NCT05036590Recruiting
Efficiency Assessment of BREFORM. A Multicentric Stepped-wedge Randomized Control Trial.
Efficiency Assessment of a Mental Health Professionals' Training Course for a Short Psychoeducational Program (BREF) for Families and Caregivers of Patients With Schizophrenia or First Psychotic Episode.
Source: ClinicalTrials.gov · Last updated 12 Jun 2026
Brief summary (registry, in English)
In psychiatry, caregiver burden is associated with excess physical and psychological morbidity in relatives of patients with schizophrenic disorders Single or multi-family psychoeducation for caregivers of patients with schizophrenic disorders or first episode psychosis has a direct benefit on the health of the caregiver and an indirect benefit on the health of the ill family member. It is associated with a reduction in the rate of relapse and re-hospitalization and with better compliance with treatment. For single-family psychoeducation, the number of caregivers to be treated to avoid re-hospitalization of the sick family member is 3. For caregivers, psychoeducation is accompanied by an improvement in knowledge of the disorders and coping strategies. Therefore, international recommendations recommend that psychoeducation for caregivers be systematic, early, and integrated into routine care. Currently, the organization of the French care system does not allow these recommendations to be met. In order to increase the use of psychoeducation in France, early interventions for caregivers must be offered systematically. The effectiveness of early psychoeducation for caregivers needs to be evaluated; only three randomized controlled trials are available in the literature and none have been conducted in France.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 206 (estimated)
- First submitted
- 5 Aug 2021
- Start date
- 5 Apr 2022
- Primary completion date
- 30 Jun 2026
- Lead sponsor
- Hôpital le Vinatier
- Diseases
- Schizophrenia
- NCT number
- NCT05036590
What you commit to
- Study type: Interventional
- Planned participants: 206
- From 5 Apr 2022 to the primary completion date, 30 Jun 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- receiving income for the caring activities
Other illness
- mental disorder on Axis I
- caring for several people with severe psychiatric disorders
Other
- having already benefited from a family intervention such as psychoeducation
- being legally responsible of the patient
- having difficulty understanding fluent French
- illiterate
Who the study is looking for
- people over 18yo
- first-degree relatives (parents, siblings, children) or spouse of the patient
- primary caregiver of a patient with schizophrenic disorders or first psychotic episode (DSM5)
- consenting to participate to the study
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hopital Vinatier Coordinator of this site? Confirm its status | Bron | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.