Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05036590

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

Led by Hôpital le Vinatier · Updated on 2025-02-27

206

Participants Needed

1

Research Sites

247 weeks

Total Duration

On this page

AI-Summary

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Being a first-degree relative (parent, sibling, child) or spouse of a patient
  • Being the primary caregiver of a patient with schizophrenic disorders or first psychotic episode (DSM-5)
  • Providing consent to participate in the study
Not Eligible

You will not qualify if you...

  • Having a mental disorder on Axis I
  • Having previously received family interventions such as psychoeducation
  • Caring for multiple people with severe psychiatric disorders
  • Receiving payment for caregiving activities
  • Being legally responsible for the patient
  • Difficulty understanding fluent French
  • Being illiterate

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Hopital Vinatier

Bron, France, 69678

Actively Recruiting

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Research Team

R

Romain REY, MD, PhD

CONTACT

A

Anne-Lise BOHEC, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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