Mindful Self-Compassion program for transgender and nonbinary young adults
Evaluating the Feasibility and Acceptability of Mindful Self-Compassion Among Transgender and Nonbinary Young Adults
NA · University of Rhode Island · NCT06409975
This 8-week online Mindful Self-Compassion program will be tried with transgender and nonbinary young adults to see if it is practical and acceptable.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 25 Years |
| Sex | All |
| Sponsor | University of Rhode Island (other) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Providence, Rhode Island) |
| Trial ID | NCT06409975 on ClinicalTrials.gov |
What this trial studies
This single-arm feasibility project delivers an 8-week Mindful Self-Compassion (MSC) program remotely to transgender and nonbinary young adults via weekly 2.5-hour virtual classes and a 4-hour virtual retreat. Participants are asked to practice guided activities 20–30 minutes daily and complete surveys before, mid-way, after the program, and three months later. The team will track recruitment, attendance, adherence, dropout reasons, and patterns of missing data across five consecutive groups to determine whether the program and data-collection plan are workable. Investigators will also examine whether MSC activities need tailoring to improve usability and engagement for transgender and nonbinary young adults.
Who should consider this trial
Good fit: Ideal participants are English-speaking transgender or nonbinary young adults with reliable internet access who can commit to weekly live virtual sessions and do not have extensive prior mindfulness training or high current suicide risk or very severe depressive symptoms.
Not a fit: People with recent severe physical health crises, recent head trauma or seizures, high trauma symptom scores, PHQ-8 scores indicating moderately severe depression or higher, high suicide risk, or those already practicing mindfulness regularly are unlikely to benefit from this feasibility program.
Why it matters
Potential benefit: If successful, the program could provide an accessible online way for transgender and nonbinary young adults to build self-compassion and coping skills.
How similar studies have performed: Mindful Self-Compassion programs have shown benefits for self-compassion and mental health in general and clinical populations, but they have been minimally tested specifically in transgender and nonbinary young adults.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Providence, Rhode Island
- N/A-- All study activities being conducted virtually — Providence, Rhode Island, United States (RECRUITING)
Study contacts
- Principal investigator: Jordon D Bosse, PhD — University of Rhode Island
- Study coordinator: Jordon D Bosse, PhD, RN
- Email: jordon.bosse@uri.edu
- Phone: 401-874-5313
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Healthy, transgender, nonbinary, mindful self-compassion, feasibility, acceptability