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.
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)
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
Female patients aged 10-18 years with a first-time diagnosis of anorexia nervosa (ICD-10: F50.0, F50.1, F50.9) enrolled consecutively at the Day Hospital for Children and Adolescents, Department of Psychiatry, University Hospital of Split (KBC Split), Croatia. Participants must be medically stable for Day Hospital treatment and able to complete home polysomnography and self-report questionnaires in Croatian. Excluded are patients with intellectual disability, autism spectrum disorder, psychotic or bipolar disorder, substance use disorder, chronic somatic illness affecting inflammatory markers, or prior AN diagnosis.
Cohort
Prospective
Longitudinal Fasting Blood Sampling for Biomarker Assessment
Procedure/SurgerySerial venous blood sampling conducted under standardized fasting conditions (minimum 8-hour fast) at baseline (T0) and 12-month follow-up (T1) for assessment of the following parameters: Inflammatory markers: * Complete blood count with differential * Neutrophil-to-lymphocyte ratio (NLR) * C-reactive protein (CRP, mg/L) Hormonal and nutritional markers: * Free thyroxine (fT4), free triiodothyronine (fT3) * Prolactin * 25-hydroxyvitamin D (25OH-D) Metabolic markers: * Total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides (mmol/L)
Multimodal Psychiatric Treatment Program
Other interventionStructured Day Hospital treatment program delivered over 12 months at the Department of Psychiatry comprising: 1. Psychological intervention: Acceptance and Commitment Therapy (ACT) combined with Cognitive Behavioral Therapy (CBT), delivered in individual and group format, targeting cognitive distortions, body image disturbance, emotional regulation, and values-based behavioral change 2. Supportive individual psychotherapy addressing motivation for recovery, self-esteem, and interpersonal functioning 3. Family-based work and parent sessions including psychoeducation, family communication strategies and caregiver support 4. Pharmacotherapy where clinically indicated by the treating child and adolescent psychiatrist; agent, dose, duration and modifications recorded systematically as covariates Treatment adherence, session attendance, adverse events, and changes in status are documented at each clinical contact throughout the 12-month.
Home Polysomnography - NOX A1
DeviceAmbulatory, wireless polysomnographic recording performed by the participant in their natural home environment using the NOX A1 portable device (Nox Medical, Iceland). The device records electroencephalography (EEG), electrooculography (EOG), chin electromyography (EMG), electrocardiography (ECG), respiratory effort , nasal airflow, pulse oximetry, body position, and actigraphy. Sleep staging is performed according to AASM 2023 scoring rules. Participants self-apply the device at home following standardized written and verbal instructions provided by the research team, eliminating first-night laboratory effects associated with traditional in-laboratory polysomnography. Derived sleep variables: total sleep time (TST, minutes), sleep efficiency (SE), sleep onset latency (SOL, minutes), wake after sleep onset (WASO, minutes), N1%, N2%, N3% slow-wave sleep (SWS), REM sleep %, REM latency (minutes), and arousal index. Measurements were conducted at baseline (T0) and 12-month follow-up (T1).
Change in Objective Sleep Architecture Assessed by Home Polysomnography (NOX A1)
Change from baseline in polysomnographically derived sleep parameters measured by the portable wireless NOX A1 device in the participant's home environment. Sleep staging performed according to AASM 2023 scoring criteria. Change from baseline in sleep efficiency (SE, %) as the primary polysomnographic outcome, measured by the portable wireless NOX A1 device in the participant's home environment. SE is defined as the ratio of total sleep time to time in bed, expressed as a percentage. This is the single primary reported value for this outcome measure. Additional polysomnographic parameters (total sleep time in minutes, sleep onset latency in minutes, wake after sleep onset in minutes, N1/N2/N3/REM sleep percentages, REM latency in minutes, arousal index in events/hour) will be reported as pre-specified secondary descriptive analyses, each in its respective unit of measure, and are not aggregated into a composite score. Unit of Measure: Percentage (%)
Change in Subjective Sleep Quality Assessed by the Pittsburgh Sleep Quality Index (PSQI)
Change from baseline in the Global PSQI Score as the single primary reported value. The Global PSQI Score is calculated as the sum of seven component scores and ranges from 0 to 21, with higher scores indicating worse sleep quality. A score greater than 5 indicates poor sleep quality. The seven component scores (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction) share the same unit of measure (score on a scale, range 0-3 per component) and will be reported as supplementary descriptive analyses. Unit of Measure: Score on a scale (0-21)
Change in Eating Disorder Psychopathology Assessed by the Eating Disorder Examination Questionnaire (EDE-Q)
Change from baseline in EDE-Q global score and four subscale scores: * Restraint * Eating Concern * Shape Concern * Weight Concern Each item rated on a 7-point forced-choice scale (0-6). Global score calculated as mean of four subscale scores. Higher scores indicate greater eating disorder psychopathology.
Change in Daytime Sleepiness Assessed by the Epworth Sleepiness Scale - Participant Version (ESS)
Change from baseline in ESS total score completed by the adolescent participant. Score range: 0-24 Clinical threshold: score \>10 indicates excessive daytime sleepiness Higher scores indicate greater daytime sleepiness.
Change in Daytime Sleepiness Assessed by the Epworth Sleepiness Scale - Parent/Caregiver Version (ESS-Parent)
Change from baseline in ESS total score completed independently by the parent or legal guardian of the participant, using the Croatian validated parent and caregiver version of the Epworth Sleepiness Scale. Score range: 0-24 Clinical threshold: score \>10 indicates excessive daytime sleepiness as observed by parent/caregiver.
Change in Depression, Anxiety, and Stress Assessed by the Depression Anxiety Stress Scale - 21 Items (DASS-21)
Change from baseline in three DASS-21 subscale scores: * Depression subscale * Anxiety subscale * Stress subscale Raw subscale scores multiplied by 2 per standard scoring protocol to yield values comparable to the full DASS-42. Score range per subscale (after doubling): 0-42 Higher scores indicate greater symptom severity. Severity classification per subscale: Depression: Normal 0-9 / Mild 10-13 / Moderate 14-20 * Severe 21-27 / Extremely severe ≥28 Anxiety: Normal 0-7 / Mild 8-9 / Moderate 10-14 * Severe 15-19 / Extremely severe ≥20 Stress: Normal 0-14 / Mild 15-18 / Moderate 19-25 * Severe 26-33 / Extremely severe ≥34
Change in Psychological Flexibility Assessed by the Avoidance and Fusion Questionnaire for Youth - 8 Items (AFQ-Y8)
Change from baseline in AFQ-Y8 total score reflecting psychological inflexibility, experiential avoidance and cognitive fusion in adolescent participants. Score range: 0-40 Higher scores indicate greater psychological inflexibility and experiential avoidance.
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University of Split, School of Medicine
Lead sponsor
University Hospital of Split
Collaborator
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