Severe Mental DisorderIPSNCT06019247
Individual Placement and Support Mexico
A study testing Individual placement support (IPS) in people with Severe Mental Disorder, run by Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente at 3 sites in 2 countries.
Trial summary
There is substantial data to suggest that the Individual Placement and Support (IPS) model, a the investigatorsll-known, evidence-based practice, can help people with mental illness (PSMI) succeed in competitive employment (i.e., on average 55%, but over 60% in credible studies). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Severe Mental Disorder
- What is being tested?
- Individual placement support (IPS)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 3 Oct 2024to 1 Feb 2026
- Phase
- Interventional
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Inclusion Criteria (Potential participants will be deemed eligible if they)
- Meet requirements for PSMI.
- Are receiving services from CAISAME-EP for at least one month.
- Are at least 18 years old.
- Have expressed a goal of paid, competitive employment.
- Have attended 2 informational sessions prior to recruitment.
- Have no competitive employment during the past 3 months.
- Are physically and cognitively able to participate in study for the planned year of follow-up.
- Are willing to provide informed consent.
- Agree not to seek usual vocational services.
Exclusion Criteria (Potential participants will not be eligible if they)
- Don't meet requirements for PSMI.
- Are not receiving services from CAISAME-EP for at least one month.
- Are not at least 18 years old or older than 60 years old.
- Have not expressed a goal of paid, competitive employment.
- Have not attended 2 informational sessions prior to recruitment.
- Have a competitive employment during the past 3 months.
- Are not physically and cognitively able to participate in study for the planned year of follow-up.
- Are not willing to provide informed consent.
- Don't agree not to seek usual vocational services.
Trial locations and contacts
3 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
3 sites in 2 countries
United States2 sites
Columbia University
New York, New York, 10032
Research Foundation of Mental Hygiene
New York, New York, 10032
About this study
Official title: Individual Placement and Support (IPS) for Serious Mental Illness in Jalisco, Mexico
There is substantial data to suggest that the Individual Placement and Support (IPS) model, a the investigatorsll-known, evidence-based practice, can help people with mental illness (PSMI) succeed in competitive employment (i.e., on average 55%, but over 60% in credible studies). Hothe investigatorsver, not a single country in Latin America offers IPS services. In addition, services to support employment and education tend to be ad hoc, low-intensity, and not the investigatorsll evaluated because most clinicians are not trained in evidence-based practices.
Clinicians are not trained in evidence-based approaches and do not provide high-fidelity services. The overall goal of this project is to pilot the IPS for PSMI in the Center for Comprehensive Care in Long-Stay Mental Health (CAISAME-EB, in Spanish), the largest mental health clinic in Jalisco, Mexico. CAISAME-EB integrates primary care and provides medication and psychosocial rehabilitation services to a large population of PSMI (n=~5,000). This team serves marginalized communities similar to other urban areas in low- and middle-income countries (LMICs) in Latin America and elsewhere.
Read more
The investigators will use the Dynamic Adaptation Process model to first inform the adaptation of IPS in Mexico, using our previous experience adapting IPS and deep understanding of the local context (e.g., the nature of the labor market in Mexico) to inform the adaptations. The investigators will then evaluate the implementation and impact of the adapted IPS in a pilot RCT (N = 120).
This pilot RCT will Include quantitative and qualitative assessments at baseline, 6 months, and 12 months with clients, providers, and other key stakeholders. The investigators aim to refine implementation processes, understand outcomes and tools, and estimate pothe investigatorsr for a future regional trial in Latin America.
Read the detailed description
The researchers propose to adapt, implement, and evaluate the Individual Placement and Support (IPS) model for people with serious mental illness (PSMI) in Jalisco, Mexico. Substantial data indicate that IPS can help PSMI succeed in competitive employment (i.e., 55% on average, but over 60% in credible studies). In addition, successful employment through IPS has been shown to improve quality of life, self-esteem, and community integration, and to reduce symptoms, hospitalizations, and mental health costs. With the partial exception of Chile, no country in Latin America offers IPS services. Previous regional research has reported that PSMI experience extreme poverty, exclusion from educational and employment opportunities, and multiple traumas, including violence and abuse. Evidence-based, locally adapted initiatives to improve the living conditions and social inclusion of this vulnerable population are warranted.
