RECRUITING

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

Conditions

Healthy transgender nonbinary mindful self-compassion feasibility acceptability

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-05-31

Study Completion:2028-08-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06409975

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 25 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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 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

Inclusion Criteria

Exclusion 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 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

Contacts and Locations

Study Contact

Jordon D Bosse, PhD, RN

CONTACT

401-874-5313

jordon.bosse@uri.edu

Heather Paskalides

CONTACT

(401) 874-4328

hpaskalides@uri.edu

Principal Investigator

Jordon D Bosse, PhD

PRINCIPAL_INVESTIGATOR

University of Rhode Island

Study Locations (Sites)

N/A-- All study activities being conducted virtually

Providence, Rhode Island, 02903

United States

Collaborators and Investigators

Sponsor: University of Rhode Island

Jordon D Bosse, PhD, PRINCIPAL_INVESTIGATOR, University of Rhode Island

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05-31

Study Completion Date2028-08-30

Study Record Updates

Study Start Date2025-05-31

Study Completion Date2028-08-30

Terms related to this study

Keywords Provided by Researchers

transgender
nonbinary
mindful self-compassion
feasibility
acceptability

Additional Relevant MeSH Terms

Healthy