Efficiency Assessment of BREFORM. A Multicentric Stepped-wedge Randomized Control Trial.
ConditionSchizophrenia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHôpital le Vinatier
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
control group
Other interventionThe 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.
Intervention group
Other interventionThe intervention group consists of caregivers included during the intervention period. Caregivers in the intervention group will benefit from the BREF program.
Treatment groups
206 Participants
are divided into 2 treatment groupsGroup A: Control groupActive comparator 1 intervention
Group B: intervention groupExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
one yearSecondary outcomes
1
Changes in caregiver burden severity at V1,V2 and V3 by the Zarit Burden Inventory (ZBI) scale
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.
Time frame
8 months2
Evolution of the caregivers' perceived-stress between V1, V2, V3, V4 by the Perceived Stress Scale-14 (PSS-14)
Total score of the PSS can be obtained by summing the 14 items' scores . The total score ranges from 0 to a maximum of 56, a higher score indicating a higher level of perceived stress.
Time frame
one year3
Evolution of the caregivers' mood between V1, V2, V3, V4 by the Center for Epidemiologic Studies-Depression Scale (CES-D)
The CES-D consists of 20 items in a self-report format measuring depressive symptoms experienced in the past week on a 4-point Likert scale ranging from 0 (rarely or none of the time) to 3 (most or all of the time). Depression Severity: 0-4 none, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe. ... PHQ-9 score ≥10 had a sensitivity of 88% and a specificity of 88% for major depression.
Time frame
one year4
Evolution of the caregivers' family functioning between V1, V2, V3, V4
Assessed by the Family Assessment Device scale (FAD)
Time frame
one yearSponsors and contacts
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Source ClinicalTrials.gov