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

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ClinicalTrials.gov Identifier: NCT04083989
Recruitment Status : Completed
First Posted : September 10, 2019
Last Update Posted : September 10, 2019
Sponsor:
Collaborator:
Die Filderklinik, Filderstadt, Germany
Information provided by (Responsible Party):
ARCIM Institute Academic Research in Complementary and Integrative Medicine

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

Condition or disease Intervention/treatment
Anorexia Nervosa 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.

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Study Type : Observational
Actual Enrollment : 80 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Adolescent Inpatients With Anorexia Nervosa: Changes in Heart Rate Variability, Body Warmth and Eating Disorder Features - a Prospective Controlled Study
Actual Study Start Date : May 1, 2013
Actual Primary Completion Date : October 9, 2014
Actual Study Completion Date : October 9, 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eating Disorders

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



Primary Outcome Measures :
  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 Outcome Measures :
  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)



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Ages Eligible for Study:   11 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04083989


Locations
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Germany
Die Filderklinik
Filderstadt, Baden-Württemberg, Germany, 70794
Sponsors and Collaborators
ARCIM Institute Academic Research in Complementary and Integrative Medicine
Die Filderklinik, Filderstadt, Germany

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Responsible Party: ARCIM Institute Academic Research in Complementary and Integrative Medicine
ClinicalTrials.gov Identifier: NCT04083989     History of Changes
Other Study ID Numbers: ANS_01
First Posted: September 10, 2019    Key Record Dates
Last Update Posted: September 10, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by ARCIM Institute Academic Research in Complementary and Integrative Medicine:
Anorexia nervosa
Eating disorder
Adolescents
Inpatient treatment
Integrative medicine
Anthroposophic medicine
Heart rate variability
Thermography
Additional relevant MeSH terms:
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Anorexia
Anorexia Nervosa
Feeding and Eating Disorders
Mental Disorders
Signs and Symptoms, Digestive
Signs and Symptoms