- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04770662
Obsessive-compulsive Symptoms in Children and Adolescents With Anorexia Nervosa
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.
Study Overview
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Brussel, Belgium, 1090
- UZ Brussel
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Other: research group
patients who are willing to participate in the study
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Administered Questionnaires:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Prevalence of obsessive compulsive symptoms
Time Frame: through study completion, an average of 1 year
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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').
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through study completion, an average of 1 year
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Severity of obsessive compulsive symptoms
Time Frame: through study completion, an average of 1 year
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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)
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through study completion, an average of 1 year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Correlation between the severity and total number of obsessive compulsive symptoms and BMI
Time Frame: through study completion, an average of 1 year
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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'
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through study completion, an average of 1 year
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Correlation between obsessive compulsive symptoms (severity and total number) and EDI-3 subscales
Time Frame: through study completion, an average of 1 year
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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).
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through study completion, an average of 1 year
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDIE01PAIKA2020
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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