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

University of Rhode Island

Status: Enrolling

Conditions: Healthy

Treatments: Behavioral: Mindful Self-Compassion (MSC)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06409975

2106682-1

1K01AT012495-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 25 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

50 participants in 1 patient group

Mindful Self-Compassion Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Mindful Self-Compassion (MSC)