Trans Care: An Online Intervention to Reduce Symptoms of Gender Dysphoria
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 312
- 试验地点
- 2
- 主要终点
- Change in Depression, Anxiety, and Stress Scale (DASS-21) Score
研究概览
简要总结
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.
详细描述
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 1) Feasibility and acceptability analysis (FAA) [represented by NCT05884307]
- Aim 2) A pilot randomized controlled trial (RCT) of Trans Care's efficacy [represented in this study record]
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:
- TNB Participants who received the Trans Care intervention will demonstrate improvement on quantitative measures of psychological well-being, GD symptoms, and coping strategies compared to waitlisted individuals.
- Changes will be maintained at 3 months follow-up indicating that the Trans Care intervention has a sustained impact on improving TNB individuals' coping.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Identify as transgender, transsexual, nonbinary, and/or have a transgender history.
- •Experience gender dysphoria.
- •Time available to commit to completing a 4-5-hour online intervention and 1-2 hours to complete follow up surveys
排除标准
- •under 18 years old
- •individual does not identify as transgender, transsexual, nonbinary, and/or have a transgender history
- •does not experience gender dysphoria
- •is unable to commit to the time requirements of the study
- •does not have access to an internet compatible device
结局指标
主要结局
Change in Depression, Anxiety, and Stress Scale (DASS-21) Score
时间窗: 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.
Change in Gender Congruence and Life Satisfaction Scale (GCLS) Score
时间窗: 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.
Change in Modified Gender Minority Stress and Resilience measure (M-GMSRM) Score
时间窗: 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.
Change in Trans and Nonbinary Coping Measure (TNCM) Score
时间窗: 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.
Alcohol Use Disorder Identification Test
时间窗: 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.
Number of Days in the Past Week You Consumed Alcohol
时间窗: 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
Quantity of Alcohol Use
时间窗: 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
Change in Multidimensional Gender Dysphoria Measure Scores
时间窗: 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.
次要结局
未报告次要终点