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Clinical Trial Summary

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.


Clinical Trial Description

The BREFORM project proposes to train health professionals in an early psychoeducation program, the BREF program, in order to implement it in their structure, and to evaluate its impact on the burden of caregivers of users living with a first psychotic episode or a schizophrenic disorder. Regarding caregivers' outcomes: outcome measures will be assessed at baseline (visit 1, V1), 6 weeks (Visit 2, V2), 6 months (Visit 3, V3), 12 months (Visit 4, V4) after baseline in the active group and in the treatment as usual group Regarding patients' outcomes: outcome measures will be assessed at baseline and 12 months after baseline in the active group and in the treatment as usual group Regarding mental health professionals' outcomes: outcome measures will be assessed before, after and 16 months after the training course Regarding the psychiatric departments' outcomes: outcome measures will be assessed at baseline and 36 months after baseline ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05036590
Study type Interventional
Source Hôpital le Vinatier
Contact Romain REY, MD, PhD
Phone +33437915495
Email [email protected]
Status Not yet recruiting
Phase N/A
Start date January 10, 2022
Completion date December 31, 2024

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