Severe Mental DisordersMEDECO-IPSNCT07206316
Health-economic Evaluation of the IPS (Individual Placement and Support) Model for Helping People With Severe Mental Disorders Access Employment in the Ordinary Labor Market, Compared to Standard Methods of Helping People Return to Work: a Prospective Real-life Study
An observational study of Severe Mental Disorders, run by University Hospital, Tours at 11 sites in France.
Trial summary
The Individual Placement and Support (IPS) model was developed in the United States in the 1990s to help people with severe mental health issues get back into regular jobs. This model is based on the idea that a quick job search that takes into account what patients want, followed by ongoing and intensive support in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Mental Disorders
- What is being tested?
- Individual Placement and Support Model and Standard Method
- How many people
- 234 participants
- Where
- 11 sitesFrance
- Study dates
- 2 Oct 2025to Mar 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with severe mental disorders treated in adult psychiatric wards and receiving support to return to competitive employment in the open labor market in France
Who may be able to join
- Aged ≥ 18 years
- Participant with a chronic psychiatric disorder causing significant functional impairment
- Unemployed
- Wishing to return to competitive employment in the open labor market
- Informed about the study and consenting to participate
- Able to read french
Who cannot join
- Individuals not eligible for legal employment due to irregular residency status in France
- Individuals not affiliated with a social security system
- Individuals wishing to work in a sheltered/protected setting
- Individuals currently enrolled in a training program
- Individuals refusing to participate in the study
Trial locations and contacts
11 sites in 1 country. Contact the study team or a site near you to ask about taking part.
11 sites in 1 country
France11 sites
CH Cesame
Angers, 49000
Efflam Dr Bregeon, efflam.bregeon@ch-cesame-angers.fr
CH George Sand
Bourges, 18000
Isabelle Chazalette, isabelle.chazalette@ch-george-sand.fr
Centre hospitalier Le Vinatier
Bron, 69000
Nadira DALI, nadira.dali@ch-le-vinatier.fr
CHI EPSM Oise
Clermont, 60000
Marie Cecile Dr Bralet, Marie-Cecile.BRALET@chi-clermont.fr
University hospital
Clermont-Ferrand, 63000
Isabelle Dr Chereau, ichereau@chu-clermontferrand.fr
Centre Hospitalier Marius Lacroix
La Rochelle, 17000
Louise LARROQUE, 02 ext. +33, louise.larroque@ght-atlantique17.fr
CH Esquirol
Limoges, 87000
Emilie Dr Legros-Lafarge, 587509087 ext. +33, emilie.legros-lafarge@ch-esquirol-limoges.fr
Hôpital la Colombière
Montpellier, 34000
Anaelle DONGAL, a-dongal@chu-montpellier.fr
PRISM 45
Orléans, 45000
Monique Dr Olland
CH Le Rouvray
Rouen, 76000
Emeline Dr Duhamel, emeline.duhamel@ch-lerouvray.fr
University hospital
Tours, 37000
Jérôme GRAUX, 247473756 ext. +33, j.graux@chu-tours.fr
Helen CLERY, 2 47 47 75 17 ext. +33, H.CLERY@chu-tours.fr
About this study
The Individual Placement and Support (IPS) model was developed in the United States in the 1990s to help people with severe mental health issues get back into regular jobs. This model is based on the idea that a quick job search that takes into account what patients want, followed by ongoing and intensive support in the community, is especially good for this group. To date, although the effectiveness of the IPS model has been widely demonstrated (for a review, see Metcalfe et al., 2018), only a few studies have evaluated its efficiency in foreign contexts (Knapp et al., 2013; Christensen et al., 2020).
Although the IPS model has been in place in France for around ten years, no studies have yet been conducted to validate its efficiency in the French healthcare system.
The main objective of this prospective, real-life, multicenter study is to evaluate the efficiency of the IPS practice model compared to the conventional method of follow-up by social workers for patients with severe mental illness in terms of cost per additional day worked, from a collective perspective.
- Conditions
- Severe Mental Disorders
- Being tested
- Individual Placement and Support Model, Standard Method
- Keywords
- Individual Placement and Support, Health-economic evaluation
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individual Placement and Support ModelOther
The Individual Placement and Support (IPS) model is an employment support program specifically designed for people with severe mental illness (Bond, Drake, \& Becker, 2012). The core philosophy of IPS is that anyone can obtain competitive employment in the open labor market, provided it is the right job combined with appropriate support.
IPS support is delivered by a job coach, specifically trained in this model, who devotes their entire working time to assisting patients in their vocational integration.
Standard MethodOther
In psychiatric wards, patients who wish to do so are usually offered support to initiate the process of returning to competitive employment in the open labor market. This assistance is provided by the social workers (such as social workers or educators) within the care unit.
| Study group | Role | What they receive |
|---|---|---|
| IPS (Individual Placement and Support) practice model | patients benefiting from the IPS (Individual Placement and Support) practice model for assistance in accessing employment Receives: Other: Individual Placement and Support Model | |
| standard method | patients benefiting from the standard method for assistance in accessing employment Receives: Other: Standard Method |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficiency of the IPS practice model compared to the conventional method of follow-up by social workers for patients with severe mental illness
Incremental cost-effectiveness ratio (ICER) expressed as cost per additional day worked at 18 months, from a collective perspective, of the IPS practice model in patients with severe mental disorders.
Measured: 18 months
Secondary outcomes (8)
Efficiency of the IPS model compared to the conventional method of monitoring by social workers among patients with severe mental illness
Incremental cost-utility ratio (ICUR) expressed as "cost/QALY gained at 18 months, from a collective perspective, of the IPS model in patients with severe mental disorders.
Measured: 18 months
Cost-benefit ratio of the IPS practice model compared to the conventional method of follow-up by social workers for patients with severe mental illness,
Benefit-cost ratio of the IPS model compared to the conventional method of follow-up by social workers at 18 months, from a societal perspective, among patients with severe mental illness
Measured: 18 months
Budgetary impact on the French national health insurance system (AM) of changes in clinical practices with regard to the two types of support for returning to work.
Budgetary impact for the Health Insurance system per year and over 5 years of the evolution of practices with regard to the two types of support for return to work
Measured: 5 years
Compare work productivity and activity disorders between the two groups.
Comparison of scores on the questionnaire on work productivity and activity impairment (French version of the Work Productivity and Activity Impairment, WPAI)
Measured: 0, 6, 12 and 18 months
Compare the rate of hospital care use between the two groups.
Comparison of the number of hospitalizations, number of visits to psychiatric emergency rooms, and number of day hospital visits between the two groups
Measured: 18 months
Impact of a return to work on patients' level of recovery and overall health.
Comparison of scores on a clinical scale of recovery and overall health (French version of the Recovery Assessment Scale, RAS) between the two groups
Measured: 18 months
Impact of a return to work on patients' level of social cognition.
Comparison of scores on the ACSo clinical social cognition scale between the two groups
Measured: 18 months
Impact of a return to work on patients' cognitive functioning
Comparison of scores on the clinical cognitive functioning scale (French version of the Subjective Scale to Investigate Cognition in Schizophrenia, SSTICS) between the two groups
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2025
- Study start2 Oct 2025 (estimated)
- Primary completionMar 2030 (estimated)
- Study completionMar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Mental DisordersStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 234 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07206316
- Sponsor's protocol ID
- DR240280-MEDECO-IPS
- Acronym
- MEDECO-IPS
- Status last verified
- Sep 2025
- First submitted
- 25 Sep 2025
- Last updated
- 3 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health-economic Evaluation of the IPS (Individual Placement and Support) Model for Helping People With Severe Mental Disorders Access Employment in the Ordinary Labor Market, Compared to Standard Methods of Helping People Return to Work: a Prospective Real-life Study
- ClinicalTrials.gov ID
- NCT07206316
- Acronym / sponsor ID
- MEDECO-IPS / DR240280-MEDECO-IPS
- Conditions
- Severe Mental Disorders
- Keywords
- Individual Placement and Support, Health-economic evaluation
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 234 participants (estimated)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- 2 Oct 2025 (estimated)
- Primary completion
- Mar 2030 (estimated)
- Study completion
- Mar 2030 (estimated)
- First posted
- 3 Oct 2025 (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.
