- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04998890
Improving Mental Health of Chinese University Students in Hong Kong: Adventure-based Cognitive Behavioural Intervention
August 6, 2021 updated by: Jiayan Pan, Hong Kong Baptist University
A Randomized Controlled Trial of Adventure-based Cognitive Behavioural Intervention for University Students in Hong Kong
This study delivered an adventure-based cognitive behavioral intervention program to a group of Hong Kong university students.
The program effectiveness was evaluated by a randomized controlled trial in reducing psychological distress and improving mental health of these students.
The 3-month maintenance effect was also tested.
Study Overview
Status
Completed
Intervention / Treatment
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.
Randomized controlled trial (RCT) 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 Type
Interventional
Enrollment (Actual)
458
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Hong Kong, Hong Kong
- Jiayan Pan
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: Adventure-based cognitive behavioral intervention
An adventure-based cognitive behavioral intervention program A 13-session adventure-based cognitive behavioral intervention program, including 6 lectures, 5 workshops and adventure training (one adventure day camp (2 sessions) and adventure activities in the beginning of each workshop).
One session per week, 3 hours for each session.
A variety of cognitive behavioral skills were taught in lectures and these skills were 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.
Skill briefing, case demonstration and debriefing, group sharing and discussion, in-class exercise and homework were used in the intervention program.
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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 entailed "Improving Mental Health for University Success" 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.
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NO_INTERVENTION: Control group
No intervention of the adventure-based cognitive behavioral program
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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General Health Questionnaire-12
Time Frame: baseline: before the intervention program starts
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12-item rating scale for psychological distress, scale score ranges from 0-12, with a higher score indicating a higher level of psychological distress
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baseline: before the intervention program starts
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General Health Questionnaire-12
Time Frame: post-test: 1 month upon completion of the intervention program
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12-item rating scale for 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: 1 month upon completion of the intervention program
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General Health Questionnaire-12
Time Frame: 3-month follow-up test: 3 months after completion of the intervention program
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12-item rating scale for 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: 3 months after completion of the intervention program
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Perceived Stress Scale
Time Frame: baseline: before the intervention program starts
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10-item rating scale for perceived stress, scale score ranges from 0-4, with a higher score indicating a higher level of perceived stress
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baseline: before the intervention program starts
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Perceived Stress Scale
Time Frame: post-test: 1 month upon completion of the intervention program
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10-item rating scale for perceived stress, scale score ranges from 0-4, with a higher score indicating a higher level of perceived stress
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post-test: 1 month upon completion of the intervention program
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Perceived Stress Scale
Time Frame: 3-month follow-up test: 3 months after completion of the intervention program
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10-item rating scale for perceived stress, scale score ranges from 0-4, with a higher score indicating a higher level of perceived stress
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3-month follow-up test: 3 months after completion of the intervention program
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Beck Anxiety Inventory
Time Frame: baseline: before the intervention program starts
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21-item rating scale for anxiety symptoms, scale score ranges from 0-63, with a higher score indicating a higher level of anxiety symptoms
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baseline: before the intervention program starts
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Beck Anxiety Inventory
Time Frame: post-test: 1 month upon completion of the intervention program
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21-item rating scale for anxiety symptoms, scale score ranges from 0-63, with a higher score indicating a higher level of anxiety symptoms
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post-test: 1 month upon completion of the intervention program
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Beck Anxiety Inventory
Time Frame: 3-month follow-up test: 3 months after completion of the intervention program
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21-item rating scale for anxiety symptoms, scale score ranges from 0-63, with a higher score indicating a higher level of anxiety symptoms
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3-month follow-up test: 3 months after completion of the intervention program
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Chinese Affect Scale
Time Frame: baseline: before the intervention program starts
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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
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baseline: before the intervention program starts
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Chinese Affect Scale
Time Frame: post-test: 1 month upon completion of the intervention program
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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
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post-test: 1 month upon completion of the intervention program
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Chinese Affect Scale
Time Frame: 3-month follow-up test: 3 months after completion of the intervention program
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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
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3-month follow-up test: 3 months after completion of the intervention program
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Beck Depression Inventory
Time Frame: baseline: before the intervention program starts
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21-item rating scale for depressive symptoms, scale score ranges from 0-63, with a higher score indicating a higher level of depressive symptoms
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baseline: before the intervention program starts
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Beck Depression Inventory
Time Frame: post-test: 1 month upon completion of the intervention program
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21-item rating scale for depressive symptoms, scale score ranges from 0-63, with a higher score indicating a higher level of depressive symptoms
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post-test: 1 month upon completion of the intervention program
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Beck Depression Inventory
Time Frame: 3-month follow-up test: 3 months after completion of the intervention program
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21-item rating scale for depressive symptoms, scale score ranges from 0-63, with a higher score indicating a higher level of depressive symptoms
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3-month follow-up test: 3 months after completion of the intervention program
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Automatic Thoughts Questionnaire
Time Frame: baseline: before the intervention program starts
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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.
