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

September 9, 2019 updated by: ARCIM Institute Academic Research in Complementary and Integrative Medicine

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Baden-Württemberg
      • Filderstadt, Baden-Württemberg, Germany, 70794
        • Die Filderklinik

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

7 years to 14 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Multimodal treatment for AN
Adolescent patients with AN attending an integrative medicine-based inpatient treatment program
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.
Healthy controls
Healthy volunteers assessed once to collect comparative data

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Drive for Thinness
Time Frame: 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)
At admission (timepoint 1, t1), six weeks after admission (t2), and three months after t2 (t3)
Change in Body Dissatisfaction
Time Frame: 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)
At admission (t1), six weeks after admission (t2), and three months after t2 (t3)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Anxiety
Time Frame: 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)
At admission (t1), six weeks after admission (t2), and three months after t2 (t3)
Depression
Time Frame: 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)
At admission (t1), six weeks after admission (t2), and three months after t2 (t3)
SF-12 physical
Time Frame: 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)
At admission (t1), six weeks after admission (t2), and three months after t2 (t3)
SF-12 mental
Time Frame: 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)
At admission (t1), six weeks after admission (t2), and three months after t2 (t3)
SF-12 global
Time Frame: 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)
At admission (t1), six weeks after admission (t2), and three months after t2 (t3)
Weight gain
Time Frame: 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)
At admission (t1), six weeks after admission (t2), and three months after t2 (t3)
Heart rate
Time Frame: At admission (t1), six weeks after admission (t2), and three months after t2 (t3)
Heart rate (beats/min), derived from 24h ECG recordings
At admission (t1), six weeks after admission (t2), and three months after t2 (t3)
Heart rate variability: SDNN
Time Frame: 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
At admission (t1), six weeks after admission (t2), and three months after t2 (t3)
Body warmth
Time Frame: 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)
At admission (t1), six weeks after admission (t2), and three months after t2 (t3)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
ARCIM Institute Academic Research in Complementary and Integrative Medicine

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Die Filderklinik, Filderstadt, Germany

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 9, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 9, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 5, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 9, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 10, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 10, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 9, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ANS_01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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