Clinical trial NCT04083989: Investigation of Psycho-Physiological Parameters in Adolescent Inpatients With Anorexia Nervosa
Official title: Adolescent Inpatients With Anorexia Nervosa: Changes in Heart Rate Variability, Body Warmth and Eating Disorder Features - a Prospective Controlled Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anorexia Nervosa
Keywords: Anorexia nervosa
Eating disorder
Adolescents
Inpatient treatment
Integrative medicine
Anthroposophic medicine
Heart rate variability
Thermography
Lead sponsor: ARCIM Institute Academic Research in Complementary and Integrative Medicine
Sponsor class: OTHER
Collaborators: name: Die Filderklinik, Filderstadt, Germany
First posted: 2019-09-10
Enrollment: 80
Sex: ALL
Minimum age (years): 11
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
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

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.

Eligibility 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

Primary outcomes:
measure: Change in Drive for Thinness
timeFrame: At admission (timepoint 1, t1), six weeks after admission (t2), and three months after t2 (t3)
measure: Change in Body Dissatisfaction
timeFrame: At admission (t1), six weeks after admission (t2), and three months after t2 (t3)
Secondary outcomes:
measure: Anxiety
timeFrame: At admission (t1), six weeks after admission (t2), and three months after t2 (t3)
measure: Depression
timeFrame: At admission (t1), six weeks after admission (t2), and three months after t2 (t3)
measure: SF-12 physical
timeFrame: At admission (t1), six weeks after admission (t2), and three months after t2 (t3)
measure: SF-12 mental
timeFrame: At admission (t1), six weeks after admission (t2), and three months after t2 (t3)
measure: SF-12 global
timeFrame: At admission (t1), six weeks after admission (t2), and three months after t2 (t3)
measure: Weight gain
timeFrame: At admission (t1), six weeks after admission (t2), and three months after t2 (t3)
measure: Heart rate
timeFrame: At admission (t1), six weeks after admission (t2), and three months after t2 (t3)
measure: Heart rate variability: SDNN
timeFrame: At admission (t1), six weeks after admission (t2), and three months after t2 (t3)
measure: Body warmth
timeFrame: At admission (t1), six weeks after admission (t2), and three months after t2 (t3)
Other outcomes:
Locations:
city: Filderstadt
country: Germany
facility: Die Filderklinik
state: Baden-Württemberg
Study officials:
References: