<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03815604</url>
  </required_header>
  <id_info>
    <org_study_id>10531C_179451</org_study_id>
    <nct_id>NCT03815604</nct_id>
  </id_info>
  <brief_title>Independent Housing and Support for People With Severe Mental Illness</brief_title>
  <official_title>Independent Housing and Support for People With Severe Mental Illness: Randomized Controlled Trial vs. Observational Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Bern</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Zurich</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Swiss National Science Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Bern</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background: Adequate and stable housing conditions are fundamental for the psychiatric&#xD;
      rehabilitation of individuals with severe mental illness (SMI). A common approach in&#xD;
      psychiatric rehabilitation relies on a continuum of residential services that aims at&#xD;
      enabling the person with SMI to live eventually independently. Current state of research,&#xD;
      however, shows clearly that most persons in question remain in residential care settings or&#xD;
      other treatment as usual conditions (RCS/TAU). The Independent Housing and Support (IHS)&#xD;
      scheme is a new model that aims at direct placement in an independent accommodation in the&#xD;
      community. Support is provided according to individual needs in a permanent housing situation&#xD;
      without time limit. Up to now, randomized controlled trials (RCTs) to evaluate the&#xD;
      effectiveness of IHS have only been conducted with homeless populations in North America. The&#xD;
      purpose of the present study is to evaluate IHS compared to traditional RCS/TAU for&#xD;
      non-homeless persons with severe mental illness. With this study, the investigators aim at&#xD;
      demonstrating that IHS is not inferior to RCS/TAU. The rationale for utilizing a&#xD;
      non-inferiority approach is based on the current state of research and on research that has&#xD;
      shown strong preferences for IHS against RCS/TAU by people with SMI.&#xD;
&#xD;
      Methods: As the preference issue makes RCTs in housing research difficult the investigators&#xD;
      will use a specific time window in Zurich that allows conducting a RCT due to a scarcity of&#xD;
      IHS settings and will combine the RCT with a comparative observational study in Berne where&#xD;
      IHS is already well-established. At the Zurich site, a RCT compares the effects of living&#xD;
      with IHS against living in residential care. At the Berne site, an observational study design&#xD;
      (OSD) will be applied in connection with the same types of housing as in Zurich. Propensity&#xD;
      scoring will be utilized to minimize the risk of bias in the OSD. A number of N=56 eligible&#xD;
      subjects in Zurich and N=112 subjects (due to specific requirements for propensity scoring)&#xD;
      in Berne complying with the inclusion criteria will be recruited and allocated to&#xD;
      intervention and control groups according to the site-specific study designs. Recruitment&#xD;
      period will last 21 months.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">April 1, 2019</start_date>
  <completion_date type="Anticipated">April 30, 2023</completion_date>
  <primary_completion_date type="Actual">December 31, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <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.&#xD;
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.</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Social Functioning Scale (SFS)</measure>
    <time_frame>Change from baseline (T0) to 24 months (T3)</time_frame>
    <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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Health of the Nation Outcome Scales (HoNOS)</measure>
    <time_frame>Change from baseline (T0) to 24 months (T3)</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Global Assessment of Functioning (GAF)</measure>
    <time_frame>Change from baseline (T0) to 24 months (T3)</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Manchester Short Assessment of Quality of Life (MANSA)</measure>
    <time_frame>Change from baseline (T0) to 24 months (T3)</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Symptom Check List (SCL-K-9)</measure>
    <time_frame>Change from baseline (T0) to 24 months (T3)</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diagnoses according to International Classification of Diseases 10 (ICD-10 diagnoses)</measure>
    <time_frame>The diagnoses will be assessed at baseline (T0) and after 24 months (T3)</time_frame>
    <description>Clinical records</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Camberwell Assessment of Need Short Appraisal Schedule (CANSAS)</measure>
    <time_frame>Change from baseline (T0) to 24 months (T3)</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oxford Capabilities Questionnaire - Mental Health (OxCAP)</measure>
    <time_frame>Change from baseline (T0) to 24 months (T3)</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Important life events, measured with a single item</measure>
    <time_frame>Important life events will be assessed at baseline (T0), after 6 months (T1), 12 months (T2), and after 24 months (T3)</time_frame>
    <description>Important Life Events for the last six months (at baseline) or since the last assessment, respectively. Free text with subsequent coding</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Social Support</measure>
    <time_frame>Change from baseline (T0) to 24 months (T3)</time_frame>
    <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.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Client Sociodemographic and Service Receipt Inventory - adapted (CSSRI-EU); Question 1</measure>
    <time_frame>The CSSRI-EU will be assessed at baseline (T0), after 6 months (T1), 12 months (T2), and after 24 months (T3)</time_frame>
    <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.</description>
  </other_outcome>
  <other_outcome>
    <measure>Client Sociodemographic and Service Receipt Inventory - adapted (CSSRI-EU); Question 2</measure>
