See if EDEN College can improve quality of life for people who hear voices

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This mixed-methods study combines a randomized controlled trial with a qualitative interpretative phenomenological analysis to explore how EDEN College affects quality of life and the relationship between participants and their voices. It will enroll adults aged 18–65 who hear voices for at least 6 months and are under psychiatric care, and compare the EDEN course to care-as-usual group interventions. The EDEN intervention is a ten-day, ~50-hour program, while the control arm receives standard group-therapy options. The study spans up to 44 months, including 24 months of recruitment and about 21 months of follow-up, across eight French centers. Primary outcomes focus on quality of life, with qualitative insights examining processes linking QoL changes to voice-relations dynamics.

Why it matters

Who can join: the full rules

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

Where it's running

• CH le Vinatier
  Bron, France Recruiting
• CHI EPSM Oise
  Clermont, France Not yet recruiting
• EPSM Vendée Georges Mazurelle
  La Roche-sur-Yon, France Not yet recruiting
• Assistance Publique des Hôpitaux de Marseille
  Marseille, France Not yet recruiting
• CH Sainte-Marie Privas
  Privas, France Not yet recruiting
• EPSM Lille Métropole
  Ronchin, France Not yet recruiting

Study contacts

• Principal investigator: Baptiste GAUDELUS — CH le Vinatier
• Study coordinator: Baptiste GAUDELUS
• Email: baptiste.gaudelus@ch-le-vinatier.fr
• Phone: +33(0)674497851

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• fMRI-based brain training to help reduce drug-resistant auditory hallucinations

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.