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/NCT06005961</url>
    </required_header>
    <id_info>
      <org_study_id>MBP_intervention</org_study_id>
      <nct_id>NCT06005961</nct_id>
    </id_info>
    <brief_title>Module-Based Psychological (MBP) for Community Youths</brief_title>
    <acronym>MBP_RCT</acronym>
    <official_title>A Randomised Controlled Trial of Module-Based Psychological (MBP) Intervention for Young People With Mental Distress in Hong Kong</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>
    </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>
        This waitlist, randomised controlled trial (RCT) aims to examine the effectiveness of the&#xD;
        Module-Based Psychological (MBP) intervention in reducing mental distress for youths aged&#xD;
        12-30 years in Hong Kong. The participants randomised to the MBP group will receive 4-7&#xD;
        sessions of MBP (in 6 to 10 weeks) in an individual format delivered by frontline social or&#xD;
        youth workers trained by professional clinicians. The waitlist control group will receive the&#xD;
        same intervention after 6 weeks of waiting plus a 1-month follow-up period. The MBP is&#xD;
        designed to improve the youths' abilities/skills in handling moods for better emotional&#xD;
        management. Written informed consent will be signed by participants or their&#xD;
        parents/guardians if they are under the age of 18.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This randomised controlled trial (RCT) aims to examine the effectiveness of the Module-Based&#xD;
        Psychological (MBP) intervention in reducing mental distress for youths in Hong Kong. This&#xD;
        intervention study will be delivered in an individual format for 4 sessions of core module in&#xD;
        6 weeks plus/minus 2-3 sessions of tailored-made module in 3-4 weeks by frontline social or&#xD;
        youth workers trained by professional clinicians. It is designed to improve the youths'&#xD;
        abilities and skills in handling moods for better emotional management. The MBP intervention&#xD;
        has two modules: core and tailor-made modules. The core module focuses on emotional&#xD;
        management, while the five tailor-made modules include anxiety management, mood and&#xD;
        depression management, anger management, sleeping well, and managing self-expectation and&#xD;
        compassion. The tailor-made modules will be assigned to youths according to their needs.&#xD;
        While the clinical outcome of the MBP is evaluated, its cost-effectiveness is also of&#xD;
        particular concern. Planned interim analyses are built into the project for the sake of&#xD;
        evaluation of the collected data from the ongoing trial, in which the primary research&#xD;
        question is addressed and which has the potential to modify the conduct of the study. It is&#xD;
        hypothesised that the youths who have received MBP intervention will demonstrate a greater&#xD;
        reduction in mental distress, depressive symptoms, and anxiety symptoms compared to the&#xD;
        youths in the waitlist control group. Besides, the MBP intervention will be more&#xD;
        cost-effective than waiting.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">May 2025</completion_date>
    <primary_completion_date type="Anticipated">January 2025</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>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>General mental distress</measure>
      <time_frame>baseline (T0), post-treatment (6-week, T1), and follow-up (9 week, T2)</time_frame>
      <description>Measured using the Kessler Psychological Distress Scale, 6-item version (K6). The total K6 score ranges from 0 to 24, with higher scores indicating a greater distress level.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Depressive symptoms</measure>
      <time_frame>baseline (T0), post-treatment (6-week, T1), and follow-up (9 week, T2)</time_frame>
      <description>Measured using the 7-item Depression Subscale of the Depression, Anxiety, and Stress Scale, 21-item version (DASS-D).&#xD;
  The total score ranges from 0-42, with higher scores indicating greater severity of depressive symptoms.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Anxiety symptoms</measure>
      <time_frame>baseline (T0), post-treatment (6-week, T1), and follow-up (9 week, T2)</time_frame>
      <description>Measured using the 7-item Anxiety Subscale of the Depression Anxiety and Stress Scale 21-item version (DASS-A) The total score ranges from 0-42, with higher scores indicating greater severity of anxiety symptoms.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Functioning</measure>
      <time_frame>baseline (T0), post-treatment (6-week, T1), and follow-up (9 week, T2)</time_frame>
      <description>Measured using the Social and Occupational Functioning Assessment Scale (SOFAS).&#xD;
  The score ranges from 0-100, with higher scores indicating better social and occupational functioning related to physical and mental health.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Health-related quality of life</measure>
      <time_frame>baseline (T0), post-treatment (6-week, T1), and follow-up (9 week, T2)</time_frame>
      <description>Measured using the 12-Item Short Form Health Survey (SF-12). The derived index score ranges from 0-100, with higher scores indicating better physical and mental health functioning.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Self-compassion</measure>
      <time_frame>baseline (T0), post-treatment (6-week, T1), and follow-up (9 week, T2)</time_frame>
      <description>Measured using the 12-item Self-Compassion Scale (SCS). The total score ranges from 5-60, with higher scores indicating better self-compassion.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Self-efficacy</measure>
