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

ARCIM Institute Academic Research in Complementary and Integrative Medicine80 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Anorexia Nervosa

Interventions

Integrative medicine-based multimodal treatmentOTHER

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.

Eligibility

Sex: ALLMin age: 11 YearsMax age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Die Filderklinik

Filderstadt, Baden-Wurttemberg, Germany

Outcomes

Primary Outcomes

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)

Time frame: 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)

Time frame: At admission (t1), six weeks after admission (t2), and three months after t2 (t3)

Secondary Outcomes

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)

Time frame: 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)

Time frame: 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)

Time frame: At admission (t1), six weeks after admission (t2), and three months after t2 (t3)

Data from ClinicalTrials.gov

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