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Independent Housing and Support for People With Severe Mental Illness

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03815604
Recruitment Status : Not yet recruiting
First Posted : January 24, 2019
Last Update Posted : February 21, 2019
Sponsor:
Collaborators:
University of Zurich
Swiss National Science Foundation
Information provided by (Responsible Party):
University of Bern

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 (RCS). 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 for non-homeless persons with severe mental illness. With this study, the investigators aim at demonstrating that IHS is not inferior to RCS. 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 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.


Condition or disease Intervention/treatment Phase
Severe Mental Disorder Behavioral: Independent Housing and Support (IHS) Behavioral: Residential Care Settings (RCS) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 168 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.

Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Independent Housing and Support for People With Severe Mental Illness: Randomized Controlled Trial vs. Observational Study
Estimated Study Start Date : March 1, 2019
Estimated Primary Completion Date : September 30, 2022
Estimated Study Completion Date : September 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mental Disorders

Arm Intervention/treatment
Experimental: RCT-IHS
Behavioral: At the Zurich site, the experimental intervention is called Independent Housing and Support
Behavioral: 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.

Active Comparator: RCT-RCS
Behavioral: At the Zurich site, the comparator is usual residential care
Behavioral: Residential Care Settings (RCS)
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.

Experimental: OSD-IHS
Behavioral: At the Berne site, the experimental intervention is called Independent Housing and Support
Behavioral: 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.

Active Comparator: OSD-RCS
Behavioral: At the Berne site, the comparator is usual residential care
Behavioral: Residential Care Settings (RCS)
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 Measures :
  1. Social Functioning Scale (SFS) [ Time Frame: Change from baseline (T0) to 24 months (T3) ]
    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 :
  1. Health of the Nation Outcome Scales (HoNOS) [ Time Frame: Change from baseline (T0) to 24 months (T3) ]
    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.

  2. Global Assessment of Functioning (GAF) [ Time Frame: Change from baseline (T0) to 24 months (T3) ]
    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.

  3. Manchester Short Assessment of Quality of Life (MANSA) [ Time Frame: Change from baseline (T0) to 24 months (T3) ]
    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.

  4. Symptom Check List (SCL-K-9) [ Time Frame: Change from baseline (T0) to 24 months (T3) ]
    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.

  5. Diagnoses according to International Classification of Diseases 10 (ICD-10 diagnoses) [ Time Frame: The diagnoses will be assessed at baseline (T0) and after 24 months (T3) ]
    Clinical records

  6. Camberwell Assessment of Need Short Appraisal Schedule (CANSAS) [ Time Frame: Change from baseline (T0) to 24 months (T3) ]
    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.

  7. Oxford Capabilities Questionnaire - Mental Health (OxCAP) [ Time Frame: Change from baseline (T0) to 24 months (T3) ]
    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.

  8. Important life events, measured with a single item [ Time Frame: Important life events will be assessed at baseline (T0), after 6 months (T1), 12 months (T2), and after 24 months (T3) ]
    Important Life Events for the last six months (at baseline) or since the last assessment, respectively. Free text with subsequent coding

  9. Social Support [ Time Frame: Change from baseline (T0) to 24 months (T3) ]
    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.


Other Outcome Measures:
  1. Client Sociodemographic and Service Receipt Inventory - adapted (CSSRI-EU); Question 1 [ Time Frame: The CSSRI-EU will be assessed at baseline (T0), after 6 months (T1), 12 months (T2), and after 24 months (T3) ]
    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.

  2. Client Sociodemographic and Service Receipt Inventory - adapted (CSSRI-EU); Question 2 [ Time Frame: The CSSRI-EU will be assessed at baseline (T0), after 6 months (T1), 12 months (T2), and after 24 months (T3) ]
    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.

  3. Client Sociodemographic and Service Receipt Inventory - adapted (CSSRI-EU); Question 3 [ Time Frame: The CSSRI-EU will be assessed at baseline (T0), after 6 months (T1), 12 months (T2), and after 24 months (T3) ]
    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.

  4. Client Sociodemographic and Service Receipt Inventory - adapted (CSSRI-EU); Question 4 [ Time Frame: The CSSRI-EU will be assessed at baseline (T0), after 6 months (T1), 12 months (T2), and after 24 months (T3) ]
    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.

  5. Client Sociodemographic and Service Receipt Inventory - adapted (CSSRI-EU); Question 5 [ Time Frame: The CSSRI-EU will be assessed at baseline (T0), after 6 months (T1), 12 months (T2), and after 24 months (T3) ]
    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.

  6. Client Sociodemographic and Service Receipt Inventory - adapted (CSSRI-EU); Question 6 [ Time Frame: The CSSRI-EU will be assessed at baseline (T0), after 6 months (T1), 12 months (T2), and after 24 months (T3) ]
    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.

  7. Client Sociodemographic and Service Receipt Inventory - adapted (CSSRI-EU); Question 7 [ Time Frame: The CSSRI-EU will be assessed at baseline (T0), after 6 months (T1), 12 months (T2), and after 24 months (T3) ]
    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.

  8. Client Sociodemographic and Service Receipt Inventory - adapted (CSSRI-EU); Question 8 [ Time Frame: The CSSRI-EU will be assessed at baseline (T0), after 6 months (T1), 12 months (T2), and after 24 months (T3) ]
    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.

  9. Client Sociodemographic and Service Receipt Inventory - adapted (CSSRI-EU); Question 9 [ Time Frame: The CSSRI-EU will be assessed at baseline (T0), after 6 months (T1), 12 months (T2), and after 24 months (T3) ]
    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.

  10. Mean number and duration of contacts with service user in IHS [ Time Frame: Contact frequency and duration will be assessed at baseline (T0), after 6 months (T1), 12 months (T2), and after 24 months (T3) ]
    Activity recording with medical tariff (TARMED) reimbursement tool

  11. Independent Housing and Support for people with mental disorders - Fidelity Scale [Selbstbestimmtes Wohnen mit Unterstützung für Menschen mit psychischen Beeinträchtigungen - Modelltreue Skala (SeWo-Psych)] [ Time Frame: Model Fidelity will be assessed in months 1-3 and again in month 45. ]
    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.

  12. Housing First Fidelity Scale [ Time Frame: Comparability to HF-Programs will be assessed in months 1-3 and again in month 45. ]
    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.



Information from the National Library of Medicine

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Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03815604


Contacts
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Contact: Dirk Richter, PhD +41316324707 dirk.richter@upd.unibe.ch
Contact: Christine Adamus, MSc +41316324705 christine.adamus@upd.unibe.ch

Locations
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Switzerland
University Hospital for Mental Health Bern, Center for Psychiatric Rehabilitation Not yet recruiting
Bern, Switzerland, 3008
Contact: Dirk Richter, Dr.    +41 31 632 47 07    dirk.richter@upd.unibe.ch   
Psychiatric University Hospital Zurich Not yet recruiting
Zürich, Switzerland, 8032
Contact: Matthias Jäger, PD Dr.       Matthias.Jaeger@puk.zh.ch   
Sponsors and Collaborators
University of Bern
University of Zurich
Swiss National Science Foundation
Investigators
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Principal Investigator: Dirk Richter, PhD Bern University Hospital for Mental Health

Additional Information:
Publications:
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Responsible Party: University of Bern
ClinicalTrials.gov Identifier: NCT03815604     History of Changes
Other Study ID Numbers: 10531C_179451
First Posted: January 24, 2019    Key Record Dates
Last Update Posted: February 21, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Bern:
Psychiatric Rehabilitation
Supported Housing
Residential Care

Additional relevant MeSH terms:
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Mental Disorders
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders