<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/NCT04442854</url>
  </required_header>
  <id_info>
    <org_study_id>12607815</org_study_id>
    <nct_id>NCT04442854</nct_id>
  </id_info>
  <brief_title>Cognitive Behavioral Group Therapy for University Students</brief_title>
  <official_title>A Randomized Controlled Trial of Cognitive Behavioral Group Prevention Program for Mainland Chinese University Students in Hong Kong</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hong Kong Baptist University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hong Kong Baptist University</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 developed a culturally appropriate cognitive behavioral group prevention program&#xD;
      for Mainland Chinese university students in Hong Kong. The effects of the group prevention&#xD;
      program on psychological distress, acculturative stress, cognitions, emotions, and&#xD;
      post-migration growth were examined.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Detailed description:&#xD;
&#xD;
      Previous research has found the effectiveness of group cognitive behavioral therapy in&#xD;
      improving international students' mental health and facilitating their psychological&#xD;
      adaptation. However, this kind of research in Chinese societies is scant and previous studies&#xD;
      lack control group in study design. This study developed an 8-session culturally appropriate&#xD;
      cognitive behavioral group prevention program for Mainland Chinese university students in&#xD;
      Hong Kong. Research design of randomized controlled trial was adopted. Program effectiveness&#xD;
      was evaluated at both cognitive and emotional levels, including psychological distress,&#xD;
      acculturative stress, emotions, automatic thoughts, sense-making coping, core belief&#xD;
      re-examination and post-migration growth.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 1, 2016</start_date>
  <completion_date type="Actual">September 1, 2018</completion_date>
  <primary_completion_date type="Actual">June 1, 2018</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>General Health Questionnaire-12 (GHQ-12)</measure>
    <time_frame>pre-test at intake interview</time_frame>
    <description>12 item rating scale measuring psychological distress, scale score ranges from 0-12, with a higher score indicating a higher level of psychological distress</description>
  </primary_outcome>
  <primary_outcome>
    <measure>General Health Questionnaire-12 (GHQ-12)</measure>
    <time_frame>post-test at the end of the last session of the CBT group (for the experimental group), and when the experimental group finished the intervention (for the waitlist control group), respectively.</time_frame>
    <description>12 item rating scale measuring psychological distress, scale score ranges from 0-12, with a higher score indicating a higher level of psychological distress</description>
  </primary_outcome>
  <primary_outcome>
    <measure>General Health Questionnaire-12 (GHQ-12)</measure>
    <time_frame>3-month follow-up test three months after completing the intervention</time_frame>
    <description>12 item rating scale measuring psychological distress, scale score ranges from 0-12, with a higher score indicating a higher level of psychological distress</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Acculturative Stress Scale for Chinese Students (ASSCS)</measure>
    <time_frame>pre-test at intake interview</time_frame>
    <description>35-item rating scale measuring acculturative stress, scale score ranges from 0-3, with a higher score indicating a higher level of acculturative stress</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Acculturative Stress Scale for Chinese Students (ASSCS)</measure>
    <time_frame>post-test at the end of the last session of the CBT group (for the experimental group), and when the experimental group finished the intervention (for the waitlist control group), respectively.</time_frame>
    <description>35-item rating scale measuring acculturative stress, scale score ranges from 0-3, with a higher score indicating a higher level of acculturative stress</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Acculturative Stress Scale for Chinese Students (ASSCS)</measure>
    <time_frame>3-month follow-up test three months after completing the intervention</time_frame>
    <description>35-item rating scale measuring acculturative stress, scale score ranges from 0-3, with a higher score indicating a higher level of acculturative stress</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Chinese Automatic Thoughts Questionnaire (CATQ)</measure>
    <time_frame>pre-test at intake interview</time_frame>
    <description>14-item rating scale measuring automatic thoughts, subscale score ranges from 1-5 for the positive thought subscale and negative thought subscale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Chinese Automatic Thoughts Questionnaire (CATQ)</measure>
    <time_frame>post-test at the end of the last session of the CBT group (for the experimental group), and when the experimental group finished the intervention (for the waitlist control group), respectively.</time_frame>
    <description>14-item rating scale measuring automatic thoughts, subscale score ranges from 1-5 for the positive thought subscale and negative thought subscale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Chinese Automatic Thoughts Questionnaire (CATQ)</measure>
    <time_frame>3-month follow-up test three months after completing the intervention</time_frame>
    <description>14-item rating scale measuring automatic thoughts, subscale score ranges from 1-5 for the positive thought subscale and negative thought subscale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-migration Growth Scale (PMGS)</measure>
