Cognitive Behavioral Intervention and Adventure Training for Chinese University Students in Hong Kong

September 17, 2020 updated by: Jiayan Pan, Hong Kong Baptist University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
193

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Adventure-based cognitive behavioral intervention
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.
Other: adventure-based cognitive behavioral intervention
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
baseline: before the intervention program starts
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
post-test: 1 month upon completion of the intervention program
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
3-month follow-up test: 3 months after completion of the intervention program

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Perceived Stress Scale
Time Frame: baseline: before the intervention program starts
10-item rating scale for perceived stress, scale score ranges from 0-4, with a higher score indicating a higher level of perceived stress
baseline: before the intervention program starts
Perceived Stress Scale
Time Frame: post-test: 1 month upon completion of the intervention program
10-item rating scale for perceived stress, scale score ranges from 0-4, with a higher score indicating a higher level of perceived stress
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
10-item rating scale for perceived stress, scale score ranges from 0-4, with a higher score indicating a higher level of perceived stress
3-month follow-up test: 3 months after completion of the intervention program
Beck Depression Inventory
Time Frame: baseline: before the intervention program starts
21-item rating scale for depressive symptoms, scale score ranges from 0-63, with a higher score indicating a higher level of depressive symptions
baseline: before the intervention program starts
Beck Depression Inventory
Time Frame: post-test: 1 month upon completion of the intervention program
21-item rating scale for depressive symptoms, scale score ranges from 0-63, with a higher score indicating a higher level of depressive symptions
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
21-item rating scale for depressive symptoms, scale score ranges from 0-63, with a higher score indicating a higher level of depressive symptions
3-month follow-up test: 3 months after completion of the intervention program
Beck Anxiety Inventory
Time Frame: baseline: before the intervention program starts
21-item rating scale for anxiety symptoms, scale score ranges from 0-63, with a higher score indicating a higher level of anxiety symptoms
baseline: before the intervention program starts
Beck Anxiety Inventory
Time Frame: post-test: 1 month upon completion of the intervention program
21-item rating scale for anxiety symptoms, scale score ranges from 0-63, with a higher score indicating a higher level of anxiety symptoms
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
21-item rating scale for anxiety symptoms, scale score ranges from 0-63, with a higher score indicating a higher level of anxiety symptoms
3-month follow-up test: 3 months after completion of the intervention program
Automatic Thoughts Questionnaire
Time Frame: baseline: before the intervention program starts
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
baseline: before the intervention program starts
Automatic Thoughts Questionnaire
Time Frame: post-test: 1 month upon completion of the intervention program
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
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
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
3-month follow-up test: 3 months after completion of the intervention program
Chinese Affect Scale
Time Frame: baseline: before the intervention program starts
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
baseline: before the intervention program starts
Chinese Affect Scale
Time Frame: post-test: 1 month upon completion of the intervention program
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
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
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
3-month follow-up test: 3 months after completion of the intervention program

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hong Kong Baptist University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 9, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 17, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 23, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 23, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 17, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • FRG2/14-15/090

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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