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/NCT06026709</url>
    </required_header>
    <id_info>
      <org_study_id>CAMS&amp;PUMC-IEC-2023-018</org_study_id>
      <nct_id>NCT06026709</nct_id>
    </id_info>
    <brief_title>Effectiveness and Cost-effectiveness of an Integrated Psychological Internet Intervention (MindWellness) in Chinese COPD Patients: Study Protocol of a Randomized Controlled Trial</brief_title>
    <official_title>Effectiveness and Cost-effectiveness of an Integrated Psychological Internet Intervention (MindWellness) in Chinese COPD Patients: Study Protocol of a Randomized Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Peking Union Medical College</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Peking Union Medical College</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>
        Background Mental health problems in chronic obstructive pulmonary disease (COPD) patients&#xD;
        are prominent and neglected. Web-based self-help therapies may effectively reduce mental&#xD;
        health problems, but their effectiveness has not been evaluated in Chinese COPD patients. We&#xD;
        developed an integrated Internet-based psychological intervention (MindWellness). This study&#xD;
        aims to evaluate the effectiveness and cost-effectiveness of MindWellness in enhancing the&#xD;
        mental wellbeing of COPD patients.&#xD;
  &#xD;
        Methods This study is a multicenter, two-arm, randomized controlled trial (RCT) with a&#xD;
        parallel-group design to enroll at least 420 COPD patients over 35 years. Participants will&#xD;
        be assigned to receive either usual care group or the usual care + MindWellness group.&#xD;
        Assessments will take place at baseline (T0), 4 weeks (T1), 8 weeks (T2), and 16 weeks (T3)&#xD;
        after baseline, and participants will be asked to complete questionnaires and take physical&#xD;
        measurements. The primary outcome measure will assess mental well-being using the Warwick&#xD;
        Edinburgh Mental Wellbeing Scale (WEMWBS). Secondary outcome measures will assess mental&#xD;
        health, physical health, COPD symptoms, health risk behaviors, socio-economic indicators, and&#xD;
        healthcare utilization and expenditure. Analyses will utilize an intention-to-treat analysis.&#xD;
  &#xD;
        Discussion This study is the first RCT to examine the value of MindWellness, the&#xD;
        internet-based psychological intervention for COPD patients. If this low-cost intervention is&#xD;
        effective, it could be rapidly scaled up for providing mental health care of COPD patients in&#xD;
        China.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 15, 2023</start_date>
    <completion_date type="Anticipated">June 15, 2024</completion_date>
    <primary_completion_date type="Anticipated">April 15, 2024</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>Supportive Care</primary_purpose>
      <masking>Double (Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>the Warwick Edinburgh Mental Wellbeing Scale (WEMWBS)</measure>
      <time_frame>at baseline (T0), 4 weeks (T1), 8 weeks (T2), and 16 weeks (T3) after baseline</time_frame>
      <description>Patients'mental wellbeing</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">1200</enrollment>
    <condition>Chronic Obstructive Pulmonary Disease</condition>
    <condition>Depression</condition>
    <condition>Anxiety</condition>
    <arm_group>
      <arm_group_label>usual care + MindWellness group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>usual care</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>MindWellness</intervention_name>
      <description>The online intervention &quot;MindWellness&quot; integrates two distinct trainings for anxiety and depression. Each training includes approximately twenty 10-minute sessions, and each are centered around different themes. These two trainings will be delivered through a WeChat Mini Program.</description>
      <arm_group_label>usual care + MindWellness group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Age 35 years or older;&#xD;
  &#xD;
            2. Post-bronchodilator FEV1/FVC ≤70% or confirmed COPD patients;&#xD;
  &#xD;
            3. Literate and able to type;&#xD;
  &#xD;
            4. Have a smartphone;&#xD;
  &#xD;
            5. Be proficient in using the WeChat applet;&#xD;
  &#xD;
            6. Willingness to self-help iCBT sessions for 8 weeks, 10-20 minutes of practice per&#xD;
               session, roughly 1 hour per week, time and place flexible;&#xD;
