Clinical trial NCT03815604: Independent Housing and Support for People With Severe Mental Illness
Official title: Independent Housing and Support for People With Severe Mental Illness: Randomized Controlled Trial vs. Observational Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Severe Mental Disorder
Keywords: Psychiatric Rehabilitation
Supported Housing
Residential Care
Lead sponsor: University of Bern
Sponsor class: OTHER
Collaborators: name: University of Zurich
name: Swiss National Science Foundation
First posted: 2019-01-24
Enrollment: 143
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Social Functioning Scale (SFS)
timeFrame: Change from baseline (T0) to 24 months (T3)
Secondary outcomes:
measure: Health of the Nation Outcome Scales (HoNOS)
timeFrame: Change from baseline (T0) to 24 months (T3)
measure: Global Assessment of Functioning (GAF)
timeFrame: Change from baseline (T0) to 24 months (T3)
measure: Manchester Short Assessment of Quality of Life (MANSA)
timeFrame: Change from baseline (T0) to 24 months (T3)
measure: Symptom Check List (SCL-K-9)
timeFrame: Change from baseline (T0) to 24 months (T3)
measure: Diagnoses according to International Classification of Diseases 10 (ICD-10 diagnoses)
timeFrame: The diagnoses will be assessed at baseline (T0) and after 24 months (T3)
measure: Camberwell Assessment of Need Short Appraisal Schedule (CANSAS)
timeFrame: Change from baseline (T0) to 24 months (T3)
measure: Oxford Capabilities Questionnaire - Mental Health (OxCAP)
timeFrame: Change from baseline (T0) to 24 months (T3)
measure: Important life events, measured with a single item
timeFrame: Important life events will be assessed at baseline (T0), after 6 months (T1), 12 months (T2), and after 24 months (T3)
measure: Social Support
timeFrame: Change from baseline (T0) to 24 months (T3)
Other outcomes:
measure: Client Sociodemographic and Service Receipt Inventory - adapted (CSSRI-EU); Question 1
timeFrame: The CSSRI-EU will be assessed at baseline (T0), after 6 months (T1), 12 months (T2), and after 24 months (T3)
measure: Client Sociodemographic and Service Receipt Inventory - adapted (CSSRI-EU); Question 2
timeFrame: The CSSRI-EU will be assessed at baseline (T0), after 6 months (T1), 12 months (T2), and after 24 months (T3)
measure: Client Sociodemographic and Service Receipt Inventory - adapted (CSSRI-EU); Question 3
timeFrame: The CSSRI-EU will be assessed at baseline (T0), after 6 months (T1), 12 months (T2), and after 24 months (T3)
measure: Client Sociodemographic and Service Receipt Inventory - adapted (CSSRI-EU); Question 4
timeFrame: The CSSRI-EU will be assessed at baseline (T0), after 6 months (T1), 12 months (T2), and after 24 months (T3)
measure: Client Sociodemographic and Service Receipt Inventory - adapted (CSSRI-EU); Question 5
timeFrame: The CSSRI-EU will be assessed at baseline (T0), after 6 months (T1), 12 months (T2), and after 24 months (T3)
measure: Client Sociodemographic and Service Receipt Inventory - adapted (CSSRI-EU); Question 6
timeFrame: The CSSRI-EU will be assessed at baseline (T0), after 6 months (T1), 12 months (T2), and after 24 months (T3)
measure: Client Sociodemographic and Service Receipt Inventory - adapted (CSSRI-EU); Question 7
timeFrame: The CSSRI-EU will be assessed at baseline (T0), after 6 months (T1), 12 months (T2), and after 24 months (T3)
measure: Client Sociodemographic and Service Receipt Inventory - adapted (CSSRI-EU); Question 8
timeFrame: The CSSRI-EU will be assessed at baseline (T0), after 6 months (T1), 12 months (T2), and after 24 months (T3)
measure: Client Sociodemographic and Service Receipt Inventory - adapted (CSSRI-EU); Question 9
timeFrame: The CSSRI-EU will be assessed at baseline (T0), after 6 months (T1), 12 months (T2), and after 24 months (T3)
measure: Mean number and duration of contacts with service user in IHS
timeFrame: Contact frequency and duration will be assessed at baseline (T0), after 6 months (T1), 12 months (T2), and after 24 months (T3)
measure: Independent Housing and Support for people with mental disorders - Fidelity Scale [Selbstbestimmtes Wohnen mit Unterstützung für Menschen mit psychischen Beeinträchtigungen - Modelltreue Skala (SeWo-Psych)]
timeFrame: Model Fidelity will be assessed in months 1-3 and again in month 45.
measure: Housing First Fidelity Scale
timeFrame: Comparability to HF-Programs will be assessed in months 1-3 and again in month 45.
Locations:
city: Bern
country: Switzerland
facility: University Hospital for Mental Health Bern, Center for Psychiatric Rehabilitation
city: Zürich
country: Switzerland
facility: Psychiatric University Hospital Zurich
Study officials:
affiliation: Bern University Hospital for Mental Health
name: Dirk Richter, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.