A Prospective, Multicenter, Randomized Clinical Trial for Evaluating the Safety and Efficacy of Software-delivered Cognitive Behavioral Therapy for Insomnia in Patients With Insomnia Disorder.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 236
- 试验地点
- 5
- 主要终点
- The Change of Insomnia Severity from Baseline to Follow-up
研究概览
简要总结
The goal of this prospective multicenter clinical trial is to evaluate the efficacy and safety of software-delivered cognitive behavioral therapy for insomnia (CBT-I) in Chinese patients with insomnia disorder (ID). The main questions it aims to answer are: (1) whether the software-delivered CBT-I is more effective than an online patient education (online-PE) at improving insomnia. (2) whether the software-delivered CBT-I is safe for treatment of insomnia symptoms.
Participants will be randomized to receive (1) a software-delivered CBT-I using automated software called 'resleep' (one kind of digital device expected to treat insomnia targeted for Chinese patients); (2) online patient education (online-PE) about sleep.
Researchers will compare the efficacy of a software-delivered CBT-I program and an online sleep education control at improving insomnia symptoms and other psychological outcomes.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged ≥18 years old, no gender limitation;
- •Own a mobile-phone, access the Internet, and be skilled in using software;
- •Meet the diagnostic criteria of insomnia disorder in the Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition) (DSM-5);
- •Insomnia symptoms appear at least 3 nights per week and last for at least 3 months;
- •ISI scores ≥ 12 ;
- •Volunteer to participate in this experiment and sign a written informed consent.
排除标准
- •Generalized Anxiety Disorder Scale-7 (GAD-7) scores ≥ 15;
- •Patients Health Questionnaire-9 (PHQ-9) scores ≥ 20;
- •Current thoughts of suicide or self-injury (defined as PHQ-9 9th item score ≥ 1);
- •Confirmed physical diseases that may affect sleep, such as congestive heart failure, chronic obstructive pulmonary disease acute phase, cardiovascular and cerebrovascular disease acute phase, etc.
- •Current diagnosed neurological or mental illness (major depressive disorder, bipolar disorder, epilepsy, schizophrenia, etc.) that may affect sleep;
- •Diagnoses of other untreated sleep disorders, such as obstructive sleep apnea, restless leg syndrome (RLS);
- •Usual bedtime (when the subject attempts to fall asleep) is earlier than 8 p.m. or later than 2 a.m., or usual waking (arising) time is earlier than 4 a.m. or later than 10 a.m.
- •Alcohol or drug abusers (other than nicotine dependence) in the past year;
- •Pregnant or lactating women;
- •Undergoing systematic psychotherapy within the past 3 months;
- •Undergoing other cognitive behavioral therapy for sleep disorders;
- •Unstable usage of medication regimens that affect sleep (changes in type, dosage and method of use within the past 1 month);
- •Night shift workers, travelers across time zones;
- •Subjects who have not responded to previous CBT-I;
- •Other conditions deemed unsuitable for clinical trials by the investigator.
结局指标
主要结局
The Change of Insomnia Severity from Baseline to Follow-up
时间窗: Baseline, post-intervention, follow-up (3 months after post-intervention)
The insomnia severity is assessed with the Insomnia Severity Index (ISI), a 7-item questionnaire well validated in insomnia research in multiple patient populations. The change of ISI scores from baseline to follow-up is the primary outcome.
次要结局
- Sleep Quality(Baseline, post-intervention, follow-up (3 months after post-intervention))
- Insomnia Remission(Baseline, post-intervention, follow-up (3 months after post-intervention))
- Insomnia Treatment Response(Baseline, post-intervention, follow-up (3 months after post-intervention))
- Anxiety(Baseline, post-intervention, follow-up (3 months after post-intervention))
- Depression(Baseline, post-intervention, follow-up (3 months after post-intervention))
- Sleep Parameters Assessed by Sleep Diary(Baseline, post-intervention, follow-up (3 months after post-intervention))
- Life Quality(Baseline, post-intervention, follow-up (3 months after post-intervention))
研究者
Hongqiang Sun
Professor
Peking University Sixth Hospital