Insomnia
Conditions
Keywords
Insomnia, Cognitive-Behavioral Therapy, Internet-Based, Self-Help, Randomized Controlled Trial
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.
Interventions
BEHAVIORALCognitive-Behavioral Therapy
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.
Sponsors
The University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* Have suicidal ideas based on self-report
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| Subjects' acceptability and credibility to the treatment measured by Treatment acceptability and credibility rating scale | Baseline and 1-week posttreatment | — |
Countries
Hong Kong
Outcome results
None listed