About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Single group
Treatments tested in this trial
Mindful Self-Compassion (MSC)
BehavioralMSC 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 engaging with the formal practices that have been taught in weeks 1-5.
Treatment groups
Trial outcomes
Primary outcomes
Recruitment of participants into study
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
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
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
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
Secondary outcomes
Frequency of Use of Intervention Activities and perceived usefulness
Participant quantitative ratings on the usefulness of each formal meditation and informal practice (0 not useful -10 very useful), frequency of use since the intervention ended (more than once a day, daily, a few times a week, weekly, a few times a month, monthly, once or twice since the intervention ended, not at all) as well qualitative feedback about how the activities have been incorporated in everyday life.
Percent of sample retained at follow-up
Total number of participants who complete the follow-up measures at 12 weeks divided by the number of participants who completed the intervention.
Other outcomes
Total Practice Time During Intervention Weeks
Total time spent will be calculated by summing participants' weekly self-reports of frequency (# days, 0-7) and duration of home practice (0-30+ minutes; 5 minute increments) with formal and informal self-compassion activities.
Sponsors and contacts
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University of Rhode Island
Lead sponsor
National Center for Complementary and Integrative Health (NCCIH)
Collaborator