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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06409975
• Other study ID #: 2106682-1
• Secondary ID: 1K01AT012495-01
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 2024
• Est. completion date: July 2028

Study information

• Verified date: October 2023
• Source: University of Rhode Island
• Contact: Jordon D Bosse, PhD, RN
• Phone: 401-874-5313
• Email: jordon.bosse[@]uri.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: July 2028
• Est. primary completion date: December 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 25 Years

Eligibility

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 20 or higher on the patient health questionnaire-8 (PHQ-8)

• Score 3 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 symptoms of re-experiencing (i.e. "flashbacks") or dissociation in past 6 months

• 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 or 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 6 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

Related Conditions & MeSH terms

• Healthy

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Rhode Island	National Center for Complementary and Integrative Health (NCCIH)

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Total Practice Time During Intervention Weeks	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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.	12 weeks after the intervention is completed
Secondary	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.	12 weeks after the intervention is completed