The Individual Placement and Support (IPS) model was developed in the United States in the 1990s to help people with severe mental health issues get back into regular jobs. This model is based on the idea that a quick job search that takes into account what patients want, followed by ongoing and intensive support in the community, is especially good for this group. To date, although the effectiveness of the IPS model has been widely demonstrated (for a review, see Metcalfe et al., 2018), only a few studies have evaluated its efficiency in foreign contexts (Knapp et al., 2013; Christensen et al., 2020).
Although the IPS model has been in place in France for around ten years, no studies have yet been conducted to validate its efficiency in the French healthcare system.
The main objective of this prospective, real-life, multicenter study is to evaluate the efficiency of the IPS practice model compared to the conventional method of follow-up by social workers for patients with severe mental illness in terms of cost per additional day worked, from a collective perspective.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IPS (Individual Placement and Support) practice model | – | Other: Individual Placement and Support Modelpatients benefiting from the IPS (Individual Placement and Support) practice model for assistance in accessing employment |
| standard method | – | Other: Standard Methodpatients benefiting from the standard method for assistance in accessing employment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with severe mental disorders treated in adult psychiatric wards and receiving support to return to competitive employment in the open labor market in France
Key inclusion criteria (6 listed)
- Aged ≥ 18 years
- Participant with a chronic psychiatric disorder causing significant functional impairment
- Unemployed
- Wishing to return to competitive employment in the open labor market
- Informed about the study and consenting to participate
Key exclusion criteria (5 listed)
- Individuals not eligible for legal employment due to irregular residency status in France
- Individuals not affiliated with a social security system
- Individuals wishing to work in a sheltered/protected setting
- Individuals currently enrolled in a training program
- Individuals refusing to participate in the study
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 |
|---|---|---|
| Individual Placement and Support ModelThe Individual Placement and Support (IPS) model is an employment support program specifically designed for people with severe mental illness (Bond, Drake, \& Becker, 2012). The core philosophy of IPS is that anyone can obtain competitive employment in the open labor market, provided it is the right job combined with appropriate support. IPS support is delivered by a job coach, specifically trained in this model, who devotes their entire working time to assisting patients in their vocational integration. | Other | IPS (Individual Placement and Support) practice model |
| Standard MethodIn psychiatric wards, patients who wish to do so are usually offered support to initiate the process of returning to competitive employment in the open labor market. This assistance is provided by the social workers (such as social workers or educators) within the care unit. | Other | standard method |
Primary outcome
Efficiency of the IPS practice model compared to the conventional method of follow-up by social workers for patients with severe mental illness
Time frame: 18 months
Incremental cost-effectiveness ratio (ICER) expressed as cost per additional day worked at 18 months, from a collective perspective, of the IPS practice model in patients with severe mental disorders.
8 secondary outcomes
Efficiency of the IPS model compared to the conventional method of monitoring by social workers among patients with severe mental illness
Time frame: 18 months
Cost-benefit ratio of the IPS practice model compared to the conventional method of follow-up by social workers for patients with severe mental illness,
Time frame: 18 months
Budgetary impact on the French national health insurance system (AM) of changes in clinical practices with regard to the two types of support for returning to work.
Time frame: 5 years
Compare work productivity and activity disorders between the two groups.
Time frame: 0, 6, 12 and 18 months
Compare the rate of hospital care use between the two groups.
Time frame: 18 months
Impact of a return to work on patients' level of recovery and overall health.
Time frame: 18 months
Impact of a return to work on patients' level of social cognition.
Time frame: 18 months
Impact of a return to work on patients' cognitive functioning
Time frame: 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2025.
- Individual participant dataSharing planned: Undecided
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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.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Mental Disorders, run by University Hospital, Tours at 11 sites in France.
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 6 inclusion and 5 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: opening soon, as of the sponsor's last update on 3 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jérôme GRAUX (247473756 ext. +33, j.graux@chu-tours.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficiency of the IPS practice model compared to the conventional method of follow-up by social workers for patients with severe mental illness (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Oct 2025.