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

NCT05534763 | Completed

• 1 other identifier: 2022-00577-01
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Conditions

Gender Dysphoria; Emotion Regulation; Internet Delivered Treatment

Outcome Measures

Primary Outcomes (10)

• Number of participants recruited to I-ER GD.

  Measures will include recruitment rate during study inclusion period (0-30 participants).

  At pretreatment.

• Client Satisfaction Questionnaire (CSQ-8; Attkisson & Zwick, 1982) in I-ER GD

  Measures treatment satisfaction after treatment. Range 8-32, higher values equals higher satisfaction with treatment.

  At post-treatment (week 12).

• The Credibility and Expectancy Questionnaire (Devilly & Borkovec, 2000) in I-ER GD.

  Measures treatment credibility and expectancy for positive change. Range 0-5, higher values equals higher treatment credibility and expectancy.

  At treatment week 2.

• The Negative effects Questionnaire (NEQ; Rozental et al. 2016) in I-ER GD.

  Measures negative effects of psychological treatment after an intervention. Range 0-20, higher values equals worse outcomes, and more negative effects of treatment.

  At post-treatment (week 12).

• The internet intervention Patient Adherence Scale (iiPAS; Lenhard et al. 2019) in I-ER GD

  Measures adherence to treatment at two timepoints of the treatment. Range 0-20. Higher scores indicate better adherence.

  At mid-treatment (week 5).

• The internet intervention Patient Adherence Scale (iiPAS; Lenhard et al. 2019) in I-ER GD

  Measures adherence to treatment at two timepoints of the treatment. Range 0-20. Higher scores indicate better adherence.

  At post-treatment (week 12).

• Number of participants recruited to I-ER SUPPORT.

  Measures will include recruitment rate during study inclusion period (0-15 participants).

  At pretreatment.

• The Client Satisfaction Questionnaire (CSQ-8; Attkisson & Zwick, 1982) in I-ER SUPPORT

  Measures treatment satisfaction. Range 8-32, higher values equals higher satisfaction with treatment.

  At post-treatment (week 10).

• The Credibility and Expectancy Questionnaire (Devilly & Borkovec, 2000) in I-ER SUPPORT

  Measures treatment credibility and expectancy for positive change. Range 0-5, higher values equals higher treatment credibility and expectancy.

  At treatment week 2.

• The Negative effects Questionnaire (NEQ; Rozental et al. 2016) in I-ER SUPPORT.

  Measures negative effects of psychological treatment. Range 0-20, higher values equals worse outcomes, and more negative effects of treatment.

  At post-treatment (week 10).

Secondary Outcomes (25)

• Changes in Gender minority stress and resilience (GMSR, Testa et al 2014) for I-ER GD.

  At pre-treatment and at post treatment (week 12)

• Changes in The Difficulties in emotion regulation scale, (DERS-16; Gratz & Roemer, 2004) for I-ER GD.

  At pre-treatment and at post treatment (week 12)

• Changes in The Difficulties in emotion regulation scale, (DERS-16; Gratz & Roemer, 2004) for I-ER GD.

  Weekly during the treatment (weeks 1-11)

• Changes in The Emotion Regulation Questionnaire, (ERQ; Gross & John, 2003) for I-ER GD.

  At pre-treatment and at post treatment (week 12)

• Changes inThe Alcohol Use Disorders Identification Test (AUDIT; Berman, Wennberg & Källmén, 2012) for I-ER GD.

  At baseline and at post treatment (week 12)

Study Arms (2)

IERGD

EXPERIMENTAL

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.

Behavioral: IERGD

IER SUPPORT

OTHER

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.

Other: IER SUPPORT

Interventions

IERGD 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.

IERGD

IER SUPPORT 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.

IER SUPPORT

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• Being at least 18 years of age;
• Reporting elevated self-perceived psychiatric symptoms (e.g., depression, anxiety, suicidality) or functional impairment (difficulties maintaining school, work or daily routines);
• Be able to write and read in Swedish; and
• Have daily access to a computer with internet connection.

You may not qualify if:

• Evidence of active untreated mania, psychosis or other severe psychiatric symptoms that are deemed primary and need treatment;
• Current and increased suicide risk, such as intrusive suicide thoughts, or current suicide plans, or recent suicide attempt;
• Current enrollment in another psychological intervention study or currently receiving regular psychological treatment or
• Less than 6 weeks of stable psychopharmacotherapy if such treatment is ongoing.

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

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

Stockholm, 17176, Sweden

Location

MeSH Terms

Conditions

Gender Dysphoria; Emotional Regulation

Condition Hierarchy (Ancestors)

Sexual Dysfunctions, Psychological; Mental Disorders; Self-Control; Social Behavior; Behavior

Study Officials

• Hanna Sahlin, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Study 1 is a feasibility study with pre- and post-assessments evaluating feasibility, acceptability and satisfaction of the study protocol and the preliminary efficacy of I-ER. Study 1 consists of IERGD (a behavioral intervention for individuals with GD) and IER SUPPORT (a parallell behavioral course for a support person to the person with GD).

Study Record Dates

• First Submitted: August 30, 2022
• First Posted: September 9, 2022
• Study Start: August 24, 2022
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: September 11, 2023

Record last verified: 2023-09

Locations

SE (1)