xml: <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/NCT05995587</url>
    </required_header>
    <id_info>
      <org_study_id>EA220105</org_study_id>
      <nct_id>NCT05995587</nct_id>
    </id_info>
    <brief_title>Mindfulness-Based Cognitive Therapy in Older People</brief_title>
    <official_title>Mindfulness-Based Cognitive Therapy in Managing Depressive Symptoms in Older People: A Non-Randomised Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>The University of Hong Kong</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>The Hong Kong Jockey Club Charities Trust</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Christian Family Service Centre</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>The Mental Health Association of Hong Kong</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>The Salvation Army, Hong Kong and Macau Command</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Caritas Medical Centre, Hong Kong</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Haven of Hope Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>The University of Hong Kong</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Mindfulness-based interventions, such as mindfulness-based cognitive therapy (MBCT), have the&#xD;
        potential in improving psychological health in older people. With the growing older people&#xD;
        population, there is a need for greater social welfare capacity to promote their well-being.&#xD;
        The project aims to:&#xD;
  &#xD;
          1. Evaluate the effectiveness of MBCT in improving mental health and mindfulness in older&#xD;
             people with depressive symptoms as compared to care as usual;&#xD;
  &#xD;
          2. Compare the effectiveness between MBCT led by mindfulness teacher and that led by social&#xD;
             workers;&#xD;
  &#xD;
          3. Examine psychological flexibility as a potential mechanism of change in MBCT for&#xD;
             depressive symptoms.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Depression is one of the most common yet under-recognized mental disorders in older adults in&#xD;
        Hong Kong, and it is estimated that approximately one in 10 older people has clinically&#xD;
        significant depression. With population aging, the number of older people with depression is&#xD;
        slated to double in the next two decades, creating a substantial burden on the individuals,&#xD;
        caregivers, and health care system. While pharmacological interventions are effective in&#xD;
        reducing depression, medical risks can be complicated due to polypharmacy in older people.&#xD;
        Non-pharmacological interventions may benefit the population by addressing the underlying&#xD;
        dysfunctional cognitive processes associated with depression.&#xD;
  &#xD;
        Mindfulness-based interventions, such as mindfulness-based cognitive therapy (MBCT), have the&#xD;
        potential in improving psychological health in older people. MBCT is a group intervention&#xD;
        originally designed to prevent recurrent depressive disorders. It combines mindfulness&#xD;
        practices and cognitive-behavioural elements to enhance an individual's understanding of the&#xD;
        interacting relationships among thoughts, emotions, bodily sensations, and behaviours.&#xD;
        Mindfulness practice emphasizes on developing a moment-to-moment, non-judgmental awareness&#xD;
        and may be helpful in alleviating depression by directing individual's attention to the&#xD;
        present instead of ruminating in the past. Systematic reviews have shown the efficacy of MBCT&#xD;
        in reducing depression, anxiety, loneliness, stress, sleep problems, ruminations, general&#xD;
        mood, and positive affect. However, over half of the included studies lacked a control group&#xD;
        and mixed findings were observed possibly because of inconsistent modifications to the&#xD;
        protocol, methodological flaws, and study limitations.&#xD;
  &#xD;
        The application of MBCT in the Chinese older population is understudied. Recently, a&#xD;
        randomized controlled trial on MBCT for older people were conducted in Hong Kong. By&#xD;
        comparing a standard MBCT to an active control group (physical exercise + health education)&#xD;
        for older people with depression, it has been found that while both groups showed a reduction&#xD;
        in the severity of depressive symptoms, only the MBCT group showed improvement in&#xD;
        mindfulness.&#xD;
  &#xD;
        With these promising findings, more studies are needed to establish the evidence base for the&#xD;
        intervention and inform clinical practice in this population. The investigators aim to&#xD;
        explore whether a modified MBCT based on older people's feedback can reduce depressive&#xD;
        symptoms and improve mindfulness. With the growing older people population and thus a need&#xD;
        for greater social welfare capacity to promote their well-being, the investigators will also&#xD;
