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Official title Feasibility and Acceptability of Mindful Self-Compassion Among Transgender and Nonbinary Young Adults
ClinicalTrials.gov ID: NCT06409975
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 29. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- speak and understand English
You likely can't join if
- has had formal mindfulness training (i.e. mindfulness-based stress reduction course) or engages in regular mindfulness practice (15 minutes more than...
- 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
See the full eligibility 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
- 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...
- 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...
- Reports any other acute physical or mental illness symptoms that may make group participation difficult
The study team makes the final eligibility decision.
Where it's taking place
- Providence, Rhode Island, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 29 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Providence, Rhode Island, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.