Clinical trial NCT06050616: Multimodal Longitudinal and Predictive Modelling to Understand Eating Disorder Development
Official title: Multimodal Longitudinal and Machine Learning-based Predictive Modelling to Understand the Development of Eating Disorders
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Binge-Eating Disorder
Anorexia Nervosa
Bulimia Nervosa
Keywords: Eating Disorders
Binge-Eating Disorder
Anorexia Nervosa
Bulimia Nervosa
Neuroimaging
Lead sponsor: King's College London
Sponsor class: OTHER
Collaborators: name: Delosis Limited
name: NeuroSpin
First posted: 2023-09-22
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be recruited via online and physical posters among people living in or near London, UK, and from eating disorder clinics in London.

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Eating disorder diagnosis
timeFrame: Administered at the screening phase and within two weeks of the other assessments.
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Institute of Psychiatry, Psychology & Neuroscience, King's College London
Study officials:
affiliation: King's College London
name: Zuo Zhang, PhD
role: PRINCIPAL_INVESTIGATOR
References: