Clinical Trials Logo

Clinical 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). 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.


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT06019247
Study type Interventional
Source Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente
Contact RICARDO ARTURO SARACCO ALVAREZ, Ph.D.
Phone 525541605349
Email saracco@imp.edu.mx
Status Not yet recruiting
Phase N/A
Start date August 2023
Completion date August 2025

See also
  Status Clinical Trial Phase
Recruiting NCT05056415 - Effect and Cost-effectiveness of the Everyday Life Rehabilitation Intervention N/A
Active, not recruiting NCT06219265 - Neuropsychological and Electrophysiological Effects of Dance Therapy With People With Severe Mental Disorders N/A
Not yet recruiting NCT05056181 - "MenPhys: Intervention Protocol for Physical Wellness in Mental Health" N/A
Recruiting NCT05533749 - Evaluating the Effectiveness of the GILL eHealth Intervention to Improve Physical Health and Lifestyle Behaviours in Patients With Severe Mental Illness N/A
Completed NCT05456984 - The PsychOsis and Diabetes Service Model (PODS) Population Profile Study.
Recruiting NCT06182787 - Development of a Model for Digital Monitoring of the Mental State of the Hospitalized Patient
Completed NCT04792268 - Electronic Clinical Decision Support for Diabetes and Dysglycaemia in Secondary Mental Healthcare N/A
Not yet recruiting NCT05274126 - Implementation of a Social and Mental Health Support to Promote Recovery in Five Mental Health Facilities in Paris Area N/A
Active, not recruiting NCT05406518 - Proposal to Improve the Program of Attention to the Families. Implementation and Evaluation Based on a Needs Analysis N/A
Recruiting NCT06315114 - A Transdiagnostic Mentalization-based Intervention for Parents With Mental Disorders N/A
Completed NCT06069739 - Health Education Programme Through Physical Exercise for People With Severe Mental Disorders N/A
Completed NCT06315049 - Music Therapy to Reduce Anxiety in Community-Dwelling Individuals With Severe Mental Illness N/A
Recruiting NCT04891445 - Hepatitis C in Severe Mental Disorders: Nursing Programme N/A
Active, not recruiting NCT05496907 - Psychosis and Type 2 Diabetes Study (PODS) N/A
Recruiting NCT03980743 - Interactive Obesity Treatment Approach for Obesity Prevention in Adults With Early Serious Mental Illness: iOTA-SMI N/A
Completed NCT03583203 - Tobacco Intensive Motivational and Estimate Risk N/A
Recruiting NCT05273021 - Validation of the Dutch Translation of the Tobacco, Alcohol, Prescription Medication and Other Substances (TAPS)-Tool
Active, not recruiting NCT06370793 - Ningbo Severe Mental Disorders Cohort
Terminated NCT04775407 - COVID-19 Serological Testing of Patients With a Mental Disorder From the Catchment Area of the Capital Region of Denmark
Active, not recruiting NCT05157854 - Development and Evaluation of an Intervention (AiMH) for People With Severe Mental Illness Living in Supported Housing