Cognitive Behavioral Therapy for Insomnia (CBT-I) in Schizophrenia - A Randomized Controlled Clinical Trial (SLEEPINS)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Change in Insomnia Severity Index score (ISI) (Morin 2011)
研究概览
简要总结
Sleep problems are pervasive in people with schizophrenia. In our study, our goal is to determine whether we can alleviate sleep symptoms and improve quality of life and well-being in patients with major psychiatric disorders through cognitive behavioral therapy (CBT) delivered via the internet or in groups.
At the same time, the study provides information on factors that are commonly associated with sleep and well-being in patients. The intervention study is conducted as a Randomized Controlled Clinical Trial (RCT), in which subjects are randomized into three groups: 1) Treatment as usual (TAU), 2) TAU and Internet-based therapy for insomnia (ICBT-I), and 3) TAU and group therapy for insomnia (GCBT-I).
详细描述
Sleep is important for well-being. Lack of sleep and poor quality of sleep (Insomnia) are risk factors for psychiatric and somatic diseases such as depression, cardiovascular disease, diabetes and memory disorders and increases the risk of cognitive errors and accidents.
Psychiatric patients suffer from a wide variety of sleep disorders. Insomnia symptoms are known to increase the likelihood of later depression and even the use of disability pensions due to depression.
Various sleep disorders are also common in patients with schizophrenia. Previous studies on schizophrenia have reported-, symptoms of insomnia, especially the problem of falling asleep and poor sleep quality, circadian rhythm disruption, hypersomnolence and nightmares among the patients.
Cognitive behavioural therapy for insomnia (CBT-I) is an evidence-based treatment for insomnia. CBT-I can be implemented as an individual treatment, on a group basis or via the internet. There is evidence that CBT-I can also be used to treat a patient with a major psychiatric disorders, but randomized clinical trials (RCT) have rarely been published. Our research is based on the hypothesis that symptoms of insomnia in patients with schizophrenia can improved by CBT-I and, further, by improving patients' sleep quality their health and quality of life can also be improved.
The present study is designed to investigate the effect of two different treatment programs as compared to treatment as usual (TAU). The purpose of this study is to determine whether CBT-I can help relieve sleep symptoms and improve quality of life and well-being in patients with schizophrenia. At the same time, the study provides information on factors that are commonly associated with sleep and well-being in patients with major psychiatric disorders. The intervention study is conducted as an RCT, in which subjects are randomized into three groups: 1) Treatment as usual (TAU), 2) TAU and Internet-based therapy for insomnia (ICBT-I), and 3) TAU and group therapy for insomnia (GCBT-I).
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •To participate in the study, patients must meet the following criteria:
- •Have previously participated in the nationwide SUPER Finland study (www.superfinland.fi, a study on genetic mechanisms of psychotic disorders and a part of the Stanley Global Initiative) and have given permission for subsequent contact.
- •Be currently in psychiatric care at HUS
- •Be 18 years of age or older
- •Have a serious mental disorder (schizophrenia or schizoaffective disorder)
- •Have a stable medical condition
- •Have self-reported sleep problems: difficulty falling asleep, difficulty staying asleep, poor quality of sleep, or dissatisfaction with sleep
- •Have access to an electronic inquiry and treatment program and use of e-mail
- •Be able to participate in a sleep group if randomized.
排除标准
- •Exclusion criteria include:
- •ongoing cognitive-behavioral psychotherapy
- •diagnosed sleep disorder such as sleep apnea
- •insufficient Finnish language skills (insomnia interventions are produced in Finnish, so good Finnish language skills are required)
结局指标
主要结局
Change in Insomnia Severity Index score (ISI) (Morin 2011)
时间窗: baseline, 12, 24 and 36 weeks from the baseline
A 7-item questionnaire used to assess insomnia severity with a score ranging between 0 to 28. Each questionnaire item addresses an aspect about sleep that is rated by the respondent on a 5-point scale (i.e., 0=no problem to 4=very severe problem).
Change in the health-related quality of life (HRQoL) instrument 15D score (Sintonen, 2001)
时间窗: baseline, 12, 24 and 36 weeks from the baseline
The 15D is a generic, comprehensive, 15-dimensional, standardized, self-administered measure of health-related quality of life (HRQoL) that can be used both as a profile and single index score measure. The maximum score is 1 (no problems on any dimension) and the minimum score is 0 (being dead).
次要结局
- Objective information on activity from EMFIT Sleep Tracker data (Emfit Ltd)(baseline to week 13)
- Self-reported variables for chronotype (Horne 1976)(baseline, 12, 24 and 36 weeks from the baseline)
- Self-reported variables for tiredness, fatigue, subjective memory, stress and recovery (Lundqvist 2016)(baseline, 12, 24 and 36 weeks from the baseline)
- Self-reported variables for symptoms of depression (Korenke 2001)(baseline, 12, 24 and 36 weeks from the baseline)
- Objective information on recovery of the autonomic nervous system from EMFIT Sleep Tracker data (Emfit Ltd)(baseline to week 13)
- Self-reported subjective sleep quality collected through a digital smartphone app (AIDO Healthcare)(baseline to week 36)
- Self-reported subjective mood collected through a digital smartphone app (AIDO Healthcare)(baseline to week 36)
- Self-reported variables for dreaming and nightmares (adapted from Sandman 2015)(baseline, 12, 24 and 36 weeks from the baseline)
- Self-reported variables for functional ability (adapted from Tuomi 1998).(baseline, 12, 24 and 36 weeks from the baseline)
- Cognitive performance is measure with the psychomotor vigilance test (PVT) (Basner 2011) via a web-based interface(baseline, 12, 24 and 36 weeks from the baseline)
- Self-reported subjective fatigue collected through a digital smartphone app (AIDO Healthcare)(baseline to week 36)
- Self-reported variables for sleep quantity and quality (adapted from Partinen 1996)(baseline, 12, 24 and 36 weeks from the baseline)
- Self-reported variables for symptoms of psychosis (adapted from Haddoc 1999),(baseline, 12, 24 and 36 weeks from the baseline)
- Subjective measures of Dysfunctional Beliefs and Attitudes about Sleep (DBAS-16) (Morin 2007)(baseline, 12, 24 and 36 weeks from the baseline)
- Objective information on sleep from Actigraphy (ACG) data(baseline (1 week) and week 12(1 week))
- Self-reported variables for lifestyle(baseline, 12, 24 and 36 weeks from the baseline)
- Self-reported Feedback Questionnaire(12 weeks)
- Objective information on circadian rhythms from Actigraphy (ACG) data(baseline (1 week) and week 12(1 week))
- Subjective sleep diary tracking(baseline (1 week) and week 12(1 week))
研究者
Tiina M. Paunio
Professor of Psychiatry and Vice Dean of Education / Department of Psychiatry, Faculty of Medicine, University of Helsinki, Research Professor / National Institute for Health and Welfare
Helsinki University Central Hospital