        examine whether a modified MBCT led by social workers under the supervision of a mindfulness&#xD;
        teacher can benefit the population.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">May 31, 2022</start_date>
    <completion_date type="Anticipated">November 30, 2023</completion_date>
    <primary_completion_date type="Anticipated">October 4, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>Participants in the intervention group will either receive mindfulness training from a certified mindfulness teacher or from social workers (supervised by a certified mindfulness teacher). The care as usual group will receive usual service provided in District Elderly Community Centres (DECC) and Integrated Community Centre for Mental Wellness (ICCMW).</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change from baseline depression at Week 8</measure>
      <time_frame>Baseline and Week 8</time_frame>
      <description>Depression will be measured by the validated Chinese version of the Patient Health Questionnaire (PHQ-9). The total score will be used, ranging from 0 to 27. Higher scores indicate higher levels of depressive symptoms.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change from baseline anxiety at Week 8</measure>
      <time_frame>Baseline and Week 8</time_frame>
      <description>Anxiety will be measured by the validated Chinese version of the Generalized Anxiety Disorder scale (GAD-7). The total score will be used, ranging from 0 to 21. Higher scores indicate higher levels of anxiety symptoms.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change from baseline stress at Week 8</measure>
      <time_frame>Baseline and Week 8</time_frame>
      <description>Stress will be measured by the Chinese validated Perceived Stress Scale (PSS). The total score will be used, ranging from 0 to 40. Higher scores indicate greater stress.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change from baseline mindfulness at Week 8</measure>
      <time_frame>Baseline and Week 8</time_frame>
      <description>Mindfulness will be measured by the Chinese validated Five Facet Mindfulness Questionnaire Short Form (FFMQ-SF). The total score of the FFMQ-SF (ranging from 20 to 100) as well as the total score (ranging from 4 to 20) of the five subscales (i.e., observe, describe, acting with awareness, nondjuding, and nonreactivity) will be used. Higher scores indicate higher mindfulness.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change from baseline psychological flexibility at Week 8</measure>
      <time_frame>Baseline and Week 8</time_frame>
      <description>Psychological flexibility will be assessed by the Chinese version of the Comprehensive Assessment of Acceptance and Commitment Therapy Processes (CompACT). Items are rated on a 0 (strongly disagree) to 6 (strongly agree) scale. The total score of the CompAct scale (ranging from 0 to 48), Valued Action subscale (ranging 0 to 18), Openness to Experience subscale (ranging from 0 to 18), and Behavioural Awareness subscale (ranging from 0 to 12) will be used. Higher scores indicate greater psychological flexibility.</description>
    </primary_outcome>
    <other_outcome>
      <measure>Change from baseline depression at Week 12</measure>
      <time_frame>Baseline and Week 12</time_frame>
      <description>Depression will be measured by the validated Chinese version of the Patient Health Questionnaire (PHQ-9). The total score will be used, ranging from 0 to 27. Higher scores indicate higher levels of depressive symptoms.</description>
    </other_outcome>
    <other_outcome>
      <measure>Change from baseline anxiety at Week 12</measure>
      <time_frame>Baseline and Week 12</time_frame>
      <description>Anxiety will be measured by the validated Chinese version of the Generalized Anxiety Disorder scale (GAD-7). The total score will be used, ranging from 0 to 21. Higher scores indicate higher levels of anxiety symptoms.</description>
    </other_outcome>
    <other_outcome>
      <measure>Change from baseline stress at Week 12</measure>
      <time_frame>Baseline and Week 12</time_frame>
      <description>Stress will be measured by the Chinese validated Perceived Stress Scale (PSS). The total score will be used, ranging from 0 to 40. Higher scores indicate greater stress.</description>
    </other_outcome>
    <other_outcome>
      <measure>Change from baseline mindfulness at Week 12</measure>
      <time_frame>Baseline and Week 12</time_frame>
      <description>Mindfulness will be measured by the Chinese validated Five Facet Mindfulness Questionnaire Short Form (FFMQ-SF). The total score of the FFMQ-SF (ranging from 20 to 100) as well as the total score (ranging from 4 to 20) of the five subscales (i.e., observe, describe, acting with awareness, nondjuding, and nonreactivity) will be used. Higher scores indicate higher mindfulness.</description>
    </other_outcome>
    <other_outcome>
      <measure>Change from baseline psychological flexibility at Week 12</measure>
