Cognitive Behavior Group TherapyNCT04442854
Cognitive Behavioral Group Therapy for University Students
A study testing cognitive behavioral group therapy in people with Cognitive Behavior Group Therapy, run by Hong Kong Baptist University at 1 site in Hong Kong.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cognitive Behavior Group Therapy
- What is being tested?
- cognitive behavioral group therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Nov 2016to 1 Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial of Cognitive Behavioral Group Prevention Program for Mainland Chinese University Students in Hong Kong
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.
Read the 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.
- Conditions
- Cognitive Behavior Group Therapy
- Being tested
- cognitive behavioral group therapy
- Keywords
- Chinese university student, mental health
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cognitive behavioral group therapyOther
A 8-session cognitive behavior group intervention tailor-made for Mainland Chinese university students in Hong Kong
| Study group | Role | What they receive |
|---|---|---|
| cognitive behavioral group therapy | Experimental | 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. Receives: Other: cognitive behavioral group therapy |
| Wait-list control group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
General Health Questionnaire-12 (GHQ-12)
12 item rating scale measuring psychological distress, scale score ranges from 0-12, with a higher score indicating a higher level of psychological distress
Measured: pre-test at intake interview
General Health Questionnaire-12 (GHQ-12)
12 item rating scale measuring psychological distress, scale score ranges from 0-12, with a higher score indicating a higher level of psychological distress
Measured: 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.
General Health Questionnaire-12 (GHQ-12)
12 item rating scale measuring psychological distress, scale score ranges from 0-12, with a higher score indicating a higher level of psychological distress
Measured: 3-month follow-up test three months after completing the intervention
Acculturative Stress Scale for Chinese Students (ASSCS)
35-item rating scale measuring acculturative stress, scale score ranges from 0-3, with a higher score indicating a higher level of acculturative stress
Measured: pre-test at intake interview
Acculturative Stress Scale for Chinese Students (ASSCS)
35-item rating scale measuring acculturative stress, scale score ranges from 0-3, with a higher score indicating a higher level of acculturative stress
Measured: 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.
Acculturative Stress Scale for Chinese Students (ASSCS)
35-item rating scale measuring acculturative stress, scale score ranges from 0-3, with a higher score indicating a higher level of acculturative stress
Measured: 3-month follow-up test three months after completing the intervention
Secondary outcomes (15)
Chinese Automatic Thoughts Questionnaire (CATQ)
14-item rating scale measuring automatic thoughts, subscale score ranges from 1-5 for the positive thought subscale and negative thought subscale
Measured: pre-test at intake interview
Chinese Automatic Thoughts Questionnaire (CATQ)
14-item rating scale measuring automatic thoughts, subscale score ranges from 1-5 for the positive thought subscale and negative thought subscale
Measured: 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 Automatic Thoughts Questionnaire (CATQ)
14-item rating scale measuring automatic thoughts, subscale score ranges from 1-5 for the positive thought subscale and negative thought subscale
Measured: 3-month follow-up test three months after completing the intervention
Post-migration Growth Scale (PMGS)
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
Measured: pre-test at intake interview
Post-migration Growth Scale (PMGS)
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
Measured: 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.
