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

NCT06409975 | Recruiting DMC

• 2 other identifiers: 2106682-11K01AT012495-01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (6)

• Recruitment of participants into study

  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

  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

  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

  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

  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

  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 Outcomes (2)

• Frequency of Use of Intervention Activities and perceived usefulness

  12 weeks after the intervention is completed

• Percent of sample retained at follow-up

  12 weeks after the intervention is completed

Other Outcomes (1)

• Total Practice Time During Intervention Weeks

  immediately after the intervention

Study Arms (1)

Mindful Self-Compassion Intervention

EXPERIMENTAL

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)

Interventions

Mindful Self-Compassion (MSC) BEHAVIORAL

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.

Mindful Self-Compassion Intervention

Eligibility Criteria

• Age: 18 Years - 25 Years
• Gender Eligibility Details: have a gender identity that is transgender, non-binary, genderqueer (i.e. not cisgender)
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Rhode Island: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

N/A-- All study activities being conducted virtually

Providence, Rhode Island, 02903, United States

RECRUITING

Study Officials

• Jordon D Bosse, PhD

  University of Rhode Island

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jordon D Bosse, PhD, RN

CONTACT

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

Heather Paskalides

CONTACT

(401) 874-4328; hpaskalides@uri.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2023
• First Posted: May 10, 2024
• Study Start: June 12, 2025
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): August 30, 2028
• Last Updated: July 11, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF, CSR
• 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).
• 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.

Locations

US (1)