- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04442854
Cognitive Behavioral Group Therapy for University Students
A Randomized Controlled Trial of Cognitive Behavioral Group Prevention Program for Mainland Chinese University Students in Hong Kong
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Hong Kong, Hong Kong
- Jiayan Pan
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Chinese students from Mainland China who were studying at local universities in Hong Kong
- GHQ-12 score of 2 or above (0-0-1-1)
- Willingness to participate in the study
Exclusion Criteria:
- GHQ-12 score of 11 or above (0-0-1-1)
- One or more psychotic disorders
- Severe depression diagnosed by professionals with suicidal attempts/ideation in the past 3 months
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: cognitive behavioral group therapy
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.
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A 8-session cognitive behavior group intervention tailor-made for Mainland Chinese university students in Hong Kong
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No Intervention: Wait-list control group
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
General Health Questionnaire-12 (GHQ-12)
Time Frame: pre-test at intake interview
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12 item rating scale measuring psychological distress, scale score ranges from 0-12, with a higher score indicating a higher level of psychological distress
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pre-test at intake interview
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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.
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12 item rating scale measuring psychological distress, scale score ranges from 0-12, with a higher score indicating a higher level of psychological distress
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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.
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General Health Questionnaire-12 (GHQ-12)
Time Frame: 3-month follow-up test three months after completing the intervention
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12 item rating scale measuring psychological distress, scale score ranges from 0-12, with a higher score indicating a higher level of psychological distress
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3-month follow-up test three months after completing the intervention
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Acculturative Stress Scale for Chinese Students (ASSCS)
Time Frame: pre-test at intake interview
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35-item rating scale measuring acculturative stress, scale score ranges from 0-3, with a higher score indicating a higher level of acculturative stress
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pre-test at intake interview
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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.
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35-item rating scale measuring acculturative stress, scale score ranges from 0-3, with a higher score indicating a higher level of acculturative stress
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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.
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Acculturative Stress Scale for Chinese Students (ASSCS)
Time Frame: 3-month follow-up test three months after completing the intervention
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35-item rating scale measuring acculturative stress, scale score ranges from 0-3, with a higher score indicating a higher level of acculturative stress
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3-month follow-up test three months after completing the intervention
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Chinese Automatic Thoughts Questionnaire (CATQ)
Time Frame: pre-test at intake interview
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14-item rating scale measuring automatic thoughts, subscale score ranges from 1-5 for the positive thought subscale and negative thought subscale
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pre-test at intake interview
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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.
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14-item rating scale measuring automatic thoughts, subscale score ranges from 1-5 for the positive thought subscale and negative thought subscale
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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.
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Chinese Automatic Thoughts Questionnaire (CATQ)
Time Frame: 3-month follow-up test three months after completing the intervention
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14-item rating scale measuring automatic thoughts, subscale score ranges from 1-5 for the positive thought subscale and negative thought subscale
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3-month follow-up test three months after completing the intervention
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Post-migration Growth Scale (PMGS)
Time Frame: pre-test at intake interview
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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
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pre-test at intake interview
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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.
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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
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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.
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Post-migration Growth Scale (PMGS)
Time Frame: 3-month follow-up test three months after completing the intervention
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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
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3-month follow-up test three months after completing the intervention
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Chinese Making Sense of Adversity Scale (CMSAS)
Time Frame: pre-test at intake interview
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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
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pre-test at intake interview
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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.
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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
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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.
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Chinese Making Sense of Adversity Scale (CMSAS)
Time Frame: 3-month follow-up test three months after completing the intervention
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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
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3-month follow-up test three months after completing the intervention
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Core Belief Inventory (CBI)
Time Frame: pre-test at intake interview
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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
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pre-test at intake interview
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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.
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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
|
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.
|
Core Belief Inventory (CBI)
Time Frame: 3-month follow-up test three months after completing the intervention
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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
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3-month follow-up test three months after completing the intervention
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Chinese Affect Scale (CAS)
Time Frame: pre-test at intake interview
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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
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pre-test at intake interview
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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.
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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
|
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.
|
Chinese Affect Scale (CAS)
Time Frame: 3-month follow-up test three months after completing the intervention
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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
|
3-month follow-up test three months after completing the intervention
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 12607815
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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