<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01719120</url>
  </required_header>
  <id_info>
    <org_study_id>CBTI-001</org_study_id>
    <nct_id>NCT01719120</nct_id>
  </id_info>
  <brief_title>Internet-Based Cognitive-Behavioral Therapy for Insomnia</brief_title>
  <official_title>Internet-Based Self-Help Cognitive-Behavioral Therapy for Insomnia (CBTI): A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The University of Hong Kong</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The University of Hong Kong</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to develop an Internet-based self-help therapy program for insomnia&#xD;
      in Chinese language, and to conduct a randomized waiting-list controlled trial on the&#xD;
      efficacy of Internet-based self-help therapy for insomnia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is a randomized controlled trial in patients with insomnia. Eligible subjects will&#xD;
      be randomly assigned to self-help treatment with telephone consultation (SHTC), self-help&#xD;
      treatment without telephone consultation (SH), or waiting-list control. The subjects will&#xD;
      receive self-help treatment once per week for 6 consecutive weeks. In addition to self-help&#xD;
      treatment, the subjects in SHTC group will receive telephone consultation once per week for 6&#xD;
      consecutive weeks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">May 2015</completion_date>
  <primary_completion_date type="Actual">April 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>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.</measure>
    <time_frame>Baseline, 1-week, 5-week, and 12-week posttreatment.</time_frame>
    <description>12-week posttreatment is only for within-group comparison in treatment groups</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Self-rated sleep quality score measured by the Pittsburgh Sleep Quality Index (PSQI) questionnaire</measure>
    <time_frame>Baseline, 1-week, 5-week, and 12-week posttreatment.</time_frame>
    <description>12-week posttreatment is only for within-group comparison in treatment groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-rated sleep-related cognition score measured by Dysfunctional Beliefs and Attitudes about Sleep Scale (DBAS)</measure>
    <time_frame>Baseline, 1-week, 5-week, and 12-week posttreatment.</time_frame>
    <description>12-week posttreatment is only for within-group comparison in treatment groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-rated severity of depressive and anxiety symptoms measured by Hospital Anxiety and Depression Scale (HADS)</measure>
    <time_frame>Baseline, 1-week, 5-week, and 12-week posttreatment</time_frame>
    <description>12-week posttreatment is only for within-group comparison in treatment groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>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)</measure>
    <time_frame>Baseline, 1-week, 5-week, and 12-week posttreatment.</time_frame>
    <description>12-week posttreatment is only for within-group comparison in treatment groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-rated fatigue score measured by Multidimensional Fatigue Inventory (MFI)</measure>
    <time_frame>Baseline, 1-week, 5-week, and 12-week posttreatment.</time_frame>
    <description>12-week posttreatment is only for within-group comparison in treatment groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjects' acceptability and credibility to the treatment measured by Treatment acceptability and credibility rating scale</measure>
    <time_frame>Baseline and 1-week posttreatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjects' adherence to the treatment measured by Treatment adherence rating scale</measure>
    <time_frame>1-week posttreatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjects' satisfaction to the treatment measured by Treatment satisfaction rating scale</measure>
    <time_frame>Treatment Week 2-6</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Potential side effects associated with each component of CBT measured by Symptom checklist</measure>
    <time_frame>Treatment Week 2-6 and 1-week posttreatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-rated sleep quality score changes from baseline to 12-week posttreatment measured by Insomnia Severity Index questionnaire</measure>
    <time_frame>Baseline, treatment Week 3, 1-week, 5-week and 12 week posttreatment.</time_frame>
    <description>12-week posttreatment is only for within-group comparison in treatment groups</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">312</enrollment>
  <condition>Insomnia</condition>
  <arm_group>
    <arm_group_label>Self-help CBT with tel. consultation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Self-help CBT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The subjects will receive self-help cognitive-behavioral therapy (SH)once per week for 6 consecutive weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Waiting-list control (WL)</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Cognitive-Behavioral Therapy</intervention_name>
