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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
312
CBT for insomnia aims at changing dysfunctional cognitive beliefs and maladaptive behaviors contributed to the maintenance of insomnia. It involves 4 main components including behavioral, cognitive, educational, and relaxation treatments.
the University of Hong Kong
Hong Kong, Hong Kong
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.
12-week posttreatment is only for within-group comparison in treatment groups
Time frame: Baseline, 1-week, 5-week, and 12-week posttreatment.
Self-rated sleep quality score measured by the Pittsburgh Sleep Quality Index (PSQI) questionnaire
12-week posttreatment is only for within-group comparison in treatment groups
Time frame: 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)
12-week posttreatment is only for within-group comparison in treatment groups
Time frame: 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)
12-week posttreatment is only for within-group comparison in treatment groups
Time frame: 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)
12-week posttreatment is only for within-group comparison in treatment groups
Time frame: Baseline, 1-week, 5-week, and 12-week posttreatment.
Self-rated fatigue score measured by Multidimensional Fatigue Inventory (MFI)
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12-week posttreatment is only for within-group comparison in treatment groups
Time frame: Baseline, 1-week, 5-week, and 12-week posttreatment.
Subjects' acceptability and credibility to the treatment measured by Treatment acceptability and credibility rating scale
Time frame: Baseline and 1-week posttreatment
Subjects' adherence to the treatment measured by Treatment adherence rating scale
Time frame: 1-week posttreatment
Subjects' satisfaction to the treatment measured by Treatment satisfaction rating scale
Time frame: Treatment Week 2-6
Potential side effects associated with each component of CBT measured by Symptom checklist
Time frame: 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
12-week posttreatment is only for within-group comparison in treatment groups
Time frame: Baseline, treatment Week 3, 1-week, 5-week and 12 week posttreatment.