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.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 206
- 试验地点
- 2
- 主要终点
- Changes in the severity of caregiver burden between V1 and V4 by the Zarit Burden Inventory scale (ZBI)
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Control group
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.
干预措施: control group (Other)
intervention group
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.
干预措施: Intervention group (Other)
结局指标
主要结局
Changes in the severity of caregiver burden between V1 and V4 by the Zarit Burden Inventory scale (ZBI)
时间窗: 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.
次要结局
- 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)