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

NCT07694193 | Not Yet Recruiting

• 1 other identifier: PHRIPEDENRCT
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 8

Brief Summary

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). Volonteers must be between 18 and 65 years old and hear perturbating voices for 6 months or more; they 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 interventions (named CAU for "Care As Usual") will combined an individualized program mixing Social skills training, cognitive remediation, psychoeducation, mediation therapy and social therapy and representing between 40 and 60 hours of training. Our primary hypothesis is that EDEN College Courses will provide a significant better improvement of Quality of life than usual groups provided in post intervention. the voice hearers Quality of life will be assessed through the Mental Well Being (main criteria is Warwick Edimburg Mental Well Being Scale- WEMWBS), the Self Estime and the internalized Stigma of Mental Illness processes (secondary criterias). Our secondary hypothesis are:

• EDEN College course will decrease voice hearing / AVH phenomena measured with PSYRATS-AH and AHRS /HCS scales in post intervention
• EDEN College course will improve the quality of relationship between the voice hearer and his voices, measured by BAVQ-R and VAAS 9 scales
• EDEN College effects on quality of life and on AVH phenomena will be stables one year after the end of interventions.
• Improvement on quality of life and improvement on quality of relationship between the voice hearers and his voices are linked (IPA part of the study) Participants will be asked to:
• Participate to an individual meeting with an investigator be explained the goals of this study and ask all the questions they have on it before giving their consent to participate.
• Participate to 7 individual meetings (around 1 hour each) with members of research team (2 before interventions; 1 during the intervention; 2 after the intervention and 2 one year after the end of intervention) to answer researchers questions on their voices, needed to score the PSYRATS-AH and AHRS/HCS scales, and quote 5 questionnaires on mental well being, self esteem, internalized stigma of mental Illness and relationship with voices.
• Participate to EDEN College or CAU sessions (about 50 hours of training ) dispended in a 8 mounth period
• Answer a mounthly phone call (about 10 minutes) with a member of the research team regarding their participation on the study and any mental healthcare or support services received outside the study
• A subset of participants may be invited to take part in a one-hour interview after completing the groups or EDEN training programmes. The purpose of this interview is to explore participants' perspectives and experiences of the groups or training programmes, and their perceptions of any changes in their quality of life (qualitative part of the study).

Conditions

Hallucinations, Auditory

Keywords

Auditory Verbal Hallucinations (AVH); Voice Hearing; Mental Well-Being

Outcome Measures

Primary Outcomes (1)

• Demonstrate that participation in "EDEN College" training programs improves participants' mental well-being following the sessions.

  the result of the scale of Warwick Edimburg Mental Well Being Scale (WEMWBS) total score (14 items self administred questionnaire). The minimum score is 14, which corresponds to the lowest possible level of positive mental well-being. The maximum score is 70, which corresponds to the highest possible level of positive mental well-being.

  1, 9, 12, 21 months after enrollment

Secondary Outcomes (1)

• Psychotic SYmptoms RATing Scale- Auditory Hallucinations: PSYRATS-AH

  0, 1, 9, 12, 21 months after enrollment

Study Arms (2)

EDEN College Intervention

EXPERIMENTAL

The EDEN College intervention is delivered in a group format and consists of two modules of five full-day sessions each, for a total of 10 training days. Sessions are held every two weeks, with a 4- to 6-week break between the two modules. The programme therefore extends over approximately 9 months and provides 50 hours of group-based intervention. Each training day follows a standardized structure designed to combine psychoeducation, experiential learning, peer exchange and skills development. Sessions include opportunities for participants to share their current experiences of hearing voices, thematic workshops, psychophysical exercises, and group discussions.

Behavioral: EDEN College

TAU intervention

ACTIVE COMPARATOR

TAU programme will consist of an individualized combination of one or more of group interventions routinely delivered within participating mental health services. Participants allocated to this arm will receive 40 to 60 hours of group-based care over a 8-month period.

Behavioral: TAU

Interventions

EDEN College BEHAVIORAL

EDEN College is a group format and consists of two modules of five full-day sessions each, for a total of 10 training days and 50h of active intervention. Each training day follows a standardized structure designed to combine experiential learning, peer exchange and skills development. Sessions include opportunities to share participants current experiences of hearing voices, thematic workshops, psychophysical exercises, and group discussions. First module, "Explore Voices," focuses on developing participants' understanding of voice-hearing experiences and prepare them to dialogue with their voices. Second module, "Dialogue with Voices," focuses on modifying the relationship between participants and their voices through Open Dialogue / talking with voices inspired exercises and creative workshops.

EDEN College Intervention

TAU BEHAVIORAL

Individualized combination of one or more of group interventions routinely delivered within participating mental health services. Types of groups offered : Psychoeducation groups: structured educational interventions designed to enhance participants' knowledge and self-management skills. Social Skills Training groups: interventions aimed at developing communication, emotional regulation and interpersonal problem-solving skills. Cognitive Remediation groups: interventions targeting neurocognitive functions, social cognition or metacognition. Therapeutic Activity groups: interventions using artistic, creative or physical activities as therapeutic media Sociotherapeutic groups: group interventions promoting interpersonal experiences, and the sharing of experiences related to living with a mental health condition.

TAU intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hôpital le Vinatier: lead
• Direction Générale de la Santé, France: collaborator

Study Sites (8)

CH le Vinatier

Bron, 69678, France

Location

CHI EPSM Oise

Clermont, 60607, France

Location

EPSM Vendée Georges Mazurelle

La Roche-sur-Yon, 85026, France

Location

Assistance Publique des Hôpitaux de Marseille

Marseille, 13009, France

Location

CH Sainte-Marie Privas

Privas, 07000, France

Location

EPSM Lille Métropole

Ronchin, 59370, France

Location

CH Laborit- Poitiers

Saint-Benoît, 86280, France

Location

EPSM-Réunion

Sainte-Marie-de-Ré, 97438, France

Location

MeSH Terms

Conditions

Hallucinations; Psychological Well-Being

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Personal Satisfaction; Behavior

Study Officials

• Baptiste GAUDELUS

  CH le Vinatier

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Baptiste GAUDELUS

CONTACT

+33(0)674497851; baptiste.gaudelus@ch-le-vinatier.fr

Lydie SARTELET

CONTACT

+3350°437915531; lydie.sartelet@ch-le-vinatier.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The clinician-rated outcome measures (PSYRATS-AH, AHRS and HCS) will be administered by assessors who are blinded to treatment allocation.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: EDEN-RCT study will employ a multicenter mixed-methods design using a connected phases approach, combining a randomized controlled trial for the quantitative component with an Interpretative Phenomenological Analysis (IPA) study for the qualitative component. Participants recruitment: Recruitment will be conducted among the active patient populations receiving care within the clinical departments of the eight centers participating in the study. All healthcare professionals working in each participating center will be informed of the study initiation and its general procedures, namely the comparison of EDEN College with Care-as-usual (CAU) group interventions. These professionals may provide the study information sheet to adult voice-hearers and refer interested individuals to an appointment with one of the study investigators.

Study Record Dates

• First Submitted: July 3, 2026
• First Posted: July 9, 2026
• Study Start (Estimated): September 15, 2026
• Primary Completion (Estimated): September 15, 2029
• Study Completion (Estimated): September 15, 2029
• Last Updated: July 9, 2026

Record last verified: 2026-07

Locations

FR (8)