    <time_frame>pre-test at intake interview</time_frame>
    <description>14-item rating scale measuring personal growth after migration, scale score ranges from 1-6, with a higher score indicating a higher level of post-migration growth</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-migration Growth Scale (PMGS)</measure>
    <time_frame>post-test at the end of the last session of the CBT group (for the experimental group), and when the experimental group finished the intervention (for the waitlist control group), respectively.</time_frame>
    <description>14-item rating scale measuring personal growth after migration, scale score ranges from 1-6, with a higher score indicating a higher level of post-migration growth</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-migration Growth Scale (PMGS)</measure>
    <time_frame>3-month follow-up test three months after completing the intervention</time_frame>
    <description>14-item rating scale measuring personal growth after migration, scale score ranges from 1-6, with a higher score indicating a higher level of post-migration growth</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Chinese Making Sense of Adversity Scale (CMSAS)</measure>
    <time_frame>pre-test at intake interview</time_frame>
    <description>12-item rating scale measuring sense-making coping strategies of Chinese people, scale score ranges from 1-6, with higher scores indicating a greater tendency to use the sense-making coping</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Chinese Making Sense of Adversity Scale (CMSAS)</measure>
    <time_frame>post-test at the end of the last session of the CBT group (for the experimental group), and when the experimental group finished the intervention (for the waitlist control group), respectively.</time_frame>
    <description>12-item rating scale measuring sense-making coping strategies of Chinese people, scale score ranges from 1-6, with higher scores indicating a greater tendency to use the sense-making coping</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Chinese Making Sense of Adversity Scale (CMSAS)</measure>
    <time_frame>3-month follow-up test three months after completing the intervention</time_frame>
    <description>12-item rating scale measuring sense-making coping strategies of Chinese people, scale score ranges from 1-6, with higher scores indicating a greater tendency to use the sense-making coping</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Core Belief Inventory (CBI)</measure>
    <time_frame>pre-test at intake interview</time_frame>
    <description>9-item rating scale measuring core belief re-examination, scale score ranges from 0-5, with a higher score indicating a higher level of core belief re-examination</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Core Belief Inventory (CBI)</measure>
    <time_frame>post-test at the end of the last session of the CBT group (for the experimental group), and when the experimental group finished the intervention (for the waitlist control group), respectively.</time_frame>
    <description>9-item rating scale measuring core belief re-examination, scale score ranges from 0-5, with a higher score indicating a higher level of core belief re-examination</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Core Belief Inventory (CBI)</measure>
    <time_frame>3-month follow-up test three months after completing the intervention</time_frame>
    <description>9-item rating scale measuring core belief re-examination, scale score ranges from 0-5, with a higher score indicating a higher level of core belief re-examination</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Chinese Affect Scale (CAS)</measure>
    <time_frame>pre-test at intake interview</time_frame>
    <description>20-item rating scale measuring trait and state affect of Chinese-speaking people, subscale scores range from 1-6, with a higher score indicating a higher level of positive/negative emotion</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Chinese Affect Scale (CAS)</measure>
    <time_frame>post-test at the end of the last session of the CBT group (for the experimental group), and when the experimental group finished the intervention (for the waitlist control group), respectively.</time_frame>
    <description>20-item rating scale measuring trait and state affect of Chinese-speaking people, subscale scores range from 1-6, with a higher score indicating a higher level of positive/negative emotion</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Chinese Affect Scale (CAS)</measure>
    <time_frame>3-month follow-up test three months after completing the intervention</time_frame>
    <description>20-item rating scale measuring trait and state affect of Chinese-speaking people, subscale scores range from 1-6, with a higher score indicating a higher level of positive/negative emotion</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">74</enrollment>
  <condition>Cognitive Behavior Group Therapy</condition>
  <arm_group>
    <arm_group_label>cognitive behavioral group therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A cognitive behavioral group prevention program An 8-session, cognitive behavioral group prevention program, featuring cultural appropriateness. One session per week, 3 hours for each session. The program contents include psychoeducation, cognitive skills training to identify and challenge maladaptive cognitions, and behavioral skills training. Each session contains mood check and homework. Participants' own examples are used in the group to demonstrate the CBT skills.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Wait-list control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No immediate intervention No intervention was provided when the experimental group was receiving services, but the same cognitive behavioral group prevention program was delivered to the wait-list control group after that.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>cognitive behavioral group therapy</intervention_name>
