Peer SupportNCT05842889
Adaptation and Implementation of Peer Support in Brazil
An observational study of Peer Support, run by Yale University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Peer Support
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2024to May 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults, at least 18 years of age, living with severe mental illness receiving acute care services in Campinas Brazil
Who may be able to join
- At least 18 years of age and receiving acute care services in Campinas Brazil.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Yale University Program for Recovery and Community Health
New Haven, Connecticut, 06513
Maria O'Connell, Ph.D., 203-764-7593, maria.oconnel@yale.edu
Kimberly D Antunes, BSW, 203-764-8694, kimberly.antunes@yale.edu
About this study
Official title: Adaptation and Implementation of Peer Support to Optimize Engagement and Outcomes for People With Serious Mental Illness in Campinas, Brazil
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).
- Conditions
- Peer Support
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
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.
Measured: 6 month follow up
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.
Measured: 9 month follow up
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.
Measured: 12 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start1 Aug 2024
- Primary completionMay 2025 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peer SupportStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05842889
- Sponsor's protocol ID
- 2000033021
- Other IDs
- 1R34MH131238-01
- Status last verified
- Jan 2025
- First submitted
- 17 Apr 2023
- Last updated
- 13 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptation and Implementation of Peer Support to Optimize Engagement and Outcomes for People With Serious Mental Illness in Campinas, Brazil
- ClinicalTrials.gov ID
- NCT05842889
- Acronym / sponsor ID
- 2000033021
- Conditions
- Peer Support
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- May 2025 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 6 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults, at least 18 years of age, living with severe mental illness receiving acute care services in Campinas Brazil
Key inclusion criteria (1 listed)
- At least 18 years of age and receiving acute care services in Campinas Brazil.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in Engagement in Care
Time frame: Baseline
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.
Change in Engagement in Care
Time frame: 6 month follow up
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.
Change in Engagement in Care
Time frame: 9 month follow up
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.
Change in Engagement in Care
Time frame: 12 month follow up
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yale University Program for Recovery and Community Health
New Haven, United States
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peer Support, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Engagement in Care (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2025.