Individual Placement and Support Mexico

Official title

Individual Placement and Support (IPS) for Serious Mental Illness in Jalisco, Mexico

Overview

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.

Interventions

• Other 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 propos

Primary outcome measures

• IPS Employment impact measure [Time frame: One year]
• Assessment of psychiatric symptoms [Time frame: One year]
• Assessment of mental and physical functioning. [Time frame: One year]

Secondary outcome measures (6)

• 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]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Supportive care

Study locations

United States · 2 centers

• Columbia University — New York
• Research Foundation of Mental Hygiene — New York

Mexico · 1 center

• Instituto Jalisciense de Salud Mental — Zapopan

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 PMID 42063094

Identifiers

NCT: NCT06019247 · IC22176.0

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