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Independent Housing and Support for People With Severe Mental Illness

Primary Purpose

Severe Mental Disorder

Status
Active
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Independent Housing and Support (IHS)
Residential Care Settings and other Treatment as Usual (RCS/TAU)
Sponsored by
University of Bern
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Severe Mental Disorder focused on measuring Psychiatric Rehabilitation, Supported Housing, Residential Care

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University Hospital for Mental Health Bern, Center for Psychiatric Rehabilitation
  • Psychiatric University Hospital Zurich

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Arm Label

RCT-IHS

RCT-RCS/TAU

OSD-IHS

OSD-RCS/TAU

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Health of the Nation Outcome Scales (HoNOS)
The HoNOS will be used to assess changes in participant's functioning. It will be rated by key worker on a 5-point Likert scale in terms of the following items: 1) aggression, 2) self-harm, 3) substance use, 4) cognitive dysfunction, 5) physical disability, 6) hallucinations and delusions, 7) depression, 8) other symptoms, 9) personal relationships, 10) overall functioning, 11) residential problems, 12) occupational problems. The summed-up total-score ranges from 0 to 48 with lower score indicating better functioning.
Global Assessment of Functioning (GAF)
The GAF is a scale rated by key worker and will be used to assess changes in participant's functioning. Illness severity is rated as a single item based on psychopathology and functioning on a 1 to 100 scale with higher score as indicator for better functioning.
Manchester Short Assessment of Quality of Life (MANSA)
The MANSA is an interview and will be used to assess changes in participant's quality of life. It consists of three sections with total 25 items: 1) personal details, consistent over time (date of birth, gender, diagnosis), 2) personal details, potentially varying over time and to be redocumented if change has occurred (education, employment, income, state benefits, living situation, people the participant lives with, type of residence), and 3) 16 questions that are asked every time. Four of the section three questions are termed objective and are to be answered with yes/no. Twelve of the section three questions are called subjective and ask for answering participant's satisfaction on a 7-point Likert scale. The final score will be computed by averaging the 12 individual items with higher score indicates higher quality of life.
Symptom Check List (SCL-K-9)
The SCL-K-9 is a questionnaire and will be used to assess changes in participant's mental state on a 5-point Likert scale, including items from all of the nine subscales of the original SCL-90-R: 1) depression, 2) anxiety, 3) somatization, 4) phobic fear, 5) obsessive-compulsive, 6) psychoticism, 7) social insecurity, 8) paranoid thinking, 9) hostility. The total-score ranges from 0 to 36 with lower score indicating better mental states.
Diagnoses according to International Classification of Diseases 10 (ICD-10 diagnoses)
Clinical records
Camberwell Assessment of Need Short Appraisal Schedule (CANSAS)
The CANSAS is an interview and will be used to assess changes in participant's needs in 22 health and social domains on a 3-point Likert scale (no problem; met need; unmet need). For interpretation, the met and unmet needs each will be summed-up.
Oxford Capabilities Questionnaire - Mental Health (OxCAP)
The OxCAP is a questionnaire and will be used to assess changes in participant's capabilities that covers the following domains of functioning and welfare based on 16 items to answer on a 5-point Likert scale: 1) life, 2) bodily health, 3) bodily integrity, 4) senses, imagination and thought, 5) emotions, 6) practical reason, 7) affiliation, 8) species, 9) play, and 10) control over one's environment. The initial index total-score ranges from 16 to 80 and is converted into a standardised 0 to 100 final score with higher score indicating better capabilities.
Important life events, measured with a single item
Important Life Events for the last six months (at baseline) or since the last assessment, respectively. Free text with subsequent coding
Social Support
A self-generated questionnaire will be used to measure changes in participant's social and living support. The questionnaire consists of 24 items to be answered on a 5-point Likert scale. Total score rages from 24 to 120 with higher score indicating higher support.

Full Information

First Posted
December 4, 2018
Last Updated
March 8, 2023
Sponsor
University of Bern
Collaborators
University of Zurich, Swiss National Science Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT03815604
Brief Title
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

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
December 31, 2022 (Actual)
Study Completion Date
April 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Bern
Collaborators
University of Zurich, Swiss National Science Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Mental Disorder
Keywords
Psychiatric Rehabilitation, Supported Housing, Residential Care

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
143 (Actual)

8. Arms, Groups, and Interventions

Arm Title
RCT-IHS
Arm Type
Experimental
Arm Description
Behavioral: At the Zurich site, the experimental intervention is called Independent Housing and Support
Arm Title
RCT-RCS/TAU
Arm Type
Active Comparator
Arm Description
Behavioral: At the Zurich site, the comparator is usual residential care
Arm Title
OSD-IHS
Arm Type
Experimental
Arm Description
Behavioral: At the Berne site, the experimental intervention is called Independent Housing and Support
Arm Title
OSD-RCS/TAU
Arm Type
Active Comparator
Arm Description
Behavioral: At the Berne site, the comparator is usual residential care
Intervention Type
Behavioral
Intervention Name(s)
Independent Housing and Support (IHS)
Intervention Description
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
Intervention Name(s)
Residential Care Settings and other Treatment as Usual (RCS/TAU)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Social Functioning Scale (SFS)
Description
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.
Time Frame
Change from baseline (T0) to 24 months (T3)
Secondary Outcome Measure Information:
Title
Health of the Nation Outcome Scales (HoNOS)
Description
The HoNOS will be used to assess changes in participant's functioning. It will be rated by key worker on a 5-point Likert scale in terms of the following items: 1) aggression, 2) self-harm, 3) substance use, 4) cognitive dysfunction, 5) physical disability, 6) hallucinations and delusions, 7) depression, 8) other symptoms, 9) personal relationships, 10) overall functioning, 11) residential problems, 12) occupational problems. The summed-up total-score ranges from 0 to 48 with lower score indicating better functioning.
Time Frame
Change from baseline (T0) to 24 months (T3)
Title
Global Assessment of Functioning (GAF)
Description
The GAF is a scale rated by key worker and will be used to assess changes in participant's functioning. Illness severity is rated as a single item based on psychopathology and functioning on a 1 to 100 scale with higher score as indicator for better functioning.
Time Frame
Change from baseline (T0) to 24 months (T3)
Title
Manchester Short Assessment of Quality of Life (MANSA)
Description
The MANSA is an interview and will be used to assess changes in participant's quality of life. It consists of three sections with total 25 items: 1) personal details, consistent over time (date of birth, gender, diagnosis), 2) personal details, potentially varying over time and to be redocumented if change has occurred (education, employment, income, state benefits, living situation, people the participant lives with, type of residence), and 3) 16 questions that are asked every time. Four of the section three questions are termed objective and are to be answered with yes/no. Twelve of the section three questions are called subjective and ask for answering participant's satisfaction on a 7-point Likert scale. The final score will be computed by averaging the 12 individual items with higher score indicates higher quality of life.
Time Frame
Change from baseline (T0) to 24 months (T3)
Title
Symptom Check List (SCL-K-9)
Description
The SCL-K-9 is a questionnaire and will be used to assess changes in participant's mental state on a 5-point Likert scale, including items from all of the nine subscales of the original SCL-90-R: 1) depression, 2) anxiety, 3) somatization, 4) phobic fear, 5) obsessive-compulsive, 6) psychoticism, 7) social insecurity, 8) paranoid thinking, 9) hostility. The total-score ranges from 0 to 36 with lower score indicating better mental states.
Time Frame
Change from baseline (T0) to 24 months (T3)
Title
Diagnoses according to International Classification of Diseases 10 (ICD-10 diagnoses)
Description
Clinical records
Time Frame
