<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/NCT03775148</url>
  </required_header>
  <id_info>
    <org_study_id>PSY002</org_study_id>
    <nct_id>NCT03775148</nct_id>
  </id_info>
  <brief_title>A Transdiagnostic Sleep and Circadian Treatment for Depression</brief_title>
  <official_title>A Transdiagnostic Sleep and Circadian Treatment for Depression: A Pilot Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chinese University of Hong Kong</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of California, Berkeley</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </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 a transdiagnostic Sleep and Circadian Treatment (TranS-C)&#xD;
      in treating Major Depressive Disorder (MDD) in Chinese adults. Sleep disturbance is highly&#xD;
      comorbid with a range of psychological disorders, especially MDD. MDD is a major public&#xD;
      health concern and a leading cause of disability worldwide. A shift in treatment&#xD;
      perspectives, from a disorder-specific approach to a transdiagnostic approach, has been&#xD;
      proposed. While the disorder-specific approach tends to understand and treat different mental&#xD;
      disorders as independent psychological problems, the transdiagnostic approach aims to&#xD;
      identify common clinical features (e.g. sleep disturbances) across a range of psychological&#xD;
      disorders. The transdiagnostic approach would potentially facilitate timely dissemination of&#xD;
      evidence-based psychological treatments and contribute to significant public health&#xD;
      implications.&#xD;
&#xD;
      This study will be a pilot randomized controlled trial on the efficacy of TranS-C for MDD.&#xD;
      TranS-C integrates elements of evidence-based interventions, namely cognitive-behavioral&#xD;
      therapy for insomnia, delayed sleep phase type, and interpersonal and social rhythm therapy.&#xD;
      Prior to all study procedures, an online informed consent (with phone support) will be&#xD;
      obtained from potential participants. Around 40 eligible participants will be randomly&#xD;
      assigned to the TranS-C group or the care-as-usual control group (CAU group) in a ratio of&#xD;
      1:1. The randomization will be performed by an independent assessor using a&#xD;
      computer-generated list of numbers. No deception is necessary. Participants in the TranS-C&#xD;
      group will receive TranS-C once per week for 6 consecutive weeks respectively. The group&#xD;
      treatment will be delivered by a clinical psychology trainee under the supervision of a&#xD;
      clinical psychologist. The TranS-C group will complete a set of online/paper-and-pencil&#xD;
      questionnaires before the treatment commences, 1-week, and 12-week after the treatment&#xD;
      sessions are completed. The CAU group will complete the same set of online/paper-and-pencil&#xD;
      questionnaires during the same periods.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Actual">August 31, 2019</completion_date>
  <primary_completion_date type="Actual">August 31, 2019</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 the Patient Health Questionnaire (PHQ-9)</measure>
    <time_frame>Pre-treatment, 1-week post-treatment and 12-week post treatment</time_frame>
    <description>The PHQ-9, a 20-item questionnaire used for screening, diagnosing, monitoring and measuring the severity of depression, which scores each of the nine DSM-IV criteria as &quot;0&quot; (not at all) to &quot;3&quot; (nearly every day). PHQ-9 scores of 5, 10, 15, and 20 represents mild, moderate, moderately severe and severe depression</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Hospital Anxiety and Depression Scale (HADS)</measure>
    <time_frame>Pre-treatment, 1-week post-treatment and 12-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. HADS scores of 8-10, 11-14, and 15-21 represent mild, moderate, and severe anxiety and depression separately.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Insomnia Severity Index (ISI)</measure>
    <time_frame>Pre-treatment, 1-week post-treatment and 12-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. Total score categories: 0-7 is no clinically significant insomnia, 8-14 is subthreshold insomnia,15-21 is clinical insomnia (moderate severity), and 22-28 is clinical insomnia (severe)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in 7-Day Sleep Diary</measure>
    <time_frame>Pre-treatment, 1-week post-treatment and 12-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. Severity of sleep disturbances: sleep latency of time awake after sleep onset greater than 30 min; or last awakening occurring more than 30 min before desired time and before total sleep time reaches 6.5 hours; sleep efficiency is lower than 85%. Frequency: sleep difficulties present three or more nights per week.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Multidimensional Fatigue Inventory (MFI)</measure>
    <time_frame>Pre-treatment, 1-week post-treatment and 12-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. Scores on each subscale range from 4 to 20, with higher scores indicating greater fatigue.</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 12-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. The SF-6D index, scored from 0.0 (worst health state) to 1.0 (best health state)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Sheehan Disability Scale (SDS)</measure>
