Peer Support for Mental Health in Hormone Care
This study is looking at whether a peer support program can help improve mental health for people receiving hormone care who also experience mild depression or anxiety. You might be able to join if you are 18 or older, speak English, are receiving hormone care in Michigan, and have mild depression or anxiety symptoms (based on specific questionnaires). The study will compare a "peer support group" where you're matched with a mentor, to "Enhanced Usual Care" which provides community resources but no peer support. The main goal is to see if the peer support program is acceptable and practical, and if it can improve mental health. This study plans to enroll 100 participants.
- Study design
- This study is an interventional study that will randomly assign participants to either a peer support group or an enhanced usual care group. It plans to enroll 100 participants.
- What's involved
- If you join, you will participate in the study for 6 months. If in the peer support group, you will have sessions with a peer mentor, suggested once a month or more as needed.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for 6 months, with assessments at the beginning and at 6 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Feasibility and Acceptability of Peer Intervention for Improving Mental Health Among People Accessing Hormone Care
At a glance
Conditions
NCT07354113
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
University of Michigan
Ann Arbor, Michiganno site contact published
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Daphna Stroumsa, MD, MPH, MSc · PRINCIPAL_INVESTIGATOR · University of Michigan
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
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Inclusion
Exclusion
What this trial measures
- Feasibility assessed by Acceptability based on the average total Abbreviated Acceptability Rating Profile (AARP) score at 6 months6 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.
- 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 sessions6 months
This is defined as the total number of one-on-one in-person sessions vs one-on-one virtual sessions.
- Feasibility assessed by Practicality based on the total the number participants engaged with group sessions in-person vs. number of participants engaged virtually6 months
This is defined as the total number of participants engaged with group sessions in-person vs. number of participants engaged virtually.
- Safety based on the number of related adverse events6 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: 1. \- Mild adverse event (AE) - No treatment needed 2. \- Moderate AE - Resolved with treatment 3. \- Severe AE - Inability to carry on normal activities, required professional medical attention 4. \- Life-threatening or disabling AE 5. \- Fatal AE