Individual Placement and Support Mexico

NCT06019247 | Enrolling By Invitation DMC

• 1 other identifier: IC22176.0
• Study Type: interventional
• Target: 120
• Locations: 2 countries
• Sites: 3

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.

Conditions

Severe Mental Disorder

Keywords

Individual placement and support; Serious mental illness; Jalisco; Mexico

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  One year

Secondary Outcomes (6)

• Baseline customer demographics.

  six months

• Quarterly client employment interviews

  six months

• Follow-up interviews.

  one year

• IPS Participation Measure

  one year

• Employment specialist service log (time spent direct services, collaborating with mental health experts and job support).

  six months

Study Arms (2)

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.

Other: Individual placement support (IPS)

Interventions

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.

Adapted IPS

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente: lead
• Instituto Jalisciense de Salud Mental (SALME): collaborator
• Research Foundation for Mental Hygiene, Inc.: collaborator
• Columbia University: collaborator

Study Sites (3)

Columbia University

New York, New York, 10032, United States

Location

Research Foundation of Mental Hygiene

New York, New York, 10032, United States

Location

Instituto Jalisciense de Salud Mental

Zapopan, Jalisco, 45170, Mexico

Location

MeSH Terms

Conditions

Mental Disorders

Study Officials

• JESUS A. ALDANA LOPEZ, MPH

  Jalisco Institute of Mental Health (SALME)

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: UNDER DIRECTOR OF CLINICAL RESEARCH

Model Details: 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.

Study Record Dates

• First Submitted: May 2, 2023
• First Posted: August 31, 2023
• Study Start: October 3, 2024
• Primary Completion: December 1, 2025
• Study Completion: February 1, 2026
• Last Updated: March 18, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2); ME (1)