Internet-Based Cognitive-Behavioral Therapy for Insomnia
- Conditions
- Insomnia
- Interventions
- Behavioral: Cognitive-Behavioral Therapy
- Registration Number
- NCT01719120
- Lead Sponsor
- The University of Hong Kong
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 312
- 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
- Have suicidal ideas based on self-report
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Self-help CBT Cognitive-Behavioral Therapy The subjects will receive self-help cognitive-behavioral therapy (SH)once per week for 6 consecutive weeks. Self-help CBT with tel. consultation Cognitive-Behavioral Therapy 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.
- Primary Outcome Measures
Name Time Method 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. Baseline, 1-week, 5-week, and 12-week posttreatment. 12-week posttreatment is only for within-group comparison in treatment groups
- Secondary Outcome Measures
Name Time Method Self-rated sleep quality score measured by the Pittsburgh Sleep Quality Index (PSQI) questionnaire Baseline, 1-week, 5-week, and 12-week posttreatment. 12-week posttreatment is only for within-group comparison in treatment groups
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. 12-week posttreatment is only for within-group comparison in treatment groups
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 12-week posttreatment is only for within-group comparison in treatment groups
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. 12-week posttreatment is only for within-group comparison in treatment groups
Self-rated fatigue score measured by Multidimensional Fatigue Inventory (MFI) Baseline, 1-week, 5-week, and 12-week posttreatment. 12-week posttreatment is only for within-group comparison in treatment groups
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. 12-week posttreatment is only for within-group comparison in treatment groups
Trial Locations
- Locations (1)
the University of Hong Kong
🇭🇰Hong Kong, Hong Kong