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

NCT05036590 | Recruiting

• 1 other identifier: 2020-A00269-30
• Study Type: interventional
• Target: 206
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

• Changes in the severity of caregiver burden between V1 and V4 by the Zarit Burden Inventory scale (ZBI)

  The ZBI consists of 22 items rated on a 5-point Likert scale that ranges from 0 (never) to 4 (nearly always) with the sum of scores ranging between 0-88. Higher scores indicate greater burden. A score of 17 or more was considered high burden.

  one year

Secondary Outcomes (33)

• Changes in caregiver burden severity at V1,V2 and V3 by the Zarit Burden Inventory (ZBI) scale

  8 months

• Evolution of the caregivers' perceived-stress between V1, V2, V3, V4 by the Perceived Stress Scale-14 (PSS-14)

  one year

• Evolution of the caregivers' mood between V1, V2, V3, V4 by the Center for Epidemiologic Studies-Depression Scale (CES-D)

  one year

• Evolution of the caregivers' family functioning between V1, V2, V3, V4

  one year

• Evolution of the caregivers' quality of life between V1, V2, V3, V4

  one year

Study Arms (2)

Control group

ACTIVE COMPARATOR

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.

Other: control group

intervention group

EXPERIMENTAL

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.

Other: Intervention group

Interventions

control group 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.

Control group

Intervention group OTHER

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

intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hôpital le Vinatier: lead

Study Sites (1)

Hopital Vinatier

Bron, 69678, France

RECRUITING

MeSH Terms

Conditions

Schizophrenia

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Romain REY, MD, PhD

  CH LE VINATIER

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Romain REY, MD, PhD

CONTACT

+33437915495; romain.rey@ch-le-vinatier.fr

Anne-Lise BOHEC, PhD

CONTACT

+33437915495; Anne-lise.BOHEC@ch-le-vinatier.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multicentric Stepped-wedge Randomized Control Trial

Study Record Dates

• First Submitted: August 5, 2021
• First Posted: September 5, 2021
• Study Start: April 5, 2022
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 27, 2025

Record last verified: 2025-02

Locations

FR (1)