Clinical trial NCT01719120: Internet-Based Cognitive-Behavioral Therapy for Insomnia
Official title: Internet-Based Self-Help Cognitive-Behavioral Therapy for Insomnia (CBTI): A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia
Keywords: Insomnia
Cognitive-Behavioral Therapy
Internet-Based
Self-Help
Randomized Controlled Trial
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2012-11-01
Enrollment: 312
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: Baseline, 1-week, 5-week, and 12-week posttreatment.
Secondary outcomes:
measure: Self-rated sleep quality score measured by the Pittsburgh Sleep Quality Index (PSQI) questionnaire
timeFrame: Baseline, 1-week, 5-week, and 12-week posttreatment.
measure: Self-rated sleep-related cognition score measured by Dysfunctional Beliefs and Attitudes about Sleep Scale (DBAS)
timeFrame: Baseline, 1-week, 5-week, and 12-week posttreatment.
measure: Self-rated severity of depressive and anxiety symptoms measured by Hospital Anxiety and Depression Scale (HADS)
timeFrame: Baseline, 1-week, 5-week, and 12-week posttreatment
measure: 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)
timeFrame: Baseline, 1-week, 5-week, and 12-week posttreatment.
measure: Self-rated fatigue score measured by Multidimensional Fatigue Inventory (MFI)
timeFrame: Baseline, 1-week, 5-week, and 12-week posttreatment.
measure: Subjects' acceptability and credibility to the treatment measured by Treatment acceptability and credibility rating scale
timeFrame: Baseline and 1-week posttreatment
measure: Subjects' adherence to the treatment measured by Treatment adherence rating scale
timeFrame: 1-week posttreatment
measure: Subjects' satisfaction to the treatment measured by Treatment satisfaction rating scale
timeFrame: Treatment Week 2-6
measure: Potential side effects associated with each component of CBT measured by Symptom checklist
timeFrame: Treatment Week 2-6 and 1-week posttreatment
measure: Self-rated sleep quality score changes from baseline to 12-week posttreatment measured by Insomnia Severity Index questionnaire
timeFrame: Baseline, treatment Week 3, 1-week, 5-week and 12 week posttreatment.
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: the University of Hong Kong
Study officials:
affiliation: The University of Hong Kong
name: Ka-Fai Chung, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ho FY, Chung KF, Yeung WF, Ng TH, Cheng SK. Weekly brief phone support in self-help cognitive behavioral therapy for insomnia disorder: Relevance to adherence and efficacy. Behav Res Ther. 2014 Dec;63:147-56. doi: 10.1016/j.brat.2014.10.002. Epub 2014 Oct 23.