Evaluating the Feasibility and Acceptability of Mindful Self-Compassion Among Transgender and Nonbinary Young Adults
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Recruitment of participants into study
研究概览
简要总结
The goal of this single-arm feasibility study is to evaluate the feasibility and acceptability of an 8-week mindful self-compassion intervention and associated data-collection plan among transgender and nonbinary young adults. Participants will be asked to:
- Complete weekly 2.5-hour virtual classes for 8 weeks and a 4-hour virtual retreat
- Practice specific activities in between classes for 20-30 minutes a day
- Answer survey questions before starting the intervention, half-way through the intervention, after the intervention, and 3-months after the intervention ends.
详细描述
The specific aims of this study are to: 1) evaluate the feasibility and acceptability of an 8-week Mindful Self-Compassion (MSC) intervention and data collection plan (pre-, post-, 3-month follow-up) with 5 consecutive groups of transgender and nonbinary young adults (TNYA), 2) evaluate the usability of MSC intervention activities by TNYA and determine whether MSC activities need to be tailored for TNYA, and 3) explore data collected throughout each intervention implementation to evaluate patterns of missingness and potential participant burden, intervention adherence, and reasons for dropout.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 29 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •transgender, nonbinary, genderqueer (or another non-cisgender identity)
- •have reliable access to a smart phone or computer/tablet and the Internet and is reasonably able to make the time commitment required of the program (self-report)
- •speak and understand English
排除标准
- •has had formal mindfulness training (i.e. mindfulness-based stress reduction course) or engages in regular mindfulness practice (15 minutes more than twice a week for the last six months or more)
- •Score 15 or higher on the patient health questionnaire-8 (PHQ-8)
- •Score 2 or higher on the Columbia Suicide Severity Rating Scale
- •Experienced an acute physical health crisis (e.g., chemotherapy, recovery from severe injury) (Germer & Neff, 2019, p. 80) in the past year
- •Head trauma, seizure, or loss of consciousness in the past 6 months
- •Reports a history of trauma AND Scores 14 or higher on Post-Traumatic Checklist, 6-item Civilian version
- •Reports a diagnosis of a personality disorder
- •Reports a diagnosis of schizophrenia or a history of psychosis
- •Reports acute panic attack in the past month and history of acute panic attacks with concern/worry about having another one in the future OR Reports severe social anxiety which would make attending class too difficult
- •Reports an acute episode of psychosis or suicide attempt in the past 12 months
- •Has engaged in non-suicidal self-injury in the past 6 months
- •Currently prescribed antipsychotic medications, benzodiazepine (equivalent to 30mg diazepam/day) or opioids (>40mg morphine equivalent/day)
- •Prescribed any other psychiatric medication, including medication for opioid use disorder, whose dose has been changed in the past 8 weeks or is anticipated to change in the next 2 months.
- •Currently engage in harmful drinking (5 or more drinks on one occasion (Flentje et al., 2020) more than once in the past 2 weeks; OR have any concerns about the expectation to not be using substances during group sessions
- •has undergone detoxification from alcohol or other drugs and has been in sustained remission (with or without medication) for less than 1 year
- •Has been hospitalized overnight for mental health related reasons in the past year (any diagnoses except bipolar disorder) OR have a diagnosis of bipolar disorder and have had an episode of mania or have been hospitalized in the past 2 years
- •Reports any other acute physical or mental illness symptoms that may make group participation difficult
研究组 & 干预措施
Mindful Self-Compassion Intervention
All enrolled participants will complete the remotely delivered 8 week MSC intervention (described in interventions). Participants are encouraged to practice the formal meditations and/or informal skills taught each week between sessions. Participants will give feedback on self-compassion activities and the overall intervention. They will also complete several measures before, during, and after the intervention and at 3-month follow-up.
干预措施: Mindful Self-Compassion (MSC) (Behavioral)
结局指标
主要结局
Recruitment of participants into study
时间窗: immediately after the intervention
Intervention feasibility will be determined by the ability to recruit adequate study samples (N=10 per cohort; 5 cohorts total)
Percent of Sample Completing the Intervention
时间窗: immediately after the intervention
Intervention feasibility will also be determined by the percent of participants who complete the intervention, defined as completing at least 6/8 intervention sessions.
Percent of participants who report satisfaction with MSC as Excellent or Good
时间窗: immediately after the intervention, at 12-week follow-up
Participant quantitative ratings (Excellent, Good, Fair, Poor, Awful) of their satisfaction with the intervention and qualitative feedback on intervention will be collected at the end of the intervention to evaluate the acceptability of the overall 8-week intervention and again at 12-week follow-up.
Likelihood of recommending to others
时间窗: immediately after the intervention, at 12-week follow-up
Participants will also be asked how likely they would be to recommend the intervention to others (0-not at all likely; 10-very likely) and the strongest reason for their rating \[Net Promoter Score\] at the end of the intervention and again at 12-week follow-up
Intent to use specific intervention activities in the future
时间窗: immediately after the intervention
Participant quantitative ratings (0 not useful -10 very useful) and qualitative feedback on formal meditations and informal practices will be collected at the end of the intervention to evaluate the usability of intervention/components, including the likelihood (0 not likely, 10- very likely) that they will use each activity in the future.
Percent of completed data at each data-collection point
时间窗: baseline, intervention week 4, immediately after the intervention, and 12 weeks after the intervention is completed
Percent of completed data collected at each time point (pre-intervention, mid-intervention, post-intervention, and 3-month follow-up) and the amount of time it takes to complete individual measures and all measures will be used to evaluate the feasibility of the data collection plan
次要结局
- Frequency of Use of Intervention Activities and perceived usefulness(12 weeks after the intervention is completed)
- Percent of sample retained at follow-up(12 weeks after the intervention is completed)