Impact of EDEN College Courses on the Quality of Life of Voice-Hearers
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 240
- 试验地点
- 16
- 主要终点
- Demonstrate that participation in "EDEN College" training programs improves participants' mental well-being following the sessions.
研究概览
简要总结
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).
详细描述
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.
The study will be conducted over a period of 44 months, including 24 months of participant recruitment and 21 months of follow-up (± 30 days).
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. A minimum period of 24 hours will be respected between the provision of the information sheet and the appointment with the investigator.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
盲法说明
The clinician-rated outcome measures (PSYRATS-AH, AHRS and HCS) will be administered by assessors who are blinded to treatment allocation.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 (guardianship or curatorshipor) may be included in the study.
排除标准
- •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.
- •Behavioral disturbances incompatible with participation in half-day group sessions
- •Refusal to participate in the study
研究组 & 干预措施
EDEN College Intervention
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.
干预措施: EDEN College (Behavioral)
TAU intervention
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.
干预措施: TAU (Behavioral)
结局指标
主要结局
Demonstrate that participation in "EDEN College" training programs improves participants' mental well-being following the sessions.
时间窗: 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.
次要结局
- Psychotic SYmptoms RATing Scale- Auditory Hallucinations: PSYRATS-AH(0, 1, 9, 12, 21 months after enrollment)