      <time_frame>baseline (T0), post-treatment (6-week, T1), and follow-up (9 week, T2)</time_frame>
      <description>Measured using the 10-item General Self-Efficacy Scale (GSE). The total score ranges from 10 and 40, with higher scores indicating more self-efficacy.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">400</enrollment>
    <condition>Mental Disorder</condition>
    <condition>Depressive Symptoms</condition>
    <condition>Anxiety Symptoms</condition>
    <arm_group>
      <arm_group_label>MBP intervention arm</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>The MBP intervention has two modules: the core and the tailor-made modules. The core module focuses on emotional management, while the five tailor-made modules include anxiety management, mood and depression management, anger management, sleeping well, and managing self-expectation and compassion.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Waitlist control arm</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Participants allocated to the waitlist control group will wait for 6 plus 4 weeks before receiving the MBP intervention.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Module-Based Psychological (MBP) Intervention</intervention_name>
      <description>Participants will receive one core module related to emotional management and maximum two tailor-made modules according to the participant's needs. Each weekly session lasts for 1 hours. The core module will last for 6 weeks and the tailor-made modules will last for 3 - 4 weeks.</description>
      <arm_group_label>MBP intervention arm</arm_group_label>
      <arm_group_label>Waitlist control arm</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. LevelMind@JC users aged from 12-30&#xD;
  &#xD;
            2. Reported at-least mild mental distress&#xD;
  &#xD;
            3. Have sufficient proficiency in Chinese to understand verbal instructions&#xD;
  &#xD;
            4. Able to give informed consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Known diagnosis of intellectual disability&#xD;
  &#xD;
            2. Known diagnosis of organic brain disorder&#xD;
  &#xD;
            3. Known psychiatric diagnosis within two years&#xD;
  &#xD;
            4. Current substance abuse&#xD;
  &#xD;
            5. Receiving any psychiatric treatments or structural psychological therapies such as&#xD;
               cognitive behavioural therapy, mentalisation-based therapy and low-intensity online&#xD;
               intervention, narrative therapy, mindfulness, and art-informed therapy&#xD;
  &#xD;
            6. Current or active suicidal ideation or attempts&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>12 Years</minimum_age>
      <maximum_age>30 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Christy Lai-ming Hui</last_name>
      <role>Principal Investigator</role>
      <affiliation>The University of Hong Kong</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Yi-nam Suen</last_name>
      <phone>(852) 39179579</phone>
      <email>suenyn@hku.hk</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Gabriel Chun-hei Lai</last_name>
      <phone>(852) 94517644</phone>
      <email>gchlai@hku.hk</email>
    </overall_contact_backup>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 11, 2023</study_first_submitted>
    <study_first_submitted_qc>August 20, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>September 7, 2023</last_update_submitted>
    <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 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>Dr. Christy Lai-ming Hui</investigator_full_name>
      <investigator_title>Associate professor</investigator_title>
    </responsible_party>
    <keyword>randomised controlled trial</keyword>
    <keyword>module-based psychological intervention</keyword>
    <keyword>youths</keyword>
    <keyword>mental distress</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Mental Disorders</mesh_term>
      <mesh_term>Depression</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/NCT06005961
  org study id: MBP_intervention
  nct id: NCT06005961
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This waitlist, randomised controlled trial (RCT) aims to examine the effectiveness of the
        Module-Based Psychological (MBP) intervention in reducing mental distress for youths aged
        12-30 years in Hong Kong. The participants randomised to the MBP group will receive 4-7
        sessions of MBP (in 6 to 10 weeks) in an individual format delivered by frontline social or
        youth workers trained by professional clinicians. The waitlist control group will receive the
        same intervention after 6 weeks of waiting plus a 1-month follow-up period. The MBP is
        designed to improve the youths' abilities/skills in handling moods for better emotional
        management. Written informed consent will be signed by participants or their
        parents/guardians if they are under the age of 18.
  This randomised controlled trial (RCT) aims to examine the effectiveness of the Module-Based
        Psychological (MBP) intervention in reducing mental distress for youths in Hong Kong. This
        intervention study will be delivered in an individual format for 4 sessions of core module in
        6 weeks plus/minus 2-3 sessions of tailored-made module in 3-4 weeks by frontline social or
        youth workers trained by professional clinicians. It is designed to improve the youths'
        abilities and skills in handling moods for better emotional management. The MBP intervention
        has two modules: core and tailor-made modules. The core module focuses on emotional
        management, while the five tailor-made modules include anxiety management, mood and
        depression management, anger management, sleeping well, and managing self-expectation and
        compassion. The tailor-made modules will be assigned to youths according to their needs.
