Independent Housing and Support for People With Severe Mental Illness: Randomized Controlled Trial vs. Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 143
- 试验地点
- 4
- 主要终点
- Social Functioning Scale (SFS)
研究概览
简要总结
Background: Adequate and stable housing conditions are fundamental for the psychiatric rehabilitation of individuals with severe mental illness (SMI). A common approach in psychiatric rehabilitation relies on a continuum of residential services that aims at enabling the person with SMI to live eventually independently. Current state of research, however, shows clearly that most persons in question remain in residential care settings or other treatment as usual conditions (RCS/TAU). The Independent Housing and Support (IHS) scheme is a new model that aims at direct placement in an independent accommodation in the community. Support is provided according to individual needs in a permanent housing situation without time limit. Up to now, randomized controlled trials (RCTs) to evaluate the effectiveness of IHS have only been conducted with homeless populations in North America. The purpose of the present study is to evaluate IHS compared to traditional RCS/TAU for non-homeless persons with severe mental illness. With this study, the investigators aim at demonstrating that IHS is not inferior to RCS/TAU. The rationale for utilizing a non-inferiority approach is based on the current state of research and on research that has shown strong preferences for IHS against RCS/TAU by people with SMI.
Methods: As the preference issue makes RCTs in housing research difficult the investigators will use a specific time window in Zurich that allows conducting a RCT due to a scarcity of IHS settings and will combine the RCT with a comparative observational study in Berne where IHS is already well-established. At the Zurich site, a RCT compares the effects of living with IHS against living in residential care. At the Berne site, an observational study design (OSD) will be applied in connection with the same types of housing as in Zurich. Propensity scoring will be utilized to minimize the risk of bias in the OSD. A number of N=56 eligible subjects in Zurich and N=112 subjects (due to specific requirements for propensity scoring) in Berne complying with the inclusion criteria will be recruited and allocated to intervention and control groups according to the site-specific study designs. Recruitment period will last 21 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary mental disorder according to ICD-10-categories
- •Age 18 to 65 years
- •Ability to communicate in German language
- •Ability to give informed consent
- •Written informed consent as documented by signature
- •Ability to take medication if indicated
- •Willingness to handle out of pocket expenses or established assistance by custodian/guardian
排除标准
- •Severe learning disability, intoxication, delirium, dementia
- •Participants lacking capacity
- •Indication for hospital treatment due to acute symptomatology at admission
- •Acute endangerment of self or others
结局指标
主要结局
Social Functioning Scale (SFS)
时间窗: Change from baseline (T0) to 24 months (T3)
The SFS is a self-rating questionnaire and will be used to assess changes in participant's social inclusion in terms of the following subscales: 1) social engagement/withdrawal, 2) interpersonal behavior, 3) independence-performance, 4) independence-competence, 5) recreation, 6) pro-social activities, and 7) employment/occupation. The SFS includes 76 items in a varying answer format. In 68 items, participants are asked to answer on a 4-point Likert scale. The total-score ranges from 0 to 135 with higher score indicating better social inclusion.
次要结局
- Global Assessment of Functioning (GAF)(Change from baseline (T0) to 24 months (T3))
- Diagnoses according to International Classification of Diseases 10 (ICD-10 diagnoses)(The diagnoses will be assessed at baseline (T0) and after 24 months (T3))
- Important life events, measured with a single item(Important life events will be assessed at baseline (T0), after 6 months (T1), 12 months (T2), and after 24 months (T3))
- Manchester Short Assessment of Quality of Life (MANSA)(Change from baseline (T0) to 24 months (T3))
- Oxford Capabilities Questionnaire - Mental Health (OxCAP)(Change from baseline (T0) to 24 months (T3))
- Health of the Nation Outcome Scales (HoNOS)(Change from baseline (T0) to 24 months (T3))
- Social Support(Change from baseline (T0) to 24 months (T3))
- Symptom Check List (SCL-K-9)(Change from baseline (T0) to 24 months (T3))
- Camberwell Assessment of Need Short Appraisal Schedule (CANSAS)(Change from baseline (T0) to 24 months (T3))