Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05842889 |
| Other study ID # |
2000033021 |
| Secondary ID |
1R34MH131238-01 |
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
August 2024 |
| Est. completion date |
May 2025 |
Study information
| Verified date |
May 2023 |
| Source |
Yale University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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 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.
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 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 LMICs to
adapt EBPs.
