Internet-Based Cognitive-Behavioral Therapy for Insomnia

This study is currently recruiting participants.
Verified December 2013 by The University of Hong Kong
Sponsor:
Information provided by (Responsible Party):
The University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01719120
First received: October 29, 2012
Last updated: December 10, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
Insomnia
Behavioral: Cognitive-Behavioral Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Internet-Based Self-Help Cognitive-Behavioral Therapy for Insomnia (CBTI): A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by The University of Hong Kong:

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. [ Time Frame: Baseline, 1-week, 5-week, and 12-week posttreatment. ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, 1-week, 5-week, and 12-week posttreatment. ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline, 1-week, 5-week, and 12-week posttreatment. ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline, 1-week, 5-week, and 12-week posttreatment ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline, 1-week, 5-week, and 12-week posttreatment. ] [ Designated as safety issue: No ]
    12-week posttreatment is only for within-group comparison in treatment groups

  • Self-rated fatigue score measured by Multidimensional Fatigue Inventory (MFI) [ Time Frame: Baseline, 1-week, 5-week, and 12-week posttreatment. ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and 1-week posttreatment ] [ Designated as safety issue: No ]
  • Subjects' adherence to the treatment measured by Treatment adherence rating scale [ Time Frame: 1-week posttreatment ] [ Designated as safety issue: No ]
  • Subjects' satisfaction to the treatment measured by Treatment satisfaction rating scale [ Time Frame: Treatment Week 2-6 ] [ Designated as safety issue: No ]
  • Potential side effects associated with each component of CBT measured by Symptom checklist [ Time Frame: Treatment Week 2-6 and 1-week posttreatment ] [ Designated as safety issue: Yes ]
  • 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. ] [ Designated as safety issue: No ]
    12-week posttreatment is only for within-group comparison in treatment groups


Estimated Enrollment: 297
Study Start Date: August 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01719120

Contacts
Contact: Kai-Fai Chung, MBBS (852)2255 3656 kfchung@hkucc.hku.hk

Locations
Hong Kong
the University of Hong Kong Recruiting
Hong Kong, Hong Kong
Contact: Yan-Yee Fiona Ho, BSocSc    852-22554043    hoyy@hku.hk   
Principal Investigator: Kai-Fai Chung, MBBS         
Sub-Investigator: Yan-Yee Fiona Ho, BSocSc         
Sponsors and Collaborators
The University of Hong Kong
Investigators
Principal Investigator: Ka-Fai Chung, MBBS The University of Hong Kong
  More Information

No publications provided

Responsible Party: The University of Hong Kong
ClinicalTrials.gov Identifier: NCT01719120     History of Changes
Other Study ID Numbers: CBTI-001
Study First Received: October 29, 2012
Last Updated: December 10, 2013
Health Authority: Hong Kong: Department of Health

Keywords provided by The University of Hong Kong:
Insomnia
Cognitive-Behavioral Therapy
Internet-Based
Self-Help
Randomized Controlled Trial

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Mental Disorders

ClinicalTrials.gov processed this record on April 23, 2014