NCT06019247: IPS

Individual Placement and Support Mexico

ENROLLING BY INVITATION NA Last updated 18 March 2025

What this trial tests

NA trial testing Individual placement support (IPS) in Severe Mental Disorder in 120 participants. Enrolling by invitation.

Timeline

3 October 2024

Primary endpoint
1 December 2025

1 February 2026

Quick facts

Lead sponsor	Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente
Phase	NA
Status	ENROLLING BY INVITATION
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	supportive care
Enrollment	120
Start date	3 October 2024
Primary completion	1 December 2025
Estimated completion	1 February 2026
Sites	3 locations across United States, Mexico

Drugs / interventions tested

• Individual placement support (IPS)

Conditions studied

• Severe Mental Disorder — all drugs for Severe Mental Disorder →

Sponsor

Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente

Who can join

Adults 18 to 60, any sex, with Severe Mental Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Supported employment as a global mental health intervention.
   Mascayano F, Drake RE. · · 2024 · cited 1× · PMID 39464548 · DOI 10.1017/gmh.2024.112
2. 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.
   Aldana-López JA, Saracco-Alvarez R, Durand-Arias S, Carmona-Huerta J, et al · · 2026 · PMID 42063094 · DOI 10.1186/s40814-026-01809-7