Online Intervention for Gender Dysphoria

Recruiting in Palo Alto (17 mi)

Overseen by Stephanie Budge, PhD, LP

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Wisconsin, Madison

Disqualifiers: Under 18, No internet access, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the Trans Care Web App, Trans Care Online Intervention, and Trans Care Web Application treatment for gender dysphoria?

Research shows that e-health services, like online interventions, can be effective and beneficial for transgender and gender diverse people by improving health-related outcomes and being easy to integrate into daily life. Additionally, virtual visits for trans youth have been rated highly for usability and safety, suggesting that online interventions can be a valuable part of transgender healthcare. ^{1 2 3 4 5}

Is the online intervention for gender dysphoria safe for humans?

Research on virtual visits for trans youth during the COVID-19 pandemic found that participants perceived these online appointments to be as safe or safer than in-person visits. This suggests that online interventions for gender care are generally considered safe by users. ^{2 3 4 6 7}

How is the Trans Care Web App treatment for gender dysphoria different from other treatments?

The Trans Care Web App is unique because it provides an online platform specifically designed for transgender and gender diverse people, offering flexible and discreet access to psychological support and information, which can help overcome barriers to traditional medical interventions for gender dysphoria. ^{1 3 4 5 8}

Research Team

Stephanie Budge, PhD, LP

Principal Investigator

University of Wisconsin, Madison

Eligibility Criteria

This trial is for transgender, transsexual, nonbinary individuals or those with a transgender history who are experiencing gender dysphoria. Participants need to have the time to commit to a 2-3-hour online intervention and follow-up surveys.

Inclusion Criteria

Experience gender dysphoria

I identify as transgender, transsexual, nonbinary, or have a transgender history.

I can dedicate 3-5 hours for an online intervention and follow-up surveys.

Exclusion Criteria

I am younger than 18 years old.

Does not experience gender dysphoria

I do not identify as transgender, transsexual, nonbinary, or have a transgender history.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants engage in the Trans Care online intervention, which consists of eight modules aimed at reducing symptoms of gender dysphoria and improving well-being.

up to 4 weeks

Follow-up

Participants are monitored for sustained improvements in psychological well-being, gender dysphoria symptoms, and coping strategies.

3 months

Waitlist Control

Participants in the waitlist control group are offered the intervention within one month of the completion of data collection.

Treatment Details

Interventions

• Trans Care Web App (Behavioural Intervention)

Trial Overview The Trans Care Web App is being tested in this study. It's an online program with eight modules designed to reduce symptoms of gender dysphoria, increase active coping skills, and improve overall well-being.

Participant Groups

Group I: Trans Care Intervention Experimental Treatment 1 Intervention

Group II: Waitlist Control Active Control 1 Intervention

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials

1,249

Recruited

3,255,000+

Robert Drape

University of Wisconsin, Madison

Chief Executive Officer since 2007

Executive MBA from the University of Wisconsin – Madison, Bachelor's degree in Biology from Augustana College (IL)

Dr. Ciara Barclay-Buchanan

University of Wisconsin, Madison

Chief Medical Officer since 2023

MD from Wayne State University School of Medicine

Findings from Research

The Male Transition Toolkit (MaTT) was found to be a feasible and acceptable web-based psychosocial intervention for male spouses of women with breast cancer, based on a randomized controlled trial with 40 dyads over four weeks.

While the intervention did not significantly change quality of life scores between groups, a decrease in caregiver guilt was associated with an increase in the quality of life for male spouses, suggesting potential benefits that warrant further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility Study of an Online Intervention to Support Male Spouses of Women With Breast Cancer. Duggleby, W., Ghosh, S., Struthers-Montford, K., et al.[2022]

The implementation of an electronic consultation (eConsult) service between primary care providers and transgender care specialists significantly improved access to care, with a median response time of just 1.2 days and one-third of consultations avoiding face-to-face referrals.

Primary care providers found the eConsult service highly valuable, with 95% rating it as excellent or very good, indicating that it not only enhances access but also supports providers in managing complex transgender health issues effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of an electronic consultation service for transgender care. Singh, J., Lou, A., Green, M., et al.[2021]

E-health services have been shown to effectively improve health-related outcomes for transgender and gender diverse (TGD) individuals, as well as enhance the professional expertise of healthcare providers, based on a systematic review of 27 studies from 8 countries.

