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

University of Michigan

Status: Enrolling

Conditions: Hormone Care; Anxiety; Mild Depression

Treatments: Other: Enhanced Usual Care (EUC); Behavioral: Peer support group

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07354113

HUM00279649

5K23MD016950-04 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Peer support group

Experimental group

Description:

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.

Treatment:

Behavioral: Peer support group

Enhanced Usual Care (EUC)

Other group

Description:

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.

Treatment:

Other: Enhanced Usual Care (EUC)