    <description>A 8-session cognitive behavior group intervention tailor-made for Mainland Chinese university students in Hong Kong</description>
    <arm_group_label>cognitive behavioral group therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Chinese students from Mainland China who were studying at local universities in Hong&#xD;
             Kong&#xD;
&#xD;
          -  GHQ-12 score of 2 or above (0-0-1-1)&#xD;
&#xD;
          -  Willingness to participate in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  GHQ-12 score of 11 or above (0-0-1-1)&#xD;
&#xD;
          -  One or more psychotic disorders&#xD;
&#xD;
          -  Severe depression diagnosed by professionals with suicidal attempts/ideation in the&#xD;
             past 3 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jiayan Pan, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hong Kong Baptist University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Jiayan Pan</name>
      <address>
        <city>Hong Kong</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Hong Kong</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>June 19, 2020</study_first_submitted>
  <study_first_submitted_qc>June 19, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 23, 2020</study_first_posted>
  <last_update_submitted>September 24, 2020</last_update_submitted>
  <last_update_submitted_qc>September 24, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 28, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hong Kong Baptist University</investigator_affiliation>
    <investigator_full_name>Jiayan Pan</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Chinese university student</keyword>
  <keyword>mental health</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04442854
org study id: 12607815
nct id: NCT04442854
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This study developed a culturally appropriate cognitive behavioral group prevention program
      for Mainland Chinese university students in Hong Kong. The effects of the group prevention
      program on psychological distress, acculturative stress, cognitions, emotions, and
      post-migration growth were examined.
Detailed description:

      Previous research has found the effectiveness of group cognitive behavioral therapy in
      improving international students' mental health and facilitating their psychological
      adaptation. However, this kind of research in Chinese societies is scant and previous studies
      lack control group in study design. This study developed an 8-session culturally appropriate
      cognitive behavioral group prevention program for Mainland Chinese university students in
      Hong Kong. Research design of randomized controlled trial was adopted. Program effectiveness
      was evaluated at both cognitive and emotional levels, including psychological distress,
      acculturative stress, emotions, automatic thoughts, sense-making coping, core belief
      re-examination and post-migration growth.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: General Health Questionnaire-12 (GHQ-12)
time frame: pre-test at intake interview
description: 12 item rating scale measuring psychological distress, scale score ranges from 0-12, with a higher score indicating a higher level of psychological distress
measure: General Health Questionnaire-12 (GHQ-12)
time frame: post-test at the end of the last session of the CBT group (for the experimental group), and when the experimental group finished the intervention (for the waitlist control group), respectively.
description: 12 item rating scale measuring psychological distress, scale score ranges from 0-12, with a higher score indicating a higher level of psychological distress
measure: General Health Questionnaire-12 (GHQ-12)
time frame: 3-month follow-up test three months after completing the intervention
description: 12 item rating scale measuring psychological distress, scale score ranges from 0-12, with a higher score indicating a higher level of psychological distress
measure: Acculturative Stress Scale for Chinese Students (ASSCS)
time frame: pre-test at intake interview
description: 35-item rating scale measuring acculturative stress, scale score ranges from 0-3, with a higher score indicating a higher level of acculturative stress
measure: Acculturative Stress Scale for Chinese Students (ASSCS)
time frame: post-test at the end of the last session of the CBT group (for the experimental group), and when the experimental group finished the intervention (for the waitlist control group), respectively.
description: 35-item rating scale measuring acculturative stress, scale score ranges from 0-3, with a higher score indicating a higher level of acculturative stress
measure: Acculturative Stress Scale for Chinese Students (ASSCS)
time frame: 3-month follow-up test three months after completing the intervention
description: 35-item rating scale measuring acculturative stress, scale score ranges from 0-3, with a higher score indicating a higher level of acculturative stress
measure: Chinese Automatic Thoughts Questionnaire (CATQ)
time frame: pre-test at intake interview
description: 14-item rating scale measuring automatic thoughts, subscale score ranges from 1-5 for the positive thought subscale and negative thought subscale
measure: Chinese Automatic Thoughts Questionnaire (CATQ)
time frame: post-test at the end of the last session of the CBT group (for the experimental group), and when the experimental group finished the intervention (for the waitlist control group), respectively.
