Clinical trial NCT05534763: Internet-delivered Treatment for Transgender Individuals With Co-occurring Mental Health Problems
Official title: Internet-delivered Emotion Regulation Treatment (I-ER GD) for Transgender Adults and Co-occurring Mental Health Problems
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gender Dysphoria
Emotion Regulation
Internet Delivered Treatment
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2022-09-09
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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).
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Number of participants recruited to I-ER GD.
timeFrame: At pretreatment.
measure: Client Satisfaction Questionnaire (CSQ-8; Attkisson & Zwick, 1982) in I-ER GD
timeFrame: At post-treatment (week 12).
measure: The Credibility and Expectancy Questionnaire (Devilly & Borkovec, 2000) in I-ER GD.
timeFrame: At treatment week 2.
measure: The Negative effects Questionnaire (NEQ; Rozental et al. 2016) in I-ER GD.
timeFrame: At post-treatment (week 12).
measure: The internet intervention Patient Adherence Scale (iiPAS; Lenhard et al. 2019) in I-ER GD
timeFrame: At mid-treatment (week 5).
measure: The internet intervention Patient Adherence Scale (iiPAS; Lenhard et al. 2019) in I-ER GD
timeFrame: At post-treatment (week 12).
measure: Number of participants recruited to I-ER SUPPORT.
timeFrame: At pretreatment.
measure: The Client Satisfaction Questionnaire (CSQ-8; Attkisson & Zwick, 1982) in I-ER SUPPORT
timeFrame: At post-treatment (week 10).
measure: The Credibility and Expectancy Questionnaire (Devilly & Borkovec, 2000) in I-ER SUPPORT
timeFrame: At treatment week 2.
measure: The Negative effects Questionnaire (NEQ; Rozental et al. 2016) in I-ER SUPPORT.
timeFrame: At post-treatment (week 10).
Secondary outcomes:
measure: Changes in Gender minority stress and resilience (GMSR, Testa et al 2014) for I-ER GD.
timeFrame: At pre-treatment and at post treatment (week 12)
measure: Changes in The Difficulties in emotion regulation scale, (DERS-16; Gratz & Roemer, 2004) for I-ER GD.
timeFrame: At pre-treatment and at post treatment (week 12)
measure: Changes in The Difficulties in emotion regulation scale, (DERS-16; Gratz & Roemer, 2004) for I-ER GD.
timeFrame: Weekly during the treatment (weeks 1-11)
measure: Changes in The Emotion Regulation Questionnaire, (ERQ; Gross & John, 2003) for I-ER GD.
timeFrame: At pre-treatment and at post treatment (week 12)
measure: Changes inThe Alcohol Use Disorders Identification Test (AUDIT; Berman, Wennberg & Källmén, 2012) for I-ER GD.
timeFrame: At baseline and at post treatment (week 12)
measure: Changes inThe Drug Use Disorders Identification Test (DUDIT; Berman, Wennberg & Källmén, 2012) for I-ER GD.
timeFrame: At baseline and at post treatment (week 12)
measure: Changes in Gender Congruence and Life Satisfaction Scale (GCLS; Dhejne et al. 2019) for I-ER GD
timeFrame: At baseline and at post treatment (week 12)
measure: Changes in Work and social adjustment scale (WSAS; Marks 1986) for I-ER GD
timeFrame: At baseline and at post treatment (week 12)
measure: Changes in Social Interaction Anxiety Scale (SIAS; Mattick & Clarke 1998) for I-ER GD
timeFrame: At pre-treatment and at post treatment (week 12)
measure: Changes in Social Interaction Anxiety Scale (SIAS; Mattick & Clarke 1998) for I-ER GD
timeFrame: Weekly during the treatment (weeks 1-11)
measure: Changes in Montgomery Åsberg Depression Rating Scale (MADRS-S; Montgomery & Åsberg 1979) for I-ER GD
timeFrame: At pre-treatment and post treatment (week 12)
measure: Changes in Deliberate Self-Harm Inventory (DSHI-9; Lundh, Karim & Quillisch 2007) for I-ER GD
timeFrame: At pre-treatment and at post treatment (week 12)
measure: Changes in Deliberate Self-Harm Inventory (DSHI-9; Lundh, Karim & Quillisch 2007) for I-ER GD
timeFrame: Weekly during the treatment (weeks 1-11)
measure: Changes in Brunnsviken Brief Quality of Life Inventory (BBQ; Lindner et al, 2016) for I-ER GD
timeFrame: At pre-treatment and at post treatment (week 12)
measure: Changes in Satisfaction With Life, Swedish (SWLS; Diener 1985) for I-ER GD
timeFrame: At pre-treatment and at post treatment (week 12)
measure: Changes in Perceived Stress Scale (PSS-14; Cohen, Kamarck & Mermelstein 1983) for I-ER GD
timeFrame: At pre-treatment and at post treatment (week 12)
measure: Changes in Multidimensional Scale of Perceived Social Support (MSPSS; Zimet et al, 1988) for I-ER GD
timeFrame: At pre-treatment and at post treatment (week 12)
measure: Changes in Rosenberg's scale of self-esteem (Rosenberg; Schmitt & Allik 2005) for I-ER GD
timeFrame: At pre-treatment and at post treatment (week 12)
measure: Changes in Rumination Response Scale (RRS-10; Nolen-Hoeksema, Morrow 1991) for I-ER GD
timeFrame: At pre-treatment and at post treatment (week 12)
measure: Changes in Affect Labeling Questionnaire (ALQ; Sahi et al, in prep.) for I-ER GD
timeFrame: At pre-treatment and at post treatment (week 12)
measure: Changes in The Gender/Sex diversity belief scale (GSDB; Schudson & van Anders, 2022) for I-ER SUPPORT
timeFrame: At pre-treatment and at post treatment (week 10)
measure: Changes in Affect Labeling Questionnaire (ALQ; Sahi et al, in prep.) for I-ER SUPPORT
timeFrame: At pre-treatment and at post treatment (week 10)
measure: Changes in The Emotion Regulation Questionnaire, (ERQ; Gross & John, 2003) for I-ER SUPPORT.
timeFrame: At pre-treatment and at post treatment (week 10)
measure: Changes in The Difficulties in emotion regulation scale, (DERS-16; Gratz & Roemer, 2004) for I-ER SUPPORT
timeFrame: At pre-treatment and at post treatment (week 10)
measure: Changes in The Difficulties in emotion regulation scale, (DERS-16; Gratz & Roemer, 2004) for I-ER SUPPORT
timeFrame: Weekly during the treatment (weeks 1-10)
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: ANOVA, Karolinska University Hospital, Norra Stationsgatan 69, Plan 4
Study officials:
affiliation: Karolinska Institutet
name: Hanna Sahlin, PhD
role: PRINCIPAL_INVESTIGATOR
References: