Back to resultsInternet-Based Cognitive-Behavioral Therapy for Insomnia
Primary Purpose
Insomnia
Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Cognitive-Behavioral Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Insomnia focused on measuring Insomnia, Cognitive-Behavioral Therapy, Internet-Based, Self-Help, Randomized Controlled Trial
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
Sites / Locations
- the University of Hong Kong
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
Self-help CBT with tel. consultation
Self-help CBT
Waiting-list control (WL)
Arm Description
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.
The subjects will receive self-help cognitive-behavioral therapy (SH)once per week for 6 consecutive weeks.
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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
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
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
Self-rated fatigue score measured by Multidimensional Fatigue Inventory (MFI)
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
Subjects' adherence to the treatment measured by Treatment adherence rating scale
Subjects' satisfaction to the treatment measured by Treatment satisfaction rating scale
Potential side effects associated with each component of CBT measured by Symptom checklist
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
Full Information
NCT ID
NCT01719120
First Posted
October 29, 2012
Last Updated
May 12, 2016
Sponsor
The University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT01719120
Brief Title
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
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
May 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Hong Kong
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia
Keywords
Insomnia, Cognitive-Behavioral Therapy, Internet-Based, Self-Help, Randomized Controlled Trial
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
312 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Self-help CBT with tel. consultation
Arm Type
Experimental
Arm Description
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.
Arm Title
Self-help CBT
Arm Type
Experimental
Arm Description
The subjects will receive self-help cognitive-behavioral therapy (SH)once per week for 6 consecutive weeks.
Arm Title
Waiting-list control (WL)
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive-Behavioral Therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
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.
Description
12-week posttreatment is only for within-group comparison in treatment groups
Time Frame
Baseline, 1-week, 5-week, and 12-week posttreatment.
Secondary Outcome Measure Information:
Title
Self-rated sleep quality score measured by the Pittsburgh Sleep Quality Index (PSQI) questionnaire
Description
12-week posttreatment is only for within-group comparison in treatment groups
Time Frame
Baseline, 1-week, 5-week, and 12-week posttreatment.
Title
Self-rated sleep-related cognition score measured by Dysfunctional Beliefs and Attitudes about Sleep Scale (DBAS)
Description
12-week posttreatment is only for within-group comparison in treatment groups
Time Frame
Baseline, 1-week, 5-week, and 12-week posttreatment.
Title
Self-rated severity of depressive and anxiety symptoms measured by Hospital Anxiety and Depression Scale (HADS)
Description
12-week posttreatment is only for within-group comparison in treatment groups
Time Frame
Baseline, 1-week, 5-week, and 12-week posttreatment
Title
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)
Description
12-week posttreatment is only for within-group comparison in treatment groups
Time Frame
Baseline, 1-week, 5-week, and 12-week posttreatment.
Title
Self-rated fatigue score measured by Multidimensional Fatigue Inventory (MFI)
Description
12-week posttreatment is only for within-group comparison in treatment groups
Time Frame
Baseline, 1-week, 5-week, and 12-week posttreatment.
Title
Subjects' acceptability and credibility to the treatment measured by Treatment acceptability and credibility rating scale
Time Frame
Baseline and 1-week posttreatment
Title
Subjects' adherence to the treatment measured by Treatment adherence rating scale
Time Frame
1-week posttreatment
Title
Subjects' satisfaction to the treatment measured by Treatment satisfaction rating scale
Time Frame
Treatment Week 2-6
Title
Potential side effects associated with each component of CBT measured by Symptom checklist
Time Frame
Treatment Week 2-6 and 1-week posttreatment
Title
Self-rated sleep quality score changes from baseline to 12-week posttreatment measured by Insomnia Severity Index questionnaire
Description
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ka-Fai Chung, MBBS
Organizational Affiliation
The University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
the University of Hong Kong
City
Hong Kong
Country
Hong Kong
12. IPD Sharing Statement
Citations:
PubMed Identifier
25461790
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.
Results Reference
result
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Internet-Based Cognitive-Behavioral Therapy for Insomnia
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