description: 14-item rating scale measuring automatic thoughts, subscale score ranges from 1-5 for the positive thought subscale and negative thought subscale
measure: Chinese Automatic Thoughts Questionnaire (CATQ)
time frame: 3-month follow-up test three months after completing the intervention
description: 14-item rating scale measuring automatic thoughts, subscale score ranges from 1-5 for the positive thought subscale and negative thought subscale
measure: Post-migration Growth Scale (PMGS)
time frame: pre-test at intake interview
description: 14-item rating scale measuring personal growth after migration, scale score ranges from 1-6, with a higher score indicating a higher level of post-migration growth
measure: Post-migration Growth Scale (PMGS)
time frame: post-test at the end of the last session of the CBT group (for the experimental group), and when the experimental group finished the intervention (for the waitlist control group), respectively.
description: 14-item rating scale measuring personal growth after migration, scale score ranges from 1-6, with a higher score indicating a higher level of post-migration growth
measure: Post-migration Growth Scale (PMGS)
time frame: 3-month follow-up test three months after completing the intervention
description: 14-item rating scale measuring personal growth after migration, scale score ranges from 1-6, with a higher score indicating a higher level of post-migration growth
measure: Chinese Making Sense of Adversity Scale (CMSAS)
time frame: pre-test at intake interview
description: 12-item rating scale measuring sense-making coping strategies of Chinese people, scale score ranges from 1-6, with higher scores indicating a greater tendency to use the sense-making coping
measure: Chinese Making Sense of Adversity Scale (CMSAS)
time frame: post-test at the end of the last session of the CBT group (for the experimental group), and when the experimental group finished the intervention (for the waitlist control group), respectively.
description: 12-item rating scale measuring sense-making coping strategies of Chinese people, scale score ranges from 1-6, with higher scores indicating a greater tendency to use the sense-making coping
measure: Chinese Making Sense of Adversity Scale (CMSAS)
time frame: 3-month follow-up test three months after completing the intervention
description: 12-item rating scale measuring sense-making coping strategies of Chinese people, scale score ranges from 1-6, with higher scores indicating a greater tendency to use the sense-making coping
measure: Core Belief Inventory (CBI)
time frame: pre-test at intake interview
description: 9-item rating scale measuring core belief re-examination, scale score ranges from 0-5, with a higher score indicating a higher level of core belief re-examination
measure: Core Belief Inventory (CBI)
time frame: post-test at the end of the last session of the CBT group (for the experimental group), and when the experimental group finished the intervention (for the waitlist control group), respectively.
description: 9-item rating scale measuring core belief re-examination, scale score ranges from 0-5, with a higher score indicating a higher level of core belief re-examination
measure: Core Belief Inventory (CBI)
time frame: 3-month follow-up test three months after completing the intervention
description: 9-item rating scale measuring core belief re-examination, scale score ranges from 0-5, with a higher score indicating a higher level of core belief re-examination
measure: Chinese Affect Scale (CAS)
time frame: pre-test at intake interview
description: 20-item rating scale measuring trait and state affect of Chinese-speaking people, subscale scores range from 1-6, with a higher score indicating a higher level of positive/negative emotion
measure: Chinese Affect Scale (CAS)
time frame: post-test at the end of the last session of the CBT group (for the experimental group), and when the experimental group finished the intervention (for the waitlist control group), respectively.
description: 20-item rating scale measuring trait and state affect of Chinese-speaking people, subscale scores range from 1-6, with a higher score indicating a higher level of positive/negative emotion
measure: Chinese Affect Scale (CAS)
time frame: 3-month follow-up test three months after completing the intervention
description: 20-item rating scale measuring trait and state affect of Chinese-speaking people, subscale scores range from 1-6, with a higher score indicating a higher level of positive/negative emotion
arm group label: cognitive behavioral group therapy
arm group type: Experimental
description: A cognitive behavioral group prevention program An 8-session, cognitive behavioral group prevention program, featuring cultural appropriateness. One session per week, 3 hours for each session. The program contents include psychoeducation, cognitive skills training to identify and challenge maladaptive cognitions, and behavioral skills training. Each session contains mood check and homework. Participants' own examples are used in the group to demonstrate the CBT skills.
arm group label: Wait-list control group
arm group type: No Intervention
description: No immediate intervention No intervention was provided when the experimental group was receiving services, but the same cognitive behavioral group prevention program was delivered to the wait-list control group after that.
intervention type: Other
intervention name: cognitive behavioral group therapy
description: A 8-session cognitive behavior group intervention tailor-made for Mainland Chinese university students in Hong Kong
arm group label: cognitive behavioral group therapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Jiayan Pan, PhD
role: Principal Investigator
affiliation: Hong Kong Baptist University
facility: 
country: Hong Kong
responsible party type: Principal Investigator
investigator affiliation: Hong Kong Baptist University
investigator full name: Jiayan Pan
investigator title: Associate Professor
sharing ipd: No