Eating Disorders and Autism Spectrum Disorders

Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau (Other)
Overall Status
Recruiting
CT.gov ID
NCT04564170
Collaborator
(none)
135
1
68
2

Study Details

Study Description

Brief Summary

This is an observational study where patients with eating disorders (ED) are compared with healthy controls without eating disorder (HC) regarding eating disorders features and autism spectrum features. Also patients will be reassessed after 5 years.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The first author who suggested that eating disorders (EAD) and autism spectrum disorders (ASD) share common features was Christopher Gilberg in 1980. Currently it is known that patients with ED have social impairment, which is also a risk marker to develop ED, eating disturbances are overrepresented in ASD, ED and ASD have common behavioural features such as rigidity, perfectionism, and harm avoidance; and common cognitive profiles such as inflexibility, high attention to detail, high scores in systemizing profiles and poor results in advanced theory of mind tests. This relationship is also supported by similar neural phenotypes such as atypical structure and function in social brain regions found in both disorders.

    The aim of the present study is to explore the relationship between ED and ASD traits in a sample of Spanish participants diagnosed with AN, bulimia nervosa (BN), binge-eating disorder (BED) and other eating disorders (OED). Specifically, the investigators aim to explore possible differences within the different ED and its particular transdiagnostic features in association with autistic traits.

    The sample will consist of 90 patients with ED and 45 healthy controls (HC) without any current or lifetime history of mental disorder, both groups will be compared regarding ED and ASD features. Also patients will be reassessed in a 5 year follow up.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    135 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Cross-Sectional
    Official Title:
    Characterization and Relationship Between Eating Disorders and Autism Spectrum Disorders.
    Actual Study Start Date :
    Apr 1, 2020
    Anticipated Primary Completion Date :
    Sep 1, 2021
    Anticipated Study Completion Date :
    Dec 1, 2025

    Arms and Interventions

    Arm Intervention/Treatment
    ED

    Patients with Eating Disorders

    HC

    Healthy Controls without eating disorders

    Outcome Measures

    Primary Outcome Measures

    1. Autism Spectrum Quotient [one year]

      A self report measure of autism traits. Its values range from 0 to 50. Higher scores mean higher autistic traits.

    2. Eating Disorders Inventory [one year]

      A self report measure of Eating Disorders characteristics. Its values range from 0 to 192, higher values mean higher eating disorders symptomatology.

    Secondary Outcome Measures

    1. Bulimic Investigatory Test Edinburgh [one year]

      A self report measure of bulimic symptoms where higher scores mean more bulimic symptomatology. Scores range from 0 and 78.

    2. Quality of Life Enjoyment and Satisfaction Questionnaire [one year]

      The Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) is a self-report measure designed to enable investigators to easily obtain sensitive measures of the degree of enjoyment and satisfaction experienced by subjects in various areas of daily functioning. Its values range from 93 to 465. Higher values mean higher quality of life.

    3. Beck Depression Inventory [one year]

      a self report measure of depression symptomatology. Scores rang form 0 to 63, higher scores mean more depressive symptomatology.

    4. Scale Unawareness of Mental Disorders. [one year]

      A scale to asess awareness of mental disorders where higher punctuation mean higher levels of unawareness of the disorder. Scores range from 20 to 100.

    5. Body Shape Questionnaire [one year]

      A a self-report measure of the body shape preoccupations typical of bulimia nervosa and anorexia nervosa. Higher scores mean higher concern with shape. Score range from 34 to 204.

    6. Rosenberg Self -Esteem Scale [one year]

      A self report measure of self esteem. Its scores range from 10 to 40 where higher scores mean higher self -esteem

    7. State Trait Anxiety Inventory [one year]

      A self report measure of anxiety symptomatology. It has two scores one for state of anxiety and another for trait of anxiety, each subscale values range from 0 to 60, higher scores mean higher state or trait of anxiety.

    8. Inventory of interpersonal problems personality disorder [one year]

      A self report measure which is used to identify problems associated with particular personality disorders. Its values range from 0 to 256, higher scores mean higher interpersonal problems.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Inclusion Criteria:
    • Being Diagnosed with ED
    Exclusion Criteria:
    • language or intellectual impairment

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cristina Carmona Barcelona Spain 08041

    Sponsors and Collaborators

    • Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
    ClinicalTrials.gov Identifier:
    NCT04564170
    Other Study ID Numbers:
    • IIBSP-TCA-2020-11
    First Posted:
    Sep 25, 2020
    Last Update Posted:
    Oct 5, 2020
    Last Verified:
    Sep 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 5, 2020