Anorexia NervosaNCT04083989
Investigation of Psycho-Physiological Parameters in Adolescent Inpatients With Anorexia Nervosa
An observational study of Anorexia Nervosa, run by ARCIM Institute Academic Research in Complementary and Integrative Medicine at 1 site in Germany.
Trial summary
A study to assess changes in mental and physical symptoms in adolescent inpatients with anorexia nervosa, a severe eating disorder. Read more about this study
- Who is it for?
- Ages 11 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Anorexia Nervosa
- What is being tested?
- Integrative medicine-based multimodal treatment
- How many people
- 80 participants
- Where
- 1 siteGermany
- Study dates
- 1 May 2013to 9 Oct 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Anorexia Nervosa
- Being tested
- Integrative medicine-based multimodal treatment
- Keywords
- Anorexia nervosa, Eating disorder, Adolescents, Inpatient treatment, Integrative medicine, Anthroposophic medicine, Heart rate variability, Thermography
- Medical subject headings
- Anorexia Nervosa, Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Multimodal treatment for AN | Adolescent patients with AN attending an integrative medicine-based inpatient treatment program Receives: Other: Integrative medicine-based multimodal treatment | |
| Healthy controls | Healthy volunteers assessed once to collect comparative data |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: At admission (t1), six weeks after admission (t2), and three months after t2 (t3)
Secondary outcomes (9)
Anxiety
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)
Measured: At admission (t1), six weeks after admission (t2), and three months after t2 (t3)
Depression
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)
Measured: At admission (t1), six weeks after admission (t2), and three months after t2 (t3)
SF-12 physical
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)
Measured: At admission (t1), six weeks after admission (t2), and three months after t2 (t3)
SF-12 mental
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)
Measured: At admission (t1), six weeks after admission (t2), and three months after t2 (t3)
SF-12 global
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)
Measured: At admission (t1), six weeks after admission (t2), and three months after t2 (t3)
Weight gain
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)
Measured: At admission (t1), six weeks after admission (t2), and three months after t2 (t3)
Heart rate
Heart rate (beats/min), derived from 24h ECG recordings
Measured: At admission (t1), six weeks after admission (t2), and three months after t2 (t3)
Heart rate variability: SDNN
Standard deviation of normal to normal (NN) intervals (ms), derived from 24h ECG recordings
Measured: At admission (t1), six weeks after admission (t2), and three months after t2 (t3)
Body warmth
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)
Measured: At admission (t1), six weeks after admission (t2), and three months after t2 (t3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2019
- Study start1 May 2013
- Primary completion9 Oct 2014
- Study completion9 Oct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- ARCIM Institute Academic Research in Complementary and Integrative Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Die Filderklinik, Filderstadt, Germany
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04083989
- Sponsor's protocol ID
- ANS_01
- Status last verified
- Sep 2019
- First submitted
- 5 Sep 2019
- Last updated
- 10 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adolescent Inpatients With Anorexia Nervosa: Changes in Heart Rate Variability, Body Warmth and Eating Disorder Features - a Prospective Controlled Study
- ClinicalTrials.gov ID
- NCT04083989
- Acronym / sponsor ID
- ANS_01
- Conditions
- Anorexia Nervosa
- Keywords
- Anorexia nervosa, Eating disorder, Adolescents, Inpatient treatment, Integrative medicine, Anthroposophic medicine, Heart rate variability, Thermography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- ARCIM Institute Academic Research in Complementary and Integrative MedicineUniversity, hospital or other
- Collaborators
- Die Filderklinik, Filderstadt, Germany
- Study start
- 1 May 2013 (actual)
- Primary completion
- 9 Oct 2014 (actual)
- Study completion
- 9 Oct 2014 (actual)
- First posted
- 10 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multimodal treatment for AN | – | Other: Integrative medicine-based multimodal treatmentAdolescent patients with AN attending an integrative medicine-based inpatient treatment program |
| Healthy controls | – | –Healthy volunteers assessed once to collect comparative data |
Who may qualify
- Ages
- 11 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Integrative medicine-based multimodal treatmentMultimodal 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. | Other | Multimodal treatment for AN |
Primary outcome
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)
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)
9 secondary outcomes
Anxiety
Time frame: 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)
SF-12 physical
Time frame: 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)
SF-12 global
Time frame: 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)
Heart rate
Time frame: 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)
Body warmth
Time frame: At admission (t1), six weeks after admission (t2), and three months after t2 (t3)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anorexia Nervosa, run by ARCIM Institute Academic Research in Complementary and Integrative Medicine at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Drive for Thinness (time frame: At admission (timepoint 1, t1), six weeks after admission (t2), and three months after t2 (t3)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2019; AzTrials last refreshed its copy on 7 Nov 2026.