Post-migration Growth Scale (PMGS)
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
Measured: 3-month follow-up test three months after completing the intervention
Chinese Making Sense of Adversity Scale (CMSAS)
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
Measured: pre-test at intake interview
Chinese Making Sense of Adversity Scale (CMSAS)
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
Measured: 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 Making Sense of Adversity Scale (CMSAS)
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
Measured: 3-month follow-up test three months after completing the intervention
Core Belief Inventory (CBI)
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
Measured: pre-test at intake interview
Core Belief Inventory (CBI)
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
Measured: 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)
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
Measured: 3-month follow-up test three months after completing the intervention
Chinese Affect Scale (CAS)
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
Measured: pre-test at intake interview
Chinese Affect Scale (CAS)
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
Measured: 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)
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
Measured: 3-month follow-up test three months after completing the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2020
- Study start1 Nov 2016
- Primary completion1 Jun 2018
- Study completion1 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive Behavior Group TherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hong Kong Baptist University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiayan Pan, Hong Kong Baptist University
- Investigators
- Jiayan Pan, PhD, Principal investigator, Hong Kong Baptist University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04442854
- Sponsor's protocol ID
- 12607815
- Status last verified
- Sep 2020
- First submitted
- 19 Jun 2020
- Last updated
- 28 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Cognitive Behavioral Group Prevention Program for Mainland Chinese University Students in Hong Kong
- ClinicalTrials.gov ID
- NCT04442854
- Acronym / sponsor ID
- 12607815
- Conditions
- Cognitive Behavior Group Therapy
- Keywords
- Chinese university student, mental health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Hong Kong Baptist UniversityUniversity, hospital or other
- Study start
- 1 Nov 2016 (actual)
- Primary completion
- 1 Jun 2018 (actual)
- Study completion
- 1 Sep 2018 (actual)
- First posted
- 23 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cognitive behavioral group therapy | Experimental | Other: cognitive behavioral group therapyA 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. |
| Wait-list control group | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cognitive behavioral group therapyA 8-session cognitive behavior group intervention tailor-made for Mainland Chinese university students in Hong Kong | Other | cognitive behavioral group therapy |
Primary outcome
General Health Questionnaire-12 (GHQ-12)
Time frame: pre-test at intake interview
12 item rating scale measuring psychological distress, scale score ranges from 0-12, with a higher score indicating a higher level of psychological distress
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.
12 item rating scale measuring psychological distress, scale score ranges from 0-12, with a higher score indicating a higher level of psychological distress
General Health Questionnaire-12 (GHQ-12)
Time frame: 3-month follow-up test three months after completing the intervention
12 item rating scale measuring psychological distress, scale score ranges from 0-12, with a higher score indicating a higher level of psychological distress
Acculturative Stress Scale for Chinese Students (ASSCS)
Time frame: pre-test at intake interview
35-item rating scale measuring acculturative stress, scale score ranges from 0-3, with a higher score indicating a higher level of acculturative stress
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.
35-item rating scale measuring acculturative stress, scale score ranges from 0-3, with a higher score indicating a higher level of acculturative stress
Acculturative Stress Scale for Chinese Students (ASSCS)
Time frame: 3-month follow-up test three months after completing the intervention
35-item rating scale measuring acculturative stress, scale score ranges from 0-3, with a higher score indicating a higher level of acculturative stress
15 secondary outcomes
Chinese Automatic Thoughts Questionnaire (CATQ)
Time frame: pre-test at intake interview
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.
Chinese Automatic Thoughts Questionnaire (CATQ)
Time frame: 3-month follow-up test three months after completing the intervention
Post-migration Growth Scale (PMGS)
Time frame: pre-test at intake interview
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.
Post-migration Growth Scale (PMGS)
Time frame: 3-month follow-up test three months after completing the intervention
Chinese Making Sense of Adversity Scale (CMSAS)
Time frame: pre-test at intake interview
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.
Chinese Making Sense of Adversity Scale (CMSAS)
Time frame: 3-month follow-up test three months after completing the intervention
Core Belief Inventory (CBI)
Time frame: pre-test at intake interview
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.
Core Belief Inventory (CBI)
Time frame: 3-month follow-up test three months after completing the intervention
Chinese Affect Scale (CAS)
Time frame: pre-test at intake interview
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.
Chinese Affect Scale (CAS)
Time frame: 3-month follow-up test three months after completing the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jiayan Pan, PhD principal investigator
Hong Kong Baptist University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cognitive behavioral group therapy in people with Cognitive Behavior Group Therapy, run by Hong Kong Baptist University at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
General Health Questionnaire-12 (GHQ-12) (time frame: pre-test at intake interview). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2020.