Mindful Self-Compassion for Healthy Subjects

Overseen By Heather Paskalides

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Rhode Island

Must not be taking: Antipsychotics, Benzodiazepines, Opioids, others

Disqualifiers: Mindfulness training, PHQ-8 score, Psychosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 11

Duration: 8 weeks

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of 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.

Who Is on the Research Team?

Jordon D Bosse, PhD

Principal Investigator

University of Rhode Island

Are You a Good Fit for This Trial?

This trial is for transgender, nonbinary, or genderqueer young adults who speak English and have reliable internet plus a smart device. They should be able to commit time to weekly virtual classes and daily practice activities.

Inclusion Criteria

I have reliable internet and can commit time to the program.

I can speak and understand English.

I identify as transgender, nonbinary, genderqueer, or another non-cisgender identity.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants complete an 8-week Mindful Self-Compassion intervention with weekly 2.5-hour virtual classes and a 4-hour virtual retreat

8 weeks

8 virtual classes, 1 virtual retreat

Follow-up

Participants are monitored for safety and effectiveness after treatment, with surveys conducted at 3-months post-intervention

12 weeks

Surveys conducted at 3-months post-intervention

What Are the Treatments Tested in This Trial?

Interventions

• Mindful Self-Compassion (MSC)

Trial Overview The study tests an 8-week Mindful Self-Compassion (MSC) program involving weekly virtual classes, a retreat, daily practices, and surveys before, during, after the intervention, and at a 3-month follow-up.

How Is the Trial Designed?

Group I: Mindful Self-Compassion Intervention Experimental Treatment 1 Intervention

All enrolled participants will complete the remotely delivered 8 week MSC intervention (described in interventions). Participants are encouraged to practice the formal meditations and/or informal skills taught each week between sessions. Participants will give feedback on self-compassion activities and the overall intervention. They will also complete several measures before, during, and after the intervention and at 3-month follow-up.

Who Is Running the Clinical Trial?

University of Rhode Island

Lead Sponsor

Trials

57

Recruited

22,400+

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Trials

886

Recruited

677,000+