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

Anorexia Nervosa Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04083989
• Other study ID #: ANS_01
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Anorexia
• Anorexia Nervosa

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)