跳至主要内容
临床试验/NCT05000749
NCT05000749
进行中(未招募)
不适用

A Hybrid Effectiveness-Implementation Multisite Trial of a Dialectical Behavior Therapy Skills Group for Veterans at High-Risk for Suicide Attempt

VA Office of Research and Development5 个研究点 分布在 1 个国家目标入组 156 人2023年4月30日

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Suicide, Attempted
发起方
VA Office of Research and Development
入组人数
156
试验地点
5
主要终点
Change in Emotion dysregulation
状态
进行中(未招募)
最后更新
3个月前

概览

简要总结

Veteran suicide death is a national crisis. Risk factors include emotion dysregulation, which occurs across mental health disorders. Dialectical behavior therapy (DBT) is an evidence-based suicide intervention that targets emotion dysregulation but is resource-intensive and not widely available at VHA. A more efficient evidence-based DBT Skills Group (DBT-SG) is associated with reduced suicidal ideation and emotion dysregulation and likely more feasible to implement at VHA. This is a randomized controlled trial to test whether DBT-SG in addition to VHA treatment-as-usual, compared to only VHA treatment-as-usual, reduces Veteran emotion dysregulation.

详细描述

This is a randomized controlled trial at four VHA medical centers. Veterans will be randomized to VHA treatment-as-usual or VHA treatment-as-usual plus DBT-SG.

注册库
clinicaltrials.gov
开始日期
2023年4月30日
结束日期
2027年2月26日
最后更新
3个月前
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

责任方
Sponsor

入排标准

入选标准

  • Veteran eligible for VHA care at participating site
  • two or more suicide attempts in lifetime, with one in past 12 months, on Columbia-Suicide Severity Rating Scale (C-SSRS)
  • current suicidal ideation (endorsing a suicidal ideation scale of at least 1 \[passive ideation\] on C-SSRS
  • emotion dysregulation (score 95 or greater on DERS)
  • can attend group sessions
  • willing to provide contact information for at least one person who can help locate the participant if study staff are unable to contact them (information for three contact persons will be requested; a participant must provide at least one contact person's information to be included in the study)
  • access to telephone; if insufficient access to videoteleconference and local facility is using remote procedures for study, willing to request access to VA-provided device

排除标准

  • significant cognitive impairment (score \< 28 on modified Telephone Interview for Cognitive Status (mTICS)
  • inability to read English or communicate in spoken and written English
  • plan to move away or be unavailable in the next 18 months

结局指标

主要结局

Change in Emotion dysregulation

时间窗: Up to18 month follow-up

Emotion dysregulation will be assessed with the Difficulties in Emotion Regulation Scale, a self-report measure. The scale ranges 36-180 with a higher score indicating greater difficulties in emotion regulation.

次要结局

  • Coping(Up to 18 month follow-up)
  • Columbia-Suicide Severity Rating Scale(Up to 18 month follow-up)

研究点 (5)

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