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

Official title

Efficiency Assessment of a Mental Health Professionals' Training Course for a Short Psychoeducational Program (BREF) for Families and Caregivers of Patients With Schizophrenia or First Psychotic Episode.

Overview

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.

Detailed 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

Interventions

• Other 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.
• 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.

Primary outcome measures

• Changes in the severity of caregiver burden between V1 and V4 by the Zarit Burden Inventory scale (ZBI) [Time frame: one year]

Secondary outcome measures (12)

• Changes in caregiver burden severity at V1,V2 and V3 by the Zarit Burden Inventory (ZBI) scale [Time frame: 8 months]
• Evolution of the caregivers' perceived-stress between V1, V2, V3, V4 by the Perceived Stress Scale-14 (PSS-14) [Time frame: one year]
• Evolution of the caregivers' mood between V1, V2, V3, V4 by the Center for Epidemiologic Studies-Depression Scale (CES-D) [Time frame: one year]
• Evolution of the caregivers' family functioning between V1, V2, V3, V4 [Time frame: one year]
• Evolution of the caregivers' quality of life between V1, V2, V3, V4 [Time frame: one year]
• Evolution of the caregivers' sense of competence between V1, V2, V3, V4 [Time frame: one year]
• Evolution of the caregivers' number of consultations with the general practitioner (GP) [Time frame: 12 months period before baseline assessment versus 12 months period after baseline assessment]
• Evolution of the caregivers' number of days off work [Time frame: 12 months period before baseline assessment vs. 12 months period after baseline assessment]
• Evolution of the caregivers' number of days on long-term leave or disability [Time frame: 12 months period before baseline assessment vs. 12 months period after baseline assessment]
• Evolution of the caregivers' number of work days [Time frame: 12 months]
• Evolution of the caregivers' willingness to pay someone to replace them in their caring activities during one hour [Time frame: 12 months]
• Evolution of the caregivers' number of suicide attempts assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) [Time frame: 12 months period before baseline assessment vs. 12 months period after baseline assessment]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Other

Study locations

France · 1 center

• Hopital Vinatier — Bron

Identifiers

NCT: NCT05036590 · 2020-A00269-30

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