<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/NCT03291301</url>
  </required_header>
  <id_info>
    <org_study_id>PSY001</org_study_id>
    <nct_id>NCT03291301</nct_id>
  </id_info>
  <brief_title>Group Cognitive Behavioral Therapy and Acupressure for Insomnia</brief_title>
  <official_title>The Efficacy of Cognitive Behavioral Therapy (CBT) and Acupressure for Insomnia: A Pilot Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chinese University of Hong Kong</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chinese University of Hong Kong</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will examine the use of cognitive behavioural therapy (CBT) and acupressure in&#xD;
      treating insomnia in Chinese adults. The main components of CBT for insomnia (CBT-I) includes&#xD;
      psychoeducation, sleep restriction, stimulus control, cognitive restructuring, and&#xD;
      relaxation. CBT-I is widely used in western countries but it fails to address patient&#xD;
      preference among Chinese adults with insomnia, as demonstrated in a previous study examining&#xD;
      the subjective experience of chronic insomnia in Hong Kong Chinese adults. The study revealed&#xD;
      that Chinese adults showed distrust in hypnotics and preferred traditional Chinese medicine&#xD;
      (TCM) which was believed to be more natural. In order to maximize the therapeutic effects of&#xD;
      psychological interventions for insomnia, integrative medicine with a combination of CBT-I&#xD;
      and TCM could be an alternative to address insomnia in the Chinese population. Acupressure, a&#xD;
      non-invasive therapy, is commonly used in TCM. It is suggested that acupressure can induce&#xD;
      relaxation and improve sleep quality. Some studies have demonstrated the separate efficacy of&#xD;
      CBT-I and acupressure in treating insomnia. However, few studies have examined the effect of&#xD;
      their combination.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 11, 2017</start_date>
  <completion_date type="Actual">May 31, 2018</completion_date>
  <primary_completion_date type="Actual">April 30, 2018</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Insomnia Severity Index</measure>
    <time_frame>Pre-treatment, 1-week post-treatment and 4-week post treatment</time_frame>
    <description>A 7-item scale designed to evaluate perceived insomnia severity. Ratings on the 5-point Likert scale are obtained on the perceived severity of sleep-onset, sleep-maintenance, early morning awakening problems, satisfaction with current sleep pattern, interference with daily functioning, noticeably of impairment attributed to the sleep problem, and level of distress caused by the sleep problem.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in 7-Day Sleep Diary</measure>
    <time_frame>Pre-treatment, 1-week post-treatment and 4-week post treatment</time_frame>
    <description>The standardized sleep diary records sleep-onset latency (SOL; min), wake after sleep onset (WASO; min), total wake time (TWT; min), total sleep time (TST; min), time in bed (TIB; min); sleep efficiency (SE; calculated as TST/TIB * 100%), etc.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Hospital Anxiety and Depression Scale (HADS)</measure>
    <time_frame>Pre-treatment, 1-week post-treatment and 4-week post treatment</time_frame>
    <description>A 14-item self-rating scale that measures anxiety and depression in both hospital and community settings. It is divided into an Anxiety subscale (HADS-A) and a Depression subscale (HADS-D) both containing seven intermingled items. It is for screening purpose and not meant to be a diagnostic tool.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Dysfunctional Beliefs and Attitudes about Sleep Scale - 16-item version (DBAS-16)</measure>
    <time_frame>Pre-treatment, 1-week post-treatment and 4-week post treatment</time_frame>
    <description>A 16-item self-report measure designed to evaluate sleep related cognitions (e.g., faulty beliefs and appraisals, unrealistic expectations, perceptual and attention bias).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Multidimensional Fatigue Inventory (MFI)</measure>
    <time_frame>Pre-treatment, 1-week post-treatment and 4-week post treatment</time_frame>
    <description>A 20-item self-report instrument designed to measure fatigue. Ratings on a 5-point Likert scale are obtained on the dimensions of general fatigue, physical fatigue, mental fatigue, reduced motivation and reduced activity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Short Form (Six-Dimension) Health Survey - The Chinese (Hong Kong) Version (SF-6D)</measure>
    <time_frame>Pre-treatment, 1-week post-treatment and 4-week post treatment</time_frame>
    <description>A preference-based single index measure of health. A six-digit number represents each SF-6D health state, each digit denotes the level of one of six SF-6D dimensions: physical functioning, role limitation, social functioning, bodily pain, mental health, and vitality.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change in Credibility-Expectancy Questionnaire (CEQ)</measure>
    <time_frame>Pre-treatment and 1-week post-treatment</time_frame>
