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

NCT ID: NCT05534763

Last Updated: 2023-09-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-24
• Study Completion Date: 2023-06-30

Brief 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

Gender Dysphoria; Emotion Regulation; Internet Delivered Treatment

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

IERGD

I-ER GD is a 10-week intervention directed to the person with GD, provided via the internet with therapist-support. During treatment, participants have an assigned psychologist to interact with and be offered support by, either through feedback on assignments, asynchronous chats or, if needed, by telephone. I-ER GD will focus on increasing adaptive emotion regulation skills, healthy identity development, interpersonal effectiveness skills, coping and building a resilient lifestyle through psychoeducation on gender minority stress, practicing adaptive emotion regulation skills, and reducing emotional and behavioral avoidance.

Group Type: EXPERIMENTAL

IERGD

Intervention Type: BEHAVIORAL

A 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.

IER SUPPORT

I-ER Support is a 5-week intervention directed to a support person, provided as an optional addition to I-ER GD. I-ER Support is administered in the same manner and in parallel to the I-ER GD intervention. Treatment content is based on the same principles as I-ER GD, but from the perspective of increasing emotional support and understanding of GD. The support person could benefit from increased coping and emotion regulation skills, as they may also be exposed to discrimination or stigma due to having a transgender child, sibling or loved one. In better understanding the processes of being stigmatized and with improved emotion regulation skills, the support person may offer better support and help alleviate burdening effects for the individual with GD. For this reason, I-ER support is primarily aimed at people without trans-experience.

Group Type: OTHER

IER SUPPORT

Intervention Type: OTHER

A 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.

Interventions

IERGD

A 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.

Intervention Type: BEHAVIORAL

IER SUPPORT

A 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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Patients having had an initial assessment at ANOVA for GD between March 2022 and November 2022 and found eligible for a diagnostic assessment period and having been put on a waitlist for continued evaluation.

2. Being at least 18 years of age;

3. Reporting elevated self-perceived psychiatric symptoms (e.g., depression, anxiety, suicidality) or functional impairment (difficulties maintaining school, work or daily routines);

4. Be able to write and read in Swedish; and

5. Have daily access to a computer with internet connection.

Exclusion Criteria

1. Evidence of active untreated mania, psychosis or other severe psychiatric symptoms that are deemed primary and need treatment;

2. Current and increased suicide risk, such as intrusive suicide thoughts, or current suicide plans, or recent suicide attempt;

3. Current enrollment in another psychological intervention study or currently receiving regular psychological treatment or

4. Less than 6 weeks of stable psychopharmacotherapy if such treatment is ongoing.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Karolinska Institutet

OTHER

Sponsor Role: lead

Responsible Party

Hanna Sahlin

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hanna Sahlin, PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

ANOVA, Karolinska University Hospital, Norra Stationsgatan 69, Plan 4

Stockholm, , Sweden

Countries

Sweden

Other Identifiers

2022-00577-01

Identifier Type: -

Identifier Source: org_study_id