Clinical Trials Directory

Trials / Completed

CompletedNCT05534763

Internet-delivered Treatment for Transgender Individuals With Co-occurring Mental Health Problems

Internet-delivered Emotion Regulation Treatment (I-ER GD) for Transgender Adults and Co-occurring Mental Health Problems

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
24 (actual)
Sponsor
Karolinska Institutet · Academic / Other
Sex
All
Age
18 Years – 60 Years
Healthy volunteers
Not accepted

Summary

This project aims to develop and evaluate if an internet delivered psychological intervention for transgender individuals undergoing assessment for gender dysphoria and a support person, is feasible, acceptable and effective in increasing emotional skills, strengthening a healthy identity development, social support and resilience to current and future mental illness. In two studies, a psychological treatment for transgender adults (18+) seeking health care for gender dysphoria and a support person (i.e., relative, friend) will be evaluated. The project will be carried out at a specialized unit for transgender health care (ANOVA) at Karolinska University Hospital

Detailed description

There are no psychosocial treatments for young transgender adults seeking treatment for gender dysphoria - psychological distress due to the incongruence between one's assigned sex and one's gender identity. This project aims to develop and evaluate if an internet delivered psychological intervention for individuals undergoing assessment for gender dysphoria and a support person, is feasible, acceptable and effective in increasing emotional skills, strengthening a healthy identity development, social support and resilience to current and future mental illness. Data and Method: In three studies, a psychological treatment for transgender adults (18+) seeking care for gender dysphoria and a support person (i.e., relative, friend) will be evaluated. Study 1 is a feasibility study (N=40) with pre-, post- and weekly assessments evaluating the intervention's feasibility, credibility, acceptability and preliminary efficacy. Study 2 is a qualitative interview study exploring participants' experience of the intervention. Plan for project realization: The project will be carried out at a specialized unit for transgender health care (ANOVA) at Karolinska University Hospital, with a large patient recruitment base and extensive experience of clinical studies providing good opportunities for later implementation in regular care. Relevance: Studies show elevated rates of psychopathology in transgender adults. It has been suggested that experiences of minority stress, e.g., discrimination, internalized transphobia and gender identity concealment exhausts the ability to regulate negative emotions in an adaptive way. There is a need for treatment and preventive psychological interventions, particularly as the number of young transgender adults seeking gender affirming treatment has increased markedly during the 2000s. This project will lead to increased knowledge about the specific needs of this growing patient group and develop health care in accordance with national guidelines.

Conditions

Interventions

TypeNameDescription
BEHAVIORALIERGDA 10 week behavioral treatment focusing on gender minority stress, maladaptive and adaptive emotion regulation, emotional awareness, the functionality of emotions, interpersonal skills and values and valued actions.
OTHERIER SUPPORTA 5-week behavioral course for a designated support person (family, friend, other) to the person with GD. The course focuses on teachings on living with minority stress, maladaptive and adaptive emotion regulation, emotional awareness, validation, interpersonal skills and values.

Timeline

Start date
2022-08-24
Primary completion
2023-06-30
Completion
2023-06-30
First posted
2022-09-09
Last updated
2023-09-11

Locations

1 site across 1 country: Sweden

Source: ClinicalTrials.gov record NCT05534763. Inclusion in this directory is not an endorsement.