Anxiety, Hormone Care, Mild Depression
Conditions
Keywords
Peer support group, Enhanced usual care
Brief 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. Participants will take part in this study for 6 months.
Interventions
BEHAVIORALPeer 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.
OTHEREnhanced 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.
Sponsors
University of Michigan
National Institute on Minority Health and Health Disparities (NIMHD)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility assessed by Acceptability based on the average total Abbreviated Acceptability Rating Profile (AARP) score at 6 months | 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. | 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 | 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 | 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 | 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 |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORDaphna Stroumsa, MD, MPH, MSc
University of Michigan
Outcome results
None listed