NCT04998890

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
458

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 6, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 10, 2021

Completed
Last Updated

August 10, 2021

Status Verified

August 1, 2021

Enrollment Period

3 years

First QC Date

August 6, 2021

Last Update Submit

August 6, 2021

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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

    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

    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

    3-month follow-up test: 3 months after completion of the intervention program

Secondary Outcomes (21)

  • Perceived Stress Scale

    baseline: before the intervention program starts

  • Perceived Stress Scale

    post-test: 1 month upon completion of the intervention program

  • Perceived Stress Scale

    3-month follow-up test: 3 months after completion of the intervention program

  • Beck Depression Inventory

    baseline: before the intervention program starts

  • Beck Depression Inventory

    post-test: 1 month upon completion of the intervention program

  • +16 more secondary outcomes

Study Arms (2)

Adventure-based cognitive behavioral intervention

EXPERIMENTAL

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.

Other: adventure-based cognitive behavioral intervention

Control group

NO INTERVENTION

No intervention of the adventure-based cognitive behavioral program

Interventions

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.

Adventure-based cognitive behavioral intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jiayan Pan

Hong Kong, Hong Kong

Location

Study Officials

  • Jiayan Pan, PhD

    Hong Kong Baptist University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 6, 2021

First Posted

August 10, 2021

Study Start

January 1, 2018

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

August 10, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations