Severe Mental DisorderNCT03815604
Independent Housing and Support for People With Severe Mental Illness
A study testing Independent Housing and Support (IHS) and Residential Care Settings and other Treatment as Usual (RCS/TAU) in people with Severe Mental Disorder, run by University of Bern at 2 sites in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Severe Mental Disorder
- What is being tested?
- Independent Housing and Support (IHS) and Residential Care Settings and other Treatment as Usual (RCS/TAU)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 143 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 1 Apr 2019to 30 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
University Hospital for Mental Health Bern, Center for Psychiatric Rehabilitation
Bern, 3008
Psychiatric University Hospital Zurich
Zurich, 8032
About this study
Official title: Independent Housing and Support for People With Severe Mental Illness: Randomized Controlled Trial vs. Observational Study
Background: Adequate and stable housing conditions are fundamental for the psychiatric rehabilitation of individuals with severe mental illness (SMI). A common approach in psychiatric rehabilitation relies on a continuum of residential services that aims at enabling the person with SMI to live eventually independently. Current state of research, however, shows clearly that most persons in question remain in residential care settings or other treatment as usual conditions (RCS/TAU). The Independent Housing and Support (IHS) scheme is a new model that aims at direct placement in an independent accommodation in the community. Support is provided according to individual needs in a permanent housing situation without time limit. Up to now, randomized controlled trials (RCTs) to evaluate the effectiveness of IHS have only been conducted with homeless populations in North America. The purpose of the present study is to evaluate IHS compared to traditional RCS/TAU for non-homeless persons with severe mental illness. With this study, the investigators aim at demonstrating that IHS is not inferior to RCS/TAU. The rationale for utilizing a non-inferiority approach is based on the current state of research and on research that has shown strong preferences for IHS against RCS/TAU by people with SMI.
Methods: As the preference issue makes RCTs in housing research difficult the investigators will use a specific time window in Zurich that allows conducting a RCT due to a scarcity of IHS settings and will combine the RCT with a comparative observational study in Berne where IHS is already well-established. At the Zurich site, a RCT compares the effects of living with IHS against living in residential care. At the Berne site, an observational study design (OSD) will be applied in connection with the same types of housing as in Zurich. Propensity scoring will be utilized to minimize the risk of bias in the OSD. A number of N=56 eligible subjects in Zurich and N=112 subjects (due to specific requirements for propensity scoring) in Berne complying with the inclusion criteria will be recruited and allocated to intervention and control groups according to the site-specific study designs. Recruitment period will last 21 months.
- Conditions
- Severe Mental Disorder
- Being tested
- Independent Housing and Support (IHS), Residential Care Settings and other Treatment as Usual (RCS/TAU)
- Keywords
- Psychiatric Rehabilitation, Supported Housing, Residential Care
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Independent Housing and Support (IHS)Behavioural
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.
Residential Care Settings and other Treatment as Usual (RCS/TAU)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| RCT-IHS | Experimental | Behavioral: At the Zurich site, the experimental intervention is called Independent Housing and Support Receives: Behavioral: Independent Housing and Support (IHS) |
| RCT-RCS/TAU | Active comparator | Behavioral: At the Zurich site, the comparator is usual residential care Receives: Behavioral: Residential Care Settings and other Treatment as Usual (RCS/TAU) |
| OSD-IHS | Experimental | Behavioral: At the Berne site, the experimental intervention is called Independent Housing and Support Receives: Behavioral: Independent Housing and Support (IHS) |
| OSD-RCS/TAU | Active comparator | Behavioral: At the Berne site, the comparator is usual residential care Receives: Behavioral: Residential Care Settings and other Treatment as Usual (RCS/TAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline (T0) to 24 months (T3)
Secondary outcomes (9)
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.
Measured: Change from baseline (T0) to 24 months (T3)
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.
Measured: Change from baseline (T0) to 24 months (T3)
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.
Measured: Change from baseline (T0) to 24 months (T3)
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.
Measured: Change from baseline (T0) to 24 months (T3)
Diagnoses according to International Classification of Diseases 10 (ICD-10 diagnoses)
Clinical records
Measured: The diagnoses will be assessed at baseline (T0) and after 24 months (T3)
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.
Measured: Change from baseline (T0) to 24 months (T3)
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.
Measured: Change from baseline (T0) to 24 months (T3)
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
Measured: Important life events will be assessed at baseline (T0), after 6 months (T1), 12 months (T2), and after 24 months (T3)
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.
Measured: Change from baseline (T0) to 24 months (T3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2019
- Study start1 Apr 2019
- Primary completion31 Dec 2022
- Study completion30 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Severe Mental DisorderStudies of the same condition, open and under way.
