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

Hôpital le Vinatier

Status: Enrolling

Conditions: Schizophrenia

Treatments: Other: Intervention group; Other: control group

Study type: Interventional

Funder types: Other

Identifiers

NCT05036590

2020-A00269-30

Details and patient eligibility

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.

Full 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

Enrollment: 206 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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206 participants in 2 patient groups

Control group

Active Comparator group

Description:

The design is a stepped-wedge cluster randomized controlled trial. The study will be conducted in 9 centers (clusters) and will be conducted in 6 successive phases of 4 months each. During the first period, groups will be in the control period, then sequentially and according to a randomly defined order, at each time, one group will go into the intervention period after a transition period of 4 months allowing the intervention to be deployed (training of three health professionals for each center and then implementation of the BREF program). Thus, each cluster will belong successively to the control group and the intervention group. During the control period, caregivers will be supported according to the usual practices of each center. During the intervention period, the BREF program will be offered to all eligible caregivers.

Treatment:

Other: control group

intervention group

Experimental group

Description:

Thus, each cluster will belong successively to the control group and the intervention group. During the intervention period, the BREF program will be offered to all eligible caregivers.

Treatment:

Other: Intervention group