CBT-I for Psychosis: Guidelines, Preliminary Efficacy, and Functional Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 2
- 主要终点
- Insomnia Severity Index (ISI)
研究概览
简要总结
The goal of this project is to develop guidelines for the clinical tailoring of Cognitive Behavioral Therapy for Insomnia (CBT-I) for Veterans with psychotic disorders and insomnia, and to test the acceptability, feasibility, and preliminary efficacy of CBT-I for improving sleep-related functional outcomes in this population.
详细描述
The goal of this project is to develop guidelines for the clinical tailoring of Cognitive Behavioral Therapy for Insomnia (CBT-I) for Veterans with psychotic disorders and insomnia, and to test the acceptability, feasibility, and preliminary efficacy of CBT-I for improving sleep-related functional outcomes in this population.
Specific Aim 1: Develop empirically-derived guidelines for the clinical tailoring of CBT-I materials and procedures for Veterans with psychotic disorders through an iterative process with input from Veteran clients, CBT-I experts and providers, as well as those with expertise in psychotic disorders.
Specific Aim 2: Establish the acceptability of CBT-I for Veterans with psychotic disorders and insomnia when delivered using guidelines developed in Specific Aim 1 in order to make further refinements to the guidelines in a preliminary trial with 6 Veterans with psychosis and insomnia.
Specific Aim 3: Conduct a randomized controlled trial (n=60) to test the feasibility and preliminary efficacy of CBT-I in producing positive changes at post-treatment and 3-month follow-up on the outcomes of insomnia symptoms, sleep quality, and functioning.
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)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnostic and Statistical Manual of Disorders, 5th edition (DSM 5) diagnosis of schizophrenic disorders (295.0-295.9), affective psychoses (296.0-296.1, 296.4-296.8), or major depression with psychotic features (296.24, 296.34).
- •Self-reported symptoms of insomnia via an Insomnia Severity Index (ISI) score of 15 or greater.
- •Age between 18 and 80 as determined by medical record review.
- •Participation in outpatient mental health services at a designated study site.
- •Sufficient clinical stability to participate as deemed by a treatment provider.
- •Capacity to sign Informed Consent.
排除标准
- •Current problematic drug or alcohol use that impacts functioning and study engagement, as deemed by a treatment provider.
- •Currently in CBT-I treatment, determined by medical records.
- •Positive screen for sleep apnea via a portable sleep apnea screening device or a prior diagnosis of sleep apnea in medical records.
结局指标
主要结局
Insomnia Severity Index (ISI)
时间窗: Participants will be assessed following completion of the study intervention, an expected average of 10 weeks.
ISI score; scored on a scale of 0 to 28, with higher scores indicating worse insomnia severity.
次要结局
- Veterans RAND 36-Item Health Survey Mental Component Score(Participants will be assessed a second time following completion of the study intervention, an expected average of 22 weeks.)
- Insomnia Severity Index (ISI)(Participants will be assessed a second time following completion of the study intervention, an expected average of 22 weeks.)
- World Health Organization Disability Assessment Schedule (WHO-DAS), Participation in Society Subscale(Participants will be assessed a second time following completion of study intervention, an estimated average of 22 weeks.)