      <time_frame>Baseline and Week 12</time_frame>
      <description>Psychological flexibility will be assessed by the Chinese version of the Comprehensive Assessment of Acceptance and Commitment Therapy Processes (CompACT). Items are rated on a 0 (strongly disagree) to 6 (strongly agree) scale. The total score of the CompAct scale (ranging from 0 to 48), Valued Action subscale (ranging 0 to 18), Openness to Experience subscale (ranging from 0 to 18), and Behavioural Awareness subscale (ranging from 0 to 12) will be used. Higher scores indicate greater psychological flexibility.</description>
    </other_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">96</enrollment>
    <condition>Depressive Symptoms</condition>
    <arm_group>
      <arm_group_label>MBCT (mindfulness teacher)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants in the MBCT (mindfulness teacher) group will receive mindfulness training from a certified mindfulness teacher.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>MBCT (social workers)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants in the MBCT (social workers) group will receive mindfulness training from social workers (supervised by a certified mindfulness teacher).</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Care as usual group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>The care as usual group will receive usual service provided in District Elderly Community Centres (DECC) and Integrated Community Centre for Mental Wellness (ICCMW).</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Mindfulness-based cognitive therapy (MBCT)</intervention_name>
      <description>MBCT combines mindfulness meditation with cognitive behavioural therapy (CBT) elements to reduce or prevent recurrent major depressive disorders.</description>
      <arm_group_label>MBCT (mindfulness teacher)</arm_group_label>
      <arm_group_label>MBCT (social workers)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  60 years or older&#xD;
  &#xD;
            -  have depressive symptoms of mild level or above, as indicated by scoring 5 or more in&#xD;
               PHQ-9&#xD;
  &#xD;
            -  can give informed consent to participate&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  known history of autism, intellectual disability, schizophrenia-spectrum disorder,&#xD;
               bipolar disorder, Parkinson's disease, or dementia&#xD;
  &#xD;
            -  imminent suicidal risk&#xD;
  &#xD;
            -  difficulty in communication&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>60 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Terry Lum, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Department of Social Work and Social Administration, The University of Hong Kong</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Gloria Wong, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Department of Social Work and Social Administration, The University of Hong Kong</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Yun-Lin Wang, PhD</last_name>
      <phone>+852-3917-5594</phone>
      <email>yunlinw@hku.hk</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Yun-Han Wang, PhD</last_name>
      <phone>+852-3917-1755</phone>
      <email>yunhanw@hku.hk</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Amity Place (Kwun Tong Central)</name>
        <address>
          <city>Kwun Tong</city>
          <country>Hong Kong</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>May Kou</last_name>
        <phone>+852-2346-3798</phone>
        <email>maykou@mhahk.org.hk</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Shun On District Elderly Community Centre (DECC)</name>
        <address>
          <city>Kwun Tong</city>
          <country>Hong Kong</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Kwai Yee Lau</last_name>
        <phone>+852-2727-1234</phone>
        <email>kwaiyee_lau@cfsc.org.hk</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Haven of Hope District Elderly Community Service</name>
        <address>
          <city>Sai Kung</city>
          <country>Hong Kong</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Pui Ling Cheng</last_name>
        <phone>+852-2702-1113</phone>
        <email>plcheng@hohcs.org.hk</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Wellness Zone - Integrated Community Centre for Mental Wellness</name>
        <address>
          <city>Sai Kung</city>
          <country>Hong Kong</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Chak Ling Lee</last_name>
        <phone>+852-2706-7198</phone>
        <email>cl_lee@cfsc.org.hk</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Caritas Cheng Shing Fung District Elderly Centre (Sham Shui Po)</name>
        <address>
          <city>Sham Shui Po</city>
          <country>Hong Kong</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Ho Yee Kwan</last_name>
        <phone>+852-2729-1211</phone>
        <email>kwanjoyce@caritassws.org.hk</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Tai Po Multi-service Centre for Senior Citizens</name>
