Investigation of Psycho-Physiological Parameters in Adolescent Inpatients With Anorexia Nervosa

Study Overview
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Brief Summary
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A study to assess changes in mental and physical symptoms in adolescent inpatients with anorexia nervosa, a severe eating disorder.

Detailed Description
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This is a prospective controlled trial to assess changes in psycho-physiological parameters, including eating disorder features (drive for thinness, body dissatisfaction) and comorbid symptoms such as anxiety, depression and quality of life as well as heart rate variability, body warmth and BMI in adolescent inpatients with anorexia nervosa. Parameters were assessed at admission, six weeks after admission and three months thereafter and compared to reference values of healthy controls.

Official Title
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Adolescent Inpatients With Anorexia Nervosa: Changes in Heart Rate Variability, Body Warmth and Eating Disorder Features - a Prospective Controlled Study

Conditions
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Anorexia Nervosa

Intervention / Treatment
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* Other: Integrative medicine-based multimodal treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 11-18 years Restrictive subtype of adolescent AN Fulfilling the AN diagnostic criteria of the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV and V) Admitted to the Filderklinik for inpatient treatment Exclusion Criteria: Patients diagnosed with the binge-purge subtype of adolescent AN or with other eating disorders Healthy controls: BMI beyond the defined norm for their age group Healthy controls: acute or chronic disorders including psychiatric disorders, heart defects, cardiac arrhythmia, other disorders requiring medication

Ages Eligible for Study
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Minimum Age: 11 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Multimodal treatment for AN<br>Adolescent patients with AN attending an integrative medicine-based inpatient treatment program | Other: Integrative medicine-based multimodal treatment<br>* Multimodal inpatient treatment program based on anthroposophic medicine, including individual and group psychotherapy, family therapy, art therapies and specific nursing applications such as embrocations, rhythmical massage and oil dispersion baths.<br>|
| Healthy controls<br>Healthy volunteers assessed once to collect comparative data | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Drive for Thinness | Assessed with the 7-item subscale Drive for Thinness of the self-reporting Eating Disorder Inventory-2 at admission to the hospital (t1), six weeks after admission (t2) and three months after t2 (t3) | At admission (timepoint 1, t1), six weeks after admission (t2), and three months after t2 (t3) | 
| Change in Body Dissatisfaction | Assessed with the 9-item subscale Body Dissatisfaction of the self-reporting Eating Disorder Inventory-2 at admission to the hospital (t1), six weeks after admission (t2) and three months after t2 (t3) | At admission (t1), six weeks after admission (t2), and three months after t2 (t3) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety | Assessed with the 7-item subscale Anxiety of the self-reporting Hospital Anxiety and Depression Scale at admission to the hospital (t1), six weeks after admission (t2) and three months after t2 (t3) | At admission (t1), six weeks after admission (t2), and three months after t2 (t3) | 
| Depression | Assessed with the 7-item subscale Depression of the self-reporting Hospital Anxiety and Depression Scale at admission to the hospital (t1), six weeks after admission (t2) and three months after t2 (t3) | At admission (t1), six weeks after admission (t2), and three months after t2 (t3) | 
| SF-12 physical | Physical health-related quality of life, assessed with the 6-item subscale Physical Health of the self-reporting Health-Related Quality of Life Questionnaire (SF-12) at admission to the hospital (t1), six weeks after admission (t2) and three months after t2 (t3) | At admission (t1), six weeks after admission (t2), and three months after t2 (t3) | 
| SF-12 mental | Mental health-related quality of life, assessed with the 6-item subscale Mental Health of the self-reporting Health-Related Quality of Life Questionnaire (SF-12) at admission to the hospital (t1), six weeks after admission (t2) and three months after t2 (t3) | At admission (t1), six weeks after admission (t2), and three months after t2 (t3) | 
| SF-12 global | Overall health-related quality of life, assessed with the self-reporting 12-item Health-Related Quality of Life Questionnaire (SF-12 sum-score) at admission to the hospital (t1), six weeks after admission (t2) and three months after t2 (t3) | At admission (t1), six weeks after admission (t2), and three months after t2 (t3) | 
| Weight gain | Change in BMI (kg/m2) based on body weight measurements taken at admission to the hospital (t1), six weeks after admission (t2) and three months after t2 (t3) | At admission (t1), six weeks after admission (t2), and three months after t2 (t3) | 
| Heart rate | Heart rate (beats/min), derived from 24h ECG recordings | At admission (t1), six weeks after admission (t2), and three months after t2 (t3) | 
| Heart rate variability: SDNN | Standard deviation of normal to normal (NN) intervals (ms), derived from 24h ECG recordings | At admission (t1), six weeks after admission (t2), and three months after t2 (t3) | 
| Body warmth | Body surface temperature (°C) at the inner canthi of both eyes, measured with high-resolution infrared thermography at admission (t1), six weeks after admission (t2) and three months after t2 (t3) | At admission (t1), six weeks after admission (t2), and three months after t2 (t3) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anorexia nervosa, Eating disorder, Adolescents, Inpatient treatment, Integrative medicine, Anthroposophic medicine, Heart rate variability, Thermography