Anorexia NervosaNCT04770662
Obsessive-compulsive Symptoms in Children and Adolescents With Anorexia Nervosa
A study testing Questionnaires in people with Anorexia Nervosa, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
Trial summary
The purpose of this study is to determine obsessive-compulsive symptoms and BMI changes in children and adolescents with anorexia nervosa and find out whether there is a group-level correlation between the two. Read more about this study
- Who is it for?
- Ages 10 to 18 years, women only
- Conditions the study is for
- Anorexia Nervosa
- What is being tested?
- Questionnaires
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Nov 2020to 30 Mar 2022
- Phase
- Interventional
- 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 10 to 18 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Dutch-speaking female patients with parents who have sufficient command of Dutch
- Minors from 10 years up to and including 18 years old
- Known with the diagnosis of anorexia nervosa and registered for treatment in Paika Food Clinic Service (outpatients and/or inpatients)
- Informed consent obtained from the minor herself and parent (s) / guardian
Who cannot join
- Patients or parents of patients who do not have sufficient command of Dutch
- Male patients
- Minors <10 years and adults older than 18 years
- Minors and / or parent (s) / guardians have not given written permission to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Obsessive-compulsive Symptoms in Children and Adolescents With Anorexia Nervosa and Possible Correlation With BMI
The purpose of this study is to determine obsessive-compulsive symptoms and BMI changes in children and adolescents with anorexia nervosa and find out whether there is a group-level correlation between the two. We also investigate a possible link between obsessive compulsive symptoms and the psychological features of eating disorders.
It is a national, academic, interventional study. The data will be acquired through questionnaires.
Read the detailed description
Children and adolescents with anorexia nervosa show a high psychiatric co-morbidity. In clinical practice, compulsions and compulsive thoughts are frequently reported in children and adolescents with anorexia nervosa. Obsessive compulsive disorder occurs in 19% of patients with anorexia nervosa and anorexia nervosa is seen in 3-17% of female patients with obsessive compulsive disorder.
A precise explanation for this coexistence is still unknown.An underlying genetic correlation and common neuropsychological factors and personality traits are described in the literature as possible explanations. Little is know about the relation between obsessive compulsive symptoms and the psychological features of eating disorders.
It is also unclear whether obsessive compulsive symptoms can be seen as a result of the underweight and weight loss associated with anorexia nervosa and whether these symptoms clear up with weight recovery. Research on this is very limited and shows different results. The aim of this study is to examine obsessive compulsive symptoms and weight change in children and adolescents with anorexia nervosa and to determine whether there is a group-level correlation between the two.
It is a national, academic, interventional study. The data will be acquired through the following questionnaires:
- Questionnaires to be completed by the minor:
- Dutch version of the Children's Yale-Brown Obsessive Compulsive Scale (CYBOCS, Goodman W.K. e.a., vertaald en bewerkt door Lidewij Wolters en Else de Haan, DAT de Bascule, juni 2012, existing of two parts CY-BOCS Symptom Checklist en CY-BOCS Severity Ratings)
- Dutch version of the Eating Disorder Inventory-3 (EDI-3, David M. Garner, Nederlandse vertaling door Tatjana van Strien, Hogrefe Uitgevers B.V. Amsterdam, 2014)
- Questionnaires to be completed by the parent or guardian:
- General questionnaire: personal data, family and school and social information, child psychiatric history
- Dutch version of the problem part of the Child Behavior Checklist (CBCL, T.M. Achenbach, Nederlandse vertaling door F.C. Verhulst en J. van der Ende, Erasmus MC - Sophia Kinderziekenhuis Rotterdam, 2001)
- Anorectic Behavior Observation Scale (ABOS, Vandereycken W., Universitair Centrum Kortenberg, 1992)
- Consent Form to contact if the completed questionnaires have increased results
- Conditions
- Anorexia Nervosa
- Being tested
- Questionnaires
- Keywords
- obsessive compulsive symptoms
- Medical subject headings
- Anorexia Nervosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesOther
Administered Questionnaires:
- Dutch version of Children's Yale-Brown Obsessive Compulsive Scale (CYBOCS, Goodman W.K. e.a.)