        <address>
          <city>Tai Po</city>
          <country>Hong Kong</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Wai Man Lau</last_name>
        <phone>+852-2653-6811</phone>
        <email>WaiMan.Lau@hkm.salvationarmy.org</email>
      </contact>
    </location>
    <location_countries>
      <country>Hong Kong</country>
    </location_countries>
    <reference>
      <citation>Geiger PJ, Boggero IA, Brake CA, Caldera CA, Combs HL, Peters JR, Baer RA. Mindfulness-Based Interventions for Older Adults: A Review of the Effects on Physical and Emotional Well-being. Mindfulness (N Y). 2016 Apr;7(2):296-307. doi: 10.1007/s12671-015-0444-1. Epub 2015 Sep 14.</citation>
      <PMID>27200109</PMID>
    </reference>
    <reference>
      <citation>Hou J, Wong SY, Lo HH, Mak WW, Ma HS. Validation of a Chinese version of the Five Facet Mindfulness Questionnaire in Hong Kong and development of a short form. Assessment. 2014 Jun;21(3):363-71. doi: 10.1177/1073191113485121. Epub 2013 Apr 16.</citation>
      <PMID>23596271</PMID>
    </reference>
    <reference>
      <citation>Ng SM. Validation of the 10-item Chinese perceived stress scale in elderly service workers: one-factor versus two-factor structure. BMC Psychol. 2013 Jun 19;1(1):9. doi: 10.1186/2050-7283-1-9. eCollection 2013.</citation>
      <PMID>25566361</PMID>
    </reference>
    <reference>
      <citation>Shih VWY, Chan WC, Tai OK, Wong HL, Cheng CPW, Wong CSM. Mindfulness-Based Cognitive Therapy for Late-Life Depression: a Randomised Controlled Trial. East Asian Arch Psychiatry. 2021 Jun;31(2):27-35. doi: 10.12809/eaap2075.</citation>
      <PMID>34987115</PMID>
    </reference>
    <reference>
      <citation>Sun WJ, Xu L, Chan WM, Lam TH, Schooling CM. Depressive symptoms and suicide in 56,000 older Chinese: a Hong Kong cohort study. Soc Psychiatry Psychiatr Epidemiol. 2012 Apr;47(4):505-14. doi: 10.1007/s00127-011-0362-z. Epub 2011 Mar 8.</citation>
      <PMID>21384121</PMID>
    </reference>
    <reference>
      <citation>Tong X, An D, McGonigal A, Park SP, Zhou D. Validation of the Generalized Anxiety Disorder-7 (GAD-7) among Chinese people with epilepsy. Epilepsy Res. 2016 Feb;120:31-6. doi: 10.1016/j.eplepsyres.2015.11.019. Epub 2015 Nov 28.</citation>
      <PMID>26709880</PMID>
    </reference>
    <reference>
      <citation>Wang W, Bian Q, Zhao Y, Li X, Wang W, Du J, Zhang G, Zhou Q, Zhao M. Reliability and validity of the Chinese version of the Patient Health Questionnaire (PHQ-9) in the general population. Gen Hosp Psychiatry. 2014 Sep-Oct;36(5):539-44. doi: 10.1016/j.genhosppsych.2014.05.021. Epub 2014 Jun 6.</citation>
      <PMID>25023953</PMID>
    </reference>
    <reference>
      <citation>Thomas, R., Chur-Hansen, A. &amp; Turner, M. A Systematic Review of Studies on the Use of Mindfulness-Based Cognitive Therapy for the Treatment of Anxiety and Depression in Older People. Mindfulness 11, 1599-1609 (2020). https://doi.org/10.1007/s12671-020-01336-3</citation>
    </reference>
    <reference>
      <citation>Morris, J. (2019). Development and validation of a short form of the Comprehensive assessment of Acceptance and Commitment Therapy processes (CompACT-SF). University of Nottingham.</citation>
    </reference>
    <reference>
      <citation>Segal, Z. V., Williams, J. M. G., &amp; Teasdale, J. D. (2012). Mindfulness-based cognitive therapy for depression. Guilford Press.</citation>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 8, 2023</study_first_submitted>
    <study_first_submitted_qc>August 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 16, 2023</study_first_posted>
    <last_update_submitted>August 15, 2023</last_update_submitted>
    <last_update_submitted_qc>August 15, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>The University of Hong Kong</investigator_affiliation>
      <investigator_full_name>Professor Terry Y.S. Lum</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <keyword>Mindfulness-based cognitive therapy</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Depression</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <provided_document_section>
      <provided_document>
        <document_type>Study Protocol and Statistical Analysis Plan</document_type>
        <document_has_protocol>Yes</document_has_protocol>
        <document_has_icf>No</document_has_icf>
        <document_has_sap>Yes</document_has_sap>
        <document_date>August 8, 2023</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/87/NCT05995587/Prot_SAP_000.pdf</document_url>
      </provided_document>
    </provided_document_section>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05995587
  org study id: EA220105
  nct id: NCT05995587
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Mindfulness-based interventions, such as mindfulness-based cognitive therapy (MBCT), have the
        potential in improving psychological health in older people. With the growing older people
        population, there is a need for greater social welfare capacity to promote their well-being.
