<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/NCT03811327</url>
  </required_header>
  <id_info>
    <org_study_id>PSY005</org_study_id>
    <nct_id>NCT03811327</nct_id>
  </id_info>
  <brief_title>Zero-time Exercise for Depression</brief_title>
  <official_title>Zero-time Exercise for Depression: A Pilot Randomised 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 feasibility and effectiveness of a new lifestyle-integrated&#xD;
      exercise, viz. Zero-time Exercise (ZTEx), for the management of depressive symptoms in&#xD;
      Chinese adults in Hong Kong. ZTEx refers to the integration of simple strength- and&#xD;
      stamina-enhancing physical activity into daily life, which can be done anytime, anywhere and&#xD;
      by anyone. Depression is often accompanied by a tendency to sedentary behaviours and sleep&#xD;
      disturbances, and sedentary lifestyles is associated with depression. The conventional&#xD;
      psychological treatment approach for depression, viz. Cognitive Behavioural Therapy (CBT),&#xD;
      emphasises the relationship between activity and mood. One of the treatment components in CBT&#xD;
      for depression, viz. Behavioural Activation (BA), aims to promote activity engagement that&#xD;
      are reinforcing and consistent with the long-term goals in reducing sedentary behaviour and&#xD;
      increasing physical activity. The simple and brief ZTEx uses a foot-in-the-door approach to&#xD;
      initiate simple behaviour change as an entry-level step for facilitating BA for participants&#xD;
      with depression. A pilot randomized controlled trial (RCT) has shown some evidence on the&#xD;
      effectiveness of ZTEx on improving insomnia. However, investigators have found no RCT on the&#xD;
      effectiveness of ZTEx for the management of depressive symptoms.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2019</start_date>
  <completion_date type="Actual">August 31, 2019</completion_date>
  <primary_completion_date type="Actual">July 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>Baseline, 1-week post-treatment and 4-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>Baseline, 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. 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>Baseline, 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. 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 Multidimensional Fatigue Inventory (MFI)</measure>
    <time_frame>Baseline, 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. Scores on each subscale range from 4 to 20, with higher scores indicating greater fatigue</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in International Physical Activities Questionnaire - Chinese version (IPAQ-C)</measure>
    <time_frame>Baseline, 1-week post-treatment and 4-week post treatment</time_frame>
    <description>IPAQ-C is a short form questionnaire assessing walking, moderate-intensity activities and vigorous-intensity activities undertaken across 4 domains - leisure time physical activity, domestic and gardening (yard) activities, work-related physical activity and transport-related physical activity. Both continuous and categorical scores can be represented. For continuous scoring, the items provide separate scores on the three specific types of activities. Computation of the total score requires summation of the duration (in minutes) and frequency (days) of the three specific type of activities. Median minutes/week or median MET-minutes/week is derived for each type of activity - Walking = 3.3 METs, Moderate PA = 4.0 METs and Vigorous PA = 8.0 METs. For categorical scoring, category 1 represents the lowest level of physical activity, category 2 represents moderate level of physical activity, and category 3 represents the highest level of physical 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>Baseline, 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. 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>Baseline, 1-week post-treatment and 4-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>
  <secondary_outcome>
    <measure>Change in Ecological momentary assessment (EMA)</measure>
    <time_frame>Baseline, 1-week post-treatment and 4-week post treatment</time_frame>
    <description>A smartphone application will be developed and installed in the participant's smartphones for recording the participants' momentary mood, daytime insomnia symptoms as well as activities.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">14</enrollment>
  <condition>Depression</condition>
  <arm_group>
    <arm_group_label>Treatment group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Zero-time Exercise group</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Waitlist group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Zero-time Exercise</intervention_name>
    <description>A 2-hour group ZTEx training once per week for 2 consecutive weeks (totally 4 hours)</description>
    <arm_group_label>Treatment group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Hong Kong residents aged 18-65 years&#xD;
&#xD;
          -  Cantonese language fluency&#xD;
&#xD;
          -  Patient Health Questionnaire (PHQ-9) score ≥ 10 and ≤ 14; and&#xD;
&#xD;
          -  Willingness to provide informed consent and comply with the trial protocol.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy;&#xD;
&#xD;
          -  Have high levels of suicidal ideation (referral information to professional services&#xD;
             will be provided);&#xD;
&#xD;
          -  Unstable psychotropic drugs within 2 weeks before study entry and throughout the&#xD;
             treatment phase;&#xD;
&#xD;
          -  Current involvement in psychotherapy for depression;&#xD;
&#xD;
          -  Having unsafe conditions and are not recommended for exercising by physicians; and&#xD;
&#xD;
          -  Major psychiatric, medical or neurocognitive disorders that would make participation&#xD;
             infeasible or interfere with the adherence to physical exercising.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <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>March 2020</verification_date>
  <study_first_submitted>January 18, 2019</study_first_submitted>
  <study_first_submitted_qc>January 18, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 22, 2019</study_first_posted>
  <last_update_submitted>March 9, 2020</last_update_submitted>
  <last_update_submitted_qc>March 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 11, 2020</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>Zero-time Exercise</keyword>
  <keyword>Depression</keyword>
  <keyword>Lifestyle</keyword>
  <keyword>Behavioural Activation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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/NCT03811327
org study id: PSY005
nct id: NCT03811327
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This study will examine the feasibility and effectiveness of a new lifestyle-integrated
      exercise, viz. Zero-time Exercise (ZTEx), for the management of depressive symptoms in
      Chinese adults in Hong Kong. ZTEx refers to the integration of simple strength- and
      stamina-enhancing physical activity into daily life, which can be done anytime, anywhere and
      by anyone. Depression is often accompanied by a tendency to sedentary behaviours and sleep
      disturbances, and sedentary lifestyles is associated with depression. The conventional
      psychological treatment approach for depression, viz. Cognitive Behavioural Therapy (CBT),
      emphasises the relationship between activity and mood. One of the treatment components in CBT
      for depression, viz. Behavioural Activation (BA), aims to promote activity engagement that
      are reinforcing and consistent with the long-term goals in reducing sedentary behaviour and
      increasing physical activity. The simple and brief ZTEx uses a foot-in-the-door approach to
      initiate simple behaviour change as an entry-level step for facilitating BA for participants
      with depression. A pilot randomized controlled trial (RCT) has shown some evidence on the
      effectiveness of ZTEx on improving insomnia. However, investigators have found no RCT on the
      effectiveness of ZTEx for the management of depressive symptoms.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change in the Patient Health Questionnaire (PHQ-9)
time frame: Baseline, 1-week post-treatment and 4-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: Baseline, 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. 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: Baseline, 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. 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 Multidimensional Fatigue Inventory (MFI)
time frame: Baseline, 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. Scores on each subscale range from 4 to 20, with higher scores indicating greater fatigue
measure: Change in International Physical Activities Questionnaire - Chinese version (IPAQ-C)
time frame: Baseline, 1-week post-treatment and 4-week post treatment
description: IPAQ-C is a short form questionnaire assessing walking, moderate-intensity activities and vigorous-intensity activities undertaken across 4 domains - leisure time physical activity, domestic and gardening (yard) activities, work-related physical activity and transport-related physical activity. Both continuous and categorical scores can be represented. For continuous scoring, the items provide separate scores on the three specific types of activities. Computation of the total score requires summation of the duration (in minutes) and frequency (days) of the three specific type of activities. Median minutes/week or median MET-minutes/week is derived for each type of activity - Walking = 3.3 METs, Moderate PA = 4.0 METs and Vigorous PA = 8.0 METs. For categorical scoring, category 1 represents the lowest level of physical activity, category 2 represents moderate level of physical activity, and category 3 represents the highest level of physical activity.
measure: Change in Short Form (Six-Dimension) Health Survey - The Chinese (Hong Kong) Version (SF-6D)
time frame: Baseline, 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. 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: Baseline, 1-week post-treatment and 4-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 Ecological momentary assessment (EMA)
time frame: Baseline, 1-week post-treatment and 4-week post treatment
description: A smartphone application will be developed and installed in the participant's smartphones for recording the participants' momentary mood, daytime insomnia symptoms as well as activities.
arm group label: Treatment group
arm group type: Experimental
description: Zero-time Exercise group
arm group label: Waitlist group
arm group type: No Intervention
intervention type: Behavioral
intervention name: Zero-time Exercise
description: A 2-hour group ZTEx training once per week for 2 consecutive weeks (totally 4 hours)
arm group label: Treatment group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
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: Depression
mesh term: Depressive Disorder