In Mexico, mental health care for PSMI is often fragmented and does not follow evidence-based practices (EBP). The Jalisco Mental Health System, a large network of mental health facilities throughout the state of Jalisco, is an exception. The researchers plan to implement IPS at the Center for Comprehensive Care in Long-Stay Mental Health (CAISAME-EB, in Spanish), the largest mental health clinic in Jalisco. CAISAME-EB integrates primary care and provides medication and psychosocial rehabilitation services to a large population of PSMI (n=~5,000). The usual care services are of lower intensity than IPS and lack most of its key components.
This team serves marginalized communities similar to other urban areas in low- and middle-income countries (LMICs) in Latin America and elsewhere. In addition, the regional government of Jalisco has committed to expanding the implementation of the adapted IPS program if the trial is successful.
Ricardo Saracco (National Institute of Psychiatry Ramón de la Fuente Muñiz, INPRF) and Alejandro Aldana (Jalisco Institute of Mental Health, IJSM) have brought together key stakeholders to collaborate with researchers in the US (Susser, Dixon, Bello, Mascayano). All have extensive expertise in psychosis research and in the implementation of evidence-based mental health practices in a variety of contexts, including Latin America. In addition, the INPRF and IJSM teams have a long-standing relationship in Mexico and have recently collaborated with the US team on a study of the impact of the COVID-19 pandemic on health care workers (e.g., the Health Care Workers HEROES study).
The investigators will initially use the Dynamic Adaptation Process model9 to inform the adaptation of IPS in Mexico. The investigators note that IPS has been adapted for successful implementation in more than 20 countries and for marginalized communities within the US (e.g., Latinxs). This prior experience and our deep understanding of the local context (e.g., the nature of the nature of the labor market in Mexico) will inform the adaptations. Second, the researchers will evaluate the implementation and impact of the revised intervention in a pilot RCT (N = 120). This pilot RCT will include quantitative and qualitative assessments at baseline, 6, and 12 months, conducted with clients (e.g., employment, financial well-being of the investigators), providers (e.g., attitudes toward the intervention), and providers (e.g., attitudes toward the intervention), (e.g., attitudes toward EBP), and other key stakeholders (e.g., potential employers). The researchers primary goals are to refine implementation processes, understand outcomes and tools, and assess investigators for a future, regional trial in Latin America.
The investigators are already part of a network of investigators in Latin America resulting from a previous NIMH grant (i.e., "RedeAmericas", contact PI Susser) that includes many investigators who would be willing and able to conduct a regional trial.
- Conditions
- Severe Mental Disorder
- Being tested
- Individual placement support (IPS)
- Keywords
- Individual placement and support, Serious mental illness, Jalisco, Mexico
- 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 support (IPS)Other
IPS is the most studied psychiatric rehabilitation intervention in the world. It is based on eight principles: inclusion of all clients who have declared a desire to work, no pre-vocational training, benefits counseling, rapid job search, treatment team-level integration of vocational and clinical services, consideration of client preferences in all decisions, assistance in job development, provision of follow-up supports after finding employment, and a focus on competitive employment. We propose to adapt and pilot the IPS to improve employment and health among people with severe mental disorders in Mexico.
| Study group | Role | What they receive |
|---|---|---|
| Usual Services. | No intervention | Generally, providers of rehabilitation Usual Care for PSMI at CAISAME-EP include 2 full-time psychologists, 2 full-time social workers, a half-time occupational therapist, and a half-time psychiatrist. This team, however, also provides services to clients with other mental conditions (e.g., substance use). As a result, the Usual Care services are of lower intensity than IPS and omit most of the key ingredients of the intervention. Moreover, it does not follow a standardized manual/protocol. The Usual Care team also offers other services such as psychiatric medication, individual and group psychotherapy, and psychoeducation for clients and relatives. |
| Adapted IPS | Experimental | The IPS program adaptation process, will be conducted with 2 teams of providers, each consisting of an employment specialist, a case manager: psychologist, social worker and a psychiatrist, who will work in coordination to provide IPS services (each specialist will have between 15 and 20 clients). The IPS team will consist of providers and will be trained by the Research Adaptation Team in consultation and supervised. Weekly case-oriented supervision with a trained IPS supervisor, biweekly telephone contact, and telephone consultations as needed will help the IPS teams maintain high fidelity IPS. Following randomization, individuals assigned to receive IPS will be assigned to an IPS treatment team and will be introduced directly to their assigned case managers. Case management and IPS staff will be in close proximity to facilitate both IPS staff attendance at case management team meetings and the ongoing interaction necessary for efficient IPS implementation. Receives: Other: Individual placement support (IPS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
IPS Employment impact measure
The aim of the evaluation is to measure the impact of the IPS programme on the employability of the participants. Outcome measures will be based on a baseline interview and quarterly interviews with participants. The impact of the intervention will be measured by changes from baseline in time in jobs held, hours worked and wages earned.
