Efficiency Assessment of BREFORM. A Multicentric Stepped-wedge Randomized Control Trial.
Recruiting · NCT05036590 · Interventional (participants receive a specific treatment) · Lead sponsor: Hôpital le Vinatier
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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
Exclusion criteria
- 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
1 location listed.
- Hopital Vinatier - Bron, France