Anxiety & Depression Association of America

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

Purpose

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

Eligibility

Eligible Ages: Over 18 Years
Eligible Sex: All
Accepts Healthy Volunteers: No

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

Study Design

Phase: N/A
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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.
Primary Purpose: Treatment
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
Experimental Peer support group	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.	Behavioral: Peer support group 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.
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.	Other: 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.

Recruiting Locations

More Details

Status: Recruiting
Sponsor: University of Michigan

Study Contact

Study Coordinator
734- 647-3101
POSIT-Study@med.umich.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.