University of Wisconsin
Madison, Wisconsin, 53705, United States
NCT Number: NCT05903911
The current project aims to improve the well-being of trans and nonbinary (TNB) individuals through an online intervention (Trans Care) targeting the reduction of symptoms of gender dysphoria. The Trans Care intervention will involve the creation of an online intervention comprised of eight modules intended to reduce symptoms of gender dysphoria, increase active coping, and improve the well-being of TNB individuals. Aim 2 is a randomized controlled trial of the proposed intervention and will enroll 260 TNB participants.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Madison, Wisconsin, 53705, United States
The overall purpose of this project is to create a free intervention that can be disseminated widely throughout TNB communities to improve well-being in an easy, accessible way. Development and execution of the Trans Care intervention involves two primary aims:
Aim 2 is a RCT in which participants' scores of psychological wellbeing and coping strategies in the intervention vs waitlist control group will be analyzed. Additionally, participants who drop out of the RCT will be asked to complete measures at dropout to determine what dose size of Trans Care (i.e., how many modules) is necessary to have a significant change in mental well-being. Finally, waitlisted participants will be offered the intervention within one month of the completion of data collection.
Aim 2 Hypotheses:
Aim 2 Endpoints:
The primary endpoint of Aim 2 will be to determine if participants who engaged the Trans Care intervention experienced psychological improvement in their mental health as a result of completing the intervention.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
an educational and interactive website designed to improve coping strategies of TNB individuals
Time frame: before and after intervention (participants will have up to 1 month to complete intervention), 3 month follow up
DASS-21 is a composite measurement used to assess symptoms of depression, anxiety, and stress in community settings. The 21-item survey is comprised of three subscales for Depression, Anxiety, and Stress. Responses are provided on a 4-point Likert scale, Where 0 = Did not apply to me, 1 = applied to me some degree, or some of the time, 2 = applied to me a considerable degree or good part of time, and 3 = applied to me very much or most of the time. Total possible range of scores is from 0 to 63, with higher scores indicating higher levels of symptoms.
Time frame: before and after intervention (participants will have up to 1 month to complete intervention), 3 month follow up
GCLS measures gender congruence and life satisfaction in a 38-item self assessment, for a total possible range of scores from 38-190 where higher values indicate greater gender congruence, greater gender-related well-being, and greater life satisfaction.
Time frame: before and after intervention (participants will have up to 1 month to complete intervention), 3 month follow up
Total scores are calculated for each scale based on summed values assigned to possible response options. The first 8 items are scored 0 for "never," 1 for "yes, before age 18," 2 for "yes, after age 18," and 3 for "yes, in the past year." Scores from these items are then summed where a higher score indicates more frequent and recent experiences of gender related prejudice. All other items are scored from 0 - 4 according to responses ranging from strongly disagree to strongly agree. Items within each subscale (i.e., non-affirmation of identity, internalized transphobia, and negative expectations for the future) are summed with high scores indicating greater distress.
Time frame: before and after intervention (participants will have up to 1 month to complete intervention), 3 month follow up
TNCM assesses the unique ways of coping with gender-related stress. The measure includes six subscales (Social Support/Connection (5 items); Social Activism (4 items); Hope (5 items); Strategic Gender Expression (5 items); Behavioral Avoidance (5 items); Identity Nondisclosure (4 items). Responses to items are recorded on a 5-point scale from 1 (I do not do this) to 5 (I almost always do this). Scale items are summed to create subscale scores. A higher score indicates greater frequency of use of that coping strategy.
Time frame: before and after intervention (participants will have up to 1 month to complete intervention), 3 month follow up
This is scored from 0-4 where higher scores are indicative of increased dependence on alcohol.
Time frame: before and after intervention (participants will have up to 1 month to complete intervention), 3 month follow up
7 = 7 days, 6 = 6 days, 5 = 5 days, 4 = 4 days, 3 = 3 days, 2 = 2 days, 1 = 1 day, 0 =no days
Time frame: before and after intervention (participants will have up to 1 month to complete intervention), 3 month follow up
How many alcoholic drinks, on average, have you had per day during the pastweek? An alcoholic drink is defined as 1 beer, 1 glass of wine, 1 shot of alcohol, or 1mixed drink.
Response options:
5 = 12+ drinks, 4 = 8-11 drinks, 3 = 5-7 drinks, 2 = 3-4 drinks, 1 = 1-2 drinks, 0 =none
Time frame: before and after intervention (participants will have up to 1 month to complete intervention), 3 month follow up
The Multidimensional Gender Dysphoria Measure is a 25-item survey each scored from 1 (strongly disagree) to 6 (strongly agree) for a total possible range of scores of 5-30 in each of 5 domains: Body Gender Dysphoria, Social Gender Dysphoria, Variability of Gender Dysphoria, Relief from Gender Dysphoria, and Internalized Gender Normativity. Higher scores indicate greater gender dysphoria distress.
University of Wisconsin, Madison
Other
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