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Impact of EDEN College Courses on the Quality of Life of Voice-Hearers

RecruitingNAAges 18 Years - 65 YearsAllHôpital le Vinatier
NCT07694193 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The goal of this Mixed study, combining a randomized controlled trial and an Interpretative Phenomenological Analysis (IPA-qualitative study) is to evaluate the effects of the EDEN College courses on quality of life, compared with usual group interventions provided in mental health services in adult people who hear voices (or present Auditory Verbal Hallucinations (AVH). Volunteers must be between 18 and 65 years old and hearing voices for 6 months or more; Volunteers must receive care from a psychiatrist or a psychiatric team. The main questions it aims to answer are: Does EDEN College improve quality of life in a better way than usual group interventions (RCT part)? What processes are linking changes in quality of life and changes in the relationship between voice-hearers and their voices (IPA part)?. EDEN college is a ten days representing about 50 hours course. Usual group interven

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📋 Eligibility rules (as published)
Inclusion Criteria: * Have received written and oral information about the study and have provided written informed consent prior to participation. * Be aged between 18 and 65 years. * Be affiliated with, or entitled to, the French national health insurance system. * Be under the care of a psychiatrist or a psychiatric care team. * Have experienced auditory verbal hallucinations (AVH) for at least 6 months. * Have a PSYRATS-AH total score ≥25 at inclusion day. * Have sufficient proficiency in spoken and written French to understand the study procedures and complete the self-report questionnaires. * Participants subject to french legal protective measures (guardianship or curatorshipor) may be included in the study. Exclusion Criteria: * Auditory verbal hallucinations occurring exclusively in the context of substance use. * Auditory verbal hallucinations attributable to an organic neurological or medical condition. * Severe cognitive impairment preventing participation in half-day group sessions. * Behavioral disturbances incompatible with participation in half-day group sessions * Refusal to participate in the study
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What it tests

  • EDEN College
  • TAU
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Where

8 sites
CH le Vinatier
Bron, France
CHI EPSM Oise
Clermont, France
EPSM Vendée Georges Mazurelle
La Roche-sur-Yon, France
Assistance Publique des Hôpitaux de Marseille
Marseille, France
CH Sainte-Marie Privas
Privas, France
EPSM Lille Métropole
Ronchin, France
CH Laborit- Poitiers
Saint-Benoît, France
EPSM-Réunion
Sainte-Marie-de-Ré, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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