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Completed

NCT Number: NCT04083989

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

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

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Key information

Conditions

Anorexia Nervosa Feeding and Eating Disorders Mental Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

11 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Die Filderklinik

Filderstadt, Baden-Wurttemberg, 70794, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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)

  2. 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

  1. Anxiety

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

    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)

  2. Depression

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

    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)

  3. SF-12 physical

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

    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)

  4. SF-12 mental

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

    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)

  5. SF-12 global

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

    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)

  6. Weight gain

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

    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)

  7. Heart rate

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

    Heart rate (beats/min), derived from 24h ECG recordings

  8. Heart rate variability: SDNN

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

    Standard deviation of normal to normal (NN) intervals (ms), derived from 24h ECG recordings

  9. Body warmth

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

    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)

Sponsors and collaborators

Lead sponsor

ARCIM Institute Academic Research in Complementary and Integrative Medicine

Other

Collaborators

  • Die Filderklinik, Filderstadt, Germany

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Sep 10, 2019
Registry last updated
Sep 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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