Internet-Based Cognitive-Behavioral Therapy for Insomnia

Study Overview
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Brief Summary
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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
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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.

Official Title
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Internet-Based Self-Help Cognitive-Behavioral Therapy for Insomnia (CBTI): A Randomized Controlled Trial

Conditions
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Insomnia

Intervention / Treatment
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* Behavioral: Cognitive-Behavioral Therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Self-help CBT with tel. consultation<br>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. | Behavioral: Cognitive-Behavioral Therapy<br>* 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.<br>|
| Experimental: Self-help CBT<br>The subjects will receive self-help cognitive-behavioral therapy (SH)once per week for 6 consecutive weeks. | Behavioral: Cognitive-Behavioral Therapy<br>* 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.<br>|
| No Intervention: Waiting-list control (WL)<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Baseline, 1-week, 5-week, and 12-week posttreatment. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 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 | Baseline, 1-week, 5-week, and 12-week posttreatment. | 
| Self-rated fatigue score measured by Multidimensional Fatigue Inventory (MFI) | 12-week posttreatment is only for within-group comparison in treatment groups | 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 | 12-week posttreatment is only for within-group comparison in treatment groups | Baseline, treatment Week 3, 1-week, 5-week and 12 week posttreatment. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Insomnia, Cognitive-Behavioral Therapy, Internet-Based, Self-Help, Randomized Controlled Trial