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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04083989
Other study ID # ANS_01
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 1, 2013
Est. completion date October 9, 2014

Study information

Verified date September 2019
Source ARCIM Institute Academic Research in Complementary and Integrative Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date October 9, 2014
Est. primary completion date October 9, 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 11 Years to 18 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Germany Die Filderklinik Filderstadt Baden-Württemberg

Sponsors (2)

Lead Sponsor Collaborator
ARCIM Institute Academic Research in Complementary and Integrative Medicine Die Filderklinik, Filderstadt, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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)
Primary 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 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)
Secondary 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)
Secondary 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)
Secondary 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)
Secondary 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)
Secondary 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)
Secondary 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)
Secondary 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)
Secondary 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)
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