CClinicalTrials.gg
RecruitingNCT05842889Updated Jan 13, 2025

Adaptation and Implementation of Peer Support in Brazil

An observational study in Peer Support, sponsored by Yale University. Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-13.

Sponsored by Yale University · Observational

From the registry’s dates

  • Primary completion was expected by May 2025, 1 year 5 months ago, but the record still lists the study as recruiting.
  • Started Aug 2024; still recruiting 2 years 2 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
48
Ages
18 Years and older
Sex
All
01

Study summary

Mental disorders are among the leading causes of disability and morbidity worldwide, including Brazil, where despite having a comprehensive network of publicly-funded, free, community-based mental health treatment, it is estimated that only 26% of people with psychiatric conditions successfully connect to community-based care.

The study team hypothesizes that the successful adaptation and implementation of an evidence-based model of peer support to Brazilian culture, will contribute to enhanced levels of engagement, improved continuity of care, and improvements in quality of life and wellbeing among persons living with Serious Mental Illness (SMI) in Brazil. After this study, it will have established the feasibility, acceptability, safety and tolerability, of adapting a low-cost, culturally-responsive, evidence-based intervention to improve post-acute supports for people with SMI who access community mental health treatment.

Read the detailed description

Mental disorders are among the leading causes of disability and morbidity worldwide-conditions that are compounded by a vast treatment gap where an estimated 70% of people who need mental health care go without adequate or any treatment at all. In Brazil, despite having a comprehensive network of publicly-funded, free, community-based mental health treatment, it is estimated that only 26% of people with psychiatric conditions successfully connect to community-based care. The remaining seek treatment only under emergency or crisis conditions, contributing to overcrowding in emergency departments, long waiting periods for psychiatric beds, psychiatric boarding, poorer overall quality of care, and an overreliance on a hospital system that is already overburdened (and increasingly so due to COronaVIrus Disease of 2019 (COVID-19). This problem has increasingly and disproportionately affected people with a serious mental illness (SMI) who are poor and non-white. Goals of recovery and rebuilding a meaningful life in the community become overshadowed by those of stabilization and symptom management.

Contributing factors to this mental health treatment gap are plenty (i.e., stigma and discrimination, workforce shortages, economic disparities, lack of timely follow-up and engagement, discontinuous and fragmented linkages between care settings), yet solutions are scarce. The proposed project uses a participatory research and adaptation design that involves stakeholders, including persons living with SMI, family members, clinicians, community services staff and administrators, throughout all stages of project development and implementation.

The study hypotheses include that the successful adaptation and implementation of an evidence-based model of peer support to Brazilian culture, will contribute to enhanced levels of engagement, improved continuity of care, and improvements in quality of life and wellbeing among persons living with SMI in Brazil. To this end, the following specific aims are proposed: 1) To work with local stakeholders in Campinas, Brazil on the cultural adaptation of an evidence-based peer intervention targeting connections with a peer as a mediator of engagement in postacute mental and physical healthcare; 2) To employ an experimental therapeutics approach in determining the degree to which multi-level targets are engaged in the pathway improved outcomes through a pilot clinical trial; 3) To assess the feasibility, acceptability, safety, tolerability, and potential for dissemination of the adapted peer intervention at multiple levels. After this study, it is hypothesized that the feasibility, acceptability, safety and tolerability, of adapting a low-cost, culturally-responsive, evidence-based intervention to improve quality of care of people with SMI who access community mental health treatment will be established. Moreover, through a Yale-University of Campinas partnership, these actions will foster international collaboration as a strategy to develop an innovative technology that would be ready for an implementation and effectiveness trial (R01) in poor communities in Latin countries.

Finally, the adaptation strategy developed in this proposal can be used in other Low and Middle Income Countries (LMICs) to adapt evidence-based practices (EBPs).

02

Conditions studied

  • Peer Support
03

In context

Lead sponsor

Yale University is the lead sponsor of 1,724 studies on the registry; 298 are open to participants now.

Of its 210 completed or terminated interventional studies of FDA-regulated products, 126 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Adults, at least 18 years of age, living with severe mental illness receiving acute care services in Campinas Brazil

Inclusion criteria

  • At least 18 years of age and receiving acute care services in Campinas Brazil.

Exclusion criteria

Exclusion Criteria:

  • None
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
48 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Change in Engagement in Care

    Participants will be asked about number of appointments and group activities scheduled, missed and attended as part of the intake process of the quantitative interview.

    Time frame: Baseline

  2. Change in Engagement in Care

    Participants will be asked about number of appointments and group activities scheduled, missed and attended as part of the intake process of the quantitative interview.

    Time frame: 6 month follow up

  3. Change in Engagement in Care

    Participants will be asked about number of appointments and group activities scheduled, missed and attended as part of the intake process of the quantitative interview.

    Time frame: 9 month follow up

  4. Change in Engagement in Care

    Participants will be asked about number of appointments and group activities scheduled, missed and attended as part of the intake process of the quantitative interview.

    Time frame: 12 month follow up

07

Study locations

1 of 1 sites recruiting
  • Yale University Program for Recovery and Community Health
    New Haven, Connecticut 06513, United States
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 13, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05842889
Lead sponsor
Yale University
Collaborators
National Institute of Mental Health (NIMH)
Responsible party
Sponsor
First posted
May 6, 2023
Start date
Aug 1, 2024
Primary completion
May 2025 (estimated)
Completion
May 2025 (estimated)
Last update
Jan 13, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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