        While the clinical outcome of the MBP is evaluated, its cost-effectiveness is also of
        particular concern. Planned interim analyses are built into the project for the sake of
        evaluation of the collected data from the ongoing trial, in which the primary research
        question is addressed and which has the potential to modify the conduct of the study. It is
        hypothesised that the youths who have received MBP intervention will demonstrate a greater
        reduction in mental distress, depressive symptoms, and anxiety symptoms compared to the
        youths in the waitlist control group. Besides, the MBP intervention will be more
        cost-effective than waiting.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: General mental distress
  time frame: baseline (T0), post-treatment (6-week, T1), and follow-up (9 week, T2)
  description: Measured using the Kessler Psychological Distress Scale, 6-item version (K6). The total K6 score ranges from 0 to 24, with higher scores indicating a greater distress level.
  measure: Depressive symptoms
  time frame: baseline (T0), post-treatment (6-week, T1), and follow-up (9 week, T2)
  description: Measured using the 7-item Depression Subscale of the Depression, Anxiety, and Stress Scale, 21-item version (DASS-D).
  The total score ranges from 0-42, with higher scores indicating greater severity of depressive symptoms.
  measure: Anxiety symptoms
  time frame: baseline (T0), post-treatment (6-week, T1), and follow-up (9 week, T2)
  description: Measured using the 7-item Anxiety Subscale of the Depression Anxiety and Stress Scale 21-item version (DASS-A) The total score ranges from 0-42, with higher scores indicating greater severity of anxiety symptoms.
  measure: Functioning
  time frame: baseline (T0), post-treatment (6-week, T1), and follow-up (9 week, T2)
  description: Measured using the Social and Occupational Functioning Assessment Scale (SOFAS).
  The score ranges from 0-100, with higher scores indicating better social and occupational functioning related to physical and mental health.
  measure: Health-related quality of life
  time frame: baseline (T0), post-treatment (6-week, T1), and follow-up (9 week, T2)
  description: Measured using the 12-Item Short Form Health Survey (SF-12). The derived index score ranges from 0-100, with higher scores indicating better physical and mental health functioning.
  measure: Self-compassion
  time frame: baseline (T0), post-treatment (6-week, T1), and follow-up (9 week, T2)
  description: Measured using the 12-item Self-Compassion Scale (SCS). The total score ranges from 5-60, with higher scores indicating better self-compassion.
  measure: Self-efficacy
  time frame: baseline (T0), post-treatment (6-week, T1), and follow-up (9 week, T2)
  description: Measured using the 10-item General Self-Efficacy Scale (GSE). The total score ranges from 10 and 40, with higher scores indicating more self-efficacy.
  arm group label: MBP intervention arm
  arm group type: Active Comparator
  description: The MBP intervention has two modules: the core and the tailor-made modules. The core module focuses on emotional management, while the five tailor-made modules include anxiety management, mood and depression management, anger management, sleeping well, and managing self-expectation and compassion.
  arm group label: Waitlist control arm
  arm group type: Other
  description: Participants allocated to the waitlist control group will wait for 6 plus 4 weeks before receiving the MBP intervention.
  intervention type: Behavioral
  intervention name: Module-Based Psychological (MBP) Intervention
  description: Participants will receive one core module related to emotional management and maximum two tailor-made modules according to the participant's needs. Each weekly session lasts for 1 hours. The core module will last for 6 weeks and the tailor-made modules will last for 3 - 4 weeks.
  arm group label: MBP intervention arm
  arm group label: Waitlist control arm
  criteria: 
  gender: All
  minimum age: 12 Years
  maximum age: 30 Years
  healthy volunteers: No
  last name: Christy Lai-ming Hui
  role: Principal Investigator
  affiliation: The University of Hong Kong
  last name: Yi-nam Suen
  phone: (852) 39179579
  email: suenyn@hku.hk
  last name: Gabriel Chun-hei Lai
  phone: (852) 94517644
  email: gchlai@hku.hk
  responsible party type: Principal Investigator
  investigator affiliation: The University of Hong Kong
  investigator full name: Dr. Christy Lai-ming Hui
  investigator title: Associate professor
  mesh term: Mental Disorders
  mesh term: Depression
  sharing ipd: No