NCT05036590

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.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 206 (estimated)
• Sponsor: Hôpital le Vinatier · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

• Schizophrenia

Interventions

Type	Name	Description
OTHER	control group	The control group consisted of caregivers included during the control period, before the intervention was deployed, i.e., before the BREF program was implemented by the centers.
OTHER	Intervention group	The intervention group consists of caregivers included during the intervention period. Caregivers in the intervention group will benefit from the BREF program.

Timeline

• Start date: 2022-04-05
• Primary completion: 2026-06-30
• Completion: 2026-12-31
• First posted: 2021-09-05
• Last updated: 2025-02-27

Locations

1 site across 1 country: France