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

Condition(s) studied

Investigational drug(s) / intervention(s)

EDEN College: 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.

TAU: 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.

Study 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). 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).

Eligibility

Primary outcome measure(s)

• Demonstrate that participation in "EDEN College" training programs improves participants' mental well-being following the sessions. — 1, 9, 12, 21 months after enrollment
  the result of the scale of Warwick Edinburgh Mental Well Being Scale (WEMWBS) total score (14 items self administerd 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.

Trial sites (8)

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