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NCT06019247 · ClinicalTrials.gov record · last posted 2025-03-18

Individual Placement and Support Mexico

Study acronym: IPS
StatusEnrolling by Invitation
PhaseNot applicable
Started2024-10-03
View on ClinicalTrials.gov ↗
Record status
This record was last updated March 18, 2025 (before its estimated December 1, 2025 completion). Its status may not reflect the trial's current state.
from the ClinicalTrials.gov record
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.

Amendment record 2 amendments on the ClinicalTrials.gov record

This ClinicalTrials.gov record has been amended 2 times since 2023-08-24; most recent amendment 2025-03-13. DataLookout shows field-level changes from the day a trial enters its daily monitoring; earlier amendments are counted here from the ClinicalTrials.gov version history. See every version on ClinicalTrials.gov ↗

2025-03-13
Status change Not Yet RecruitingEnrolling by Invitationv2
Trial Details
NCT Number NCT06019247
Lead Sponsor Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente
Collaborators: Instituto Jalisciense de Salud Mental (SALME), Research Foundation for Mental Hygiene, Inc., Columbia University
Conditions Severe Mental Disorder
Enrollment 120 participants
Start Date 2024-10-03
Primary Completion 2025-12-01 (estimated)
Study Completion 2026-02-01 (estimated)
Updated on ClinicalTrials.gov 2025-03-18