Measured: One year
Assessment of psychiatric symptoms
Indicators of participants' mental well-being will be measured at baseline, six months and twelve months. Psychiatric symptoms will be measured using the Colorado Symptom Index.
Measured: One year
Assessment of mental and physical functioning.
Outcomes of physical and mental functioning in daily life will be measured at baseline, six months and twelve months using the Study Short-Form 12-Item and physical and mental functioning at work using the Functional Assessment Battery.
Measured: One year
Secondary outcomes (6)
Baseline customer demographics.
Participants will be interviewed at baseline prior to randomisation. Outcome demographic data will include age, ethnicity, gender, educational attainment, marital status, employment and financial status. Additional data will describe housing, justice system involvement, social capital and health service use.
Measured: six months
Quarterly client employment interviews
Quarterly client interviews will document past-quarter employment, including jobs held, hours worked, and wages earned. Interviews will document job termination during quarters when jobs ended. The interviews will take place at CAISAME-EP if/when possible, considering the constraints imposed by the COVID-19 pandemic. When clients are unavailable for interview, a research assistant in Mexico will make several efforts to track and schedule the interview until the next interview period. Next interviews can track employment during missed intervals. These delays do not typically compromise data quality because the data describe continuous data collapsed over specified periods.
Measured: six months
Follow-up interviews.
The follow-up interviews, conducted at 6 and 12 months after randomisation, complement the quarterly employment interview and include measures of health and functioning that mirror those administered at baseline. Additional data will be collected on housing, social capital and health service use. The follow-up interviews are conducted at the same time as the corresponding quarterly employment interviews. As with the quarterly employment interviews, if clients are unavailable for the follow-up interview, the research assistant will make several efforts to track and schedule the interview until the next quarterly interview period.
Measured: one year
IPS Participation Measure
Monthly client interviews document the employment specialist's engagement with participants and the number of times and length of contact with the participant in job search activities. The type and number of job search activities in which participants have been involved are also recorded in the interview.
Measured: one year
Employment specialist service log (time spent direct services, collaborating with mental health experts and job support).
Once a month, employment specialists complete service logs describing IPS service provision over the past week. Collecting this data on a time-sampling basis has been shown to be more reliable than using a continuous measure. Specialist activities documented will include time spent providing both direct (vs indirect) and community (vs office) services, as well as time spent working with mental health clinicians in the clinic, working on job development, and working on job support. These times can be compared to current IPS programme standards associated with high fidelity and assessed in relation to the adaptations resulting from the Dynamic Adaptation Process.
Measured: six months
Participant employment report (weeks worked, hours worked per week, hourly wage, start and end dates of work) and feedback to IPS teams.
Quarterly client interviews will report on employment in the previous quarter, including jobs held, hours worked and wages earned. Interviews will document job quits in quarters in which jobs ended. If clients are unavailable for interview, a research assistant in Mexico will make several efforts to track and schedule the interview until the next interview period. Subsequent interviews may document employment during missed intervals. These delays do not usually affect the quality of the data, as the data describe continuous data that are aggregated over specific time periods.
Summaries of the Employment Specialist's reports are provided to the IPS Team Leaders to monitor implementation and address potential issues in collaboration with the IPS teams and IPS TA/QA.
Measured: Eighteen months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2023
- Study start3 Oct 2024
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Severe Mental DisorderStudies of the same condition, open and under way.