    <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.</description>
    <arm_group_label>Self-help CBT</arm_group_label>
    <arm_group_label>Self-help CBT with tel. consultation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Hong Kong residents aged ≥18 years&#xD;
&#xD;
          -  Predominant complaint of difficulty initiating or maintaining sleep or early morning&#xD;
             awakening or nonrestorative sleep with associated distress or impairment in social,&#xD;
             occupational and other important areas of functioning for at least 3 nights per week&#xD;
             for at least 3 months based on self- administered questionnaire&#xD;
&#xD;
          -  Able to read Chinese and type Chinese or English&#xD;
&#xD;
          -  Have Internet access (PC/ mobile phone), and with an email address&#xD;
&#xD;
          -  Willing to give informed consent and comply with the trial protocol&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Have suicidal ideas based on self-report&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ka-Fai Chung, MBBS</last_name>
    <role>Principal Investigator</role>
    <affiliation>The University of Hong Kong</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>the University of Hong Kong</name>
      <address>
        <city>Hong Kong</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Hong Kong</country>
  </location_countries>
  <results_reference>
    <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.</citation>
    <PMID>25461790</PMID>
  </results_reference>
  <verification_date>May 2016</verification_date>
  <study_first_submitted>October 29, 2012</study_first_submitted>
  <study_first_submitted_qc>October 29, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 1, 2012</study_first_posted>
  <last_update_submitted>May 12, 2016</last_update_submitted>
  <last_update_submitted_qc>May 12, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 13, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Insomnia</keyword>
  <keyword>Cognitive-Behavioral Therapy</keyword>
  <keyword>Internet-Based</keyword>
  <keyword>Self-Help</keyword>
  <keyword>Randomized Controlled Trial</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sleep Initiation and Maintenance Disorders</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01719120
org study id: CBTI-001
nct id: NCT01719120
lead sponsor: 
has dmc: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: 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.
description: 12-week posttreatment is only for within-group comparison in treatment groups
measure: 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.
description: 12-week posttreatment is only for within-group comparison in treatment groups
measure: 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.
description: 12-week posttreatment is only for within-group comparison in treatment groups
measure: 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
description: 12-week posttreatment is only for within-group comparison in treatment groups
measure: 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.
description: 12-week posttreatment is only for within-group comparison in treatment groups
measure: Self-rated fatigue score measured by Multidimensional Fatigue Inventory (MFI)
time frame: Baseline, 1-week, 5-week, and 12-week posttreatment.
description: 12-week posttreatment is only for within-group comparison in treatment groups
measure: Subjects' acceptability and credibility to the treatment measured by Treatment acceptability and credibility rating scale
time frame: Baseline and 1-week posttreatment
measure: Subjects' adherence to the treatment measured by Treatment adherence rating scale
time frame: 1-week posttreatment
measure: Subjects' satisfaction to the treatment measured by Treatment satisfaction rating scale
time frame: Treatment Week 2-6
measure: Potential side effects associated with each component of CBT measured by Symptom checklist
time frame: Treatment Week 2-6 and 1-week posttreatment
measure: 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.
description: 12-week posttreatment is only for within-group comparison in treatment groups
arm group label: Self-help CBT with tel. consultation
arm group type: Experimental
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 group label: Self-help CBT
arm group type: Experimental
description: The subjects will receive self-help cognitive-behavioral therapy (SH)once per week for 6 consecutive weeks.
arm group label: Waiting-list control (WL)
arm group type: No Intervention
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: Cognitive-Behavioral Therapy
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.
arm group label: Self-help CBT
arm group label: Self-help CBT with tel. consultation
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Ka-Fai Chung, MBBS
role: Principal Investigator
affiliation: The University of Hong Kong
facility: 
country: Hong Kong
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.
PMID: 25461790
responsible party type: Sponsor
mesh term: Sleep Initiation and Maintenance Disorders