        The project aims to:
  
          1. Evaluate the effectiveness of MBCT in improving mental health and mindfulness in older
             people with depressive symptoms as compared to care as usual;
  
          2. Compare the effectiveness between MBCT led by mindfulness teacher and that led by social
             workers;
  
          3. Examine psychological flexibility as a potential mechanism of change in MBCT for
             depressive symptoms.
  Depression is one of the most common yet under-recognized mental disorders in older adults in
        Hong Kong, and it is estimated that approximately one in 10 older people has clinically
        significant depression. With population aging, the number of older people with depression is
        slated to double in the next two decades, creating a substantial burden on the individuals,
        caregivers, and health care system. While pharmacological interventions are effective in
        reducing depression, medical risks can be complicated due to polypharmacy in older people.
        Non-pharmacological interventions may benefit the population by addressing the underlying
        dysfunctional cognitive processes associated with depression.
  
        Mindfulness-based interventions, such as mindfulness-based cognitive therapy (MBCT), have the
        potential in improving psychological health in older people. MBCT is a group intervention
        originally designed to prevent recurrent depressive disorders. It combines mindfulness
        practices and cognitive-behavioural elements to enhance an individual's understanding of the
        interacting relationships among thoughts, emotions, bodily sensations, and behaviours.
        Mindfulness practice emphasizes on developing a moment-to-moment, non-judgmental awareness
        and may be helpful in alleviating depression by directing individual's attention to the
        present instead of ruminating in the past. Systematic reviews have shown the efficacy of MBCT
        in reducing depression, anxiety, loneliness, stress, sleep problems, ruminations, general
        mood, and positive affect. However, over half of the included studies lacked a control group
        and mixed findings were observed possibly because of inconsistent modifications to the
        protocol, methodological flaws, and study limitations.
  
        The application of MBCT in the Chinese older population is understudied. Recently, a
        randomized controlled trial on MBCT for older people were conducted in Hong Kong. By
        comparing a standard MBCT to an active control group (physical exercise + health education)
        for older people with depression, it has been found that while both groups showed a reduction
        in the severity of depressive symptoms, only the MBCT group showed improvement in
        mindfulness.
  
        With these promising findings, more studies are needed to establish the evidence base for the
        intervention and inform clinical practice in this population. The investigators aim to
        explore whether a modified MBCT based on older people's feedback can reduce depressive
        symptoms and improve mindfulness. With the growing older people population and thus a need
        for greater social welfare capacity to promote their well-being, the investigators will also
        examine whether a modified MBCT led by social workers under the supervision of a mindfulness
        teacher can benefit the population.
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  intervention model description: Participants in the intervention group will either receive mindfulness training from a certified mindfulness teacher or from social workers (supervised by a certified mindfulness teacher). The care as usual group will receive usual service provided in District Elderly Community Centres (DECC) and Integrated Community Centre for Mental Wellness (ICCMW).
