Clinical Trials Directory

Trials / Completed

CompletedNCT03815604

Independent Housing and Support for People With Severe Mental Illness

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
143 (actual)
Sponsor
University of Bern · Academic / Other
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Not accepted

Summary

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALIndependent Housing and Support (IHS)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.
BEHAVIORALResidential Care Settings and other Treatment as Usual (RCS/TAU)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.

Timeline

Start date
2019-04-01
Primary completion
2022-12-31
Completion
2023-04-30
First posted
2019-01-24
Last updated
2023-11-30

Locations

2 sites across 1 country: Switzerland

Source: ClinicalTrials.gov record NCT03815604. Inclusion in this directory is not an endorsement.