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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Anxiety; Mild Depression; Hormone Care
• Intervention / Treatment: Behavioral: Peer support group; Other: Enhanced Usual Care (EUC)

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Study Coordinator; Phone Number: 734- 647-3101; Email: POSIT-Study@med.umich.edu

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan
      • Contact: Daphne Stroumasa, MD, MPH, MSc; Email: daphnast@med.umich.edu
      • Principal Investigator: Daphna Stroumsa, MD, MPH, MSc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Behavioral: Peer support group; 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.
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.	Other: Enhanced Usual Care (EUC); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility assessed by Acceptability based on the average total Abbreviated Acceptability Rating Profile (AARP) score at 6 months	The 9-item AARP is adapted to specifically address this peer support intervention for individuals seeking hormone care. Participants will respond to a 6-point Likert scale rating participants agreement with each acceptability statement. Total scores range from 9-54 with a higher score indicating greater acceptability.	6 months
Feasibility based on the number of participants that agreed to participate on the study out of total number of individuals approached for study participation.		Up to 6 months (recruitment period)
Feasibility assessed by Practicality based on the total number of one-on-one in-person sessions vs one-on-one virtual sessions	This is defined as the total number of one-on-one in-person sessions vs one-on-one virtual sessions.	6 months
Feasibility assessed by Practicality based on the total the number participants engaged with group sessions in-person vs. number of participants engaged virtually	This is defined as the total number of participants engaged with group sessions in-person vs. number of participants engaged virtually.	6 months
Safety based on the number of related adverse events	Related events included will be definitely, probably, and possibly related events (defined per protocol). The grading scale that will be used for these events include: - Mild adverse event (AE) - No treatment needed; - Moderate AE - Resolved with treatment; - Severe AE - Inability to carry on normal activities, required professional medical attention; - Life-threatening or disabling AE; - Fatal AE	6 months

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: National Institute on Minority Health and Health Disparities (NIMHD)
• Investigators: Principal Investigator: Daphna Stroumsa, MD, MPH, MSc, University of Michigan

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: January 16, 2026
• First Submitted That Met QC Criteria: January 16, 2026
• First Posted (Actual): January 21, 2026

Study Record Updates

• Last Update Posted (Actual): February 20, 2026
• Last Update Submitted That Met QC Criteria: February 18, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Peer support group; Enhanced usual care
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: HUM00279649; 5K23MD016950-04 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No