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Change from baseline depression at Week 8
  time frame: Baseline and Week 8
  description: Depression will be measured by the validated Chinese version of the Patient Health Questionnaire (PHQ-9). The total score will be used, ranging from 0 to 27. Higher scores indicate higher levels of depressive symptoms.
  measure: Change from baseline anxiety at Week 8
  time frame: Baseline and Week 8
  description: Anxiety will be measured by the validated Chinese version of the Generalized Anxiety Disorder scale (GAD-7). The total score will be used, ranging from 0 to 21. Higher scores indicate higher levels of anxiety symptoms.
  measure: Change from baseline stress at Week 8
  time frame: Baseline and Week 8
  description: Stress will be measured by the Chinese validated Perceived Stress Scale (PSS). The total score will be used, ranging from 0 to 40. Higher scores indicate greater stress.
  measure: Change from baseline mindfulness at Week 8
  time frame: Baseline and Week 8
  description: Mindfulness will be measured by the Chinese validated Five Facet Mindfulness Questionnaire Short Form (FFMQ-SF). The total score of the FFMQ-SF (ranging from 20 to 100) as well as the total score (ranging from 4 to 20) of the five subscales (i.e., observe, describe, acting with awareness, nondjuding, and nonreactivity) will be used. Higher scores indicate higher mindfulness.
  measure: Change from baseline psychological flexibility at Week 8
  time frame: Baseline and Week 8
  description: Psychological flexibility will be assessed by the Chinese version of the Comprehensive Assessment of Acceptance and Commitment Therapy Processes (CompACT). Items are rated on a 0 (strongly disagree) to 6 (strongly agree) scale. The total score of the CompAct scale (ranging from 0 to 48), Valued Action subscale (ranging 0 to 18), Openness to Experience subscale (ranging from 0 to 18), and Behavioural Awareness subscale (ranging from 0 to 12) will be used. Higher scores indicate greater psychological flexibility.
  measure: Change from baseline depression at Week 12
  time frame: Baseline and Week 12
  description: Depression will be measured by the validated Chinese version of the Patient Health Questionnaire (PHQ-9). The total score will be used, ranging from 0 to 27. Higher scores indicate higher levels of depressive symptoms.
  measure: Change from baseline anxiety at Week 12
  time frame: Baseline and Week 12
  description: Anxiety will be measured by the validated Chinese version of the Generalized Anxiety Disorder scale (GAD-7). The total score will be used, ranging from 0 to 21. Higher scores indicate higher levels of anxiety symptoms.
  measure: Change from baseline stress at Week 12
  time frame: Baseline and Week 12
  description: Stress will be measured by the Chinese validated Perceived Stress Scale (PSS). The total score will be used, ranging from 0 to 40. Higher scores indicate greater stress.
  measure: Change from baseline mindfulness at Week 12
  time frame: Baseline and Week 12
  description: Mindfulness will be measured by the Chinese validated Five Facet Mindfulness Questionnaire Short Form (FFMQ-SF). The total score of the FFMQ-SF (ranging from 20 to 100) as well as the total score (ranging from 4 to 20) of the five subscales (i.e., observe, describe, acting with awareness, nondjuding, and nonreactivity) will be used. Higher scores indicate higher mindfulness.
  measure: Change from baseline psychological flexibility at Week 12
  time frame: Baseline and Week 12
  description: Psychological flexibility will be assessed by the Chinese version of the Comprehensive Assessment of Acceptance and Commitment Therapy Processes (CompACT). Items are rated on a 0 (strongly disagree) to 6 (strongly agree) scale. The total score of the CompAct scale (ranging from 0 to 48), Valued Action subscale (ranging 0 to 18), Openness to Experience subscale (ranging from 0 to 18), and Behavioural Awareness subscale (ranging from 0 to 12) will be used. Higher scores indicate greater psychological flexibility.
  arm group label: MBCT (mindfulness teacher)
  arm group type: Experimental
  description: Participants in the MBCT (mindfulness teacher) group will receive mindfulness training from a certified mindfulness teacher.
  arm group label: MBCT (social workers)
  arm group type: Experimental
  description: Participants in the MBCT (social workers) group will receive mindfulness training from social workers (supervised by a certified mindfulness teacher).
  arm group label: Care as usual group
  arm group type: No Intervention
  description: The care as usual group will receive usual service provided in District Elderly Community Centres (DECC) and Integrated Community Centre for Mental Wellness (ICCMW).
  intervention type: Behavioral
  intervention name: Mindfulness-based cognitive therapy (MBCT)
  description: MBCT combines mindfulness meditation with cognitive behavioural therapy (CBT) elements to reduce or prevent recurrent major depressive disorders.
