Cognitive Behavioral TherapyNCT04560348
Cognitive Behavioral Intervention and Adventure Training for Chinese University Students in Hong Kong
A study testing adventure-based cognitive behavioral intervention in people with Cognitive Behavioral Therapy, run by Hong Kong Baptist University.
Trial summary
This study developed an adventure-based cognitive behavioral intervention program for Hong Kong university student. The program effectiveness was evaluated in reducing psychological distress and improving mental health of university students. The 3-month maintenance effect was also tested. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cognitive Behavioral Therapy
- What is being tested?
- adventure-based cognitive behavioral intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 193 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2015to 31 Aug 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
- be of Chinese nationality
- be studying in undergraduate programs at Hong Kong Baptist University (HKBU), as the aCBI program will be provided in the form of a general education course at this university
- have GHQ-12 scores of 2-10 (0-0-1-1) (i.e., mild to moderate levels of psychological distress)
- be willing to complete the entire process of the project.
Who cannot join
- have GHQ-12 scores of 0-1 (i.e., a low level of psychological distress) or 11-12 (i.e., a high level of psychological distress)
- have one or more psychosis
- have experienced severe depression with suicidal attempts/ideation in the past 3 months, as diagnosed by a psychiatrist or a clinical psychologist.
About this study
Official title: Improving Mental Health by Cognitive Behavioral Intervention and Adventure Training for Chinese University Students in Hong Kong
This study developed an adventure-based cognitive behavioral intervention program for Hong Kong university student. The program effectiveness was evaluated in reducing psychological distress and improving mental health of university students. The 3-month maintenance effect was also tested.
Read the detailed description
University students are vulnerable to mental health problems due to the various challenges they have to face in university life. However, few studies have been conducted to evaluate the effectiveness of university counseling programs in Hong Kong. This project aims at developing and systematically evaluating a culturally adapted and adventure-based cognitive behavioral intervention (aCBI) program to decrease psychological distress and improve various mental health outcomes for Chinese university students in Hong Kong. The aCBI program was delivered in a form of general education course in a university setting. Single group Pre-posttest design was adopted.The program was evaluated its effectiveness in reducing psychological distress, perceived stress, depressive and anxiety symptoms, negative thoughts and negative emotions and increasing positive thoughts and positive emotions.
- Conditions
- Cognitive Behavioral Therapy
- Being tested
- adventure-based cognitive behavioral intervention
- Keywords
- Chinese university student, mental health, adventure training
- 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.
adventure-based cognitive behavioral interventionOther
The adventure-based cognitive behavioral intervention is a combination of cognitive behavioral therapy and adventure training. The intervention program is delivered in a 39-hour general education course in a public university in Hong Kong. The program includes 6 lectures, 5 workshops, 5 adventure games and an adventure day camp. Students are divided into two groups in workshop to practise CBT skills to deal with their own issues.
| Study group | Role | What they receive |
|---|---|---|
| Adventure-based cognitive behavioral intervention | Experimental | An adventure-based cognitive behavioral intervention program An 13-session adventure-based cognitive behavioral intervention program, including 6 lectures, 5 workshops and adventure games, and one adventure day camp (2 sessions). One session per week, 3 hours for each session. A variety of cognitive behavioral skills are taught in lectures and these skills are practiced in two groups (with appropriately 20 students in each group) in workshop to help students to apply these skills to cope with their own daily life stress. The adventure training includes a day adventure camp and five 40-minute adventure games in the beginning of each workshop. Skill briefing, case demonstration and debriefing, group sharing and discussion, in-class exercise and homework are used in the intervention program. Receives: Other: adventure-based cognitive behavioral intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
General Health Questionnaire-12
12-item rating scale for psychological distress, scale score ranges from 0-12, with a higher score indicating a higher level of psychological distress
Measured: baseline: before the intervention program starts
General Health Questionnaire-12
12-item rating scale for psychological distress, scale score ranges from 0-12, with a higher score indicating a higher level of psychological distress
Measured: post-test: 1 month upon completion of the intervention program
General Health Questionnaire-12
12-item rating scale for 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: 3 months after completion of the intervention program
Secondary outcomes (15)
Perceived Stress Scale
10-item rating scale for perceived stress, scale score ranges from 0-4, with a higher score indicating a higher level of perceived stress
