- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07658066
Use of Football in Programs to Reduce Stigma Toward Mental Illness: A Comparison of the Effectiveness of Contact Interaction and Video-Based Approaches
June 16, 2026 updated by: Kaohsiung Medical University Chung-Ho Memorial Hospital
The goal of this clinical trial is to evaluate the effectiveness of football-based interventions in reducing stigma toward mental illness among university students. The main questions it aims to answer are:
- Does participating in a contact-based education program involving football help reduce stigma toward mental illness among university students?
- What are the effects of three different intervention methods on reducing stigma toward mental illness?
Researchers will compare the traditional contact-based education program with the other two interventions to evaluate their differences in effectiveness.
Participants will:
- Be randomly assigned to one of the three intervention groups.
- Complete online assessments to measure attitudes toward mental illness before and after the intervention.
- Participate in qualitative interviews to provide in-depth feedback on their experiences and perceptions.
Study Overview
Status
Recruiting
Conditions
Study Type
Interventional
Enrollment (Estimated)
210
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 Contact
- Name: Ming-De Chen, Ph.D.
- Phone Number: 2657 +886-73121101
- Email: mdchen@kmu.edu.tw
Study Locations
-
-
-
Kaohsiung City, Taiwan
- Recruiting
- Kaohsiung Medical University Chung-Ho Memorial Hospital
-
Contact:
- Ming-De Chen, Ph.D.
- Phone Number: 2657 +886-73121101
- Email: mdchen@kmu.edu.tw
-
-
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
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- University students currently enrolled, aged between 18 and 30 years.
- In good physical condition with no contraindications to exercise (i.e., not diagnosed by a physician or advised to avoid physical activity, and with no items selected on the PAR-Q+ [Physical Activity Readiness Questionnaire for Everyone]).
- Able to follow the study procedures and provide signed informed consent.
Exclusion Criteria:
- Individuals who are unable to safely participate in football activities due to intellectual disability, pregnancy, head injury, cardiovascular disease, or other neuromuscular or musculoskeletal disorders.
- Individuals who are unable to effectively participate in the intervention program or complete assessments due to significant emotional disturbances, personality disorders, substance (alcohol) abuse, or severe mental illness.
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: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Contact-based education
Mental health education and listening to the stories of individuals with mental illness and interactive sharing.
|
A one-time session lasting approximately 1.5 to 2.5 hours, consisting of psychiatric education, storytelling by individuals with mental illness, and interactive discussion.
|
|
Experimental: Video and contact-based education
Video viewing, mental health education and listening to the stories of individuals with mental illness and interactive sharing.
|
A one-time session lasting approximately 1.5 to 2.5 hours, including football video viewing, psychiatric education, storytelling by individuals with mental illness, and interactive discussion.
|
|
Experimental: Football and contact-based education
Football interaction, video viewing, mental health education and listening to the stories of individuals with mental illness and interactive sharing.
|
A one-time session lasting approximately 1.5 to 2.5 hours.
The session includes football interactive activities, football video viewing, psychiatric education, storytelling by individuals with mental illness, and interactive discussion.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Knowledge
Time Frame: pre-intervention, immediately post-intervention, and at one- and six-month follow-ups.
|
The Mental Health Knowledge Schedule (MAKS), consisting of 12 items, will be used to assess the public's knowledge related to mental health stigma.
The questionnaire is divided into two parts: knowledge about mental illness and agreement with statements regarding mental health conditions.
Responses are rated on a five-point Likert scale (5 = Strongly agree, 4 = Slightly agree, 3 = Neither agree nor disagree / Don't know, 2 = Slightly disagree, 1 = Strongly disagree).
The total score ranges from 12 to 60, with higher scores indicating a greater level of knowledge about mental health.
Items 7 to 12 are designed to assess recognition and familiarity with various mental health conditions, helping to contextualize responses to the earlier items.
|
pre-intervention, immediately post-intervention, and at one- and six-month follow-ups.
|
|
Attitudes
Time Frame: pre-intervention, immediately post-intervention, and at one- and six-month follow-ups.
|
The Questionnaire on Stigmatizing Attitudes Towards Mental Illness will be used in this study.
After undergoing cultural adaptation and psychometric validation, the final Chinese version consists of 16 items across four dimensions: Negative Stereotypes (5 items), Social Distance (3 items), Negative Evaluation (5 items), and Self-Stigma (3 items).
Responses are measured on a six-point Likert scale (6 = Strongly agree, 5 = Agree, 4 = Slightly agree, 3 = Slightly disagree, 2 = Disagree, 1 = Strongly disagree).
The total score ranges from 16 to 96, with higher scores indicating greater levels of negative stigmatizing attitudes toward mental illness.
|
pre-intervention, immediately post-intervention, and at one- and six-month follow-ups.
|
|
Intent
Time Frame: pre-intervention, immediately post-intervention, and at one- and six-month follow-ups.
|
The Social Distance Scale will be adopted to assess participants' level of social distance toward individuals with mental illness, serving as an indicator of intent to act.
The scale consists of 8 items, which evaluate willingness to engage with people with mental illness in various situations, such as living in the same community or building, sharing a residence, dining together, forming friendships, working together, employing, or helping them.
Responses are rated on a six-point Likert scale (6 = Strongly agree, 5 = Agree, 4 = Slightly agree, 3 = Slightly disagree, 2 = Disagree, 1 = Strongly disagree).
Higher scores indicate a greater willingness to interact with individuals with mental illness.
This scale is considered to be particularly sensitive to measuring implicit bias.
|
pre-intervention, immediately post-intervention, and at one- and six-month follow-ups.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Ming-De Chen, Ph.D., Kaohsiung Medical University Chung-Ho Memorial Hospital
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)
March 2, 2026
Primary Completion (Estimated)
July 31, 2027
Study Completion (Estimated)
October 31, 2027
Study Registration Dates
First Submitted
May 27, 2026
First Submitted That Met QC Criteria
June 16, 2026
First Posted (Actual)
June 18, 2026
Study Record Updates
Last Update Posted (Actual)
June 18, 2026
Last Update Submitted That Met QC Criteria
June 16, 2026
Last Verified
July 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KMUHIRB-F(I)-20250110
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
The data will be used to publish academic papers, it has not been determined whether it will be shared with other researchers.
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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