteran
  • Report current suicidal ideation
  • Enrolled in outpatient substance abuse treatment within the past month
  • Must live within 75 miles of treatment site at time of recruitment

排除标准

  • Inability to give informed, voluntary, written consent
  • Inability to speak and understand English
  • Receipt of methadone treatment for substance use currently or within the past 6 months
  • Evidence of active, severe psychotic symptoms
  • Women who are currently pregnant

结局指标

主要结局

Change in frequency and intensity of suicidal thoughts and suicide attempts

时间窗: Change over study time period [Baseline, 1-, 3-, 6-, 12-, 18-, and 24-months]

This will be measured using the Columbia Suicide Severity Rating Scale (CSS-RS) and a modified version of the Time Line Follow-Back (TLFB).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mark A. Ilgen

Associate Professor of Psychiatry

University of Michigan

研究点 (6)

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