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Clinical Trials/NCT04083989
NCT04083989
Completed
Not Applicable

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

ARCIM Institute Academic Research in Complementary and Integrative Medicine1 site in 1 country80 target enrollmentMay 1, 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Anorexia Nervosa
Sponsor
ARCIM Institute Academic Research in Complementary and Integrative Medicine
Enrollment
80
Locations
1
Primary Endpoint
Change in Drive for Thinness
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
May 1, 2013
End Date
October 9, 2014
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
ARCIM Institute Academic Research in Complementary and Integrative Medicine
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Change in Drive for Thinness

Time Frame: At admission (timepoint 1, t1), six weeks after admission (t2), and three months after t2 (t3)

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)

Change in Body Dissatisfaction

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

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)

Secondary Outcomes

  • Weight gain(At admission (t1), six weeks after admission (t2), and three months after t2 (t3))
  • Heart rate variability: SDNN(At admission (t1), six weeks after admission (t2), and three months after t2 (t3))
  • SF-12 physical(At admission (t1), six weeks after admission (t2), and three months after t2 (t3))
  • Anxiety(At admission (t1), six weeks after admission (t2), and three months after t2 (t3))
  • SF-12 global(At admission (t1), six weeks after admission (t2), and three months after t2 (t3))
  • Depression(At admission (t1), six weeks after admission (t2), and three months after t2 (t3))
  • Body warmth(At admission (t1), six weeks after admission (t2), and three months after t2 (t3))
  • SF-12 mental(At admission (t1), six weeks after admission (t2), and three months after t2 (t3))
  • Heart rate(At admission (t1), six weeks after admission (t2), and three months after t2 (t3))

Study Sites (1)

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