- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07658066
Use of Football in Programs to Reduce Stigma Toward Mental Illness: A Comparison of the Effectiveness of Contact Interaction and Video-Based Approaches
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.
Aperçu de l'étude
Statut
Les conditions
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Ming-De Chen, Ph.D.
- Numéro de téléphone: 2657 +886-73121101
- E-mail: mdchen@kmu.edu.tw
Lieux d'étude
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Kaohsiung City, Taïwan
- Recrutement
- Kaohsiung Medical University Chung-Ho Memorial Hospital
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Contact:
- Ming-De Chen, Ph.D.
- Numéro de téléphone: 2657 +886-73121101
- E-mail: mdchen@kmu.edu.tw
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
Accepte les volontaires sains
La 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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Autre
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Comparateur actif: Contact-based education
Mental health education and listening to the stories of individuals with mental illness and interactive sharing.
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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.
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Expérimental: Video and contact-based education
Video viewing, mental health education and listening to the stories of individuals with mental illness and interactive sharing.
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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.
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Expérimental: 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.
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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.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Knowledge
Délai: pre-intervention, immediately post-intervention, and at one- and six-month follow-ups.
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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.
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pre-intervention, immediately post-intervention, and at one- and six-month follow-ups.
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Attitudes
Délai: pre-intervention, immediately post-intervention, and at one- and six-month follow-ups.
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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.
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pre-intervention, immediately post-intervention, and at one- and six-month follow-ups.
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Intent
Délai: pre-intervention, immediately post-intervention, and at one- and six-month follow-ups.
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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.
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pre-intervention, immediately post-intervention, and at one- and six-month follow-ups.
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Collaborateurs et enquêteurs
Les enquêteurs
- Chaise d'étude: Ming-De Chen, Ph.D., Kaohsiung Medical University Chung-Ho Memorial Hospital
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- KMUHIRB-F(I)-20250110
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Informations sur les médicaments et les dispositifs, documents d'étude
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