- Dutch version of Eating Disorder Inventory-3 (EDI-3, David M. Garner)
- General Questionnaire: demografic , scholar and social information and child psychiatric history
- Dutch version of the Child Behavior Checklist (CBCL, T.M. Achenbach)
- Anorectic Behavior Observation Scale (ABOS, Vandereycken W., Universitair Centrum Kortenberg, 1992)
| Study group | Role | What they receive |
|---|---|---|
| research group | Other | patients who are willing to participate in the study Receives: Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of obsessive compulsive symptoms
current obsessive compulsive symptoms are identified using the CY-BOCS Symptom Checklist (17 different categories of obsessive compulsive behaviour en thoughts, each scored by 0 (if absent) or 1 (if present). A total score is calculated by taking the mean of all 17 categories (=' total number of obsessive compulsive symptoms').
Measured: through study completion, an average of 1 year
Severity of obsessive compulsive symptoms
severity of symptoms are identified using the CY-BOCS Severity Ratings score between minimum value 0 (no impact on daily life) and maximum value 40 (high impact on daily life)
Measured: through study completion, an average of 1 year
Secondary outcomes (2)
Correlation between the severity and total number of obsessive compulsive symptoms and BMI
Correlation between the severity and the total number of obsessive compulsive symptoms using CY-BOCS Severity Ratings, score between minimum value 0 (no impact) and maximum value 40 (high impact) and BMI (in kg/m^2). For BMI we measure 'current BMI' = BMI on the moment of inclusion to the study, 'past BMI' = BMI 6 months before that en 'BMI-change' = the difference between 'past BMI' and 'current BMI'
Measured: through study completion, an average of 1 year
Correlation between obsessive compulsive symptoms (severity and total number) and EDI-3 subscales
Correlation between the severity and the total number of obsessive compulsive symptoms using CY-BOCS Severity Ratings, score between minimum value 0 (no impact) and maximum value 40 (high impact) and EDI-3 subscales. For BMI we measure 'current BMI' = BMI on the moment of inclusion to the study, 'past BMI' = BMI 6 months before that en 'BMI-change' = the difference between 'past BMI' and 'current BMI'. The EDI-3 subscales includes the eating disorder symptoms, i.e., drive for thinness (DT), bulimia (B) and body dissatisfaction (BD) and more general psychological features related to eating disorders i.e. low self-esteem (LSE), personal alienation (PA), interpersonal insecurity (II), interpersonal alienation (IA), interoceptive deficits (ID), emotional dysregulation (ED), perfectionism (P), asceticism (AS) and maturity fear (MF).
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2021
- Study start1 Nov 2020
- Primary completion31 Dec 2021
- Study completion30 Mar 2022
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.
- More trials run by Universitair Ziekenhuis BrusselThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A national, academic, interventional study. The data will be acquired through questionnaires.
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lisa Cornelis, Universitair Ziekenhuis Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04770662
- Sponsor's protocol ID
- STUDIE01PAIKA2020
- Status last verified
- May 2022
- First submitted
- 13 Feb 2021
- Last updated
- 2 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Obsessive-compulsive Symptoms in Children and Adolescents With Anorexia Nervosa and Possible Correlation With BMI
- ClinicalTrials.gov ID
- NCT04770662
- Acronym / sponsor ID
- STUDIE01PAIKA2020
- Conditions
- Anorexia Nervosa
- Keywords
- obsessive compulsive symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 30 Mar 2022 (actual)
- First posted
- 25 Feb 2021 (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.
The purpose of this study is to determine obsessive-compulsive symptoms and BMI changes in children and adolescents with anorexia nervosa and find out whether there is a group-level correlation between the two. We also investigate a possible link between obsessive compulsive symptoms and the psychological features of eating disorders.
It is a national, academic, interventional study. The data will be acquired through questionnaires.
Detailed description
Children and adolescents with anorexia nervosa show a high psychiatric co-morbidity. In clinical practice, compulsions and compulsive thoughts are frequently reported in children and adolescents with anorexia nervosa. Obsessive compulsive disorder occurs in 19% of patients with anorexia nervosa and anorexia nervosa is seen in 3-17% of female patients with obsessive compulsive disorder.
