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/NCT06039228</url>
    </required_header>
    <id_info>
      <org_study_id>KPF23GWP12</org_study_id>
      <nct_id>NCT06039228</nct_id>
    </id_info>
    <brief_title>School-based Group Acceptance and Commitment Therapy for Adolescents</brief_title>
    <official_title>Thriving Through the Storms: A School-based Mental Health Promotion Program for Building Psychological Flexibility and Resilience</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>
        The objective of the investigators' mental health promotion intervention premised on the&#xD;
        Acceptance and Commitment Therapy (ACT) framework in secondary school settings aims to&#xD;
        enhance young people's psychological flexibility and reduce their emotional distress. ACT is&#xD;
        an evidence-based approach that encourages individuals to act in alignment with their&#xD;
        identified values. The investigator's team will employ an ACT protocol for adolescents&#xD;
        developed by Louise Hayes and Joseph Ciarrochi. The study includes a single-group study&#xD;
        design. The investigator will compare the pre- and post-intervention data to assess the&#xD;
        feasibility and potential effectiveness of the group intervention.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 1, 2023</start_date>
    <completion_date type="Anticipated">August 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">June 30, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Acceptance and Action Questionnaire - II</measure>
      <time_frame>Baseline and 4 weeks</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>The 14-item Resilience Scale</measure>
      <time_frame>Baseline and 4 weeks</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Patient Health Questionnaire - 9</measure>
      <time_frame>Baseline and 4 weeks</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>General Anxiety Disorder - 7</measure>
      <time_frame>Baseline and 4 weeks</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Perceived Stress Scale</measure>
      <time_frame>Baseline and 4 weeks</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Satisfaction with Life Scale</measure>
      <time_frame>Baseline and 4 weeks</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pittsburgh Sleep Quality Index</measure>
      <time_frame>Baseline and 4 weeks</time_frame>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Depressive Symptoms</condition>
    <condition>Anxiety</condition>
    <condition>Stress</condition>
    <arm_group>
      <arm_group_label>Intervention group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Acceptance and commitment therapy</intervention_name>
      <description>Four sessions of group acceptance and commitment therapy, with each session lasting for 1.5 hours.</description>
      <arm_group_label>Intervention group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Eligible participants are adolescents who reported mild to moderate severity of&#xD;
          psychological distress, including those who report:&#xD;
  &#xD;
            -  a score of 5-19 on the Patient Health Questionnaire (PHQ-9), or&#xD;
  &#xD;
            -  a score of 5-14 on the General Anxiety Disorder-7, or&#xD;
  &#xD;
            -  a score ≥14 on the Perceived Stress Scale.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Adolescents will be excluded if they exhibit or report:&#xD;
  &#xD;
            -  violent or aggressive behavior, or&#xD;
  &#xD;
            -  active self-injurious or suicidal thought, or&#xD;
  &#xD;
            -  active psychotic symptom.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>12 Years</minimum_age>
      <maximum_age>18 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Jennifer Tang, PhD</last_name>
      <phone>39433753</phone>
      <email>jymtang@cuhk.edu.hk</email>
    </overall_contact>
    <location>
      <facility>
        <name>Department of Educational Psychology, The Chinese University of Hong Kong</name>
        <address>
          <city>Shatin</city>
          <country>Hong Kong</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Jennifer Tang, PhD</last_name>
        <phone>39433753</phone>
        <email>jymtang@cuhk.edu.hk</email>
      </contact>
    </location>
    <location_countries>
      <country>Hong Kong</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 9, 2023</study_first_submitted>
    <study_first_submitted_qc>September 9, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 15, 2023</study_first_posted>
    <last_update_submitted>September 14, 2023</last_update_submitted>
    <last_update_submitted_qc>September 14, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</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>Jennifer Yee Man Tang</investigator_full_name>
      <investigator_title>Assistant Professor</investigator_title>
    </responsible_party>
    <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>
    <!-- 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/NCT06039228
  org study id: KPF23GWP12
  nct id: NCT06039228
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The objective of the investigators' mental health promotion intervention premised on the
        Acceptance and Commitment Therapy (ACT) framework in secondary school settings aims to
        enhance young people's psychological flexibility and reduce their emotional distress. ACT is
        an evidence-based approach that encourages individuals to act in alignment with their
        identified values. The investigator's team will employ an ACT protocol for adolescents
        developed by Louise Hayes and Joseph Ciarrochi. The study includes a single-group study
        design. The investigator will compare the pre- and post-intervention data to assess the
        feasibility and potential effectiveness of the group intervention.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Acceptance and Action Questionnaire - II
  time frame: Baseline and 4 weeks
  measure: The 14-item Resilience Scale
  time frame: Baseline and 4 weeks
  measure: Patient Health Questionnaire - 9
  time frame: Baseline and 4 weeks
  measure: General Anxiety Disorder - 7
  time frame: Baseline and 4 weeks
  measure: Perceived Stress Scale
  time frame: Baseline and 4 weeks
  measure: Satisfaction with Life Scale
  time frame: Baseline and 4 weeks
  measure: Pittsburgh Sleep Quality Index
  time frame: Baseline and 4 weeks
  arm group label: Intervention group
  arm group type: Experimental
  intervention type: Behavioral
  intervention name: Acceptance and commitment therapy
  description: Four sessions of group acceptance and commitment therapy, with each session lasting for 1.5 hours.
  arm group label: Intervention group
  criteria: 
  gender: All
  minimum age: 12 Years
  maximum age: 18 Years
  healthy volunteers: No
  last name: Jennifer Tang, PhD
  phone: 39433753
  email: jymtang@cuhk.edu.hk
  facility: 
  status: Recruiting
  contact: 
  country: Hong Kong
  responsible party type: Principal Investigator
  investigator affiliation: Chinese University of Hong Kong
  investigator full name: Jennifer Yee Man Tang
  investigator title: Assistant Professor
  mesh term: Depression
  sharing ipd: No