跳至主要内容
临床试验/NCT04646200
NCT04646200进行中(未招募)不适用

Cognitive Behavioral Therapy For Insomnia (CBT-I) to Improve Functional Outcomes in Veterans With Psychosis

VA Office of Research and Development2 个研究点 分布在 1 个国家目标入组 152 人开始时间: 2021年11月29日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
152
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 examine the efficacy of Cognitive Behavioral Therapy for Insomnia (CBT-I) for improving sleep and related functional outcomes in Veterans with psychosis and insomnia.

详细描述

The goal of this project is to examine the efficacy of Cognitive Behavioral Therapy for Insomnia (CBT-I) for improving sleep and related functional outcomes in Veterans with psychosis and insomnia.

Aim 1: Evaluate the efficacy of CBT-I for reducing insomnia severity in Veterans with psychosis and insomnia.

Hypothesis 1: CBT-I participants, as compared to those in an active control condition, will show significantly greater reductions on the Insomnia Severity Index at post-treatment and at a 6-month follow-up.

Aim 2: Evaluate the efficacy of CBT-I for improving the functioning of Veterans with psychosis and insomnia. Hypothesis 2: CBT-I participants, as compared to those in an active control condition, will show significantly greater increases in mental and physical health functioning on the Veterans RAND 36-Item Health Survey at post-treatment and at a 6-month follow-up.

Aim 3: Evaluate the process that underlies the relationship between insomnia severity and functioning in Veterans with psychosis and insomnia.

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

入选标准

  • meet criteria for SMI: Schizophrenic disorder, affective psychosis, major depression with psychotic features, delusional disorder, brief psychotic disorder, unspecified psychotic disorder, schizotypal personality disorder
  • be between the ages of 18 and 80
  • be actively participating in outpatient mental health services at designated site

排除标准

  • currently in CBT-I treatment
  • planning to move out of the area during the study period

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 12 weeks; and again after approximately 6 months.

Change in the ISI score; higher scores signify greater insomnia severity; scores range from 0 to 28.

Veterans RAND 36-item Health Survey (VR-36)

时间窗: Participants will be assessed following completion of the study intervention, an expected average of 12 weeks; and again after approximately 6 months.

Change in the VR-36 score; higher scores signify a more favorable health state; scores range from 0 to 100.

次要结局

未报告次要终点

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (2)

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