A precise explanation for this coexistence is still unknown.An underlying genetic correlation and common neuropsychological factors and personality traits are described in the literature as possible explanations. Little is know about the relation between obsessive compulsive symptoms and the psychological features of eating disorders.
It is also unclear whether obsessive compulsive symptoms can be seen as a result of the underweight and weight loss associated with anorexia nervosa and whether these symptoms clear up with weight recovery. Research on this is very limited and shows different results. The aim of this study is to examine obsessive compulsive symptoms and weight change in children and adolescents with anorexia nervosa and to determine whether there is a group-level correlation between the two.
It is a national, academic, interventional study. The data will be acquired through the following questionnaires:
- Questionnaires to be completed by the minor:
- Dutch version of the Children's Yale-Brown Obsessive Compulsive Scale (CYBOCS, Goodman W.K. e.a., vertaald en bewerkt door Lidewij Wolters en Else de Haan, DAT de Bascule, juni 2012, existing of two parts CY-BOCS Symptom Checklist en CY-BOCS Severity Ratings)
- Dutch version of the Eating Disorder Inventory-3 (EDI-3, David M. Garner, Nederlandse vertaling door Tatjana van Strien, Hogrefe Uitgevers B.V. Amsterdam, 2014)
- Questionnaires to be completed by the parent or guardian:
- General questionnaire: personal data, family and school and social information, child psychiatric history
- Dutch version of the problem part of the Child Behavior Checklist (CBCL, T.M. Achenbach, Nederlandse vertaling door F.C. Verhulst en J. van der Ende, Erasmus MC - Sophia Kinderziekenhuis Rotterdam, 2001)
- Anorectic Behavior Observation Scale (ABOS, Vandereycken W., Universitair Centrum Kortenberg, 1992)
- Consent Form to contact if the completed questionnaires have increased results
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A national, academic, interventional study. The data will be acquired through questionnaires.
| Arm | Type | Receives |
|---|---|---|
| research group | Other | Other: Questionnairespatients who are willing to participate in the study |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Dutch-speaking female patients with parents who have sufficient command of Dutch
- Minors from 10 years up to and including 18 years old
- Known with the diagnosis of anorexia nervosa and registered for treatment in Paika Food Clinic Service (outpatients and/or inpatients)
- Informed consent obtained from the minor herself and parent (s) / guardian
Key exclusion criteria (4 listed)
- Patients or parents of patients who do not have sufficient command of Dutch
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 |
|---|---|---|
| QuestionnairesAdministered Questionnaires: * Dutch version of Children's Yale-Brown Obsessive Compulsive Scale (CYBOCS, Goodman W.K. e.a.) * Dutch version of Eating Disorder Inventory-3 (EDI-3, David M. Garner) * General Questionnaire: demografic , scholar and social information and child psychiatric history * Dutch version of the Child Behavior Checklist (CBCL, T.M. Achenbach) * Anorectic Behavior Observation Scale (ABOS, Vandereycken W., Universitair Centrum Kortenberg, 1992) | Other | research group |
Primary outcome
Prevalence of obsessive compulsive symptoms
Time frame: through study completion, an average of 1 year
current obsessive compulsive symptoms are identified using the CY-BOCS Symptom Checklist (17 different categories of obsessive compulsive behaviour en thoughts, each scored by 0 (if absent) or 1 (if present). A total score is calculated by taking the mean of all 17 categories (=' total number of obsessive compulsive symptoms').
Severity of obsessive compulsive symptoms
Time frame: through study completion, an average of 1 year
severity of symptoms are identified using the CY-BOCS Severity Ratings score between minimum value 0 (no impact on daily life) and maximum value 40 (high impact on daily life)
2 secondary outcomes
Correlation between the severity and total number of obsessive compulsive symptoms and BMI
Time frame: through study completion, an average of 1 year
Correlation between obsessive compulsive symptoms (severity and total number) and EDI-3 subscales
Time frame: through study completion, an average of 1 year
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 2 Jun 2022.
- Individual participant dataSharing planned: No
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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?
A study testing Questionnaires in people with Anorexia Nervosa, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
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 4 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 2 Jun 2022. 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 Belgium. 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?
Prevalence of obsessive compulsive symptoms (time frame: through study completion, an average of 1 year). 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 2 Jun 2022.