Measured: baseline: before the intervention program starts
Perceived Stress Scale
10-item rating scale for perceived stress, scale score ranges from 0-4, with a higher score indicating a higher level of perceived stress
Measured: post-test: 1 month upon completion of the intervention program
Perceived Stress Scale
10-item rating scale for perceived stress, scale score ranges from 0-4, with a higher score indicating a higher level of perceived stress
Measured: 3-month follow-up test: 3 months after completion of the intervention program
Beck Depression Inventory
21-item rating scale for depressive symptoms, scale score ranges from 0-63, with a higher score indicating a higher level of depressive symptions
Measured: baseline: before the intervention program starts
Beck Depression Inventory
21-item rating scale for depressive symptoms, scale score ranges from 0-63, with a higher score indicating a higher level of depressive symptions
Measured: post-test: 1 month upon completion of the intervention program
Beck Depression Inventory
21-item rating scale for depressive symptoms, scale score ranges from 0-63, with a higher score indicating a higher level of depressive symptions
Measured: 3-month follow-up test: 3 months after completion of the intervention program
Beck Anxiety Inventory
21-item rating scale for anxiety symptoms, scale score ranges from 0-63, with a higher score indicating a higher level of anxiety symptoms
Measured: baseline: before the intervention program starts
Beck Anxiety Inventory
21-item rating scale for anxiety symptoms, scale score ranges from 0-63, with a higher score indicating a higher level of anxiety symptoms
Measured: post-test: 1 month upon completion of the intervention program
Beck Anxiety Inventory
21-item rating scale for anxiety symptoms, scale score ranges from 0-63, with a higher score indicating a higher level of anxiety symptoms
Measured: 3-month follow-up test: 3 months after completion of the intervention program
Automatic Thoughts Questionnaire
14-item rating scale for positive and negative automatic thoughts, score ranges from 1-5 for the positive thought subscale and negative thought subscale, with a higher score indicating a higher level of positive/negative thought
Measured: baseline: before the intervention program starts
Automatic Thoughts Questionnaire
14-item rating scale for positive and negative automatic thoughts, score ranges from 1-5 for the positive thought subscale and negative thought subscale, with a higher score indicating a higher level of positive/negative thought
Measured: post-test: 1 month upon completion of the intervention program
Automatic Thoughts Questionnaire
14-item rating scale for positive and negative automatic thoughts, score ranges from 1-5 for the positive thought subscale and negative thought subscale, with a higher score indicating a higher level of positive/negative thought
Measured: 3-month follow-up test: 3 months after completion of the intervention program
Chinese Affect Scale
20-item rating scale for positive and negative emotions, score ranges from 1-6 for positive emotion subscale and negative emotion subscale, with a higher score indicating a higher level of positive/negative emotion
Measured: baseline: before the intervention program starts
Chinese Affect Scale
20-item rating scale for positive and negative emotions, score ranges from 1-6 for positive emotion subscale and negative emotion subscale, with a higher score indicating a higher level of positive/negative emotion
Measured: post-test: 1 month upon completion of the intervention program
Chinese Affect Scale
20-item rating scale for positive and negative emotions, score ranges from 1-6 for positive emotion subscale and negative emotion subscale, with a higher score indicating a higher level of positive/negative emotion
Measured: 3-month follow-up test: 3 months after completion of the intervention program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2020
- Study start1 Sep 2015
- Primary completion31 Aug 2018
- Study completion31 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive Behavioral 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
- Not applicable
- Intervention model
- Single group
- Model description
- Single group pre-posttest design
- Masking
- None (open label)
- Enrolment
- 193 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
- NCT04560348
- Sponsor's protocol ID
- FRG2/14-15/090
- Status last verified
- Sep 2020
- First submitted
- 9 Sep 2020
- Last updated
- 23 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 23 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Mental Health by Cognitive Behavioral Intervention and Adventure Training for Chinese University Students in Hong Kong
- ClinicalTrials.gov ID
- NCT04560348
- Acronym / sponsor ID
- FRG2/14-15/090
- Conditions
- Cognitive Behavioral Therapy
- Keywords
- Chinese university student, mental health, adventure training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 193 participants (actual)
- Lead sponsor
- Hong Kong Baptist UniversityUniversity, hospital or other
- Study start
- 1 Sep 2015 (actual)
- Primary completion
- 31 Aug 2018 (actual)
- Study completion
- 31 Aug 2018 (actual)
- First posted
- 23 Sep 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 an adventure-based cognitive behavioral intervention program for Hong Kong university student. The program effectiveness was evaluated in reducing psychological distress and improving mental health of university students. The 3-month maintenance effect was also tested.