The diagnoses will be assessed at baseline (T0) and after 24 months (T3)
Title
Camberwell Assessment of Need Short Appraisal Schedule (CANSAS)
Description
The CANSAS is an interview and will be used to assess changes in participant's needs in 22 health and social domains on a 3-point Likert scale (no problem; met need; unmet need). For interpretation, the met and unmet needs each will be summed-up.
Time Frame
Change from baseline (T0) to 24 months (T3)
Title
Oxford Capabilities Questionnaire - Mental Health (OxCAP)
Description
The OxCAP is a questionnaire and will be used to assess changes in participant's capabilities that covers the following domains of functioning and welfare based on 16 items to answer on a 5-point Likert scale: 1) life, 2) bodily health, 3) bodily integrity, 4) senses, imagination and thought, 5) emotions, 6) practical reason, 7) affiliation, 8) species, 9) play, and 10) control over one's environment. The initial index total-score ranges from 16 to 80 and is converted into a standardised 0 to 100 final score with higher score indicating better capabilities.
Time Frame
Change from baseline (T0) to 24 months (T3)
Title
Important life events, measured with a single item
Description
Important Life Events for the last six months (at baseline) or since the last assessment, respectively. Free text with subsequent coding
Time Frame
Important life events will be assessed at baseline (T0), after 6 months (T1), 12 months (T2), and after 24 months (T3)
Title
Social Support
Description
A self-generated questionnaire will be used to measure changes in participant's social and living support. The questionnaire consists of 24 items to be answered on a 5-point Likert scale. Total score rages from 24 to 120 with higher score indicating higher support.
Time Frame
Change from baseline (T0) to 24 months (T3)
Other Pre-specified Outcome Measures:
Title
Client Sociodemographic and Service Receipt Inventory - adapted (CSSRI-EU); Question 1
Description
The CSSRI-EU is an interview and will be used to assess participant's specific sociodemographic details and service utilization. The first question records the participants' main source of income: Salary, pension, social benefits, family support, other. No score will be calculated.
Time Frame
The CSSRI-EU will be assessed at baseline (T0), after 6 months (T1), 12 months (T2), and after 24 months (T3)
Title
Client Sociodemographic and Service Receipt Inventory - adapted (CSSRI-EU); Question 2
Description
The CSSRI-EU is an interview and will be used to assess participant's specific sociodemographic details and service utilization. The second question asks for the net income in Swiss Francs.
Time Frame
The CSSRI-EU will be assessed at baseline (T0), after 6 months (T1), 12 months (T2), and after 24 months (T3)
Title
Client Sociodemographic and Service Receipt Inventory - adapted (CSSRI-EU); Question 3
Description
The CSSRI-EU is an interview and will be used to assess participant's specific sociodemographic details and service utilization. The third question asks the whereabouts in recent six months (own apartment, with partner, with family, being homeless, other). No score will be calculated.
Time Frame
The CSSRI-EU will be assessed at baseline (T0), after 6 months (T1), 12 months (T2), and after 24 months (T3)
Title
Client Sociodemographic and Service Receipt Inventory - adapted (CSSRI-EU); Question 4
Description
The CSSRI-EU is an interview and will be used to assess participant's specific sociodemographic details and service utilization. The fourth question asks for any health care utilization for physical health problems (inpatient/outpatient). The format for each answer is 1/0. No score will be calculated.
Time Frame
The CSSRI-EU will be assessed at baseline (T0), after 6 months (T1), 12 months (T2), and after 24 months (T3)
Title
Client Sociodemographic and Service Receipt Inventory - adapted (CSSRI-EU); Question 5
Description
The CSSRI-EU is an interview and will be used to assess participant's specific sociodemographic details and service utilization. The fifth question asks for any health care utilization for mental health problems (inpatient/outpatient). The format for each answer is 1/0. No total or mean score will be calculated.
Time Frame
The CSSRI-EU will be assessed at baseline (T0), after 6 months (T1), 12 months (T2), and after 24 months (T3)
Title
Client Sociodemographic and Service Receipt Inventory - adapted (CSSRI-EU); Question 6
Description
