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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04083989
Enrollment
80
Registered
2019-09-10
Start date
2013-05-01
Completion date
2014-10-09
Last updated
2019-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anorexia Nervosa

Keywords

Anorexia nervosa, Eating disorder, Adolescents, Inpatient treatment, Integrative medicine, Anthroposophic medicine, Heart rate variability, Thermography

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.

Interventions

OTHERIntegrative 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.

Sponsors

Die Filderklinik, Filderstadt, Germany
CollaboratorUNKNOWN
ARCIM Institute Academic Research in Complementary and Integrative Medicine
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
11 Years to 18 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Drive for ThinnessAt 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 DissatisfactionAt 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

MeasureTime frameDescription
SF-12 physicalAt 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)
SF-12 mentalAt 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)
SF-12 globalAt 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)
AnxietyAt 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)
Heart rateAt admission (t1), six weeks after admission (t2), and three months after t2 (t3)Heart rate (beats/min), derived from 24h ECG recordings
Heart rate variability: SDNNAt 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
Body warmthAt 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)
Weight gainAt 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)
DepressionAt 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)

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026