  &#xD;
            7. Receive three follow-up visits within four months (2 offline, 1 online) and complete a&#xD;
               physical exam and online questionnaire; and&#xD;
  &#xD;
            8. Willingness to provide the hospital with their usual cell phone number.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Patients with a physician diagnosis of asthma or asthma-COPD overlap syndrome;&#xD;
  &#xD;
            2. Patients hospitalized for COPD within the previous one year;&#xD;
  &#xD;
            3. Having severe cognitive dysfunction and being unable to communicate;&#xD;
  &#xD;
            4. Severely ill with less than 12-month life expectancy.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>35 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 30, 2023</study_first_submitted>
    <study_first_submitted_qc>August 30, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 7, 2023</study_first_posted>
    <last_update_submitted>August 30, 2023</last_update_submitted>
    <last_update_submitted_qc>August 30, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Peking Union Medical College</investigator_affiliation>
      <investigator_full_name>Simiao Chen</investigator_full_name>
      <investigator_title>professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Lung Diseases, Obstructive</mesh_term>
      <mesh_term>Pulmonary Disease, Chronic Obstructive</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT06026709
  org study id: CAMS&PUMC-IEC-2023-018
  nct id: NCT06026709
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Background Mental health problems in chronic obstructive pulmonary disease (COPD) patients
        are prominent and neglected. Web-based self-help therapies may effectively reduce mental
        health problems, but their effectiveness has not been evaluated in Chinese COPD patients. We
        developed an integrated Internet-based psychological intervention (MindWellness). This study
        aims to evaluate the effectiveness and cost-effectiveness of MindWellness in enhancing the
        mental wellbeing of COPD patients.
  
        Methods This study is a multicenter, two-arm, randomized controlled trial (RCT) with a
        parallel-group design to enroll at least 420 COPD patients over 35 years. Participants will
        be assigned to receive either usual care group or the usual care + MindWellness group.
        Assessments will take place at baseline (T0), 4 weeks (T1), 8 weeks (T2), and 16 weeks (T3)
        after baseline, and participants will be asked to complete questionnaires and take physical
        measurements. The primary outcome measure will assess mental well-being using the Warwick
        Edinburgh Mental Wellbeing Scale (WEMWBS). Secondary outcome measures will assess mental
        health, physical health, COPD symptoms, health risk behaviors, socio-economic indicators, and
        healthcare utilization and expenditure. Analyses will utilize an intention-to-treat analysis.
  
        Discussion This study is the first RCT to examine the value of MindWellness, the
        internet-based psychological intervention for COPD patients. If this low-cost intervention is
        effective, it could be rapidly scaled up for providing mental health care of COPD patients in
        China.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Supportive Care
  masking: Double (Investigator, Outcomes Assessor)
  measure: the Warwick Edinburgh Mental Wellbeing Scale (WEMWBS)
  time frame: at baseline (T0), 4 weeks (T1), 8 weeks (T2), and 16 weeks (T3) after baseline
  description: Patients'mental wellbeing
  arm group label: usual care + MindWellness group
  arm group type: Experimental
  arm group label: usual care
  arm group type: No Intervention
  intervention type: Behavioral
  intervention name: MindWellness
  description: The online intervention "MindWellness" integrates two distinct trainings for anxiety and depression. Each training includes approximately twenty 10-minute sessions, and each are centered around different themes. These two trainings will be delivered through a WeChat Mini Program.
  arm group label: usual care + MindWellness group
  criteria: 
  gender: All
  minimum age: 35 Years
  maximum age: N/A
  healthy volunteers: No
  responsible party type: Principal Investigator
  investigator affiliation: Peking Union Medical College
  investigator full name: Simiao Chen
  investigator title: professor
  mesh term: Lung Diseases, Obstructive
  mesh term: Pulmonary Disease, Chronic Obstructive
  sharing ipd: No