NCT04083989

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 9, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 9, 2014

Completed
4.9 years until next milestone

First Submitted

Initial submission to the registry

September 5, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 10, 2019

Completed
Last Updated

September 10, 2019

Status Verified

September 1, 2019

Enrollment Period

1.4 years

First QC Date

September 5, 2019

Last Update Submit

September 9, 2019

Conditions

Anorexia Nervosa

Keywords

Anorexia nervosaEating disorderAdolescentsInpatient treatmentIntegrative medicineAnthroposophic medicineHeart rate variabilityThermography

Outcome Measures

Primary Outcomes (2)

  • 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)

  • 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 Outcomes (9)

  • Anxiety

    At admission (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)

  • SF-12 physical

    At admission (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)

  • SF-12 global

    At admission (t1), six weeks after admission (t2), and three months after t2 (t3)

  • +4 more secondary outcomes

Study Arms (2)

Multimodal treatment for AN

Adolescent patients with AN attending an integrative medicine-based inpatient treatment program

Other: Integrative medicine-based multimodal treatment

Healthy controls

Healthy volunteers assessed once to collect comparative data

Interventions

Integrative medicine-based multimodal treatmentOTHER

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.

Multimodal treatment for AN

Eligibility Criteria

Age11 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Die Filderklinik

Filderstadt, Baden-Wurttemberg, 70794, Germany

Location

MeSH Terms

Conditions

Anorexia NervosaFeeding and Eating Disorders

Condition Hierarchy (Ancestors)

Mental DisordersSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 5, 2019

First Posted

September 10, 2019

Study Start

May 1, 2013

Primary Completion

October 9, 2014

Study Completion

October 9, 2014

Last Updated

September 10, 2019

Record last verified: 2019-09

Locations

DE(1)