Recruiting

Mindful Self-Compassion

Sponsor:

University of Rhode Island

Code:

NCT06409975

Conditions

Healthy

Eligibility Criteria

Sex: All

Age: 18 - 29

Healthy Volunteers: Accepted

Interventions

Mindful Self-Compassion (MSC)

Study Details

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.

Conditions

Healthy

Study ID

NCT06409975

Start date

Jun 12, 2025

Status verified date

Jul, 2025

Completion date

Aug 30, 2028

Anticipated

Primary completion date

Mar 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 29

Healthy Volunteers: Accepted

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

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Mindful Self-Compassion 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.

Interventions

Mindful Self-Compassion (MSC)

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.

Primary outcome measure

  • Recruitment of participants into study [ Time Frame: immediately after the intervention ]
  • Percent of Sample Completing the Intervention [ Time Frame: immediately after the intervention ]
  • Percent of participants who report satisfaction with MSC as Excellent or Good [ Time Frame: immediately after the intervention, at 12-week follow-up ]
  • Likelihood of recommending to others [ Time Frame: immediately after the intervention, at 12-week follow-up ]
  • Intent to use specific intervention activities in the future [ Time Frame: immediately after the intervention ]
  • Percent of completed data at each data-collection point [ Time Frame: baseline, intervention week 4, immediately after the intervention, and 12 weeks after the intervention is completed ]

Central Contacts and Locations

Central contacts

Jordon D Bosse, PhD, RN

401-874-5313jordon.bosse@uri.edu

Heather Paskalides

(401) 874-4328hpaskalides@uri.edu

Locations

N/A-- All study activities being conducted virtually

Recruiting

Providence, Rhode Island, United States, 02903

Contacts

Jordon D Bosse, PhD

‪401-874-5313jordon.bosse@uri.edu

Principal Investigator:

Jordon D Bosse, PhD

More Information

Sponsor

University of Rhode Island

Last update posted

Jun 11, 2026

Last verified

Jul, 2025

Keywords

  • transgender
  • nonbinary
  • mindful self-compassion
  • feasibility
  • acceptability

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Rhode Island on 2026-06-11.