    <time_frame>The CSSRI-EU will be assessed at baseline (T0), after 6 months (T1), 12 months (T2), and after 24 months (T3)</time_frame>
    <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.</description>
  </other_outcome>
  <other_outcome>
    <measure>Client Sociodemographic and Service Receipt Inventory - adapted (CSSRI-EU); Question 3</measure>
    <time_frame>The CSSRI-EU will be assessed at baseline (T0), after 6 months (T1), 12 months (T2), and after 24 months (T3)</time_frame>
    <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.</description>
  </other_outcome>
  <other_outcome>
    <measure>Client Sociodemographic and Service Receipt Inventory - adapted (CSSRI-EU); Question 4</measure>
    <time_frame>The CSSRI-EU will be assessed at baseline (T0), after 6 months (T1), 12 months (T2), and after 24 months (T3)</time_frame>
    <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.</description>
  </other_outcome>
  <other_outcome>
    <measure>Client Sociodemographic and Service Receipt Inventory - adapted (CSSRI-EU); Question 5</measure>
    <time_frame>The CSSRI-EU will be assessed at baseline (T0), after 6 months (T1), 12 months (T2), and after 24 months (T3)</time_frame>
    <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.</description>
  </other_outcome>
  <other_outcome>
    <measure>Client Sociodemographic and Service Receipt Inventory - adapted (CSSRI-EU); Question 6</measure>
    <time_frame>The CSSRI-EU will be assessed at baseline (T0), after 6 months (T1), 12 months (T2), and after 24 months (T3)</time_frame>
    <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.</description>
  </other_outcome>
  <other_outcome>
    <measure>Client Sociodemographic and Service Receipt Inventory - adapted (CSSRI-EU); Question 7</measure>
    <time_frame>The CSSRI-EU will be assessed at baseline (T0), after 6 months (T1), 12 months (T2), and after 24 months (T3)</time_frame>
    <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.</description>
  </other_outcome>
  <other_outcome>
    <measure>Client Sociodemographic and Service Receipt Inventory - adapted (CSSRI-EU); Question 8</measure>
    <time_frame>The CSSRI-EU will be assessed at baseline (T0), after 6 months (T1), 12 months (T2), and after 24 months (T3)</time_frame>
    <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.</description>
  </other_outcome>
  <other_outcome>
    <measure>Client Sociodemographic and Service Receipt Inventory - adapted (CSSRI-EU); Question 9</measure>
    <time_frame>The CSSRI-EU will be assessed at baseline (T0), after 6 months (T1), 12 months (T2), and after 24 months (T3)</time_frame>
    <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.</description>
  </other_outcome>
  <other_outcome>
    <measure>Mean number and duration of contacts with service user in IHS</measure>
    <time_frame>Contact frequency and duration will be assessed at baseline (T0), after 6 months (T1), 12 months (T2), and after 24 months (T3)</time_frame>
    <description>Activity recording with medical tariff (TARMED) reimbursement tool</description>
  </other_outcome>
  <other_outcome>
    <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)]</measure>
    <time_frame>Model Fidelity will be assessed in months 1-3 and again in month 45.</time_frame>
    <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.</description>
  </other_outcome>
  <other_outcome>
    <measure>Housing First Fidelity Scale</measure>
    <time_frame>Comparability to HF-Programs will be assessed in months 1-3 and again in month 45.</time_frame>
    <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.</description>
  </other_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">143</enrollment>
  <condition>Severe Mental Disorder</condition>
  <arm_group>
    <arm_group_label>RCT-IHS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Behavioral: At the Zurich site, the experimental intervention is called Independent Housing and Support</description>
  </arm_group>
  <arm_group>
    <arm_group_label>RCT-RCS/TAU</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Behavioral: At the Zurich site, the comparator is usual residential care</description>
  </arm_group>
  <arm_group>
    <arm_group_label>OSD-IHS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Behavioral: At the Berne site, the experimental intervention is called Independent Housing and Support</description>
  </arm_group>
  <arm_group>
    <arm_group_label>OSD-RCS/TAU</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Behavioral: At the Berne site, the comparator is usual residential care</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Independent Housing and Support (IHS)</intervention_name>
    <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.</description>
    <arm_group_label>OSD-IHS</arm_group_label>
    <arm_group_label>RCT-IHS</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Residential Care Settings and other Treatment as Usual (RCS/TAU)</intervention_name>
    <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.</description>
    <arm_group_label>OSD-RCS/TAU</arm_group_label>
    <arm_group_label>RCT-RCS/TAU</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Primary mental disorder according to ICD-10-categories&#xD;
&#xD;
          -  Age 18 to 65 years&#xD;
&#xD;
          -  Ability to communicate in German language&#xD;
&#xD;
          -  Ability to give informed consent&#xD;
&#xD;
          -  Written informed consent as documented by signature&#xD;
&#xD;
          -  Ability to take medication if indicated&#xD;
&#xD;
          -  Willingness to handle out of pocket expenses or established assistance by&#xD;
             custodian/guardian&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe learning disability, intoxication, delirium, dementia&#xD;
&#xD;
          -  Participants lacking capacity&#xD;
&#xD;
          -  Indication for hospital treatment due to acute symptomatology at admission&#xD;
&#xD;
          -  Acute endangerment of self or others&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dirk Richter, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Bern University Hospital for Mental Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital for Mental Health Bern, Center for Psychiatric Rehabilitation</name>
