Independent Housing and Support for People With Severe Mental Illness

NCT03815604 | Completed

• 1 other identifier: 10531C_179451
• Study Type: interventional
• Target: 143
• Locations: 1 country
• Sites: 2

Brief 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

Severe Mental Disorder

Keywords

Psychiatric Rehabilitation; Supported Housing; Residential Care

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Health of the Nation Outcome Scales (HoNOS)

  Change from baseline (T0) to 24 months (T3)

• Global Assessment of Functioning (GAF)

  Change from baseline (T0) to 24 months (T3)

• Manchester Short Assessment of Quality of Life (MANSA)

  Change from baseline (T0) to 24 months (T3)

• Symptom Check List (SCL-K-9)

  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)

Other Outcomes (12)

• Client Sociodemographic and Service Receipt Inventory - adapted (CSSRI-EU); Question 1

  The CSSRI-EU will be assessed at baseline (T0), after 6 months (T1), 12 months (T2), and after 24 months (T3)

• Client Sociodemographic and Service Receipt Inventory - adapted (CSSRI-EU); Question 2

  The CSSRI-EU will be assessed at baseline (T0), after 6 months (T1), 12 months (T2), and after 24 months (T3)

• Client Sociodemographic and Service Receipt Inventory - adapted (CSSRI-EU); Question 3

  The CSSRI-EU will be assessed at baseline (T0), after 6 months (T1), 12 months (T2), and after 24 months (T3)

Study Arms (4)

RCT-IHS

EXPERIMENTAL

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

Behavioral: Independent Housing and Support (IHS)

RCT-RCS/TAU

ACTIVE COMPARATOR

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

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

OSD-IHS

EXPERIMENTAL

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

Behavioral: Independent Housing and Support (IHS)

OSD-RCS/TAU

ACTIVE COMPARATOR

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

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

Interventions

Independent Housing and Support (IHS) 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-IHS; RCT-IHS

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Bern: lead
• University of Zurich: collaborator
• Swiss National Science Foundation: collaborator

Study Sites (2)

University Hospital for Mental Health Bern, Center for Psychiatric Rehabilitation

Bern, 3008, Switzerland

Location

Psychiatric University Hospital Zurich

Zurich, 8032, Switzerland

Location

Related Publications (6)

• 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.

  PMID: 28620944 BACKGROUND

• 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.

  PMID: 28160182 BACKGROUND

• 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.

  PMID: 39123200 DERIVED

• 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.

  PMID: 36440393 DERIVED

• 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.

  PMID: 35126208 DERIVED

• 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.

  PMID: 32560681 DERIVED

MeSH Terms

Conditions

Mental Disorders

Interventions

Palliative Care

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Dirk Richter, PhD

  Bern University Hospital for Mental Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 4, 2018
• First Posted: January 24, 2019
• Study Start: April 1, 2019
• Primary Completion: December 31, 2022
• Study Completion: April 30, 2023
• Last Updated: November 30, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CH (2)