Independent Housing and Support for People With Severe Mental Illness

NCT ID: NCT03815604

Last Updated: 2023-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

143 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-01

Study Completion Date

2023-04-30

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.

Detailed Description

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Conditions

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Severe Mental Disorder

Keywords

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Psychiatric Rehabilitation Supported Housing Residential Care

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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RCT-IHS

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

Group Type EXPERIMENTAL

Independent Housing and Support (IHS)

Intervention Type BEHAVIORAL

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.

RCT-RCS/TAU

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type BEHAVIORAL

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.

OSD-IHS

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

Group Type EXPERIMENTAL

Independent Housing and Support (IHS)

Intervention Type BEHAVIORAL

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.

OSD-RCS/TAU

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type BEHAVIORAL

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.

Interventions

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Independent 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.

Intervention Type BEHAVIORAL

Residential 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.

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Zurich

OTHER

Sponsor Role collaborator

Swiss National Science Foundation

OTHER

Sponsor Role collaborator

University of Bern

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dirk Richter, PhD

Role: PRINCIPAL_INVESTIGATOR

Bern University Hospital for Mental Health

Locations

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University Hospital for Mental Health Bern, Center for Psychiatric Rehabilitation

Bern, , Switzerland

Site Status

Psychiatric University Hospital Zurich

Zurich, , Switzerland

Site Status

Countries

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Switzerland

References

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Richter D, Hoffmann H. Independent housing and support for people with severe mental illness: systematic review. Acta Psychiatr Scand. 2017 Sep;136(3):269-279. doi: 10.1111/acps.12765. Epub 2017 Jun 16.

Reference Type BACKGROUND
PMID: 28620944 (View on PubMed)

Richter D, Hoffmann H. Preference for Independent Housing of Persons with Mental Disorders: Systematic Review and Meta-analysis. Adm Policy Ment Health. 2017 Nov;44(6):817-823. doi: 10.1007/s10488-017-0791-4.

Reference Type BACKGROUND
PMID: 28160182 (View on PubMed)

Adamus C, Motteli S, Jager M, Richter D. Independent Supported Housing vs institutional housing rehabilitation settings for non-homeless individuals with severe mental illness - longitudinal results from an observational study. BMC Psychiatry. 2024 Aug 9;24(1):554. doi: 10.1186/s12888-024-05995-7.

Reference Type DERIVED
PMID: 39123200 (View on PubMed)

Adamus C, Motteli S, Jager M, Richter D. Independent Supported Housing for non-homeless individuals with severe mental illness: Comparison of two effectiveness studies using a randomised controlled and an observational study design. Front Psychiatry. 2022 Nov 10;13:1033328. doi: 10.3389/fpsyt.2022.1033328. eCollection 2022.

Reference Type DERIVED
PMID: 36440393 (View on PubMed)

Motteli S, Adamus C, Deb T, Frobel R, Siemerkus J, Richter D, Jager M. Independent Supported Housing for Non-homeless People With Serious Mental Illness: A Pragmatic Randomized Controlled Trial. Front Psychiatry. 2022 Jan 21;12:798275. doi: 10.3389/fpsyt.2021.798275. eCollection 2021.

Reference Type DERIVED
PMID: 35126208 (View on PubMed)

Adamus C, Motteli S, Jager M, Richter D. Independent Housing and Support for non-homeless individuals with severe mental illness: randomised controlled trial vs. observational study - study protocol. BMC Psychiatry. 2020 Jun 19;20(1):319. doi: 10.1186/s12888-020-02712-y.

Reference Type DERIVED
PMID: 32560681 (View on PubMed)

Other Identifiers

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10531C_179451

Identifier Type: -

Identifier Source: org_study_id