- More trials run by University of BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bern
- Sponsor type
- University, hospital or other
- Collaborators
- University of Zurich, Swiss National Science Foundation
- Responsible party
- Sponsor
- Investigators
- Dirk Richter, PhD, Principal investigator, Bern University Hospital for Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03815604
- Sponsor's protocol ID
- 10531C_179451
- Status last verified
- Nov 2023
- First submitted
- 4 Dec 2018
- Last updated
- 30 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28620944Richter 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.
PubMed 28160182Adamus C, Motteli S, Jager M, Richter D. Independent Supported Housing vs institutional housing rehabilitation settings for non-homeless individuals with severe mental illness - longitudinal results from an observational study. BMC Psychiatry. 2024 Aug 9;24(1):554. doi: 10.1186/s12888-024-05995-7.
PubMed 39123200Adamus C, Motteli S, Jager M, Richter D. Independent Supported Housing for non-homeless individuals with severe mental illness: Comparison of two effectiveness studies using a randomised controlled and an observational study design. Front Psychiatry. 2022 Nov 10;13:1033328. doi: 10.3389/fpsyt.2022.1033328. eCollection 2022.
PubMed 36440393Motteli 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.
PubMed 35126208Adamus 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.
PubMed 32560681
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Independent Housing and Support for People With Severe Mental Illness: Randomized Controlled Trial vs. Observational Study
- ClinicalTrials.gov ID
- NCT03815604
- Acronym / sponsor ID
- 10531C_179451
- Conditions
- Severe Mental Disorder
- Keywords
- Psychiatric Rehabilitation, Supported Housing, Residential Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- University of BernUniversity, hospital or other
- Collaborators
- University of Zurich, Swiss National Science Foundation
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 24 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| RCT-IHS | Experimental | Behavioral: Independent Housing and Support (IHS)Behavioral: At the Zurich site, the experimental intervention is called Independent Housing and Support |
| RCT-RCS/TAU | Active comparator | Behavioral: Residential Care Settings and other Treatment as Usual (RCS/TAU)Behavioral: At the Zurich site, the comparator is usual residential care |
| OSD-IHS | Experimental | Behavioral: Independent Housing and Support (IHS)Behavioral: At the Berne site, the experimental intervention is called Independent Housing and Support |
| OSD-RCS/TAU | Active comparator | Behavioral: Residential Care Settings and other Treatment as Usual (RCS/TAU)Behavioral: At the Berne site, the comparator is usual residential care |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | OSD-IHS, RCT-IHS |
| Residential Care Settings and other Treatment as Usual (RCS/TAU)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. | Behavioural | OSD-RCS/TAU, RCT-RCS/TAU |
Primary outcome
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.
9 secondary outcomes
Health of the Nation Outcome Scales (HoNOS)
Time frame: Change from baseline (T0) to 24 months (T3)
Global Assessment of Functioning (GAF)
Time frame: Change from baseline (T0) to 24 months (T3)
Manchester Short Assessment of Quality of Life (MANSA)
Time frame: Change from baseline (T0) to 24 months (T3)
Symptom Check List (SCL-K-9)
Time frame: Change from baseline (T0) to 24 months (T3)
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)
Camberwell Assessment of Need Short Appraisal Schedule (CANSAS)
Time frame: Change from baseline (T0) to 24 months (T3)
Oxford Capabilities Questionnaire - Mental Health (OxCAP)
Time frame: Change from baseline (T0) to 24 months (T3)
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)
Social Support
Time frame: Change from baseline (T0) to 24 months (T3)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2023.
- Background: PubMed 28620944Richter 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.
- Background: PubMed 28160182Richter 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.
- Derived from this study: PubMed 39123200Adamus C, Motteli S, Jager M, Richter D. Independent Supported Housing vs institutional housing rehabilitation settings for non-homeless individuals with severe mental illness - longitudinal results from an observational study. BMC Psychiatry. 2024 Aug 9;24(1):554. doi: 10.1186/s12888-024-05995-7.
- Derived from this study: PubMed 36440393Adamus C, Motteli S, Jager M, Richter D. Independent Supported Housing for non-homeless individuals with severe mental illness: Comparison of two effectiveness studies using a randomised controlled and an observational study design. Front Psychiatry. 2022 Nov 10;13:1033328. doi: 10.3389/fpsyt.2022.1033328. eCollection 2022.
- Derived from this study: PubMed 35126208Motteli 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.
- Derived from this study: PubMed 32560681Adamus 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.
- Website of psychiatric rehabilitation research groupLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dirk Richter, PhD principal investigator
Bern University Hospital for Mental Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Independent Housing and Support (IHS) and Residential Care Settings and other Treatment as Usual (RCS/TAU) in people with Severe Mental Disorder, run by University of Bern at 2 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Social Functioning Scale (SFS) (time frame: Change from baseline (T0) to 24 months (T3)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03815604, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2023.