N/A-- All study activities being conducted virtually
Providence, Rhode Island, 02903, United States
Location status: Recruiting
Location contact
Jordon D Bosse, PhD
CONTACT
401-874-5313
Jordon D Bosse, PhD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT06409975
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.
Interested in participating?
Request Info18 year–29 year
All sexes
Interventional
Not applicable
Providence, Rhode Island, 02903, United States
Location status: Recruiting
Jordon D Bosse, PhD
CONTACT
401-874-5313
Jordon D Bosse, PhD
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 engaging with the formal practices that have been taught in weeks 1-5.
Time frame: immediately after the intervention
Intervention feasibility will be determined by the ability to recruit adequate study samples (N=10 per cohort; 5 cohorts total)
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 12 weeks after the intervention is completed
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.
Time frame: 12 weeks after the intervention is completed
Total number of participants who complete the follow-up measures at 12 weeks divided by the number of participants who completed the intervention.
Time frame: immediately after the intervention
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.
Contact information is provided by the study sponsor or research team.
Heather Paskalides
CONTACT
Jordon D Bosse, PhD, RN
CONTACT
University of Rhode Island
Other
Evaluating the Feasibility and Acceptability of Mindful Self-Compassion Among Transgender and Nonbinary Young Adults
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07686393
Healthy
Bethesda, Maryland, United States
View Trial DetailsNCT07407348
Body Weight, Healthy
Nottingham, United Kingdom
View Trial DetailsNCT07169630
Alzheimer s Disease, Cognition Disorders
Bethesda, Maryland, United States
View Trial DetailsNCT01399385
Arterial Occlusive Diseases, Arteriosclerosis
Bethesda, Maryland, United States
View Trial Details