Detailed description
University students are vulnerable to mental health problems due to the various challenges they have to face in university life. However, few studies have been conducted to evaluate the effectiveness of university counseling programs in Hong Kong. This project aims at developing and systematically evaluating a culturally adapted and adventure-based cognitive behavioral intervention (aCBI) program to decrease psychological distress and improve various mental health outcomes for Chinese university students in Hong Kong. The aCBI program was delivered in a form of general education course in a university setting. Single group Pre-posttest design was adopted.The program was evaluated its effectiveness in reducing psychological distress, perceived stress, depressive and anxiety symptoms, negative thoughts and negative emotions and increasing positive thoughts and positive emotions.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single group pre-posttest design
| Arm | Type | Receives |
|---|---|---|
| Adventure-based cognitive behavioral intervention | Experimental | Other: adventure-based cognitive behavioral interventionAn adventure-based cognitive behavioral intervention program An 13-session adventure-based cognitive behavioral intervention program, including 6 lectures, 5 workshops and adventure games, and one adventure day camp (2 sessions). One session per week, 3 hours for each session. A variety of cognitive behavioral skills are taught in lectures and these skills are practiced in two groups (with appropriately 20 students in each group) in workshop to help students to apply these skills to cope with their own daily life stress. The adventure training includes a day adventure camp and five 40-minute adventure games in the beginning of each workshop. Skill briefing, case demonstration and debriefing, group sharing and discussion, in-class exercise and homework are used in the intervention program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- be of Chinese nationality
- be studying in undergraduate programs at Hong Kong Baptist University (HKBU), as the aCBI program will be provided in the form of a general education course at this university
- have GHQ-12 scores of 2-10 (0-0-1-1) (i.e., mild to moderate levels of psychological distress)
- be willing to complete the entire process of the project.
Key exclusion criteria (3 listed)
- have GHQ-12 scores of 0-1 (i.e., a low level of psychological distress) or 11-12 (i.e., a high level of psychological distress)
- have one or more psychosis
- have experienced severe depression with suicidal attempts/ideation in the past 3 months, as diagnosed by a psychiatrist or a clinical psychologist.
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 |
|---|---|---|
| adventure-based cognitive behavioral interventionThe adventure-based cognitive behavioral intervention is a combination of cognitive behavioral therapy and adventure training. The intervention program is delivered in a 39-hour general education course in a public university in Hong Kong. The program includes 6 lectures, 5 workshops, 5 adventure games and an adventure day camp. Students are divided into two groups in workshop to practise CBT skills to deal with their own issues. | Other | Adventure-based cognitive behavioral intervention |
Primary outcome
General Health Questionnaire-12
Time frame: baseline: before the intervention program starts
12-item rating scale for psychological distress, scale score ranges from 0-12, with a higher score indicating a higher level of psychological distress
General Health Questionnaire-12
Time frame: post-test: 1 month upon completion of the intervention program
12-item rating scale for psychological distress, scale score ranges from 0-12, with a higher score indicating a higher level of psychological distress
General Health Questionnaire-12
Time frame: 3-month follow-up test: 3 months after completion of the intervention program
12-item rating scale for psychological distress, scale score ranges from 0-12, with a higher score indicating a higher level of psychological distress
15 secondary outcomes
Perceived Stress Scale
Time frame: baseline: before the intervention program starts
Perceived Stress Scale
Time frame: post-test: 1 month upon completion of the intervention program
Perceived Stress Scale
Time frame: 3-month follow-up test: 3 months after completion of the intervention program
Beck Depression Inventory
Time frame: baseline: before the intervention program starts
Beck Depression Inventory
Time frame: post-test: 1 month upon completion of the intervention program
Beck Depression Inventory
Time frame: 3-month follow-up test: 3 months after completion of the intervention program
Beck Anxiety Inventory
Time frame: baseline: before the intervention program starts
Beck Anxiety Inventory
Time frame: post-test: 1 month upon completion of the intervention program
Beck Anxiety Inventory
Time frame: 3-month follow-up test: 3 months after completion of the intervention program
Automatic Thoughts Questionnaire
Time frame: baseline: before the intervention program starts
Automatic Thoughts Questionnaire
Time frame: post-test: 1 month upon completion of the intervention program
Automatic Thoughts Questionnaire
Time frame: 3-month follow-up test: 3 months after completion of the intervention program
Chinese Affect Scale
Time frame: baseline: before the intervention program starts
Chinese Affect Scale
Time frame: post-test: 1 month upon completion of the intervention program
Chinese Affect Scale
Time frame: 3-month follow-up test: 3 months after completion of the intervention program
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 23 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
Questions about this trial
What is this clinical trial studying?
A study testing adventure-based cognitive behavioral intervention in people with Cognitive Behavioral Therapy, run by Hong Kong Baptist University.
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 4 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 23 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
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 (time frame: baseline: before the intervention program starts). The study lists 3 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 23 Sep 2020.