NCT07658066

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
210

participants targeted

Target at P75+ for not_applicable

Timeline
15mo left

Started Mar 2026

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress25%
Mar 2026Oct 2027

Study Start

First participant enrolled

March 2, 2026

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 27, 2026

Completed
22 days until next milestone

First Posted

Study publicly available on registry

June 18, 2026

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2027

Last Updated

June 18, 2026

Status Verified

July 1, 2025

Enrollment Period

1.4 years

First QC Date

May 27, 2026

Last Update Submit

June 16, 2026

Conditions

Keywords

mental illnessPsychiatric disordersphysical activitystigmaexercise

Outcome Measures

Primary Outcomes (3)

  • Knowledge

    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

    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

    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.

Study Arms (3)

Contact-based education

ACTIVE COMPARATOR

Mental health education and listening to the stories of individuals with mental illness and interactive sharing.

Behavioral: Contact-Based Education

Video and contact-based education

EXPERIMENTAL

Video viewing, mental health education and listening to the stories of individuals with mental illness and interactive sharing.

Behavioral: Video + Contact-Based Education

Football and contact-based education

EXPERIMENTAL

Football interaction, video viewing, mental health education and listening to the stories of individuals with mental illness and interactive sharing.

Behavioral: Football + Contact-Based Education

Interventions

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.

Contact-based education

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.

Video and contact-based education

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.

Football and contact-based education

Eligibility Criteria

Age18 Years - 30 Years
Sexall(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan

RECRUITING

MeSH Terms

Conditions

Mental DisordersMotor ActivitySocial Stigma

Interventions

Videotape Recording

Condition Hierarchy (Ancestors)

BehaviorSocial Behavior

Intervention Hierarchy (Ancestors)

Tape RecordingAudiovisual AidsEducational TechnologyTechnologyTechnology, Industry, and AgricultureTelevision

Study Officials

  • Ming-De Chen, Ph.D.

    Kaohsiung Medical University Chung-Ho Memorial Hospital

    STUDY CHAIR

Central Study Contacts

Ming-De Chen, Ph.D.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Contact-Based Education Group (CE Group): Psychiatric health education + listening to stories shared by individuals with mental illness \& interactive communication. Video + Contact-Based Education Group (V+CE Group): Video viewing + psychiatric health education + listening to stories shared by individuals with mental illness \& interactive communication. Football + Contact-Based Education Group (F+CE Group): Football interaction + video viewing + psychiatric health education + listening to stories shared by individuals with mental illness \& interactive communication.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 27, 2026

First Posted

June 18, 2026

Study Start

March 2, 2026

Primary Completion (Estimated)

July 31, 2027

Study Completion (Estimated)

October 31, 2027

Last Updated

June 18, 2026

Record last verified: 2025-07

Locations