Efficiency Assessment of BREFORM. A Multicentric Stepped-wedge Randomized Control Trial.

Recruiting now · Not applicable

Conditions studied: Schizophrenia

In brief

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.

Key facts

Study ID

NCT05036590

Run by

Hôpital le Vinatier

People needed

206

Starts

2022-04-05

Expected to finish

2026-12-31

Last updated by the study team

2026-06-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• mental disorder on Axis I
• having already benefited from a family intervention such as psychoeducation
• caring for several people with severe psychiatric disorders
• receiving income for the caring activities
• being legally responsible of the patient
• having difficulty understanding fluent French
• illiterate

Where it is running

• Hopital Vinatier — Bron, France (enrolling)

Full record on ClinicalTrials.gov

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