Clinical trial NCT06409975: Feasibility and Acceptability of Mindful Self-Compassion Among Transgender and Nonbinary Young Adults
Official title: Evaluating the Feasibility and Acceptability of Mindful Self-Compassion Among Transgender and Nonbinary Young Adults
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Healthy
Keywords: transgender
nonbinary
mindful self-compassion
feasibility
acceptability
Lead sponsor: University of Rhode Island
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2024-05-10
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

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 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

Primary outcomes:
measure: Recruitment of participants into study
timeFrame: immediately after the intervention
measure: Percent of Sample Completing the Intervention
timeFrame: immediately after the intervention
measure: Percent of participants who report satisfaction with MSC as Excellent or Good
timeFrame: immediately after the intervention, at 12-week follow-up
measure: Likelihood of recommending to others
timeFrame: immediately after the intervention, at 12-week follow-up
measure: Intent to use specific intervention activities in the future
timeFrame: immediately after the intervention
measure: Percent of completed data at each data-collection point
timeFrame: baseline, intervention week 4, immediately after the intervention, and 12 weeks after the intervention is completed
Secondary outcomes:
measure: Frequency of Use of Intervention Activities and perceived usefulness
timeFrame: 12 weeks after the intervention is completed
measure: Percent of sample retained at follow-up
timeFrame: 12 weeks after the intervention is completed
Other outcomes:
measure: Total Practice Time During Intervention Weeks
timeFrame: immediately after the intervention
Locations:
city: Providence
country: United States
facility: N/A-- All study activities being conducted virtually
state: Rhode Island
Study officials:
affiliation: University of Rhode Island
name: Jordon D Bosse, PhD
role: PRINCIPAL_INVESTIGATOR
References: