ICD 11: HA 60.0
Conditions
Interventions
Group 1: Feasibility study: Two-week use of an app, questionnaire survey at 14 time points (before, during and after the intervention
see below for endpoints)
optional participation in an interview or focus group
Sponsors
Charité - Universitätsmedizin Berlin
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: - Personal interest in a transition process or ICD-11 (V) or (G) diagnostic code HA60.0 for gender incongruence or ICD-10 (V) or (G) code F64.0 - Age 18 or older - Proficiency in spoken and written German - Informed consent
Exclusion criteria
Exclusion criteria: - Withdrawn consent - Acute severe psychiatric disorders, e.g., acute suicidal ideation, acute schizophrenia, antisocial personality disorder; severe cognitive impairments, e.g., dementia, severe intellectual disability
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Gender identity measured using the Diversity Minimal Item Set for Germany (DiMIS) - User-friendliness measured using the System Usability Scale (SUS) and the German version of the Mobile App Rating Scale (MARS-G) - Assessment of the app (e.g. concerns, problems, positive aspects) - Technical competence and affinity measured using, amongst others, the Mobile Device Proficiency Questionnaire, Measure Digital Health Literacy (HLS19-DIGI) - Ultra-Short Scale for Assessing Affinity for Technology Interaction in User Studies (ATI-S) | — |
Secondary
| Measure | Time frame |
|---|---|
| It is assumed that the following constructs may be relevant to the app’s usage behaviour; these constructs are therefore included in the exploratory analysis: sleep, perceived stress, resilience, self-efficacy, emotion regulation, mindfulness, coping mechanisms, avoidance behaviour (in particular sleep and social withdrawal), self-esteem/self-deprecation processes, gender minority stress/proximal and distal stressors, perceived transition-specific knowledge, gender euphoria, gender dysphoria, loneliness, well-being, quality of life/life satisfaction, mood, social participation/loneliness, psychological symptoms (in particular depression, anxiety), social support. Usage behaviour of the App: - Frequency/duration of app usage - Type and number of exercises completed - Number of diary entries made Further constructs are explored: - Mindfulness measured by Mindful Attention and Awareness Scale (MAAS) - Loneliness measured by 6-Item Scale for Overall, Emotional, and Social Loneliness Emotion regulation measured by Emotion Regulation Questionnaire (ERQ) - Satisfaction with gender-affirming surgery (Van de Grift et al 2018) - Transgender and Nonbinary Minority Resilience Scales (Puckett et al 2025) - Gender dysphoria measured by the Kiel Gender Dysphoria Questionnaire (KGDQ) - Gender euphoria & dysphoria - Anxiety, depression, substance use and eating behaviour measured by Patient Health Questionnaire (PHQ-D) - Wish to have children measured using the Transgender Youth Fertility Attitudes Questionnaire and the Leipziger Kinderwunschskala (LKM) - Quality of life measured by EUROHIS-QOL - Well-being measured by WHO-5 - Life satisfaction measured by Short Scale for Assessing General Life Satisfaction (L-1) - Self-esteem measured by Rosenberg Self-Esteem Scale - Social support measured by Perceived Social Support Questionnaire (F-SozU) - Stress/coping measured by Coping Inventory for Stressful Situations (CISS) - Stress measured by Perceived Stress | — |
Countries
Germany
Contacts
Public ContactMichele Haink
Charité - Universitätsmedizin Berlin,Arbeitsbereich Geschlechterforschung in der Medizin (GIM) Campus Virchow-Klinikum
Outcome results
None listed