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临床试验/NCT02535923
NCT02535923已完成不适用

CBT-I for Psychosis: Guidelines, Preliminary Efficacy, and Functional Outcomes

VA Office of Research and Development1 个研究点 分布在 1 个国家目标入组 47 人开始时间: 2018年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
47
试验地点
1
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.

研究组 & 干预措施

Cognitive Behavioral Therapy-Insomnia

Experimental

CBT-I addresses cognitive, arousal and behavioral factors related to sleep difficulties. Sessions combine assessment, conceptualization, psychoeducation, behavioral strategies and cognitive therapy, using a consistent structure including review of participants' sleep log and adherence to behavioral guidelines, modification of time in bed, cognitive therapy, and relaxation techniques. CBT-I also incorporates psychoeducation about biological and psychological elements that regulate sleep. Other strategies include stimulus control (i.e., getting out of bed when not sleepy) to extinguish the conditioned arousal common in insomnia, and relaxation techniques to reduce arousal associated with the bed, bedroom, or bedtime.

干预措施: Cognitive Behavioral Therapy-Insomnia (Behavioral)

Health and Wellness

Active Comparator

Health and Wellness is a general self-management curriculum focused on providing education and support for managing physical and emotional well-being. Each session follows a basic structure including review of previous session material, new educational information and discussion on several topics over the course of single or multiple sessions. Each session will focus on the impact of the topic on overall health and wellness, identifying benefits and challenges to improving or maintaining health in that area, and strategies that clients may find helpful to address challenges in that area. Example topics include physical activity/exercise, nutrition/healthy eating, managing medications and side effects, and addictive behaviors (e.g., substance use, gambling, eating).

干预措施: Health and Wellness (Behavioral)

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.)
  • Veterans RAND 36-Item Health Survey Mental Component Score(Participants will be assessed following completion of the study intervention, an expected average of 10 weeks.)
  • World Health Organization Disability Assessment Schedule (WHO-DAS), Participation in Society Subscale(Participants will be assessed following completion of the study intervention, an expected average of 10 weeks.)

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (1)

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