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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

206 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-05

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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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

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Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Multicentric Stepped-wedge Randomized Control Trial

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Control group

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.

Group Type ACTIVE_COMPARATOR

control group

Intervention Type OTHER

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.

intervention group

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.

Group Type EXPERIMENTAL

Intervention group

Intervention Type OTHER

The intervention group consists of caregivers included during the intervention period. Caregivers in the intervention group will benefit from the BREF program.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No