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

Study acronym: BREFORM
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated June 12, 2026 (before its estimated June 30, 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Minor Re-verified, no change to tracked fieldsv7
  2. Notable Primary completion date: Jun 30, 2024 to Jun 30, 2026
    • Study completion date: Dec 31, 2024 to Dec 31, 2026
    v6
  3. Minor Re-verified, no change to tracked fieldsv5
  4. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Mar 15, 2022 to Apr 5, 2022
    • Site details revised
    v4
  5. Notable Start date: Feb 9, 2022 to Mar 15, 2022v3
  6. Notable Start date: Jan 10, 2022 to Feb 9, 2022v2
  7. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05036590
Lead Sponsor Hôpital le Vinatier
Conditions
(from sponsor)
Schizophrenia
Related terms Schizophrenia
Enrollment 206 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov