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

NCT ID: NCT06409975

Last Updated: 2025-07-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-12
• Study Completion Date: 2028-08-30

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.

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.

Conditions

Healthy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Mindful Self-Compassion (MSC)

Intervention Type: 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.

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.

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role: collaborator

University of Rhode Island

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jordon D Bosse, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Rhode Island

Locations

N/A-- All study activities being conducted virtually

Providence, Rhode Island, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Jordon D Bosse, PhD, RN

Role: CONTACT

jordon.bosse@uri.edu

401-874-5313

Heather Paskalides

Role: CONTACT

hpaskalides@uri.edu

(401) 874-4328

Facility Contacts

Jordon D Bosse, PhD

Role: primary

jordon.bosse@uri.edu

‪(401) 659-4050‬

Other Identifiers

1K01AT012495-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2106682-1

Identifier Type: -

Identifier Source: org_study_id