Feasibility and Acceptability of Mindful Self-Compassion Among Transgender and Nonbinary Young Adults

Официальное название

Evaluating the Feasibility and Acceptability of Mindful Self-Compassion Among Transgender and Nonbinary Young Adults

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое Mindful Self-Compassion (MSC)
  MSC is an 8-week virtual intervention with weekly 2.5-hour sessions and a 4-hour retreat (between sessions 5 and 6) which will take place online via HIPAA-compliant Zoom. Each weekly session includes an opening meditation, reflection on weekly practice, short teaching, a weekly core meditation or informal practice discussion, short break, brief centering practice, weekly core reflective activity and discussion, and self compassion skill of the week practice. The 4-hour retreat is focused on enga

Первичные конечные точки

• Recruitment of participants into study [Срок оценки: immediately after the intervention]
• Percent of Sample Completing the Intervention [Срок оценки: immediately after the intervention]
• Percent of participants who report satisfaction with MSC as Excellent or Good [Срок оценки: immediately after the intervention, at 12-week follow-up]
• Likelihood of recommending to others [Срок оценки: immediately after the intervention, at 12-week follow-up]
• Intent to use specific intervention activities in the future [Срок оценки: immediately after the intervention]
• Percent of completed data at each data-collection point [Срок оценки: baseline, intervention week 4, immediately after the intervention, and 12 weeks after the intervention is completed]

Вторичные конечные точки (2)

• Frequency of Use of Intervention Activities and perceived usefulness [Срок оценки: 12 weeks after the intervention is completed]
• Percent of sample retained at follow-up [Срок оценки: 12 weeks after the intervention is completed]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Фундаментальное исследование

Центры проведения

США · 1 центр

• N/A-- All study activities being conducted virtually — Providence

Идентификаторы

NCT: NCT06409975 · 2106682-1 · 1K01AT012495-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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