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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04564170
Other study ID # IIBSP-TCA-2020-11
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 1, 2020
Est. completion date December 2025

Study information

Verified date March 2023
Source Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Contact cristina carmona
Phone 650003427
Email ccarmonaf@santpau.cat
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 135
Est. completion date December 2025
Est. primary completion date September 1, 2021
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Being Diagnosed with ED Exclusion Criteria: - language or intellectual impairment

Study Design


Locations

Country Name City State
Spain Cristina Carmona Barcelona

Sponsors (1)

Lead Sponsor Collaborator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Country where clinical trial is conducted

Spain, 

References & Publications (11)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 11 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Autism Spectrum Quotient A self report measure of autism traits. Its values range from 0 to 50. Higher scores mean higher autistic traits. one year
Primary 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. one year
Secondary Bulimic Investigatory Test Edinburgh A self report measure of bulimic symptoms where higher scores mean more bulimic symptomatology. Scores range from 0 and 78. one year
Secondary 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. one year
Secondary Beck Depression Inventory a self report measure of depression symptomatology. Scores rang form 0 to 63, higher scores mean more depressive symptomatology. one year
Secondary 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. one year
Secondary 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. one year
Secondary 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 one year
Secondary 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. one year
Secondary 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. one year
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