Internet-Based Self-Help Cognitive-Behavioral Therapy for Insomnia (CBTI): A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 312
- 试验地点
- 1
- 主要终点
- Sleep parameters (sleep onset latency, sleep efficiency, total sleep time, times of wakening during sleep) changes from baseline to 5-week posttreatment by subjective measures using sleep log.
研究概览
简要总结
The aim of this study is to develop an Internet-based self-help therapy program for insomnia in Chinese language, and to conduct a randomized waiting-list controlled trial on the efficacy of Internet-based self-help therapy for insomnia.
详细描述
This study is a randomized controlled trial in patients with insomnia. Eligible subjects will be randomly assigned to self-help treatment with telephone consultation (SHTC), self-help treatment without telephone consultation (SH), or waiting-list control. The subjects will receive self-help treatment once per week for 6 consecutive weeks. In addition to self-help treatment, the subjects in SHTC group will receive telephone consultation once per week for 6 consecutive weeks.
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
- 是
入选标准
- •Hong Kong residents aged ≥18 years
- •Predominant complaint of difficulty initiating or maintaining sleep or early morning awakening or nonrestorative sleep with associated distress or impairment in social, occupational and other important areas of functioning for at least 3 nights per week for at least 3 months based on self- administered questionnaire
- •Able to read Chinese and type Chinese or English
- •Have Internet access (PC/ mobile phone), and with an email address
- •Willing to give informed consent and comply with the trial protocol
排除标准
- •Have suicidal ideas based on self-report
研究组 & 干预措施
Waiting-list control (WL)
Subjects in this group will not receive any kind of treatment during the waiting period. They will receive the treatment identical to the self-help group within 3 months from the baseline.
Self-help CBT with tel. consultation
Self-help CBT with tel. consultation (SHTC)group will receive telephone consultation provided by the investigator in addition to self-help cognitive-behavioral therapy once per week for 6 consecutive weeks.During the consultation, the investigator will answer questions about the treatment content, monitor whether the subjects read the assigned materials and comply with the tasks and procedures, and provide encouragement and support.
干预措施: Cognitive-Behavioral Therapy (Behavioral)
Self-help CBT
The subjects will receive self-help cognitive-behavioral therapy (SH)once per week for 6 consecutive weeks.
干预措施: Cognitive-Behavioral Therapy (Behavioral)
结局指标
主要结局
Sleep parameters (sleep onset latency, sleep efficiency, total sleep time, times of wakening during sleep) changes from baseline to 5-week posttreatment by subjective measures using sleep log.
时间窗: Baseline, 1-week, 5-week, and 12-week posttreatment.
12-week posttreatment is only for within-group comparison in treatment groups
次要结局
- Self-rated sleep quality score measured by the Pittsburgh Sleep Quality Index (PSQI) questionnaire(Baseline, 1-week, 5-week, and 12-week posttreatment.)
- Self-rated sleep-related cognition score measured by Dysfunctional Beliefs and Attitudes about Sleep Scale (DBAS)(Baseline, 1-week, 5-week, and 12-week posttreatment.)
- Self-rated severity of depressive and anxiety symptoms measured by Hospital Anxiety and Depression Scale (HADS)(Baseline, 1-week, 5-week, and 12-week posttreatment)
- Subjects' general health and quality of life regarding physical functioning, social functioning, physical role limitations, emotional role limitations, mental health, vitality, bodily pain, and general health perception measured by Short form -36 (SF-36)(Baseline, 1-week, 5-week, and 12-week posttreatment.)
- Self-rated fatigue score measured by Multidimensional Fatigue Inventory (MFI)(Baseline, 1-week, 5-week, and 12-week posttreatment.)
- Subjects' acceptability and credibility to the treatment measured by Treatment acceptability and credibility rating scale(Baseline and 1-week posttreatment)
- Subjects' adherence to the treatment measured by Treatment adherence rating scale(1-week posttreatment)
- Subjects' satisfaction to the treatment measured by Treatment satisfaction rating scale(Treatment Week 2-6)
- Potential side effects associated with each component of CBT measured by Symptom checklist(Treatment Week 2-6 and 1-week posttreatment)
- Self-rated sleep quality score changes from baseline to 12-week posttreatment measured by Insomnia Severity Index questionnaire(Baseline, treatment Week 3, 1-week, 5-week and 12 week posttreatment.)