A Hybrid Effectiveness-Implementation Multisite Trial of a Dialectical Behavior Therapy Skills Group for Veterans at High-Risk for Suicide Attempt
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 156
- 试验地点
- 10
- 主要终点
- Change in Emotion dysregulation
研究概览
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.
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
- Single (Outcomes Assessor)
盲法说明
Outcomes assessors will be masked to study condition.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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)