Users of e-health services reported that these platforms are helpful and easily integrated into their daily lives, suggesting a positive acceptability and feasibility for improving access to trans health care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Need for Inclusive Consideration of Transgender and Gender Diverse People in E-Health Services: A Systematic Review. Renner, J., Täuber, L., Nieder, TO.[2022]

A survey of 87 families who participated in virtual visits for trans youth gender care during the COVID-19 pandemic showed high usability ratings, with caregivers rating the experience even higher than the youth.

All participants felt that virtual visits met their healthcare needs and considered them as safe as in-person visits, with 94% expressing a desire to continue virtual appointments even after the pandemic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Usability of Virtual Visits for the Routine Clinical Care of Trans Youth during the COVID-19 Pandemic: Youth and Caregiver Perspectives. Silva, C., Fung, A., Irvine, MA., et al.[2021]

A scoping review of 47 articles identified 39 unique ICT-based health interventions for transgender people, primarily focusing on HIV and sexual health, but highlighted a lack of inclusion of transgender individuals in the development and evaluation of these projects.

While ICT has the potential to improve healthcare access for transgender populations, the current literature is insufficient to provide comprehensive recommendations, indicating a need for more inclusive and targeted interventions that ensure safety and efficacy for diverse transgender communities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Information and communication technology-based health interventions for transgender people: A scoping review. Wong, HTH., Prankumar, SK., Cui, J., et al.[2023]

In a study analyzing 28 adverse drug reactions (ADRs) related to gender-affirming hormone therapy from the French pharmacovigilance database, significant cardiovascular events were reported in transgender men, particularly pulmonary embolism in 50% of cases, highlighting a potential safety concern for this group.

Transgender women experienced a high incidence of meningiomas and cardiovascular events, with antiandrogens and estrogens being commonly involved, indicating the need for further research to identify risk factors and improve treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse effects of gender-affirming hormonal therapy in transgender persons: Assessing reports in the French pharmacovigilance database. Yelehe, M., Klein, M., El Aridi, L., et al.[2022]

The adapted HIV prevention app, Transpire, was found to be acceptable and useful among transmasculine individuals in a pilot study, indicating its potential as a valuable tool for enhancing sexual health knowledge and resources.

Participants expressed a desire for more comprehensive information on mental health, substance use, and hormone therapy, highlighting the need for further development of the app to better meet the diverse health needs of the transmasculine community.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preferences for and Experiences of an HIV-Prevention Mobile App Designed for Transmasculine People: Pilot Feasibility Trial and Qualitative Investigation. Jones, J., Butler, G., Woody, M., et al.[2023]

A study using machine learning (ML) and natural language processing (NLP) analyzed 1573 Reddit posts to model gender dysphoria, achieving high accuracy (0.84) and precision (0.83), indicating that these technologies can effectively identify distress related to gender dysphoria.

The most predictive factors for identifying gender dysphoria were specific clinical keywords from the DSM-5, suggesting that integrating ML and NLP into technology-delivered interventions could enhance access to mental health support for transgender and nonbinary individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Models of Gender Dysphoria Using Social Media Data for Use in Technology-Delivered Interventions: Machine Learning and Natural Language Processing Validation Study. Cascalheira, CJ., Flinn, RE., Zhao, Y., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Feasibility Study of an Online Intervention to Support Male Spouses of Women With Breast Cancer. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Evaluation of an electronic consultation service for transgender care. [2021]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Need for Inclusive Consideration of Transgender and Gender Diverse People in E-Health Services: A Systematic Review. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Usability of Virtual Visits for the Routine Clinical Care of Trans Youth during the COVID-19 Pandemic: Youth and Caregiver Perspectives. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Information and communication technology-based health interventions for transgender people: A scoping review. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Adverse effects of gender-affirming hormonal therapy in transgender persons: Assessing reports in the French pharmacovigilance database. [2022]

7. Canada pubmed.ncbi.nlm.nih.gov

Preferences for and Experiences of an HIV-Prevention Mobile App Designed for Transmasculine People: Pilot Feasibility Trial and Qualitative Investigation. [2023]

8. Canada pubmed.ncbi.nlm.nih.gov

Models of Gender Dysphoria Using Social Media Data for Use in Technology-Delivered Interventions: Machine Learning and Natural Language Processing Validation Study. [2023]