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
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Schizophrenia
- Sponsor
- Hôpital le Vinatier
- Enrollment
- 206
- Locations
- 1
- Primary Endpoint
- Changes in the severity of caregiver burden between V1 and V4 by the Zarit Burden Inventory scale (ZBI)
- Status
- Recruiting
- Last Updated
- last year
Overview
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
Investigators
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
Outcomes
Primary Outcomes
Changes in the severity of caregiver burden between V1 and V4 by the Zarit Burden Inventory scale (ZBI)
Time Frame: one year
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.
Secondary Outcomes
- Evolution of the patients' clinical severity between baseline and 12 months after baseline(Baseline assessment and 12 months after baseline assessment)
- Evolution of the patients' depressive symptoms between baseline and 12 months after baseline(Baseline assessment and 12 months after baseline assessment)
- Evolution of the patients' relapse risk factors between baseline and 12 months after baseline(Baseline assessment and 12 months after baseline assessment)
- Evolution of the mental health professionals' beliefs and knowledge about psychoeducation to caregivers(Assessed before, after and 16 months after the training course)
- Evolution of the patients' number of hospitalization in psychiatry(12 months period before baseline assessment vs. 12 months period after baseline assessment)
- Evolution of the mental health professionals' sense of competence about psychoeducation to caregivers(Assessed before, after and 16 months after the training course)
- Evolution of the mental health professionals' satisfaction of the training course(Assessed after and 16 months after the training course)
- Evolution of the mental health professionals' satisfaction of the BREF program(Assessed 16 months after the training course)
- Evolution of the psychiatric department organization regarding caregivers interventions(Assessed at baseline and 36 months after baseline)
- Evolution of the caregivers' informal caregiving activities between V1, V2, V3, V4(12 months)
- 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' quality of life between V1, V2, V3, V4(one year)
- Evolution of the caregivers' willingness to pay someone to replace them in their caring activities during one hour(12 months)
- Evolution of the caregivers' number of suicide attempts assessed by the Columbia Suicide Severity Rating Scale (C-SSRS)(12 months period before baseline assessment vs. 12 months period after baseline assessment)
- Evolution of the caregivers' family functioning between V1, V2, V3, V4(one year)
- Evolution of the caregivers' sense of competence between V1, V2, V3, V4(one year)
- Evolution of the caregivers' number of consultations with the general practitioner (GP)(12 months period before baseline assessment versus 12 months period after baseline assessment)
- Evolution of the caregivers' number of days off work(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(12 months period before baseline assessment vs. 12 months period after baseline assessment)
- Evolution of the caregivers' number of work days(12 months)
- Evolution of the caregivers' number of hours spent providing informal caregiving between V1, V2, V3, V4(12 months)
- Evolution of the patients' functioning level assessed by the Personal and social Performance scale (PSP)(Baseline assessment and 12 months after baseline assessment)
- caregivers' satisfaction(12 months)
- Evolution of the caregivers' living status (shared or non-shared household) between V1, V2, V3, V4(12 months)
- Evolution of the patients' psychotic symptoms severity between baseline and 12 months after baseline assessed by the Positive And Negative Syndrome Scale (PANSS)(12 months period before baseline assessment vs. 12 months period after baseline assessment)
- Evolution of the patients' functioning level between baseline and 12 months after baseline(Baseline assessment and 12 months after baseline assessment)
- Evolution of the patients' quality of life between baseline and 12 months after baseline(Baseline assessment and 12 months after baseline assessment)
- Evolution of the patients' number of suicide attempts(12 months period before baseline assessment vs. 12 months period after baseline assessment)
- Evolution of the patients' suicide risk level(Baseline assessment and 12 months after baseline assessment)
- Evolution of the patients' aggressive behaviors(12 months period before baseline assessment vs. 12 months period after baseline assessment)
- Sustainability of the BREF program in each psychiatric department(Assessed 36 months after baseline)