- 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
- Our pilot RCT will examine both the implementation and effectiveness of IPS. We will use the Dynamic Adaptation Process model9 to adapt and implement IPS as well as to assess fidelity and identify barriers and facilitators. Then we will enroll 120 PSMI drawn from CAISAME-EP, which covers marginalized and poor communities. The outcomes of this pilot RCT will include employment, financial well-being, and health (i.e., symptoms and functioning). We will also quantify the cost of adapting and delivering IPS in this context. We will follow NIH guidelines on rigor and transparency to ensure strict application of the scientific method. Accordingly, we provide below detailed information regarding adaptation processes, recruitment, inclusion and exclusion criteria, outcomes and measures, and data analysis.
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto Jalisciense de Salud Mental (SALME), Research Foundation for Mental Hygiene, Inc., Columbia University
- Responsible party
- Principal investigator, Ricardo Arturo Saracco Alvarez, Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente
- Investigators
- JESUS A. ALDANA LOPEZ, MPH, Study chair, Jalisco Institute of Mental Health (SALME)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06019247
- Sponsor's protocol ID
- IC22176.0
- Acronym
- IPS
- Status last verified
- Mar 2025
- First submitted
- 2 May 2023
- Last updated
- 18 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Aldana-Lopez JA, Saracco-Alvarez R, Durand-Arias S, Carmona-Huerta J, Cardenas-Garcia E, Arambula-Roman JC, Metcalfe J, Swanson S, Keleher J, Villafuerte-Jacob EC, Flores-Bizarro D, Blanco-Sierra JA, Drake RE, Susser E, Mascayano F. Feasibility and preliminary effectiveness of the Individual Placement and Support (IPS) model for people with serious mental illness in Jalisco, Mexico: a pilot study protocol. Pilot Feasibility Stud. 2026 May 1;12(1):81. doi: 10.1186/s40814-026-01809-7.
PubMed 42063094
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individual Placement and Support (IPS) for Serious Mental Illness in Jalisco, Mexico
- ClinicalTrials.gov ID
- NCT06019247
- Acronym / sponsor ID
- IPS / IC22176.0
- Conditions
- Severe Mental Disorder
- Keywords
- Individual placement and support, Serious mental illness, Jalisco, Mexico
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Instituto Nacional de Psiquiatría Dr. Ramón de la FuenteUniversity, hospital or other
- Collaborators
- Instituto Jalisciense de Salud Mental (SALME), Research Foundation for Mental Hygiene, Inc., Columbia University
- Study start
- 3 Oct 2024 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Feb 2026 (estimated)
- First posted
- 31 Aug 2023 (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.
There is substantial data to suggest that the Individual Placement and Support (IPS) model, a the investigatorsll-known, evidence-based practice, can help people with mental illness (PSMI) succeed in competitive employment (i.e., on average 55%, but over 60% in credible studies). Hothe investigatorsver, not a single country in Latin America offers IPS services. In addition, services to support employment and education tend to be ad hoc, low-intensity, and not the investigatorsll evaluated because most clinicians are not trained in evidence-based practices.
Clinicians are not trained in evidence-based approaches and do not provide high-fidelity services. The overall goal of this project is to pilot the IPS for PSMI in the Center for Comprehensive Care in Long-Stay Mental Health (CAISAME-EB, in Spanish), the largest mental health clinic in Jalisco, Mexico. CAISAME-EB integrates primary care and provides medication and psychosocial rehabilitation services to a large population of PSMI (n=~5,000). This team serves marginalized communities similar to other urban areas in low- and middle-income countries (LMICs) in Latin America and elsewhere.
The investigators will use the Dynamic Adaptation Process model to first inform the adaptation of IPS in Mexico, using our previous experience adapting IPS and deep understanding of the local context (e.g., the nature of the labor market in Mexico) to inform the adaptations. The investigators will then evaluate the implementation and impact of the adapted IPS in a pilot RCT (N = 120).
This pilot RCT will Include quantitative and qualitative assessments at baseline, 6 months, and 12 months with clients, providers, and other key stakeholders. The investigators aim to refine implementation processes, understand outcomes and tools, and estimate pothe investigatorsr for a future regional trial in Latin America.
