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

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
University of Michigan
Study ID
NCT07354113
Status
Recruiting
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Conditions

  • Anxiety
  • Hormone Care
  • Mild Depression

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Peer support group — BEHAVIORAL
    A peer mentor will be matched to mentees with participant input. The first meeting is intended to establish contact and expectations. Sessions will be scheduled according to the participant's preferences, with a suggested frequency of once a month with more as necessary and feasible. Participants in the peer support group will have access to peer support options that include: one-one one meetings with a peer mentor; group meetings with mentors and other participants; and medical appointment buddy. Participants are not required to use every option each month. Study visits will be completed baseline-6 months.
  • Enhanced Usual Care (EUC) — OTHER
    Participants randomized to the usual care group will not have access to the peer support options but will complete the study visits (baseline-6 months). All participants will be given a resource document with community resources.

Study Details

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.

Key Dates

Start date
Feb 17, 2026
Status verified
Apr 2026
Primary completion
Oct 31, 2026
Completion
Oct 31, 2026

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Peer support group
    Participants in the peer support group will be contacted by the peer coordinator to be connected with a peer mentor and will have access to peer support options, namely, one-one one meetings with a peer mentor, group meetings with mentors and other participants, and medical appointment buddy.
  • Other: Enhanced Usual Care (EUC)
    EUC Documents will be disseminated with hormone care information and resources to share with patients relevant to the participants specific hormone condition or type of hormone care.

Primary Outcome Measure

Feasibility assessed by Acceptability based on the average total Abbreviated Acceptability Rating Profile (AARP) score at 6 months [ Time Frame: 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MichiganAnn ArborMichigan48109
Daphna Stroumasa, MD, MPH, MSc
[email protected]
Daphna Stroumsa, MD, MPH, MSc (PRINCIPAL_INVESTIGATOR)

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By research site
University of Michigan· Ann Arbor, MI

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