Feasibility, Acceptability, and Preliminary Effectiveness of a Cognitive Behavioral Suicide Prevention-focused Intervention Tailored to Adults Diagnosed With Schizophrenia Spectrum Disorders: Aim 2 RCT
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Calgary Depression Rating Scale (CDRS)
研究概览
简要总结
Investigators will evaluate the feasibility and preliminary effectiveness of modified Cognitive Behavioral Suicide Prevention for psychosis (CBSPp) in comparison to services-as-usual (SAU) in a randomized controlled trial. Investigators will recruit adult clients receiving services at a community mental health (CMH) setting who have a schizophrenia spectrum disorder and recent suicidal thoughts or behaviors within 3 months of screening (n=60). Client participants will be screened, enrolled and randomized to the CBSPp or SAU group. A 4-wave design will include quantitative assessments at baseline (T1), 1-month after baseline (T2), 3-months after baseline (T3), and 5-months after baseline (T4) with in-depth qualitative interviews at T3 for a random sample of adults in the CBSPp group (n=10). Providers (n=12) will be trained to deliver CBSPp and be assessed from T1-T3 to evaluate the implementation process, including in-depth qualitative interviews at T3.
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 (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Schizophrenia Spectrum Disorder
- •Suicide ideation and/or attempt within 3 months of screening
- •Ability to speak and read in English
- •18 to 65 years of age
排除标准
- •Requiring emergency care (e.g. imminent plan to harm self) as determined by trained research staff administering the Columbia-Suicide Severity Rating Scale (C-SSRS)
- •Inappropriate for behavioral treatment according to own judgment in consultation with a treating clinician CMH
- •Impaired capacity (cognitive capacity)
结局指标
主要结局
Calgary Depression Rating Scale (CDRS)
时间窗: 4 time points (baseline, mid-treatment (1 month), post-treatment (3 months), and follow-up (5 months).
A scale to measure depression, higher scores indicate greater depression (range of 0-27)
Positive and Negative Syndrome Scale (PANSS)
时间窗: 4 time points (baseline, mid-treatment (1 month), post-treatment (3 months), and follow-up (5 months).
A scale to measure psychosis symptoms, higher scores indicate greater psychosis (range of 30-210)
Columbia Suicide Severity Rating Scale (C-SSRS)
时间窗: 4 time points (baseline, mid-treatment (1 month), post-treatment (3 months), and follow-up (5 months).
A scale to measure suicide thoughts and behavior, higher scores indicate greater suicide thoughts and behavior (range of 0-5)
次要结局
- Beck Hopelessness Scale(4 time points (baseline, mid-treatment (1 month), post-treatment (3 months), and follow-up (5 months).)
- Defeat Scale (D Scale)(4 time points (baseline, mid-treatment (1 month), post-treatment (3 months), and follow-up (5 months).)
- The Entrapment Scale(4 time points (baseline, mid-treatment (1 month), post-treatment (3 months), and follow-up (5 months).)
研究者
Lindsay Bornheimer
Assistant Professor
University of Michigan