Feasibility, Acceptability, and Preliminary Effectiveness of a Cognitive-behavioral Suicide Prevention-focused Intervention Tailored to Adults Diagnosed With Schizophrenia Spectrum Disorders: Aim 1 Open Pilot Trial to Test Modified Treatment and Measurement Prior to Aim 2 RCT (Registered Separately)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Calgary Depression Rating Scale (CDRS)
研究概览
简要总结
The investigators are modifying and testing the preliminary effectiveness and implementation of a Cognitive Behavioral Suicide Prevention for psychosis (CBSPp) intervention. In this phase of the study, CBSPp will be tested in an initial open trial (n = 10) to examine its feasibility and acceptability. Investigators will recruit clients receiving services at a community mental health setting who have a schizophrenia spectrum disorder and recent suicidal thoughts and behaviors to receive the behavioral intervention for 10-weeks. Providers will be recruited and trained to deliver the intervention. Both clients and providers will be assessed at baseline to test our approach to measurement prior to the Aim 2 RCT (registered separately). Clients will be assessed at three additional timepoints (middle of treatment, end of treatment, and 2 months after treatment ends.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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: baseline, mid-treatment (week 5 of treatment), post-treatment (week 10 of treatment), follow-up (2 months after week 10 of treatment)
A scale to measure depression with scores ranging from 0 to 27 and greater scores indicating greater depression. Item 8 of the scale measures suicide thoughts and behaviors.
Positive and Negative Symptom Rating Scale (PANSS)
时间窗: baseline, mid-treatment (week 5 of treatment), post-treatment (week 10 of treatment), follow-up (2 months after week 10 of treatment)
A scale to measure psychosis with item ratings ranging from 1 to 7. There are 3 sub-scales across 30 questions of the full scale: positive symptom scale (score range 7-49), negative symptom scale (score range 7-49), and general symptom scale (score range 16-112). Scores are summed for each of the 3 sub-scales with higher scores indicating greater presence of symptoms.
Columbia-Suicide Severity Rating Scale (C-SSRS)
时间窗: baseline, mid-treatment (week 5 of treatment), post-treatment (week 10 of treatment), follow-up (2 months after week 10 of treatment)
A scale to measure suicide thoughts and behavior. The following are C-SSRS items that have binary responses (yes/no): wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with some intent to act and without specific plan, active suicidal ideation with specific plan and intent, preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt (non-fatal), and suicide death. A numerical suicidal ideation score is assigned for the first 5 binary items ranging from 0 (no ideation) to 5 (active ideation with plan and intent)
次要结局
- Beck Hopelessness Scale(baseline, mid-treatment (week 5 of treatment), post-treatment (week 10 of treatment), follow-up (2 months after week 10 of treatment))
- The Entrapment Scale(baseline, mid-treatment (week 5 of treatment), post-treatment (week 10 of treatment), follow-up (2 months after week 10 of treatment))
- The Defeat Scale(baseline, mid-treatment (week 5 of treatment), post-treatment (week 10 of treatment), follow-up (2 months after week 10 of treatment))
研究者
Lindsay Bornheimer
Assistant Professor
University of Michigan