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Completed

NCT Number: NCT01719120

Internet-Based Cognitive-Behavioral Therapy for Insomnia

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.

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Key information

Conditions

Insomnia Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

the University of Hong Kong

Hong Kong

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive-Behavioral Therapy

Behavioral

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 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.

    Time frame: Baseline, 1-week, 5-week, and 12-week posttreatment.

    12-week posttreatment is only for within-group comparison in treatment groups

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. Subjects' acceptability and credibility to the treatment measured by Treatment acceptability and credibility rating scale

    Time frame: Baseline and 1-week posttreatment

  7. Subjects' adherence to the treatment measured by Treatment adherence rating scale

    Time frame: 1-week posttreatment

  8. Subjects' satisfaction to the treatment measured by Treatment satisfaction rating scale

    Time frame: Treatment Week 2-6

  9. Potential side effects associated with each component of CBT measured by Symptom checklist

    Time frame: Treatment Week 2-6 and 1-week posttreatment

  10. 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

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2015
First posted
Nov 1, 2012
Registry last updated
May 13, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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