Detailed description
The researchers propose to adapt, implement, and evaluate the Individual Placement and Support (IPS) model for people with serious mental illness (PSMI) in Jalisco, Mexico. Substantial data indicate that IPS can help PSMI succeed in competitive employment (i.e., 55% on average, but over 60% in credible studies). In addition, successful employment through IPS has been shown to improve quality of life, self-esteem, and community integration, and to reduce symptoms, hospitalizations, and mental health costs. With the partial exception of Chile, no country in Latin America offers IPS services. Previous regional research has reported that PSMI experience extreme poverty, exclusion from educational and employment opportunities, and multiple traumas, including violence and abuse. Evidence-based, locally adapted initiatives to improve the living conditions and social inclusion of this vulnerable population are warranted.
In Mexico, mental health care for PSMI is often fragmented and does not follow evidence-based practices (EBP). The Jalisco Mental Health System, a large network of mental health facilities throughout the state of Jalisco, is an exception. The researchers plan to implement IPS at the Center for Comprehensive Care in Long-Stay Mental Health (CAISAME-EB, in Spanish), the largest mental health clinic in Jalisco. CAISAME-EB integrates primary care and provides medication and psychosocial rehabilitation services to a large population of PSMI (n=~5,000). The usual care services are of lower intensity than IPS and lack most of its key components.
This team serves marginalized communities similar to other urban areas in low- and middle-income countries (LMICs) in Latin America and elsewhere. In addition, the regional government of Jalisco has committed to expanding the implementation of the adapted IPS program if the trial is successful.
Ricardo Saracco (National Institute of Psychiatry Ramón de la Fuente Muñiz, INPRF) and Alejandro Aldana (Jalisco Institute of Mental Health, IJSM) have brought together key stakeholders to collaborate with researchers in the US (Susser, Dixon, Bello, Mascayano). All have extensive expertise in psychosis research and in the implementation of evidence-based mental health practices in a variety of contexts, including Latin America. In addition, the INPRF and IJSM teams have a long-standing relationship in Mexico and have recently collaborated with the US team on a study of the impact of the COVID-19 pandemic on health care workers (e.g., the Health Care Workers HEROES study).
The investigators will initially use the Dynamic Adaptation Process model9 to inform the adaptation of IPS in Mexico. The investigators note that IPS has been adapted for successful implementation in more than 20 countries and for marginalized communities within the US (e.g., Latinxs). This prior experience and our deep understanding of the local context (e.g., the nature of the nature of the labor market in Mexico) will inform the adaptations. Second, the researchers will evaluate the implementation and impact of the revised intervention in a pilot RCT (N = 120). This pilot RCT will include quantitative and qualitative assessments at baseline, 6, and 12 months, conducted with clients (e.g., employment, financial well-being of the investigators), providers (e.g., attitudes toward the intervention), and providers (e.g., attitudes toward the intervention), (e.g., attitudes toward EBP), and other key stakeholders (e.g., potential employers). The researchers primary goals are to refine implementation processes, understand outcomes and tools, and assess investigators for a future, regional trial in Latin America.
The investigators are already part of a network of investigators in Latin America resulting from a previous NIMH grant (i.e., "RedeAmericas", contact PI Susser) that includes many investigators who would be willing and able to conduct a regional trial.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Our pilot RCT will examine both the implementation and effectiveness of IPS. We will use the Dynamic Adaptation Process model9 to adapt and implement IPS as well as to assess fidelity and identify barriers and facilitators. Then we will enroll 120 PSMI drawn from CAISAME-EP, which covers marginalized and poor communities. The outcomes of this pilot RCT will include employment, financial well-being, and health (i.e., symptoms and functioning). We will also quantify the cost of adapting and delivering IPS in this context. We will follow NIH guidelines on rigor and transparency to ensure strict application of the scientific method. Accordingly, we provide below detailed information regarding adaptation processes, recruitment, inclusion and exclusion criteria, outcomes and measures, and data analysis.
