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

Study acronym: EDEN-RCT
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 12 months later Sep 15, 2029 → Sep 15, 2030
See other at-risk trials from Hôpital le Vinatier

Record History

See every version on ClinicalTrials.gov ↗

  1. Notable Primary and study completion pushed from Sep 15, 2029 to Sep 15, 2030v2 Show 5 more changesShow less
    • Recruitment opened
    • Start date changed from estimate of Sep 15, 2026 to Sep 8, 2026
    • Eligibility criteria revised
    • Site details revised at 8 of 8 sites
    • Study description shortened, about 3 words
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 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 Edinburgh Mental Well Being Scale- WEMWBS), the Self Estime and the internalized Stigma of Mental Illness processes (secondary criteria). 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 the participants 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-month period * Answer a monthly 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 programs. The purpose of this interview is to explore participants' perspectives and experiences of the groups or training programs, and their perceptions of any changes in their quality of life (qualitative part of the study).
Trial Details
NCT Number NCT07694193
Lead Sponsor Hôpital le Vinatier
Collaborators: Direction Générale de la Santé, France
Conditions
(from sponsor)
Hallucinations, Auditory
Related terms Hallucinations, Psychological Well-Being
Enrollment 240 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov