Feasibility and Acceptability of Mindful Self-Compassion Among Transgender and Nonbinary Young Adults

June 8, 2026 updated by: University of Rhode Island

Evaluating the Feasibility and Acceptability of Mindful Self-Compassion Among Transgender and Nonbinary Young Adults

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Recruiting
        • N/A-- All study activities being conducted virtually
        • Principal Investigator:
          • Jordon D Bosse, PhD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Recruitment of participants into study
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)
immediately after the intervention
Percent of Sample Completing the Intervention
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.
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
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.
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
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
immediately after the intervention, at 12-week follow-up
Intent to use specific intervention activities in the future
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.
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
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
baseline, intervention week 4, immediately after the intervention, and 12 weeks after the intervention is completed

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Frequency of Use of Intervention Activities and perceived usefulness
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.
12 weeks after the intervention is completed
Percent of sample retained at follow-up
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.
12 weeks after the intervention is completed

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Total Practice Time During Intervention Weeks
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.
immediately after the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Rhode Island

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Center for Complementary and Integrative Health (NCCIH)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jordon D Bosse, PhD, University of Rhode Island

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 12, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 30, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 15, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 7, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 10, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 11, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 8, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2106682-1
  • 1K01AT012495-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Only demographic and quantitative data will be stored and preserved in Zenodo, an open dissemination research data repository. Only fully de-identified data will be shared with outside investigators at any time.

Data dictionaries, codebooks, notes about required variable transformations for descriptive analyses (if needed), and the online survey will be created, shared, and associated with the relevant datasets. Each variable in the codebook will include a brief description of the item along with the question number and question text from the online survey, variable name, variable label, value labels, and standard codes for missing values. Descriptions of composite variables, if created, will also be provided. Data collection instruments will be provided in portable document format (PDF) whenever possible. If a data collection instrument cannot be shared directly due to copyright or other issues, a link to the source of the instrument will be provided.

IPD Sharing Time Frame

Data will be made within one year of completion of the grant activities or at the time of publication of a completed data analysis (whichever comes first).

IPD Sharing Access Criteria

Researchers will be required to submit a request for data access through Zenodo, which will undergo scientific and community advisory board review to ensure scientific quality, relevance, feasibility, and adherence to best practices to the ethical conduct of research involving transgender and gender diverse persons.

Upon request approval, a data use agreement will be signed by the researcher and, if relevant, their respective institutional official. Once the DUA has been fully executed and proof of IRB approval or exemption has been provided, approval will be granted in Zenodo and the researcher will receive a unique link to access the relevant data and other files.

In view of the specificity of the project, interested investigators- particularly those who do not have members of the transgender community on their team- will be encouraged to form a collaborative arrangement with the study's investigators rather than simply receive the resources themselves.

IPD Sharing Supporting Information Type

  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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