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

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

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

Study Overview

• Status: Completed
• Conditions: Anorexia Nervosa
• Intervention / Treatment: Other: Integrative medicine-based multimodal treatment

Detailed Description

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 (Actual): 80

Contacts and Locations

Study Locations

• Germany
  • Baden-Württemberg
    • Filderstadt, Baden-Württemberg, Germany, 70794
      • Die Filderklinik

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 years to 16 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Multimodal treatment for AN; Adolescent patients with AN attending an integrative medicine-based inpatient treatment program	Other: Integrative medicine-based multimodal treatment; 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.
Healthy controls; Healthy volunteers assessed once to collect comparative data

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: ARCIM Institute Academic Research in Complementary and Integrative Medicine
• Collaborators: Die Filderklinik, Filderstadt, Germany

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2013
• Primary Completion (Actual): October 9, 2014
• Study Completion (Actual): October 9, 2014

Study Registration Dates

• First Submitted: September 5, 2019
• First Submitted That Met QC Criteria: September 9, 2019
• First Posted (Actual): September 10, 2019

Study Record Updates

• Last Update Posted (Actual): September 10, 2019
• Last Update Submitted That Met QC Criteria: September 9, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Adolescents; Integrative medicine; Heart rate variability; Eating disorder; Anthroposophic medicine; Thermography; Anorexia nervosa; Inpatient treatment
• Additional Relevant MeSH Terms: Mental Disorders; Signs and Symptoms, Digestive; Feeding and Eating Disorders; Anorexia; Anorexia Nervosa
• Other Study ID Numbers: ANS_01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No