HealthyNCT06409975
Feasibility and Acceptability of Mindful Self-Compassion Among Transgender and Nonbinary Young Adults
A study testing Mindful Self-Compassion (MSC) in people with Healthy, run by University of Rhode Island at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 29 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Mindful Self-Compassion (MSC)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jun 2025to 30 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 29 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
N/A-- All study activities being conducted virtually
Providence, Rhode Island, 02903
Jordon D Bosse, PhD, 401-874-5313, jordon.bosse@uri.edu
Jordon D Bosse, PhD
About this study
Official title: 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.
Read the 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
- Being tested
- Mindful Self-Compassion (MSC)
- Keywords
- transgender, nonbinary, mindful self-compassion, feasibility, acceptability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindful Self-Compassion (MSC)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Mindful Self-Compassion (MSC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
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.
Measured: 12 weeks after the intervention is completed
Percent of sample retained at follow-up
Total number of participants who complete the follow-up measures at 12 weeks divided by the number of participants who completed the intervention.
Measured: 12 weeks after the intervention is completed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2024
- Study start12 Jun 2025
- Primary completion31 Mar 2028 (estimated)
- Study completion30 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rhode Island
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Sponsor
- Investigators
- Jordon D Bosse, PhD, Principal investigator, University of Rhode Island
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06409975
- Sponsor's protocol ID
- 2106682-1
- Other IDs
- 1K01AT012495-01
- Status last verified
- Jul 2025
- First submitted
- 15 Nov 2023
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Feasibility and Acceptability of Mindful Self-Compassion Among Transgender and Nonbinary Young Adults
- ClinicalTrials.gov ID
- NCT06409975
- Acronym / sponsor ID
- 2106682-1
- Conditions
- Healthy
- Keywords
- transgender, nonbinary, mindful self-compassion, feasibility, acceptability
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of Rhode IslandUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 12 Jun 2025 (actual)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 30 Aug 2028 (estimated)
- First posted
- 10 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mindful Self-Compassion Intervention | Experimental | Behavioral: Mindful Self-Compassion (MSC)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 may qualify
- Ages
- 18 to 29 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Mindful Self-Compassion Intervention |
Primary outcome
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)
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.
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.
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
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.
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
2 secondary outcomes
Frequency of Use of Intervention Activities and perceived usefulness
Time frame: 12 weeks after the intervention is completed
Percent of sample retained at follow-up
Time frame: 12 weeks after the intervention is completed
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jordon D Bosse, PhD principal investigator
University of Rhode Island
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindful Self-Compassion (MSC) in people with Healthy, run by University of Rhode Island at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jordon D Bosse, PhD, RN (401-874-5313, jordon.bosse@uri.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment of participants into study (time frame: immediately after the intervention). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.