    <time_frame>Pre-treatment, 1-week post-treatment and 12-week post treatment</time_frame>
    <description>A 5-item self-report tool for assessing functional impairment in work/school, social life, and family life. Representation of scores in terms of functional impairment: 0: not at all, 1-3: mildly, 4-6: moderately, 7-9: markedly, 10: extremely</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change in Credibility-Expectancy Questionnaire (CEQ)</measure>
    <time_frame>Pre-treatment, 1-week post-treatment and 12-week post treatment</time_frame>
    <description>The 6-item CEQ yielded ratings of treatment credibility, acceptability/satisfaction, and expectations for success. it measures how much the one believe that the therapy will help to improve one's lifestyle, functioning ranging from 1 to 9 with 1 representing the lowest value and the 9 representing the highest value. Two questions asking how much improvement in the functioning the one thinks and feels that it will occur ranging 0% to 100%.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">37</enrollment>
  <condition>Depression</condition>
  <condition>Insomnia</condition>
  <arm_group>
    <arm_group_label>TranS-C Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Transdiagnostic Sleep and Circadian Treatment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CAU Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Care-As-Usual group</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C)</intervention_name>
    <description>TranS-C integrates elements of evidence-based interventions, namely cognitive-behavioural therapy for insomnia, delayed sleep phase type, and interpersonal and social rhythm therapy.</description>
    <arm_group_label>TranS-C Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Hong Kong Citizen who is able to speak Cantonese and read Chinese&#xD;
&#xD;
          2. Aged ≥ 18 years;&#xD;
&#xD;
          3. Score on PHQ-9 is 10 or above&#xD;
&#xD;
          4. More than 1 sleep or circadian problem according to the Sleep and Circadian Problem&#xD;
             Checklist, including time needed to fall asleep more than 30 minutes for more than 3&#xD;
             nights per week, less than 6 hours of sleep per night or at least 9 hour of sleep per&#xD;
             night per 24 hour period for at least 3 nights per week, variability in the sleep-wake&#xD;
             schedule at least 2.78 hours within a week, and falling asleep after 2 am on at least&#xD;
             3 nights per week&#xD;
&#xD;
          5. Adequate opportunity and circumstances for sleep to occur&#xD;
&#xD;
          6. Willing to give informed consent and comply with the trial protocol.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Major medical or neurocognitive disorders that make participation infeasible&#xD;
&#xD;
          2. Have suicidal ideation based on Beck Depression Inventory (BDI-II) Item 9 score ≥ 2 ;&#xD;
&#xD;
          3. Untreated sleep disorders based on SLEEP-50 (≥ 7 on narcolepsy; ≥ 15 on OSA; ≥ 7 on&#xD;
             RLS/PLMD)&#xD;
&#xD;
          4. Past or current involvement in a psychological treatment programme for depression&#xD;
             and/or sleep problems&#xD;
&#xD;
          5. Shift work, pregnancy, work, family, or other commitments that interfere with regular&#xD;
             night-time sleep patterns&#xD;
&#xD;
          6. Hospitalization&#xD;
&#xD;
          7. A change in psychotropic drugs within 2 weeks before baseline assessment&#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>
  <location>
    <facility>
      <name>The Chinese 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>
  <verification_date>November 2019</verification_date>
  <study_first_submitted>December 11, 2018</study_first_submitted>
  <study_first_submitted_qc>December 11, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 13, 2018</study_first_posted>
  <last_update_submitted>November 4, 2019</last_update_submitted>
  <last_update_submitted_qc>November 4, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 5, 2019</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>Depression</keyword>
  <keyword>Insomnia</keyword>
  <keyword>Transdiagnostic Sleep and Circadian Treatment</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sleep Initiation and Maintenance Disorders</mesh_term>
    <mesh_term>Depression</mesh_term>
    <mesh_term>Depressive Disorder</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/NCT03775148
org study id: PSY002
nct id: NCT03775148
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
This study will examine the use of a transdiagnostic Sleep and Circadian Treatment (TranS-C)
      in treating Major Depressive Disorder (MDD) in Chinese adults. Sleep disturbance is highly
      comorbid with a range of psychological disorders, especially MDD. MDD is a major public
      health concern and a leading cause of disability worldwide. A shift in treatment
      perspectives, from a disorder-specific approach to a transdiagnostic approach, has been
      proposed. While the disorder-specific approach tends to understand and treat different mental
      disorders as independent psychological problems, the transdiagnostic approach aims to
      identify common clinical features (e.g. sleep disturbances) across a range of psychological
      disorders. The transdiagnostic approach would potentially facilitate timely dissemination of
      evidence-based psychological treatments and contribute to significant public health
      implications.

