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Eating DisordersNCT04564170

Eating Disorders and Autism Spectrum Disorders

An observational study of Eating Disorders, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Eating Disorders
How many people
135 participants
Where
1 siteSpain
Study dates
1 Apr 2020to 20 Dec 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with ED and HC without ED.

Who may be able to join

  • Being Diagnosed with ED

Who cannot join

  • language or intellectual impairment

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Cristina Carmona

    Barcelona, Barcelona, 08041

Other trials in Spain

About this study

Official title: Characterization and Relationship Between Eating Disorders and Autism Spectrum Disorders.

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.

Read the 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.

Keywords
eating disorders, autism spectrum disorders
Medical subject headings
Feeding and Eating Disorders, Autism Spectrum Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04564170
Study groupRoleWhat they receive
EDPatients with Eating Disorders
HCHealthy Controls without eating disorders

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Autism Spectrum Quotient

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

    Measured: one year

  2. Eating Disorders Inventory

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

    Measured: one year

Secondary outcomes (8)

  1. Bulimic Investigatory Test Edinburgh

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

    Measured: one year

  2. Quality of Life Enjoyment and Satisfaction Questionnaire

    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.

    Measured: one year

  3. Beck Depression Inventory

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

    Measured: one year

  4. Scale Unawareness of Mental Disorders.

    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.

    Measured: one year

  5. Body Shape Questionnaire

    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.

    Measured: one year

  6. Rosenberg Self -Esteem Scale

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

    Measured: one year

  7. State Trait Anxiety Inventory

    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.

    Measured: one year

  8. Inventory of interpersonal problems personality disorder

    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.

    Measured: one year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Sep 2020
  2. Study start1 Apr 2020
  3. Primary completion1 Sep 2021
  4. Study completion20 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Cross-sectional
Enrolment
135 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04564170
Sponsor's protocol ID
IIBSP-TCA-2020-11
Status last verified
Feb 2025
First submitted
21 Sep 2020
Last updated
27 Feb 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Atienza, F., Moreno, Y., & Balaguer, I. (2000). Escala de autoestima de Rosenberg. Recuperado de: https://www. uv. es/uipd/cuestionarios/accesolibre/EAR.

  • Beck, A. T., Steer, R. A., & Brown, G. K. (1996). BDI-II: Beck depression inventory. Pearson.

  • Bentz M, Jepsen JRM, Pedersen T, Bulik CM, Pedersen L, Pagsberg AK, Plessen KJ. Impairment of Social Function in Young Females With Recent-Onset Anorexia Nervosa and Recovered Individuals. J Adolesc Health. 2017 Jan;60(1):23-32. doi: 10.1016/j.jadohealth.2016.08.011. Epub 2016 Oct 27.

    PubMed 28341015

  • Cooper, P. J., Taylor, M. J., Cooper, Z., & Fairbum, C. G. (1987). The development and validation of the Body Shape Questionnaire. International Journal of eating disorders, 6(4), 485-494.

  • First, M. B. (2015). DSM-5 : Manual de diagnóstico diferencial (DSM-V). Editorial Médica Panamericana.

  • Huke V, Turk J, Saeidi S, Kent A, Morgan JF. Autism spectrum disorders in eating disorder populations: a systematic review. Eur Eat Disord Rev. 2013 Sep;21(5):345-51. doi: 10.1002/erv.2244. Epub 2013 Jul 31.

    PubMed 23900859

  • Khalsa SS, Portnoff LC, McCurdy-McKinnon D, Feusner JD. What happens after treatment? A systematic review of relapse, remission, and recovery in anorexia nervosa. J Eat Disord. 2017 Jun 14;5:20. doi: 10.1186/s40337-017-0145-3. eCollection 2017.

    PubMed 28630708

  • Nielsen S, Anckarsater H, Gillberg C, Gillberg C, Rastam M, Wentz E. Effects of autism spectrum disorders on outcome in teenage-onset anorexia nervosa evaluated by the Morgan-Russell outcome assessment schedule: a controlled community-based study. Mol Autism. 2015 Mar 8;6:14. doi: 10.1186/s13229-015-0013-4. eCollection 2015.

    PubMed 25774282

  • Oldershaw A, Treasure J, Hambrook D, Tchanturia K, Schmidt U. Is anorexia nervosa a version of autism spectrum disorders? Eur Eat Disord Rev. 2011 Nov-Dec;19(6):462-74. doi: 10.1002/erv.1069. Epub 2011 Jan 30.

    PubMed 21280165

  • Spielberger, C. D., Gorsuch, R. L., Lushene, R. E., Vagg, P. R., & Jacobs, G. A. (1970). Manual for the state-trait inventory. Consulting Psychologists, Palo Alto, California.

  • Westwood H, Eisler I, Mandy W, Leppanen J, Treasure J, Tchanturia K. Using the Autism-Spectrum Quotient to Measure Autistic Traits in Anorexia Nervosa: A Systematic Review and Meta-Analysis. J Autism Dev Disord. 2016 Mar;46(3):964-77. doi: 10.1007/s10803-015-2641-0.

    PubMed 26542816

Questions about this trial

What is this clinical trial studying?

An observational study of Eating Disorders, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Autism Spectrum Quotient (time frame: one year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04564170, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2025.

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