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Not Yet Recruiting NCT07694193

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

Conditions: Hallucinations, Auditory

Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: No
Phase: NA
Enrollment: 240
Sponsor: Hôpital le Vinatier

Location: CH le Vinatier Bron

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).

Eligibility Criteria

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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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07694193). StuddyBuddy aggregates publicly available trial information.