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Obsessive-compulsive Symptoms in Children and Adolescents With Anorexia Nervosa

Primary Purpose

Anorexia Nervosa

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Questionnaires
Sponsored by
Universitair Ziekenhuis Brussel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Anorexia Nervosa focused on measuring obsessive compulsive symptoms

Eligibility Criteria

10 Years - 18 Years (Child, Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • UZ Brussel

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

research group

Arm Description

patients who are willing to participate in the study

Outcomes

Primary Outcome Measures

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').
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)

Secondary Outcome Measures

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'
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).

Full Information

First Posted
February 13, 2021
Last Updated
May 26, 2022
Sponsor
Universitair Ziekenhuis Brussel
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1. Study Identification

Unique Protocol Identification Number
NCT04770662
Brief Title
Obsessive-compulsive Symptoms in Children and Adolescents With Anorexia Nervosa
Official Title
Obsessive-compulsive Symptoms in Children and Adolescents With Anorexia Nervosa and Possible Correlation With BMI
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
November 1, 2020 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
March 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitair Ziekenhuis Brussel

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anorexia Nervosa
Keywords
obsessive compulsive symptoms

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
A national, academic, interventional study. The data will be acquired through questionnaires.
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
research group
Arm Type
Other
Arm Description
patients who are willing to participate in the study
Intervention Type
Other
Intervention Name(s)
Questionnaires
Intervention Description
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)
Primary Outcome Measure Information:
Title
Prevalence of obsessive compulsive symptoms
Description
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').
Time Frame
through study completion, an average of 1 year
Title
Severity of obsessive compulsive symptoms
Description
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)
Time Frame
through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
Correlation between the severity and total number of obsessive compulsive symptoms and BMI
Description
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'
Time Frame
through study completion, an average of 1 year
Title
Correlation between obsessive compulsive symptoms (severity and total number) and EDI-3 subscales
Description
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).
Time Frame
through study completion, an average of 1 year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
UZ Brussel
City
Brussel
ZIP/Postal Code
1090
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No

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Obsessive-compulsive Symptoms in Children and Adolescents With Anorexia Nervosa

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