Feasibility and Acceptability of Peer Intervention for Improving Mental Health Among People Accessing Hormone Care
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Feasibility assessed by Acceptability based on the average total Abbreviated Acceptability Rating Profile (AARP) score at 6 months
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 ≥
- •Interest or willingness to participate in peer support group meetings either in-person or virtually
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Enhanced Usual Care (EUC) (Other)
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.
干预措施: Peer support group (Behavioral)
结局指标
主要结局
Feasibility assessed by Acceptability based on the average total Abbreviated Acceptability Rating Profile (AARP) score at 6 months
时间窗: 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.
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
次要结局
未报告次要终点
研究者
Daphna Stroumsa
Assistant Professor of Obstetrics and Gynecology
University of Michigan