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Feasibility and Acceptability of Peer Intervention for Improving Mental Health Among People Accessing Hormone Care | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGNA

Feasibility and Acceptability of Peer Intervention for Improving Mental Health Among People Accessing Hormone Care

NCT07354113•University of Michigan

View on ClinicalTrials.gov

Summary

The purpose of this study is to test whether the peer support program is acceptable, possible, and can improve mental health among individuals accessing hormone care. Eligible participants will be enrolled and randomized to the support program or enhanced usual care arm. Participants will take part in this study for 6 months.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients with hormone condition aged 18 years or older and English speaking
•Initiating or receiving hormone care in Michigan
•Report mild depression or anxiety symptoms, as determined by:
•1. A Patient Health Questionnaire (PHQ9) score ≥ 5 AND/OR
•2. A Generalized Anxiety Disorder (GAD) score ≥ 5.
•Interest or willingness to participate in peer support group meetings either in-person or virtually

Exclusion Criteria

•Unable to provide informed consent for any reason
•Not fluent in English
•Determination by patient's attending healthcare provider that peer mentorship is not appropriate due to unstable psychosis, cognitive disorder, or severe personality disorder, or other issue
•At imminent risk of suicide, as determined by active suicide ideation with intent and/or a specific plan (endorsed Columbia Suicide Severity Rating Scale number 4 or number 5 in the past month, number 6 in the past 3 months, or spontaneous report)
•Already receiving or intending to receive formalized individual peer specialist services through another community mental health program or organization
•Residing outside of the state of Michigan, or planning to move out of the state of Michigan in the next 6 months

Locations (1)

University of Michigan

Ann Arbor, Michigan, United States

Key Dates

Start Date

March 1, 2026

Primary Completion Date

October 1, 2026

Completion Date

October 1, 2026

Last Updated

February 20, 2026

Enrollment

100

ESTIMATED participants

Conditions

Hormone CareMild DepressionAnxiety

Interventions

Peer support group

BEHAVIORAL

Enhanced Usual Care (EUC)

OTHER

Contacts

Study Coordinator

CONTACT

734- 647-3101 POSIT-Study@med.umich.edu

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 20, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Feasibility and Acceptability of Peer Intervention for Improving Mental Health Among People Accessing Hormone Care

Inclusion Criteria

Exclusion Criteria

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