    <description>The 6-item CEQ yielded ratings of treatment credibility, acceptability/satisfaction, and expectations for success.</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Insomnia</condition>
  <arm_group>
    <arm_group_label>CBT Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cognitive Behavioral Therapy for Insomnia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Combined Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cognitive Behavioral Therapy for Insomnia plus Acupressure</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Wait-list Control Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Cognitive Behavioral Therapy for Insomnia</intervention_name>
    <description>Cognitive Behavioral Therapy for Insomnia including psychoeducation, sleep restriction, stimulus control, cognitive restructuring, and relaxation.</description>
    <arm_group_label>CBT Group</arm_group_label>
    <arm_group_label>Combined Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Acupressure</intervention_name>
    <description>Acupressure, a non-invasive therapy, is commonly used in Traditional Chinese Medicine</description>
    <arm_group_label>Combined Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Hong Kong residents who are able to communicate in Cantonese;&#xD;
&#xD;
          2. Aged ≥ 18 years;&#xD;
&#xD;
          3. A current clinical DSM-5 diagnosis of insomnia disorder according to the Sleep&#xD;
             Condition Indicator (SCI) ≥ 21;&#xD;
&#xD;
          4. Insomnia Severity Index (ISI) score ≥ 8; and&#xD;
&#xD;
          5. Willing to give informed consent and comply with the trial protocol.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Have suicidal ideation based on Beck Depression inventory (BDI-II) Item 9 score ≥ 2 ;&#xD;
&#xD;
          2. Receiving psychotherapy, acupuncture, and/or practitioner-delivered acupressure&#xD;
             treatment for insomnia in the past 6 months;&#xD;
&#xD;
          3. Pregnancy; and&#xD;
&#xD;
          4. Taking herbal remedies, over-the-counter medication, or psychotropic drugs that target&#xD;
             insomnia within 2 weeks prior to the baseline assessment.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>The Chinese University of Hong Kong</name>
      <address>
        <city>Hong Kong</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Chinese University of Hong Kong</name>
      <address>
        <city>Sha Tin</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Hong Kong</country>
  </location_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>September 15, 2017</study_first_submitted>
  <study_first_submitted_qc>September 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 25, 2017</study_first_posted>
  <last_update_submitted>October 23, 2018</last_update_submitted>
  <last_update_submitted_qc>October 23, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 24, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chinese University of Hong Kong</investigator_affiliation>
    <investigator_full_name>Fiona YY Ho</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Insomnia</keyword>
  <keyword>Cognitive Behavioral Therapy</keyword>
  <keyword>CBT-I</keyword>
  <keyword>Acupressure</keyword>
  <keyword>Traditional Chinese Medicine</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/NCT03291301
org study id: PSY001
nct id: NCT03291301
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This study will examine the use of cognitive behavioural therapy (CBT) and acupressure in
      treating insomnia in Chinese adults. The main components of CBT for insomnia (CBT-I) includes
      psychoeducation, sleep restriction, stimulus control, cognitive restructuring, and
      relaxation. CBT-I is widely used in western countries but it fails to address patient
      preference among Chinese adults with insomnia, as demonstrated in a previous study examining
      the subjective experience of chronic insomnia in Hong Kong Chinese adults. The study revealed
      that Chinese adults showed distrust in hypnotics and preferred traditional Chinese medicine
      (TCM) which was believed to be more natural. In order to maximize the therapeutic effects of
      psychological interventions for insomnia, integrative medicine with a combination of CBT-I
      and TCM could be an alternative to address insomnia in the Chinese population. Acupressure, a
      non-invasive therapy, is commonly used in TCM. It is suggested that acupressure can induce
      relaxation and improve sleep quality. Some studies have demonstrated the separate efficacy of
      CBT-I and acupressure in treating insomnia. However, few studies have examined the effect of
      their combination.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change in Insomnia Severity Index
time frame: Pre-treatment, 1-week post-treatment and 4-week post treatment
description: A 7-item scale designed to evaluate perceived insomnia severity. Ratings on the 5-point Likert scale are obtained on the perceived severity of sleep-onset, sleep-maintenance, early morning awakening problems, satisfaction with current sleep pattern, interference with daily functioning, noticeably of impairment attributed to the sleep problem, and level of distress caused by the sleep problem.
