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Can a buddy system boost mental health during hormone therapy?

NCT ID NCT07354113

Symptom relief Sponsor: University of Michigan Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether a peer support program is acceptable and helpful for people with mild depression or anxiety who are starting or receiving hormone care. One hundred participants are randomly assigned to either the peer support group or usual care. The program includes one-on-one meetings, group sessions, and a medical appointment buddy over six months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
peer support group
What this could lead to
If this works, it could show that peer support is a practical way to ease mild depression and anxiety for people undergoing hormone care.
What could go wrong
This is a small feasibility study, not a large trial. It focuses on whether the program is acceptable, not on proving it works. Results may not apply to everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2026

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

anxiety anxiety disorder depressive disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Anxiety Hormone care Mild depression

Contacts and locations

Locations

  • University of Michigan

    Ann Arbor, Michigan, 48109, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.