Internet-Based Cognitive-Behavioral Therapy for Insomnia
Internet-Based Self-Help Cognitive-Behavioral Therapy for Insomnia (CBTI): A Randomized Controlled Trial
1 other identifier
interventional
312
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2012
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2012
CompletedFirst Submitted
Initial submission to the registry
October 29, 2012
CompletedFirst Posted
Study publicly available on registry
November 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedMay 13, 2016
May 1, 2016
1.7 years
October 29, 2012
May 12, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (10)
Self-rated sleep quality score measured by the Pittsburgh Sleep Quality Index (PSQI) questionnaire
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)
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)
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)
Baseline, 1-week, 5-week, and 12-week posttreatment.
Self-rated fatigue score measured by Multidimensional Fatigue Inventory (MFI)
Baseline, 1-week, 5-week, and 12-week posttreatment.
- +5 more secondary outcomes
Study Arms (3)
Self-help CBT with tel. consultation
EXPERIMENTALSelf-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.
Self-help CBT
EXPERIMENTALThe subjects will receive self-help cognitive-behavioral therapy (SH)once per week for 6 consecutive weeks.
Waiting-list control (WL)
NO INTERVENTIONSubjects 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Have suicidal ideas based on self-report
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
the University of Hong Kong
Hong Kong, Hong Kong
Related Publications (1)
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.
PMID: 25461790RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ka-Fai Chung, MBBS
The University of Hong Kong
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 29, 2012
First Posted
November 1, 2012
Study Start
August 1, 2012
Primary Completion
April 1, 2014
Study Completion
May 1, 2015
Last Updated
May 13, 2016
Record last verified: 2016-05