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
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
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.
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.
ANOVA, Karolinska University Hospital, Norra Stationsgatan 69, Plan 4
Stockholm, Sweden
Number of participants recruited to I-ER GD.
Measures will include recruitment rate during study inclusion period (0-30 participants).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: At post-treatment (week 10).
Changes in Gender minority stress and resilience (GMSR, Testa et al 2014) for I-ER GD.
Changes in the Gender minority stress and resilience scale. Range 0-17 for sub scales Gender related discrimination, rejection, victimization. Higher values represents higher levels of discrimination, rejection, victimization etc. Range 0-164 for sub scales Non-affirmation of gender identity, Internalized transphobia, Pride, Negative expectations for the future, Nondisclosure and Community connectedness. Higher values represents higher levels of whatever the sub scale covers (e.g. pride, internalized transphobia, community connectedness etc).
Time frame: 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.
Changes in the Difficulties in emotion regulation scale, DERS-16. Range 16-80. Lower values equals better outcomes.
Time frame: 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.
Changes in the Difficulties in emotion regulation scale, DERS-16. Range 16-80. Lower values equals better outcomes.
Time frame: Weekly during the treatment (weeks 1-11)
Changes in The Emotion Regulation Questionnaire, (ERQ; Gross & John, 2003) for I-ER GD.
Changes in the Emotion Regulation Questionnaire, ERQ. Subscales Cognitive reappraisal (Range 6-42). and Suppression (Range 4-28). Higher values equals better outcomes in reappraisal, and worse outcomes in Suppression.
Time frame: 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.
Changes in alcohol consumption. Range 0-40 where higher values equal higher substance use, worse outcomes.
Time frame: At baseline and at post treatment (week 12)
Changes inThe Drug Use Disorders Identification Test (DUDIT; Berman, Wennberg & Källmén, 2012) for I-ER GD.
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Changes in drug consumption. Range 0-44 where higher values equal higher substance use, worse outcomes.
Time frame: At baseline and at post treatment (week 12)
Changes in Gender Congruence and Life Satisfaction Scale (GCLS; Dhejne et al. 2019) for I-ER GD
Change and measure improvements in gender (in)congruence, related mental well-being, and life satisfaction throughout the process of undergoing gender affirming medical interventions. Range: 38-190 where higher values indicate greater gender congruence, greater gender-related well-being, and greater life satisfaction.
Time frame: At baseline and at post treatment (week 12)
Changes in Work and social adjustment scale (WSAS; Marks 1986) for I-ER GD
Changes in functioning. Ranges from 0-40 where higher scores indicate a more impaired functioning.
Time frame: At baseline and at post treatment (week 12)
Changes in Social Interaction Anxiety Scale (SIAS; Mattick & Clarke 1998) for I-ER GD
Changes in anxiety over 20 different situations. Ranges from 0-80 where higher scores indicate a higher social anxiety.
Time frame: At pre-treatment and at post treatment (week 12)
Changes in Social Interaction Anxiety Scale (SIAS; Mattick & Clarke 1998) for I-ER GD
Changes in anxiety over 20 different situations. Ranges from 0-80 where higher scores indicate a higher social anxiety.
Time frame: Weekly during the treatment (weeks 1-11)
Changes in Montgomery Åsberg Depression Rating Scale (MADRS-S; Montgomery & Åsberg 1979) for I-ER GD
Changes in depressive symptoms. Ranges from 0-54 where higher scores indicate higher depressive severity.
Time frame: At pre-treatment and post treatment (week 12)
Changes in Deliberate Self-Harm Inventory (DSHI-9; Lundh, Karim & Quillisch 2007) for I-ER GD
Changes in instances and forms of self-harming behavior. Higher number of instances indicates worse outcomes.
Time frame: At pre-treatment and at post treatment (week 12)
Changes in Deliberate Self-Harm Inventory (DSHI-9; Lundh, Karim & Quillisch 2007) for I-ER GD
Changes in instances and forms of self-harming behavior. Higher number of instances indicates worse outcomes.
Time frame: Weekly during the treatment (weeks 1-11)
Changes in Brunnsviken Brief Quality of Life Inventory (BBQ; Lindner et al, 2016) for I-ER GD
Changes in perceived quality of life. Range: 0-96. Higher scores indicate a higher perceived quality of life.
Time frame: At pre-treatment and at post treatment (week 12)
Changes in Satisfaction With Life, Swedish (SWLS; Diener 1985) for I-ER GD
Changes in global cognitive judgements of one's life. Range: 0-35. Higher score indicates higher satisfaction with one's life.
Time frame: At pre-treatment and at post treatment (week 12)
Changes in Perceived Stress Scale (PSS-14; Cohen, Kamarck & Mermelstein 1983) for I-ER GD
Changes in perceived stress. Range: 0-56. Higher scores indicate greater perceived stress.
Time frame: At pre-treatment and at post treatment (week 12)
Changes in Multidimensional Scale of Perceived Social Support (MSPSS; Zimet et al, 1988) for I-ER GD
Changes in perceived support from family, friends and significant other(s). Range: 12-84. Higher scores indicate greater perceived stress.
Time frame: At pre-treatment and at post treatment (week 12)
Changes in Rosenberg's scale of self-esteem (Rosenberg; Schmitt & Allik 2005) for I-ER GD
Changes in self-esteem. Range: 0-40. Higher scores indicate higher self-esteem.
Time frame: At pre-treatment and at post treatment (week 12)
Changes in Rumination Response Scale (RRS-10; Nolen-Hoeksema, Morrow 1991) for I-ER GD
Changes in ruminative tendencies. Range: 10-40. Higher scores indicate higher levels of ruminative response styles.
Time frame: At pre-treatment and at post treatment (week 12)
Changes in Affect Labeling Questionnaire (ALQ; Sahi et al, in prep.) for I-ER GD
Changes in one's ability to recognize emotions. Range 12-60. Higher scores indicates higher ability to recognize and label emotions.
Time frame: At pre-treatment and at post treatment (week 12)
Changes in The Gender/Sex diversity belief scale (GSDB; Schudson & van Anders, 2022) for I-ER SUPPORT
Changes in the Gender/Sex diversity belief scale. Range 23-161. Higher values equals more positive attitudes toward transgender individuals.
Time frame: At pre-treatment and at post treatment (week 10)
Changes in Affect Labeling Questionnaire (ALQ; Sahi et al, in prep.) for I-ER SUPPORT
Changes in one's ability to recognize emotions. Range 12-60. Higher scores indicates higher ability to recognize and label emotions.
Time frame: At pre-treatment and at post treatment (week 10)
Changes in The Emotion Regulation Questionnaire, (ERQ; Gross & John, 2003) for I-ER SUPPORT.
Changes in the Emotion Regulation Questionnaire, ERQ. Subscales Cognitive reappraisal (Range 6-42). and Suppression (Range 4-28). Higher values equals better outcomes in reappraisal, and worse outcomes in Suppression.
Time frame: At pre-treatment and at post treatment (week 10)
Changes in The Difficulties in emotion regulation scale, (DERS-16; Gratz & Roemer, 2004) for I-ER SUPPORT
Changes in the Difficulties in emotion regulation scale, DERS-16. Range 16-80. Lower values equals better outcomes.
Time frame: At pre-treatment and at post treatment (week 10)
Changes in The Difficulties in emotion regulation scale, (DERS-16; Gratz & Roemer, 2004) for I-ER SUPPORT
Changes in the Difficulties in emotion regulation scale, DERS-16. Range 16-80. Lower values equals better outcomes.
Time frame: Weekly during the treatment (weeks 1-10)