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

NCT ID: NCT04083989

Last Updated: 2019-09-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-05-01

Study Completion Date

2014-10-09

Brief Summary

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

Detailed Description

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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.

Conditions

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Anorexia Nervosa

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Multimodal treatment for AN

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

Integrative medicine-based multimodal treatment

Intervention Type OTHER

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.

Healthy controls

Healthy volunteers assessed once to collect comparative data

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

11 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Die Filderklinik, Filderstadt, Germany

UNKNOWN

Sponsor Role collaborator

ARCIM Institute Academic Research in Complementary and Integrative Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Die Filderklinik

Filderstadt, Baden-Wurttemberg, Germany

Site Status

Countries

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Germany

Other Identifiers

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ANS_01

Identifier Type: -

Identifier Source: org_study_id

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