Independent Housing and Support for People With Severe Mental Illness

Study Overview
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Brief Summary
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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.

Official Title
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Independent Housing and Support for People With Severe Mental Illness: Randomized Controlled Trial vs. Observational Study

Conditions
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Severe Mental Disorder

Intervention / Treatment
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* Behavioral: Independent Housing and Support (IHS)
* Behavioral: Residential Care Settings and other Treatment as Usual (RCS/TAU)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: As the preference issue makes RCTs in housing research difficult the investigators will use a specific time window in Zurich that allows conducting an 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. The investigators intend to directly compare the outcomes of a randomized controlled trial (RCT) with a study in an observational study design (OSD). Here, the investigators utilize the hypothesis that the OSD will provide similar results as the RCT.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RCT-IHS<br>Behavioral: At the Zurich site, the experimental intervention is called Independent Housing and Support | Behavioral: Independent Housing and Support (IHS)<br>* Direct placement of people with SMI in an independent accommodation in the community, usually in a flat rented by the service user. Support is provided by a coach according to individual needs in a permanent housing situation without time limit.<br>|
| Active Comparator: RCT-RCS/TAU<br>Behavioral: At the Zurich site, the comparator is usual residential care | Behavioral: Residential Care Settings and other Treatment as Usual (RCS/TAU)<br>* Placement in a common residential home or supportive housing setting with the aim to gain psycho-social stability before being able to maintain independent housing.<br>|
| Experimental: OSD-IHS<br>Behavioral: At the Berne site, the experimental intervention is called Independent Housing and Support | Behavioral: Independent Housing and Support (IHS)<br>* Direct placement of people with SMI in an independent accommodation in the community, usually in a flat rented by the service user. Support is provided by a coach according to individual needs in a permanent housing situation without time limit.<br>|
| Active Comparator: OSD-RCS/TAU<br>Behavioral: At the Berne site, the comparator is usual residential care | Behavioral: Residential Care Settings and other Treatment as Usual (RCS/TAU)<br>* Placement in a common residential home or supportive housing setting with the aim to gain psycho-social stability before being able to maintain independent housing.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Social Functioning Scale (SFS) | 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. | Change from baseline (T0) to 24 months (T3) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health of the Nation Outcome Scales (HoNOS) | The HoNOS will be used to assess changes in participant's functioning. It will be rated by key worker on a 5-point Likert scale in terms of the following items: 1) aggression, 2) self-harm, 3) substance use, 4) cognitive dysfunction, 5) physical disability, 6) hallucinations and delusions, 7) depression, 8) other symptoms, 9) personal relationships, 10) overall functioning, 11) residential problems, 12) occupational problems. The summed-up total-score ranges from 0 to 48 with lower score indicating better functioning. | Change from baseline (T0) to 24 months (T3) | 
| Global Assessment of Functioning (GAF) | The GAF is a scale rated by key worker and will be used to assess changes in participant's functioning. Illness severity is rated as a single item based on psychopathology and functioning on a 1 to 100 scale with higher score as indicator for better functioning. | Change from baseline (T0) to 24 months (T3) | 
| Manchester Short Assessment of Quality of Life (MANSA) | The MANSA is an interview and will be used to assess changes in participant's quality of life. It consists of three sections with total 25 items: 1) personal details, consistent over time (date of birth, gender, diagnosis), 2) personal details, potentially varying over time and to be redocumented if change has occurred (education, employment, income, state benefits, living situation, people the participant lives with, type of residence), and 3) 16 questions that are asked every time. Four of the section three questions are termed objective and are to be answered with yes/no. Twelve of the section three questions are called subjective and ask for answering participant's satisfaction on a 7-point Likert scale. The final score will be computed by averaging the 12 individual items with higher score indicates higher quality of life. | Change from baseline (T0) to 24 months (T3) | 
| Symptom Check List (SCL-K-9) | The SCL-K-9 is a questionnaire and will be used to assess changes in participant's mental state on a 5-point Likert scale, including items from all of the nine subscales of the original SCL-90-R: 1) depression, 2) anxiety, 3) somatization, 4) phobic fear, 5) obsessive-compulsive, 6) psychoticism, 7) social insecurity, 8) paranoid thinking, 9) hostility. The total-score ranges from 0 to 36 with lower score indicating better mental states. | Change from baseline (T0) to 24 months (T3) | 
| Diagnoses according to International Classification of Diseases 10 (ICD-10 diagnoses) | Clinical records | The diagnoses will be assessed at baseline (T0) and after 24 months (T3) | 
| Camberwell Assessment of Need Short Appraisal Schedule (CANSAS) | The CANSAS is an interview and will be used to assess changes in participant's needs in 22 health and social domains on a 3-point Likert scale (no problem; met need; unmet need). For interpretation, the met and unmet needs each will be summed-up. | Change from baseline (T0) to 24 months (T3) | 
| Oxford Capabilities Questionnaire - Mental Health (OxCAP) | The OxCAP is a questionnaire and will be used to assess changes in participant's capabilities that covers the following domains of functioning and welfare based on 16 items to answer on a 5-point Likert scale: 1) life, 2) bodily health, 3) bodily integrity, 4) senses, imagination and thought, 5) emotions, 6) practical reason, 7) affiliation, 8) species, 9) play, and 10) control over one's environment. The initial index total-score ranges from 16 to 80 and is converted into a standardised 0 to 100 final score with higher score indicating better capabilities. | Change from baseline (T0) to 24 months (T3) | 
| Important life events, measured with a single item | Important Life Events for the last six months (at baseline) or since the last assessment, respectively. Free text with subsequent coding | Important life events will be assessed at baseline (T0), after 6 months (T1), 12 months (T2), and after 24 months (T3) | 
| Social Support | A self-generated questionnaire will be used to measure changes in participant's social and living support. The questionnaire consists of 24 items to be answered on a 5-point Likert scale. Total score rages from 24 to 120 with higher score indicating higher support. | Change from baseline (T0) to 24 months (T3) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Psychiatric Rehabilitation, Supported Housing, Residential Care