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NCT Number: NCT07354113

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Hormone Care Anxiety Anxiety Disorders Mental Disorders Mild Depression

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • A Patient Health Questionnaire (PHQ9) score ≥ 5 AND/OR
  • 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

Treatment and study plan

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.

Primary outcomes

  1. Feasibility assessed by Acceptability based on the average total Abbreviated Acceptability Rating Profile (AARP) score at 6 months

    Time frame: 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.

  2. Feasibility based on the number of participants that agreed to participate on the study out of total number of individuals approached for study participation.

    Time frame: Up to 6 months (recruitment period)

  3. Feasibility assessed by Practicality based on the total number of one-on-one in-person sessions vs one-on-one virtual sessions

    Time frame: 6 months

    This is defined as the total number of one-on-one in-person sessions vs one-on-one virtual sessions.

  4. Feasibility assessed by Practicality based on the total the number participants engaged with group sessions in-person vs. number of participants engaged virtually

    Time frame: 6 months

    This is defined as the total number of participants engaged with group sessions in-person vs. number of participants engaged virtually.

  5. Safety based on the number of related adverse events

    Time frame: 6 months

    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

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • National Institute on Minority Health and Health Disparities (NIMHD)

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 21, 2026
Registry last updated
Jun 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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