Obsessive-compulsive Symptoms in Children and Adolescents With Anorexia Nervosa

Anorexia Nervosa Clinical Trial

Official title:

Obsessive-compulsive Symptoms in Children and Adolescents With Anorexia Nervosa and Possible Correlation With BMI

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04770662
• Other study ID #: STUDIE01PAIKA2020
• Status: Completed
• Phase: N/A
• Start date: November 1, 2020
• Est. completion date: March 30, 2022

Study information

• Verified date: May 2022
• Source: Universitair Ziekenhuis Brussel
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: March 30, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 10 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Anorexia
• Anorexia Nervosa

Intervention

Other:
• Questionnaires
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)

Locations

Country	Name	City	State
Belgium	UZ Brussel	Brussel

Sponsors (1)

Lead Sponsor	Collaborator
Universitair Ziekenhuis Brussel

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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').	through study completion, an average of 1 year
Primary	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)	through study completion, an average of 1 year
Secondary	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'	through study completion, an average of 1 year
Secondary	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).	through study completion, an average of 1 year