Ignite Creation Date:
2024-05-06 @ 6:57 PM
Last Modification Date:
2024-10-26 @ 2:57 PM
Study NCT ID:
NCT05842889
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-05-06
First Post:
2023-04-17
Brief Title:
Adaptation and Implementation of Peer Support in Brazil
Sponsor:
Yale University
Organization:
Yale University
Study Overview
Official Title:
Adaptation and Implementation of Peer Support to Optimize Engagement and Outcomes for People With Serious Mental Illness in Campinas Brazil
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
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 ie 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
Contributing factors to this mental health treatment gap are plenty ie 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R34MH131238-01 | NIH | None | httpsreporternihgovquickSearch1R34MH131238-01 |