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baseline: before the intervention program starts
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Automatic Thoughts Questionnaire
Time Frame: post-test: 1 month upon completion of the intervention program
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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.
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post-test: 1 month upon completion of the intervention program
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Automatic Thoughts Questionnaire
Time Frame: 3-month follow-up test: 3 months after completion of the intervention program
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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.
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3-month follow-up test: 3 months after completion of the intervention program
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Chinese Making Sense of Adversity Scale
Time Frame: baseline: before the intervention program starts
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12-item rating scale for measuring sense-making coping, score ranges from "1" = "totally disagree" to "6" = "totally agree", with a higher score indicating a higher level of sense-making coping.
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baseline: before the intervention program starts
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Chinese Making Sense of Adversity Scale
Time Frame: post-test: 1 month upon completion of the intervention program
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12-item rating scale for measuring sense-making coping, score ranges from "1" = "totally disagree" to "6" = "totally agree", with a higher score indicating a higher level of sense-making coping.
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post-test: 1 month upon completion of the intervention program
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Chinese Making Sense of Adversity Scale
Time Frame: 3-month follow-up test: 3 months after completion of the intervention program
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12-item rating scale for measuring sense-making coping, score ranges from "1" = "totally disagree" to "6" = "totally agree", with a higher score indicating a higher level of sense-making coping.
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3-month follow-up test: 3 months after completion of the intervention program
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Connor-Davidson Resilience Scale
Time Frame: baseline: before the intervention program starts
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25-item rating scale for measuring resilience, score ranges from "1" = "not true at all" to "5" = "true all the time".
All the Item scores are summed up as a total score, with a higher score indicating greater resilience.
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baseline: before the intervention program starts
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Connor-Davidson Resilience Scale
Time Frame: post-test: 1 month upon completion of the intervention program
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25-item rating scale for measuring resilience, score ranges from "1" = "not true at all" to "5" = "true all the time".
All the Item scores are summed up as a total score, with a higher score indicating greater resilience.
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post-test: 1 month upon completion of the intervention program
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Connor-Davidson Resilience Scale
Time Frame: 3-month follow-up test: 3 months after completion of the intervention program
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25-item rating scale for measuring resilience, score ranges from "1" = "not true at all" to "5" = "true all the time".
All the Item scores are summed up as a total score, with a higher score indicating greater resilience.
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3-month follow-up test: 3 months after completion of the intervention program
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
January 1, 2018
Primary Completion (ACTUAL)
December 31, 2020
Study Completion (ACTUAL)
December 31, 2020
Study Registration Dates
First Submitted
August 6, 2021
First Submitted That Met QC Criteria
August 6, 2021
First Posted (ACTUAL)
August 10, 2021
Study Record Updates
Last Update Posted (ACTUAL)
August 10, 2021
Last Update Submitted That Met QC Criteria
August 6, 2021
Last Verified
August 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- HKBU 22603717
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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