The CSSRI-EU is an interview and will be used to assess participant's specific sociodemographic details and service utilization. The sixth question asks for any intake of psychotropic medication. No score will be calculated.
Time Frame
The CSSRI-EU will be assessed at baseline (T0), after 6 months (T1), 12 months (T2), and after 24 months (T3)
Title
Client Sociodemographic and Service Receipt Inventory - adapted (CSSRI-EU); Question 7
Description
The CSSRI-EU is an interview and will be used to assess participant's specific sociodemographic details and service utilization. The seventh question asks for any contact with the criminal justice services. No score will be calculated.
Time Frame
The CSSRI-EU will be assessed at baseline (T0), after 6 months (T1), 12 months (T2), and after 24 months (T3)
Title
Client Sociodemographic and Service Receipt Inventory - adapted (CSSRI-EU); Question 8
Description
The CSSRI-EU is an interview and will be used to assess participant's specific sociodemographic details and service utilization. The eighth question asks for any internet access. No score will be calculated.
Time Frame
The CSSRI-EU will be assessed at baseline (T0), after 6 months (T1), 12 months (T2), and after 24 months (T3)
Title
Client Sociodemographic and Service Receipt Inventory - adapted (CSSRI-EU); Question 9
Description
The CSSRI-EU is an interview and will be used to assess participant's specific sociodemographic details and service utilization. The ninth question asks for any other support utilized in the past six months (daycare, workshops, vocational rehabilitation, integration services, self-help groups, other). No score will be calculated.
Time Frame
The CSSRI-EU will be assessed at baseline (T0), after 6 months (T1), 12 months (T2), and after 24 months (T3)
Title
Mean number and duration of contacts with service user in IHS
Description
Activity recording with medical tariff (TARMED) reimbursement tool
Time Frame
Contact frequency and duration will be assessed at baseline (T0), after 6 months (T1), 12 months (T2), and after 24 months (T3)
Title
Independent Housing and Support for people with mental disorders - Fidelity Scale [Selbstbestimmtes Wohnen mit Unterstützung für Menschen mit psychischen Beeinträchtigungen - Modelltreue Skala (SeWo-Psych)]
Description
The SeWo-Psych is an interview and will be used to assess model fidelity of the residential rehabilitation service Independent Housing and Support (IHS) to be conducted with heads of rehabilitation services. The 32 items are to be answered on a 5-point Likert scale, with higher score indicating higher fidelity. Score will be summed up to a total-score.
Time Frame
Model Fidelity will be assessed in months 1-3 and again in month 45.
Title
Housing First Fidelity Scale
Description
The Housing First Fidelity Scale is a 38-item interview assessing model fidelity in Housing First (HF) Programs asking for the following subscales on a 5-point Likert scale: 1) housing choice and structure, 2) separation of housing and clinical services, 3) service philosophy, 4) service array, and 5) program structure. It will be assessed to enhance comparability of IHS in Switzerland with HF-Programs. Items were answered by heads of each rehabilitation service on a 5-point Likert scale, with higher score representing higher similarity with HF-Programs.
Time Frame
Comparability to HF-Programs will be assessed in months 1-3 and again in month 45.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dirk Richter, PhD
Organizational Affiliation
Bern University Hospital for Mental Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital for Mental Health Bern, Center for Psychiatric Rehabilitation
City
Bern
ZIP/Postal Code
3008
Country
Switzerland
Facility Name
Psychiatric University Hospital Zurich
City
Zürich
ZIP/Postal Code
8032
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28620944
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.
Results Reference
background
PubMed Identifier
28160182
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.
Results Reference
background
PubMed Identifier
35126208
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.
Results Reference
derived
PubMed Identifier
32560681
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.
Results Reference
derived
Links:
URL
https://www.upd.ch/de/forschung/psychiatrische-rehabilitation/
Description
Website of psychiatric rehabilitation research group

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Independent Housing and Support for People With Severe Mental Illness

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