  arm group label: MBCT (mindfulness teacher)
  arm group label: MBCT (social workers)
  criteria: 
  gender: All
  minimum age: 60 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Terry Lum, PhD
  role: Principal Investigator
  affiliation: Department of Social Work and Social Administration, The University of Hong Kong
  last name: Gloria Wong, PhD
  role: Principal Investigator
  affiliation: Department of Social Work and Social Administration, The University of Hong Kong
  last name: Yun-Lin Wang, PhD
  phone: +852-3917-5594
  email: yunlinw@hku.hk
  last name: Yun-Han Wang, PhD
  phone: +852-3917-1755
  email: yunhanw@hku.hk
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
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  status: Recruiting
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  status: Recruiting
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  status: Recruiting
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  country: Hong Kong
  citation: Geiger PJ, Boggero IA, Brake CA, Caldera CA, Combs HL, Peters JR, Baer RA. Mindfulness-Based Interventions for Older Adults: A Review of the Effects on Physical and Emotional Well-being. Mindfulness (N Y). 2016 Apr;7(2):296-307. doi: 10.1007/s12671-015-0444-1. Epub 2015 Sep 14.
  PMID: 27200109
  citation: Hou J, Wong SY, Lo HH, Mak WW, Ma HS. Validation of a Chinese version of the Five Facet Mindfulness Questionnaire in Hong Kong and development of a short form. Assessment. 2014 Jun;21(3):363-71. doi: 10.1177/1073191113485121. Epub 2013 Apr 16.
  PMID: 23596271
  citation: Ng SM. Validation of the 10-item Chinese perceived stress scale in elderly service workers: one-factor versus two-factor structure. BMC Psychol. 2013 Jun 19;1(1):9. doi: 10.1186/2050-7283-1-9. eCollection 2013.
  PMID: 25566361
  citation: Shih VWY, Chan WC, Tai OK, Wong HL, Cheng CPW, Wong CSM. Mindfulness-Based Cognitive Therapy for Late-Life Depression: a Randomised Controlled Trial. East Asian Arch Psychiatry. 2021 Jun;31(2):27-35. doi: 10.12809/eaap2075.
  PMID: 34987115
  citation: Sun WJ, Xu L, Chan WM, Lam TH, Schooling CM. Depressive symptoms and suicide in 56,000 older Chinese: a Hong Kong cohort study. Soc Psychiatry Psychiatr Epidemiol. 2012 Apr;47(4):505-14. doi: 10.1007/s00127-011-0362-z. Epub 2011 Mar 8.
  PMID: 21384121
  citation: Tong X, An D, McGonigal A, Park SP, Zhou D. Validation of the Generalized Anxiety Disorder-7 (GAD-7) among Chinese people with epilepsy. Epilepsy Res. 2016 Feb;120:31-6. doi: 10.1016/j.eplepsyres.2015.11.019. Epub 2015 Nov 28.
  PMID: 26709880
  citation: Wang W, Bian Q, Zhao Y, Li X, Wang W, Du J, Zhang G, Zhou Q, Zhao M. Reliability and validity of the Chinese version of the Patient Health Questionnaire (PHQ-9) in the general population. Gen Hosp Psychiatry. 2014 Sep-Oct;36(5):539-44. doi: 10.1016/j.genhosppsych.2014.05.021. Epub 2014 Jun 6.
  PMID: 25023953
  citation: Thomas, R., Chur-Hansen, A. & Turner, M. A Systematic Review of Studies on the Use of Mindfulness-Based Cognitive Therapy for the Treatment of Anxiety and Depression in Older People. Mindfulness 11, 1599-1609 (2020). https://doi.org/10.1007/s12671-020-01336-3
  citation: Morris, J. (2019). Development and validation of a short form of the Comprehensive assessment of Acceptance and Commitment Therapy processes (CompACT-SF). University of Nottingham.
  citation: Segal, Z. V., Williams, J. M. G., & Teasdale, J. D. (2012). Mindfulness-based cognitive therapy for depression. Guilford Press.
  responsible party type: Principal Investigator
  investigator affiliation: The University of Hong Kong
  investigator full name: Professor Terry Y.S. Lum
  investigator title: Professor
  mesh term: Depression
  sharing ipd: No
  provided document: 