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

Completed

• Conditions: Anorexia Nervosa
• Interventions: Other: Integrative medicine-based multimodal treatment

• Registration Number: NCT04083989
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2013-05-01
• Primary Completion: 2014-10-09
• Study Completion: 2014-10-09
• Status Verified: 2019-09
• Study First Submitted: 2019-09-05
• Study First Submitted QC: 2019-09-09
• Last Update Submitted: 2019-09-09
• Study First Posted: 2019-09-10
• Last Update Posted: 2019-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Multimodal treatment for AN	Integrative medicine-based multimodal treatment	Adolescent patients with AN attending an integrative medicine-based inpatient treatment program

Primary Outcome Measures

Name	Time	Method
Change in Drive for Thinness	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)
Change in Body Dissatisfaction	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

Name	Time	Method
Weight gain	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)
Heart rate variability: SDNN	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
SF-12 physical	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)
Anxiety	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)
SF-12 global	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)
Depression	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)
SF-12 mental	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)
Heart rate	At admission (t1), six weeks after admission (t2), and three months after t2 (t3)	Heart rate (beats/min), derived from 24h ECG recordings
Body warmth	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)

Trial Locations

Locations (1)

Die Filderklinik; 🇩🇪 Filderstadt, Baden-Württemberg, Germany