      This study will be a pilot randomized controlled trial on the efficacy of TranS-C for MDD.
      TranS-C integrates elements of evidence-based interventions, namely cognitive-behavioral
      therapy for insomnia, delayed sleep phase type, and interpersonal and social rhythm therapy.
      Prior to all study procedures, an online informed consent (with phone support) will be
      obtained from potential participants. Around 40 eligible participants will be randomly
      assigned to the TranS-C group or the care-as-usual control group (CAU group) in a ratio of
      1:1. The randomization will be performed by an independent assessor using a
      computer-generated list of numbers. No deception is necessary. Participants in the TranS-C
      group will receive TranS-C once per week for 6 consecutive weeks respectively. The group
      treatment will be delivered by a clinical psychology trainee under the supervision of a
      clinical psychologist. The TranS-C group will complete a set of online/paper-and-pencil
      questionnaires before the treatment commences, 1-week, and 12-week after the treatment
      sessions are completed. The CAU group will complete the same set of online/paper-and-pencil
      questionnaires during the same periods.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change in the Patient Health Questionnaire (PHQ-9)
time frame: Pre-treatment, 1-week post-treatment and 12-week post treatment
description: The PHQ-9, a 20-item questionnaire used for screening, diagnosing, monitoring and measuring the severity of depression, which scores each of the nine DSM-IV criteria as "0" (not at all) to "3" (nearly every day). PHQ-9 scores of 5, 10, 15, and 20 represents mild, moderate, moderately severe and severe depression
measure: Change in Hospital Anxiety and Depression Scale (HADS)
time frame: Pre-treatment, 1-week post-treatment and 12-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. HADS scores of 8-10, 11-14, and 15-21 represent mild, moderate, and severe anxiety and depression separately.
measure: Change in Insomnia Severity Index (ISI)
time frame: Pre-treatment, 1-week post-treatment and 12-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. Total score categories: 0-7 is no clinically significant insomnia, 8-14 is subthreshold insomnia,15-21 is clinical insomnia (moderate severity), and 22-28 is clinical insomnia (severe)
measure: Change in 7-Day Sleep Diary
time frame: Pre-treatment, 1-week post-treatment and 12-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. Severity of sleep disturbances: sleep latency of time awake after sleep onset greater than 30 min; or last awakening occurring more than 30 min before desired time and before total sleep time reaches 6.5 hours; sleep efficiency is lower than 85%. Frequency: sleep difficulties present three or more nights per week.
measure: Change in Multidimensional Fatigue Inventory (MFI)
time frame: Pre-treatment, 1-week post-treatment and 12-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. Scores on each subscale range from 4 to 20, with higher scores indicating greater fatigue.
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 12-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. The SF-6D index, scored from 0.0 (worst health state) to 1.0 (best health state)
measure: Change in Sheehan Disability Scale (SDS)
time frame: Pre-treatment, 1-week post-treatment and 12-week post treatment
description: A 5-item self-report tool for assessing functional impairment in work/school, social life, and family life. Representation of scores in terms of functional impairment: 0: not at all, 1-3: mildly, 4-6: moderately, 7-9: markedly, 10: extremely
measure: Change in Credibility-Expectancy Questionnaire (CEQ)
time frame: Pre-treatment, 1-week post-treatment and 12-week post treatment
description: The 6-item CEQ yielded ratings of treatment credibility, acceptability/satisfaction, and expectations for success. it measures how much the one believe that the therapy will help to improve one's lifestyle, functioning ranging from 1 to 9 with 1 representing the lowest value and the 9 representing the highest value. Two questions asking how much improvement in the functioning the one thinks and feels that it will occur ranging 0% to 100%.
arm group label: TranS-C Group
arm group type: Experimental
description: Transdiagnostic Sleep and Circadian Treatment
arm group label: CAU Group
arm group type: No Intervention
description: Care-As-Usual group
intervention type: Behavioral
intervention name: Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C)
description: TranS-C integrates elements of evidence-based interventions, namely cognitive-behavioural therapy for insomnia, delayed sleep phase type, and interpersonal and social rhythm therapy.
arm group label: TranS-C Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
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
mesh term: Depression
mesh term: Depressive Disorder