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| Name | Class |
|---|---|
| Die Filderklinik, Filderstadt, Germany | UNKNOWN |
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A study to assess changes in mental and physical symptoms in adolescent inpatients with anorexia nervosa, a severe eating disorder.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multimodal treatment for AN | Adolescent patients with AN attending an integrative medicine-based inpatient treatment program |
| |
| Healthy controls | Healthy volunteers assessed once to collect comparative data |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Integrative medicine-based multimodal treatment | Other | 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. |
| 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) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Adolescent patients with Anorexia Nervosa who are admitted to the Filderklinik's ward for eating disorders to attend a specific inpatient treatment program based on anthroposophic medicine
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Die Filderklinik | Filderstadt | Baden-Wurttemberg | 70794 | Germany |
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| ID | Term |
|---|---|
| D000856 | Anorexia Nervosa |
| D001068 | Feeding and Eating Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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) |