Clinical trial NCT05036590: 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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Schizophrenia
Lead sponsor: Hôpital le Vinatier
Sponsor class: OTHER
First posted: 2021-09-05
Enrollment: 206
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multicentric Stepped-wedge Randomized Control Trial
Primary purpose: OTHER

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.

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

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

Primary outcomes:
measure: Changes in the severity of caregiver burden between V1 and V4 by the Zarit Burden Inventory scale (ZBI)
timeFrame: one year
Secondary outcomes:
measure: Changes in caregiver burden severity at V1,V2 and V3 by the Zarit Burden Inventory (ZBI) scale
timeFrame: 8 months
measure: Evolution of the caregivers' perceived-stress between V1, V2, V3, V4 by the Perceived Stress Scale-14 (PSS-14)
timeFrame: one year
measure: Evolution of the caregivers' mood between V1, V2, V3, V4 by the Center for Epidemiologic Studies-Depression Scale (CES-D)
timeFrame: one year
measure: Evolution of the caregivers' family functioning between V1, V2, V3, V4
timeFrame: one year
measure: Evolution of the caregivers' quality of life between V1, V2, V3, V4
timeFrame: one year
measure: Evolution of the caregivers' sense of competence between V1, V2, V3, V4
timeFrame: one year
measure: Evolution of the caregivers' number of consultations with the general practitioner (GP)
timeFrame: 12 months period before baseline assessment versus 12 months period after baseline assessment
measure: Evolution of the caregivers' number of days off work
timeFrame: 12 months period before baseline assessment vs. 12 months period after baseline assessment
measure: Evolution of the caregivers' number of days on long-term leave or disability
timeFrame: 12 months period before baseline assessment vs. 12 months period after baseline assessment
measure: Evolution of the caregivers' number of work days
timeFrame: 12 months
measure: Evolution of the caregivers' willingness to pay someone to replace them in their caring activities during one hour
timeFrame: 12 months
measure: Evolution of the caregivers' number of suicide attempts assessed by the Columbia Suicide Severity Rating Scale (C-SSRS)
timeFrame: 12 months period before baseline assessment vs. 12 months period after baseline assessment
measure: caregivers' satisfaction
timeFrame: 12 months
measure: Evolution of the caregivers' living status (shared or non-shared household) between V1, V2, V3, V4
timeFrame: 12 months
measure: Evolution of the caregivers' informal caregiving activities between V1, V2, V3, V4
timeFrame: 12 months
measure: Evolution of the caregivers' number of hours spent providing informal caregiving between V1, V2, V3, V4
timeFrame: 12 months
measure: Evolution of the patients' psychotic symptoms severity between baseline and 12 months after baseline assessed by the Positive And Negative Syndrome Scale (PANSS)
timeFrame: 12 months period before baseline assessment vs. 12 months period after baseline assessment
measure: Evolution of the patients' functioning level between baseline and 12 months after baseline
timeFrame: Baseline assessment and 12 months after baseline assessment
measure: Evolution of the patients' functioning level assessed by the Personal and social Performance scale (PSP)
timeFrame: Baseline assessment and 12 months after baseline assessment
measure: Evolution of the patients' quality of life between baseline and 12 months after baseline
timeFrame: Baseline assessment and 12 months after baseline assessment
measure: Evolution of the patients' clinical severity between baseline and 12 months after baseline
timeFrame: Baseline assessment and 12 months after baseline assessment
measure: Evolution of the patients' depressive symptoms between baseline and 12 months after baseline
timeFrame: Baseline assessment and 12 months after baseline assessment
measure: Evolution of the patients' relapse risk factors between baseline and 12 months after baseline
timeFrame: Baseline assessment and 12 months after baseline assessment
measure: Evolution of the patients' number of suicide attempts
timeFrame: 12 months period before baseline assessment vs. 12 months period after baseline assessment
measure: Evolution of the patients' suicide risk level
timeFrame: Baseline assessment and 12 months after baseline assessment
measure: Evolution of the patients' aggressive behaviors
timeFrame: 12 months period before baseline assessment vs. 12 months period after baseline assessment
measure: Evolution of the patients' number of hospitalization in psychiatry
timeFrame: 12 months period before baseline assessment vs. 12 months period after baseline assessment
measure: Evolution of the mental health professionals' beliefs and knowledge about psychoeducation to caregivers
timeFrame: Assessed before, after and 16 months after the training course
measure: Evolution of the mental health professionals' sense of competence about psychoeducation to caregivers
timeFrame: Assessed before, after and 16 months after the training course
measure: Evolution of the mental health professionals' satisfaction of the training course
timeFrame: Assessed after and 16 months after the training course
measure: Evolution of the mental health professionals' satisfaction of the BREF program
timeFrame: Assessed 16 months after the training course
measure: Evolution of the psychiatric department organization regarding caregivers interventions
timeFrame: Assessed at baseline and 36 months after baseline
measure: Sustainability of the BREF program in each psychiatric department
timeFrame: Assessed 36 months after baseline
Other outcomes:
Locations:
city: Bron
country: France
facility: Hopital Vinatier
Study officials:
affiliation: CH LE VINATIER
name: Romain REY, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: