Internet-Based Cognitive-Behavioral Therapy for Insomnia

May 12, 2016 updated by: The University of Hong Kong

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

312

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • The University of Hong Kong

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

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.
Time Frame: Baseline, 1-week, 5-week, and 12-week posttreatment.
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
Time Frame: Baseline, 1-week, 5-week, and 12-week posttreatment.
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)
Time Frame: Baseline, 1-week, 5-week, and 12-week posttreatment.
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)
Time Frame: Baseline, 1-week, 5-week, and 12-week posttreatment
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)
Time Frame: Baseline, 1-week, 5-week, and 12-week posttreatment.
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)
Time Frame: Baseline, 1-week, 5-week, and 12-week posttreatment.
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
Time Frame: Baseline and 1-week posttreatment
Baseline and 1-week posttreatment
Subjects' adherence to the treatment measured by Treatment adherence rating scale
Time Frame: 1-week posttreatment
1-week posttreatment
Subjects' satisfaction to the treatment measured by Treatment satisfaction rating scale
Time Frame: Treatment Week 2-6
Treatment Week 2-6
Potential side effects associated with each component of CBT measured by Symptom checklist
Time Frame: Treatment Week 2-6 and 1-week posttreatment
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
Time Frame: Baseline, treatment Week 3, 1-week, 5-week and 12 week posttreatment.
12-week posttreatment is only for within-group comparison in treatment groups
Baseline, treatment Week 3, 1-week, 5-week and 12 week posttreatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

October 29, 2012

First Submitted That Met QC Criteria

October 29, 2012

First Posted (Estimate)

November 1, 2012

Study Record Updates

Last Update Posted (Estimate)

May 13, 2016

Last Update Submitted That Met QC Criteria

May 12, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CBTI-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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