NCT06409975 Feasibility and Acceptability of Mindful Self-Compassion Among Transgender and Nonbinary Young Adults
| NCT ID | NCT06409975 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Rhode Island |
| Condition | Healthy |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2025-06-12 |
| Primary Completion | 2028-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2025-06-12 with a primary completion date of 2028-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Contact & Investigator
Jordon D Bosse, PhD
PRINCIPAL INVESTIGATOR
University of Rhode Island
Frequently Asked Questions
Who can join the NCT06409975 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 29 Years, studying Healthy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06409975 currently recruiting?
Yes, NCT06409975 is actively recruiting participants. Contact the research team at jordon.bosse@uri.edu for enrollment information.
Where is the NCT06409975 trial being conducted?
This trial is being conducted at Providence, United States.
Who is sponsoring the NCT06409975 clinical trial?
NCT06409975 is sponsored by University of Rhode Island. The principal investigator is Jordon D Bosse, PhD at University of Rhode Island. The trial plans to enroll 50 participants.