Hormone CareNCT07354113
Feasibility and Acceptability of Peer Intervention for Improving Mental Health Among People Accessing Hormone Care
A study testing Peer support group in people with Hormone Care and Mild Depression, run by University of Michigan at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hormone Care, Mild Depression, Anxiety
- What is being tested?
- Peer support group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Feb 2026to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Hormone Care, Mild Depression, Anxiety
- Being tested
- Peer support group, Enhanced Usual Care (EUC)
- Keywords
- Peer support group, Enhanced usual care
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer support groupBehavioural
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 group | Role | What they receive |
|---|---|---|
| Peer support group | Experimental | 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. Receives: Behavioral: Peer support group |
| Enhanced Usual Care (EUC) | Other | 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. Receives: Other: Enhanced Usual Care (EUC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study start17 Feb 2026
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hormone CareStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Random assignment will be completed using 1:1 computer randomization. Randomization will be stratified by indication and regimen. Randomization will occur prior to the participant's hormone initiation visit to ensure participants assigned to the intervention have standardized access to the peer support components.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Principal investigator, Daphna Stroumsa, University of Michigan
- Investigators
- Daphna Stroumsa, MD, MPH, MSc, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07354113
- Sponsor's protocol ID
- HUM00279649
- Other IDs
- 5K23MD016950-04
- Status last verified
- Jun 2026
- First submitted
- 16 Jan 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Acceptability of Peer Intervention for Improving Mental Health Among People Accessing Hormone Care
- ClinicalTrials.gov ID
- NCT07354113
- Acronym / sponsor ID
- HUM00279649
- Conditions
- Hormone Care, Mild Depression, Anxiety
- Keywords
- Peer support group, Enhanced usual care
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 17 Feb 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 21 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Random assignment will be completed using 1:1 computer randomization. Randomization will be stratified by indication and regimen. Randomization will occur prior to the participant's hormone initiation visit to ensure participants assigned to the intervention have standardized access to the peer support components.
| Arm | Type | Receives |
|---|---|---|
| Peer support group | Experimental | Behavioral: Peer support groupParticipants 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. |
| Enhanced Usual Care (EUC) | Other | 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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:
- Interest or willingness to participate in peer support group meetings either in-person or virtually
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peer support groupA 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. | Behavioural | Peer support group |
| 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. | Other | Enhanced Usual Care (EUC) |
Primary outcome
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.
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)
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.
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.
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: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daphna Stroumsa, MD, MPH, MSc principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peer support group in people with Hormone Care and Mild Depression, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.