Clinical trial NCT06019247: Individual Placement and Support Mexico
Official title: Individual Placement and Support (IPS) for Serious Mental Illness in Jalisco, Mexico
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Severe Mental Disorder
Keywords: Individual placement and support
Serious mental illness
Jalisco
Mexico
Lead sponsor: Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente
Sponsor class: OTHER
Collaborators: name: Instituto Jalisciense de Salud Mental (SALME)
name: Research Foundation for Mental Hygiene, Inc.
name: Columbia University
First posted: 2023-08-31
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

Brief 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). 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.

Eligibility criteria: 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.

Primary outcomes:
measure: IPS Employment impact measure
timeFrame: One year
measure: Assessment of psychiatric symptoms
timeFrame: One year
measure: Assessment of mental and physical functioning.
timeFrame: One year
Secondary outcomes:
measure: Baseline customer demographics.
timeFrame: six months
measure: Quarterly client employment interviews
timeFrame: six months
measure: Follow-up interviews.
timeFrame: one year
measure: IPS Participation Measure
timeFrame: one year
measure: Employment specialist service log (time spent direct services, collaborating with mental health experts and job support).
timeFrame: six months
measure: Participant employment report (weeks worked, hours worked per week, hourly wage, start and end dates of work) and feedback to IPS teams.
timeFrame: Eighteen months
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University
state: New York
city: New York
country: United States
facility: Research Foundation of Mental Hygiene
state: New York
city: Zapopan
country: Mexico
facility: Instituto Jalisciense de Salud Mental
state: Jalisco
Study officials:
affiliation: Jalisco Institute of Mental Health (SALME)
name: JESUS A. ALDANA LOPEZ, MPH
role: STUDY_CHAIR
References: