Psychoeducation Program for Family Caregivers Coordinated by an APRN
Official title: Impact of a New Psychoeducation Program Coordinated by an Advanced Practce Nurse on the Burden of Family Caregivers of Patients With a First Pyschotic Episode.
Run by Hôpital le Vinatier · NCT07041463 · Data updated 2026-11-12
A program led by an advanced practice nurse tests whether structured family psychoeducation can reduce the burden on caregivers of people with a first episode of psychosis.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 180 (estimated) |
| Sponsor | Hôpital le Vinatier Academic / other |
| Locations | 5 sites (Bohars and 4 other locations) |
| Status | Recruiting |
| Started | June 5, 2026 |
| Main results expected | November 4, 2030 |
| Study ends | November 4, 2030 |
| Registry record updated | June 9, 2026 |
| Trial ID | NCT07041463 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Caregivers of patients with a first episode psychosis (diagnosed within the past six months), aged 18-35, fluent in French, and willing to participate with consent.
✕Probably not a fit
Caregivers who are not the primary informants, who do not complete the program, or whose care situations limit benefit may see little or no improvement in burden.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional study evaluates a coordinated family psychoeducation program delivered by an APRN, including individual and group sessions and a consultation, aimed at reducing caregiver burden for relatives of patients with a first episode psychosis. The approach integrates the five levels of the family care pyramid within a multidisciplinary framework to support recovery. Participants are caregivers of recently diagnosed FEP patients who meet international FEP criteria and consent to participate, with usual care as a comparator. The study emphasizes early intervention, caregiver support, and alignment with existing evidence that multidisciplinary teams improve outcomes in early psychosis. Locations include multiple French centers under the sponsor Hôpital le Vinatier.
Why it matters
Potential benefit: If successful, caregivers may experience reduced burden, which could support better patient recovery outcomes in first-episode psychosis.
How similar studies have gone: Previous research supports family psychoeducation and early intervention approaches in psychosis, though this specific APRN-coordinated program targeting caregiver burden in FEP is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Caregiver relative of a patient under the care of the FEP team and meeting the criteria of international recommendations of FEP diagnosis made by the specialized team of less than 6 months, between 18 and 35 years of age. * Caregiver having received information about the study and having giveń consent. * Caregiver covered by a health insurance plan Exclusion Criteria: * Caregiver under curatorship, guardianship, safeguard of justice, family habilitation or future protection mandate * Caregiver participating in another study that may interact with this one * Caregiver not fluent in French (comprehension/reading) * Caregiver who has already received psycho-education on FEP * Patient's opposition to caregiver's participation in research
Where it's running
-
CH le Vinatier
Bron, France Recruiting -
CHRU de Brest - Hôpital de BOHARS,
Bohars, France Not yet recruiting -
Groupe Hospitalier Marius Lacroix
La Rochelle, France Not yet recruiting -
Hôpital La Colombière
Montpellier, France Not yet recruiting -
CHU de Nîmes
Nîmes, France Not yet recruiting
Study contacts
- Study coordinator: Caroline DAMASCENO, Nurse
- Email: caroline.damasceno@ch-le-vinatier.fr
- Phone: 07 85 58 68 10
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.