HoPe: Home Delivered Peer Led Treatment vs Home Delivered Treatment - a Randomized Controlled Multicentre Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 201
- 试验地点
- 8
- 主要终点
- Time to first readmission to inpatient hospital treatment
研究概览
简要总结
Home treatment (HT) is an effective treatment modality for patients with severe mental illness (SMI) in acute crisis that can often be considered equivalent to inpatient treatment in terms of treatment outcome. In Peer Support (PS) patients are supported by people with personal experiences in psychiatric crises. The current study investigates a combination of both approaches - a HT plus PS intervention - versus sole HT at different study sites throughout Germany. It is hypothesized that a peer-supported home-delivered treatment (HT plus PS) is more effective than a professional-led home-delivered treatment (HT alone) with respect to the time until hospital readmission, self-efficacy, psychosocial health, recovery orientation, internalized stigma and service satisfaction. Furthermore, it is hypothesized, that a peer-supported home delivered treatment (HT plus PS) is as effective as a professional-led home-delivered treatment (HT alone) with respect to disease severity and general functioning (secondary outcomes).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Investigators per study site as well as outcome assessor have no insight on group allocation
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
- •severe mental illness with indication of hospital admission (F2, F3, F6, F41, F42)
排除标准
- •primary diagnosis of F0 or F1 (Mental disorders due to known physiological conditions; Mental and behavioral disorders due to psychoactive substance use)
- •acute suicidality
- •verbal or cognitive impairment severe enough to be unable to give informed consent
结局指标
主要结局
Time to first readmission to inpatient hospital treatment
时间窗: 1 year after last patient in
次要结局
- change from baseline in psychosocial health scores as assessed by Health-49 at two months(two months after allocation)
- change from baseline in psychosocial health scores as assessed by Health-49 at twelve months(twelve months after allocation)
- change from baseline in stigma resistance scores as assessed by ISMI at twelve months(twelve months after allocation)
- change from baseline in self-efficacy expectation scores as assessed by SWE at two months(two months after allocation)
- change from baseline in self-efficacy expectation scores as assessed by SWE at twelve months(twelve months after allocation)
- means in recovery support scores as assessed by Brief INSPIRE at six months(six months after allocation)
- means in recovery support scores as assessed by Brief INSPIRE at twelve months(twelve months after allocation)
- change from baseline in stigma resistance scores as assessed by ISMI at two months(two months after allocation)
- means in service satisfaction scores as assessed by ZUF-8 at twelve months(twelve months after allocation)
- change from baseline in disease severity scores ay assessed by CGI at two months(two months after allocation)
- change from baseline in general functioning scores as assessed by GAF at two months(two months after allocation)
- change from baseline in self-efficacy expectation scores as assessed by SWE at six months(six months after allocation)
- change from baseline in psychosocial health scores as assessed by Health-49 at six months(six months after allocation)
- means in recovery support scores as assessed by Brief INSPIRE at two months(two months after allocation)
- means in service satisfaction scores as assessed by ZUF-8 at six months(six months after allocation)
- change from baseline in disease severity scores ay assessed by CGI at six months(six months after allocation)
- change from baseline in disease severity scores ay assessed by CGI at twelve months(twelve months after allocation)
- change from baseline in general functioning scores as assessed by GAF at six months(six months after allocation)
- change from baseline in stigma resistance scores as assessed by ISMI at six months(six months after allocation)
- means in service satisfaction scores as assessed by ZUF-8 at two months(two months after allocation)
- change from baseline in general functioning scores as assessed by GAF at twelve months(twelve months after allocation)