measure: Change in 7-Day Sleep Diary
time frame: Pre-treatment, 1-week post-treatment and 4-week post treatment
description: The standardized sleep diary records sleep-onset latency (SOL; min), wake after sleep onset (WASO; min), total wake time (TWT; min), total sleep time (TST; min), time in bed (TIB; min); sleep efficiency (SE; calculated as TST/TIB * 100%), etc.
measure: Change in Hospital Anxiety and Depression Scale (HADS)
time frame: Pre-treatment, 1-week post-treatment and 4-week post treatment
description: A 14-item self-rating scale that measures anxiety and depression in both hospital and community settings. It is divided into an Anxiety subscale (HADS-A) and a Depression subscale (HADS-D) both containing seven intermingled items. It is for screening purpose and not meant to be a diagnostic tool.
measure: Change in Dysfunctional Beliefs and Attitudes about Sleep Scale - 16-item version (DBAS-16)
time frame: Pre-treatment, 1-week post-treatment and 4-week post treatment
description: A 16-item self-report measure designed to evaluate sleep related cognitions (e.g., faulty beliefs and appraisals, unrealistic expectations, perceptual and attention bias).
measure: Change in Multidimensional Fatigue Inventory (MFI)
time frame: Pre-treatment, 1-week post-treatment and 4-week post treatment
description: A 20-item self-report instrument designed to measure fatigue. Ratings on a 5-point Likert scale are obtained on the dimensions of general fatigue, physical fatigue, mental fatigue, reduced motivation and reduced activity.
measure: Change in Short Form (Six-Dimension) Health Survey - The Chinese (Hong Kong) Version (SF-6D)
time frame: Pre-treatment, 1-week post-treatment and 4-week post treatment
description: A preference-based single index measure of health. A six-digit number represents each SF-6D health state, each digit denotes the level of one of six SF-6D dimensions: physical functioning, role limitation, social functioning, bodily pain, mental health, and vitality.
measure: Change in Credibility-Expectancy Questionnaire (CEQ)
time frame: Pre-treatment and 1-week post-treatment
description: The 6-item CEQ yielded ratings of treatment credibility, acceptability/satisfaction, and expectations for success.
arm group label: CBT Group
arm group type: Experimental
description: Cognitive Behavioral Therapy for Insomnia
arm group label: Combined Group
arm group type: Experimental
description: Cognitive Behavioral Therapy for Insomnia plus Acupressure
arm group label: Wait-list Control Group
arm group type: No Intervention
intervention type: Behavioral
intervention name: Cognitive Behavioral Therapy for Insomnia
description: Cognitive Behavioral Therapy for Insomnia including psychoeducation, sleep restriction, stimulus control, cognitive restructuring, and relaxation.
arm group label: CBT Group
arm group label: Combined Group
intervention type: Other
intervention name: Acupressure
description: Acupressure, a non-invasive therapy, is commonly used in Traditional Chinese Medicine
arm group label: Combined Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
facility: 
facility: 
country: Hong Kong
responsible party type: Principal Investigator
investigator affiliation: Chinese University of Hong Kong
investigator full name: Fiona YY Ho
investigator title: Assistant Professor
mesh term: Sleep Initiation and Maintenance Disorders