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Structured group course aims to boost well-being in voice-hearers

NCT ID NCT07694193

Symptom relief Sponsor: Hôpital le Vinatier Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 09, 2026 · Last updated Jul 10, 2026 · Updated 1 time

Summary

This study tests whether a 10-day group course called EDEN College can improve quality of life for adults aged 18–65 who hear voices (auditory hallucinations) for at least 6 months. Participants are randomly assigned to either EDEN College or standard group therapy. The main goal is to see if EDEN College leads to better mental well-being, self-esteem, and less stigma, with effects tracked for one year after the course ends.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
EDEN College (structured group course with experiential learning, peer exchange, and skills development)
What this could lead to
If effective, EDEN College could offer a new, structured group approach to improve mental well-being and reduce distress for people who hear voices.
What could go wrong
This is a relatively small trial (240 participants) comparing a new course to standard care, so results may not be generalizable. The intervention is intensive (50 hours over 8 months), and benefits may not last beyond one year.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 240 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Sep 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 (tutelle or curatelle) 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. * Behavioural disturbances incompatible with participation in half-day group sessions * Refusal to participate in the study

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Conditions

The condition(s) this trial relates to.

Hallucinations Psychological Well-Being

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hallucinations, auditory

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    8 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Assistance Publique des Hôpitaux de Marseille

    Marseille, 13009, France

  • CH Laborit- Poitiers

    Saint-Benoît, 86280, France

  • CH Sainte-Marie Privas

    Privas, 07000, France

  • CH le Vinatier

    Bron, 69678, France

  • CHI EPSM Oise

    Clermont, 60607, France

  • EPSM Lille Métropole

    Ronchin, 59370, France

  • EPSM Vendée Georges Mazurelle

    La Roche-sur-Yon, 85026, France

  • EPSM-Réunion

    Sainte-Marie-de-Ré, 97438, France

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