About this trial
The purpose of this observational study is to systematically evaluate how a 12-month multimodal psychiatric treatment program affects sleep quality, inflammatory and hormonal biomarkers, eating disorder psychopathology, and health-related quality of life in adolescent girls (aged 10-18 years) diagnosed with anorexia nervosa.
The main questions it aims to answer are:
* Do adolescent girls with anorexia nervosa have measurable changes in sleep patterns (total sleep time, sleep efficiency, REM sleep, deep sleep) compared to age- and sex-matched published values, and do these improve after 12 months of psychiatric treatment? * Are specific body markers (like NLR, CRP, vitamin D, and lipid profile) linked to how severe sleep problems, eating disorder symptoms, and treatment results are in this group? * To assess these outcomes, researchers will compare participants' baseline measurements to their own 12-month follow-up measurements to determine whether multimodal psychiatric treatment produces clinically meaningful improvements in sleep architecture, biomarker profiles, psychopathology, psychological flexibility, and quality of life.
Participants will:
* Take-home sleep recordings with a wireless device (NOX A1) in their usual environment at the start and after 12 months of treatment. * Complete validated self-report questionnaires assessing sleep quality (PSQI), daytime sleepiness (ESS-CHAD for children and adolescents), eating disorder symptoms (EDE-Q), depression, anxiety, and stress (DASS-21), psychological flexibility (AFQ-Y8), and health-related quality of life (KIDSCREEN-52) at baseline and 12-month follow-up. * Give blood samples at the start and after 12 months for testing of inflammation markers, hormone levels, lipids, and anthropometric measurements. * Take part in a Day Hospital Program at the Department of Psychiatry, University Hospital of Split (KBC Split), Croatia, which includes Acceptance and Commitment Therapy, Cognitive Behavioral Therapy, individual counselling, family work, and medication if needed.
Eligibility criteria
Qualifiers
Female sex assigned at birth
Age between 10 and 18 years (inclusive) at the time of study enrollment
Anorexia nervosa (F50.0)
Atypical anorexia nervosa (F50.1)
Disqualifiers
Age younger than 10 years or older than 18 years at the time of enrollment
Male sex assigned at birth
Previous diagnosis of anorexia nervosa prior to current enrollment (i.e., recurrent or relapsing AN - this study enrolls first-diagnosis cases only)
Anorexia nervosa currently in clinical remission at the time of enrollment
Trial design
Treatments tested in this trial
- Longitudinal Fasting Blood Sampling for Biomarker Assessment
- Multimodal Psychiatric Treatment Program
- Home Polysomnography - NOX A1
Treatment groups
Locations
Sponsors and collaborators
University of Split, School of Medicine
Lead sponsor
University Hospital of Split
Collaborator