Evaluation of the Individual Early Psychoeducation Program for Schizophrenic Disorders in Inpatients (NCT05329363) | Clinical Trial Compass
RecruitingNot Applicable
Evaluation of the Individual Early Psychoeducation Program for Schizophrenic Disorders in Inpatients
France200 participantsStarted 2022-06-17
Plain-language summary
Schizophrenia affects about 0.7% of the population. Poor insight, which is common in this disease, linked to poor drug compliance is leads to rehospitalisation with major impact on quality of life. Indeed, many patients relapse with exacerbation of symptoms.
Psychoeducation can improve therapeutic alliance and medication compliance.
In this context, an individual psycho-education program (PEPITS) has been developed. PEPITS carried out by nurses during the initial stages of hospitalisation.
The hypothesis is that PEPITS program will decrease relapse and improve the compliance and insight and and so the quality of life.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age between 18 and 65 years
* Patient with a diagnosed and reported schizophrenic disorder announced :
* Schizophrenia
* Schizoaffective disorder
* Or a diagnosed and reported Delusional Disorder
* Express written consent by the participant after receiving information about the study
* Be able to communicate verbally
* Participant affiliated to a social security scheme
Exclusion Criteria:
* Pregnant or breastfeeding woman
* Patient who does not speak French
* Participation in a psycho-education group in the last 2 years
* Patient under legal protection or guardianship
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Evolution of insight
Timeframe: From inclusion (T0) up to one year (T12) after randomisation