Independent Housing and Support for People With Severe Mental Illness

University of Bern

Status: Completed

Conditions: Severe Mental Disorder

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

Study type: Interventional

Funder types: Other

Identifiers

NCT03815604

10531C_179451

Details and patient eligibility

About

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.

Enrollment: 143 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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143 participants in 4 patient groups

RCT-IHS

Experimental group

Description:

Behavioral: At the Zurich site, the experimental intervention is called Independent Housing and Support

Treatment:

Behavioral: Independent Housing and Support (IHS)

RCT-RCS/TAU

Active Comparator group

Description:

Behavioral: At the Zurich site, the comparator is usual residential care

Treatment:

Behavioral: Residential Care Settings and other Treatment as Usual (RCS/TAU)

OSD-IHS

Experimental group

Description:

Behavioral: At the Berne site, the experimental intervention is called Independent Housing and Support

Treatment:

Behavioral: Independent Housing and Support (IHS)

OSD-RCS/TAU

Active Comparator group

Description:

Behavioral: At the Berne site, the comparator is usual residential care

Treatment:

Behavioral: Residential Care Settings and other Treatment as Usual (RCS/TAU)