NCT05842889

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
48

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 17, 2023

Completed
19 days until next milestone

First Posted

Study publicly available on registry

May 6, 2023

Completed
1.2 years until next milestone

Study Start

First participant enrolled

August 1, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
Last Updated

January 13, 2025

Status Verified

January 1, 2025

Enrollment Period

9 months

First QC Date

April 17, 2023

Last Update Submit

January 9, 2025

Conditions

Outcome Measures

Primary Outcomes (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.

    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.

    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.

    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.

    12 month follow up

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale University Program for Recovery and Community Health

New Haven, Connecticut, 06513, United States

RECRUITING

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2023

First Posted

May 6, 2023

Study Start

August 1, 2024

Primary Completion

May 1, 2025

Study Completion

May 1, 2025

Last Updated

January 13, 2025

Record last verified: 2025-01

Locations