Multimodal Longitudinal and Predictive Modelling to Understand Eating Disorder Development

Anorexia Nervosa Clinical Trial

— ESTRA-BED  

Official title:

Multimodal Longitudinal and Machine Learning-based Predictive Modelling to Understand the Development of Eating Disorders

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06050616
• Other study ID #: IRAS326571
• Secondary ID: MRF-058-0014-F-Z
• Status: Recruiting
• Start date: November 15, 2023
• Est. completion date: June 30, 2024

Study information

• Verified date: December 2023
• Source: King's College London
• Contact: Zuo Zhang, PhD
• Phone: +44 (0)20 7848 7883
• Email: zuo.zhang[@]kcl.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of this observational study is to elucidate the biopsychosocial (including neural, psychological, and social) basis of eating disorders (EDs). The investigators will use functional and structural neuroimaging, psychological as well as environmental data to identify both shared and distinct behavioural/neural processes across ED diagnoses. The investigators will use advanced statistical methods such as machine learning based models. The investigators will carry out analysis on the data already collected in the STRATIFY (Brain network based stratification of reinforcement-related disorders, IRAS ID 218030) and IMAGEN studies (Reinforcement-related behaviour in normal brain function and psychopathology, reference PNM/10/11-126), including participants with Anorexia Nervosa (N=60), Bulimia Nervosa (N=52), Binge eating disorder (N=27) and healthy controls. In addition, the investigators will recruit 30 new participants with a binge eating disorder using the original STRATIFY study protocol to enlarge the binge eating disorder group, so that its sample size is comparable to the other groups. Participants will complete online questionnaires, take an online clinical interview, and undergo a research visit, including brain scans, collection of blood and urine samples, and assessment using a range of cognitive and behavioural measures.

Description:

Eating disorders (EDs) are serious mental illnesses that involve a range of disturbed emotions, cognitions, and behaviours related to body shape/weight and eating. The causes of EDs are complex and involve many biological, psychological, and social factors. The investigators are interested in understanding the connections between a range of biological, psychological, social factors and eating disorders. This will help us understand the basis of diagnostic classifications, which will promote early intervention and the identification of new areas to target in treatments. The investigators will analyse the data already collected in the STRATIFY (Brain network based stratification of reinforcement-related disorders, IRAS ID 218030) and IMAGEN studies (Reinforcement-related behaviour in normal brain function and psychopathology, reference PNM/10/11-126), including patients with Anorexia Nervosa (N=60), Bulimia Nervosa (N=52), Binge eating disorder (N=27) and healthy controls. In addition, the investigators will recruit 30 new participants with a current binge eating disorder using the original STRATIFY protocol to enlarge the binge eating disorder group, so that its sample size is comparable to the other groups. Due to funding limitations, 18 participants will take part in the full assessments, including the research visit (MRI scans, blood, and urine samples). The other 12 participants will take part in the online parts of the assessments only, without the research visit. The investigators will use neuroimaging, cognitive, psychological and life events data to assess if behavioural/neural processes differentiate one eating disorder from another and if there are similar processes across ED diagnoses. The investigators will use advanced statistical methods such as machine learning based models. The investigators will further test whether the identified behavioural and neurological processes can predict future disease risk, by using data from the IMAGEN study - a longitudinal population-based genetic and imaging study - that involves over 2000 participants followed up from adolescence to early adulthood.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

Inclusion Criteria:

• Male and female volunteers, all ethnicities.
• Age of 18 to 30.
• Sufficient in English (due to validity of neuropsychological measures).
• current DSM-5 binge eating disorder.

Exclusion Criteria:

• People with brain injuries including stroke, tumours, epilepsy, neurodegenerative or other neurological disorders.
• People who are deaf or have significant hearing problems or a hearing aid that cannot be removed.
• People who are blind or have significant vision difficulties (correct near vision of 20/100 or worse in both eyes).
• People with type I or type II diabetes.
• People who are heavily medicated for serious illness (other than for mental illness).
• People who are pregnant or any possibility of being pregnant.
• People with restricted mobility, including inability to lie flat for 1.5 hours.
• People who have a history of anorexia nervosa and have not restored their body weight in the past 6 months.
• People who have participated in the STRATIFY, ESTRA or IMAGEN studies previously.

Related Conditions & MeSH terms

• Anorexia
• Anorexia Nervosa
• Binge-Eating Disorder
• Bulimia
• Bulimia Nervosa
• Feeding and Eating Disorders

Intervention

Other:
• MRI scans
Neuroimaging data will be collected with magnetic resonance imaging (MRI). Structural neuroimaging will include T1 and T2-weighted scans, and diffusion tensor imaging (DTI). Functional neuroimaging will include scans under the stop-signal task, monetary incentive delay task, and emotional faces task, and resting state.
• Psychological measures
Cognitive performance assessed by Wechsler Adult Intelligence Scale 4th Edition. Personalities assessed by NEO Five-Factor Inventory (NEO-FFI), Substance Use Risk Profile Scale (SURPS), and Temperament and Character Inventory (TCI). Other psychological assessments include Interpersonal Reactivity Index, Perceived Stress Scale, Kirby Monetary Choice Questionnaire, Passive Avoidance Learning Paradigm, and Stimulus-response compatibility.
• Life experiences
Self-report questionnaires on experiences of bullying and trauma.

Biological:
• Blood and urine samples
Blood and urine samples will be collected but will not undergo analysis in this study. Instead, these samples will be stored in a biobank for potential analysis in future research.

Other:
• Mental health symptoms
Symptoms of depression measured by the Patient Health Questionnaire -8. Symptoms of generalised anxiety, obsessives compulsive disorder, attention deficit hyperactivity disorder, social phobia, specific phobia, agoraphobia, post-traumatic stress disorder, measured by the Development and Well-Being Assessment (DAWBA). Harmful drinking measured by the Alcohol use disorders identification test. Drug use measured by the European School Survey Project on Alcohol and Other Drugs (ESPAD). Suicide risk measured by the the Mini International Neuropsychiatric Interview.

Locations

Country	Name	City	State
United Kingdom	Institute of Psychiatry, Psychology & Neuroscience, King's College London	London

Sponsors (3)

Lead Sponsor	Collaborator
King's College London	Delosis Limited, NeuroSpin

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Eating disorder diagnosis	The Eating Disorder Diagnostic Scale (DSM-5 version) will be used to assess whether the participants meet the diagnostic criteria of anorexia nervosa, bulimia nervosa, or binge eating disorder.	Administered at the screening phase and within two weeks of the other assessments.