Obsessive-compulsive Symptoms in Children and Adolescents With Anorexia Nervosa

NCT04770662 | Completed

• 1 other identifier: STUDIE01PAIKA2020
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Anorexia Nervosa

Keywords

obsessive compulsive symptoms

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• Correlation between the severity and total number of obsessive compulsive symptoms and BMI

  through study completion, an average of 1 year

• Correlation between obsessive compulsive symptoms (severity and total number) and EDI-3 subscales

  through study completion, an average of 1 year

Study Arms (1)

research group

OTHER

patients who are willing to participate in the study

Other: Questionnaires

Interventions

Questionnaires OTHER

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)

research group

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead

Study Sites (1)

UZ Brussel

Brussels, 1090, Belgium

Location

MeSH Terms

Conditions

Anorexia Nervosa

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: A national, academic, interventional study. The data will be acquired through questionnaires.

Study Record Dates

• First Submitted: February 13, 2021
• First Posted: February 25, 2021
• Study Start: November 1, 2020
• Primary Completion: December 31, 2021
• Study Completion: March 30, 2022
• Last Updated: June 2, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)