      <address>
        <city>Bern</city>
        <zip>3008</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Psychiatric University Hospital Zurich</name>
      <address>
        <city>Zürich</city>
        <zip>8032</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <link>
    <url>https://www.upd.ch/de/forschung/psychiatrische-rehabilitation/</url>
    <description>Website of psychiatric rehabilitation research group</description>
  </link>
  <reference>
    <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>
    <PMID>28620944</PMID>
  </reference>
  <reference>
    <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>
    <PMID>28160182</PMID>
  </reference>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>December 4, 2018</study_first_submitted>
  <study_first_submitted_qc>January 23, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 24, 2019</study_first_posted>
  <last_update_submitted>March 8, 2023</last_update_submitted>
  <last_update_submitted_qc>March 8, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 9, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Psychiatric Rehabilitation</keyword>
  <keyword>Supported Housing</keyword>
  <keyword>Residential Care</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mental Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03815604
org study id: 10531C_179451
nct id: NCT03815604
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
primary purpose: Supportive Care
masking: None (Open Label)
measure: Social Functioning Scale (SFS)
time frame: Change from baseline (T0) to 24 months (T3)
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.
measure: Health of the Nation Outcome Scales (HoNOS)
time frame: Change from baseline (T0) to 24 months (T3)
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.
measure: Global Assessment of Functioning (GAF)
time frame: Change from baseline (T0) to 24 months (T3)
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.
measure: Manchester Short Assessment of Quality of Life (MANSA)
time frame: Change from baseline (T0) to 24 months (T3)
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.
measure: Symptom Check List (SCL-K-9)
time frame: Change from baseline (T0) to 24 months (T3)
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.
measure: 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)
description: Clinical records
measure: Camberwell Assessment of Need Short Appraisal Schedule (CANSAS)
time frame: Change from baseline (T0) to 24 months (T3)
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.
measure: Oxford Capabilities Questionnaire - Mental Health (OxCAP)
time frame: Change from baseline (T0) to 24 months (T3)
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.
measure: 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)
description: Important Life Events for the last six months (at baseline) or since the last assessment, respectively. Free text with subsequent coding
measure: Social Support
time frame: Change from baseline (T0) to 24 months (T3)
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.
measure: 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)
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.
measure: 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)
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.
measure: 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)
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.
measure: 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)
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.
measure: 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)
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.
measure: 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)
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.
measure: 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)
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.
measure: 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)
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.
measure: 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)
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.
measure: 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)
description: Activity recording with medical tariff (TARMED) reimbursement tool
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)]
time frame: Model Fidelity will be assessed in months 1-3 and again in month 45.
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.
measure: Housing First Fidelity Scale
time frame: Comparability to HF-Programs will be assessed in months 1-3 and again in month 45.
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.
arm group label: RCT-IHS
arm group type: Experimental
description: Behavioral: At the Zurich site, the experimental intervention is called Independent Housing and Support
arm group label: RCT-RCS/TAU
arm group type: Active Comparator
description: Behavioral: At the Zurich site, the comparator is usual residential care
arm group label: OSD-IHS
arm group type: Experimental
description: Behavioral: At the Berne site, the experimental intervention is called Independent Housing and Support
arm group label: OSD-RCS/TAU
arm group type: Active Comparator
description: Behavioral: At the Berne site, the comparator is usual residential care
intervention type: Behavioral
intervention name: Independent Housing and Support (IHS)
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.
arm group label: OSD-IHS
arm group label: RCT-IHS
intervention type: Behavioral
intervention name: Residential Care Settings and other Treatment as Usual (RCS/TAU)
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.
arm group label: OSD-RCS/TAU
arm group label: RCT-RCS/TAU
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Dirk Richter, PhD
role: Principal Investigator
affiliation: Bern University Hospital for Mental Health
facility: 
facility: 
country: Switzerland
url: https://www.upd.ch/de/forschung/psychiatrische-rehabilitation/
description: Website of psychiatric rehabilitation research group
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.
PMID: 28620944
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.
PMID: 28160182
responsible party type: Sponsor
mesh term: Mental Disorders
sharing ipd: No