| Arm | Type | Receives |
|---|---|---|
| Usual Services. | No intervention | –Generally, providers of rehabilitation Usual Care for PSMI at CAISAME-EP include 2 full-time psychologists, 2 full-time social workers, a half-time occupational therapist, and a half-time psychiatrist. This team, however, also provides services to clients with other mental conditions (e.g., substance use). As a result, the Usual Care services are of lower intensity than IPS and omit most of the key ingredients of the intervention. Moreover, it does not follow a standardized manual/protocol. The Usual Care team also offers other services such as psychiatric medication, individual and group psychotherapy, and psychoeducation for clients and relatives. |
| Adapted IPS | Experimental | Other: Individual placement support (IPS)The IPS program adaptation process, will be conducted with 2 teams of providers, each consisting of an employment specialist, a case manager: psychologist, social worker and a psychiatrist, who will work in coordination to provide IPS services (each specialist will have between 15 and 20 clients). The IPS team will consist of providers and will be trained by the Research Adaptation Team in consultation and supervised. Weekly case-oriented supervision with a trained IPS supervisor, biweekly telephone contact, and telephone consultations as needed will help the IPS teams maintain high fidelity IPS. Following randomization, individuals assigned to receive IPS will be assigned to an IPS treatment team and will be introduced directly to their assigned case managers. Case management and IPS staff will be in close proximity to facilitate both IPS staff attendance at case management team meetings and the ongoing interaction necessary for efficient IPS implementation. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
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 support (IPS)IPS is the most studied psychiatric rehabilitation intervention in the world. It is based on eight principles: inclusion of all clients who have declared a desire to work, no pre-vocational training, benefits counseling, rapid job search, treatment team-level integration of vocational and clinical services, consideration of client preferences in all decisions, assistance in job development, provision of follow-up supports after finding employment, and a focus on competitive employment. We propose to adapt and pilot the IPS to improve employment and health among people with severe mental disorders in Mexico. | Other | Adapted IPS |
Primary outcome
IPS Employment impact measure
Time frame: One year
The aim of the evaluation is to measure the impact of the IPS programme on the employability of the participants. Outcome measures will be based on a baseline interview and quarterly interviews with participants. The impact of the intervention will be measured by changes from baseline in time in jobs held, hours worked and wages earned.
Assessment of psychiatric symptoms
Time frame: One year
Indicators of participants' mental well-being will be measured at baseline, six months and twelve months. Psychiatric symptoms will be measured using the Colorado Symptom Index.
Assessment of mental and physical functioning.
Time frame: One year
Outcomes of physical and mental functioning in daily life will be measured at baseline, six months and twelve months using the Study Short-Form 12-Item and physical and mental functioning at work using the Functional Assessment Battery.
6 secondary outcomes
Baseline customer demographics.
Time frame: six months
Quarterly client employment interviews
Time frame: six months
Follow-up interviews.
Time frame: one year
IPS Participation Measure
Time frame: one year
Employment specialist service log (time spent direct services, collaborating with mental health experts and job support).
Time frame: six months
Participant employment report (weeks worked, hours worked per week, hourly wage, start and end dates of work) and feedback to IPS teams.
Time frame: Eighteen 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 18 Mar 2025.
- Derived from this study: PubMed 42063094Aldana-Lopez JA, Saracco-Alvarez R, Durand-Arias S, Carmona-Huerta J, Cardenas-Garcia E, Arambula-Roman JC, Metcalfe J, Swanson S, Keleher J, Villafuerte-Jacob EC, Flores-Bizarro D, Blanco-Sierra JA, Drake RE, Susser E, Mascayano F. Feasibility and preliminary effectiveness of the Individual Placement and Support (IPS) model for people with serious mental illness in Jalisco, Mexico: a pilot study protocol. Pilot Feasibility Stud. 2026 May 1;12(1):81. doi: 10.1186/s40814-026-01809-7.
- 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.
JESUS A. ALDANA LOPEZ, MPH study chair
Jalisco Institute of Mental Health (SALME)
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individual placement support (IPS) in people with Severe Mental Disorder, run by Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: enrolling by invitation, as of the sponsor's last update on 18 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Mexico. 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?
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?
IPS Employment impact measure (time frame: One year). The study lists 3 primary outcomes in all. 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 NCT06019247, which also lists 1 linked publication.
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 18 Mar 2025.