Multimodal Longitudinal and Predictive Modelling to Understand Eating Disorder Development

NCT06050616 | Completed

• 3 other identifiers: IRAS326571MRF-058-0014-F-ZHAN-C086623/NW/0232
• Study Type: observational
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Binge-Eating Disorder; Anorexia Nervosa; Bulimia Nervosa

Keywords

Eating Disorders; Binge-Eating Disorder; Anorexia Nervosa; Bulimia Nervosa; Neuroimaging

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (4)

binge eating disorder

Participants with a current binge eating disorder, as assessed by the Eating Disorder Diagnostic Screen (DSM-5 version). These participants have been recruited as part of the STRATIFY study. An additional 30 participants will be recruited in this study to enlarge the sample size, using the same study procedure and assessments in the STRATIFY study.

Other: MRI scans; Other: Psychological measures; Other: Life experiences; Biological: Blood and urine samples; Other: Mental health symptoms

anorexia nervosa

Participants with current anorexia nervosa, as assessed by the Eating Disorder Diagnostic Screen (DSM-5 version).. These participants have been recruited as part of the STRATIFY study. Their data will be used in this study.

Other: MRI scans; Other: Psychological measures; Other: Life experiences; Biological: Blood and urine samples; Other: Mental health symptoms

bulimia nervosa

Participants with current bulimia nervosa, as assessed by the Eating Disorder Diagnostic Screen (DSM-5 version). These participants have been recruited as part of the STRATIFY study. Their data will be used in this study.

Other: MRI scans; Other: Psychological measures; Other: Life experiences; Biological: Blood and urine samples; Other: Mental health symptoms

healthy controls

Healthy controls are selected from the IMAGEN study at the third follow-up (\~age 22 years) who do not exhibit any psychiatric disorder. Their data will be used in this study. IMAGEN and STRATIFY are sister studies that employ matched study protocols.

Other: MRI scans; Other: Psychological measures; Other: Life experiences; Biological: Blood and urine samples; Other: Mental health symptoms

Interventions

MRI scans OTHER

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.

anorexia nervosa; binge eating disorder; bulimia nervosa; healthy controls

Psychological measures OTHER

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.

anorexia nervosa; binge eating disorder; bulimia nervosa; healthy controls

Life experiences OTHER

Self-report questionnaires on experiences of bullying and trauma.

anorexia nervosa; binge eating disorder; bulimia nervosa; healthy controls

Blood and urine samples BIOLOGICAL

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.

anorexia nervosa; binge eating disorder; bulimia nervosa; healthy controls

Mental health symptoms OTHER

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.

anorexia nervosa; binge eating disorder; bulimia nervosa; healthy controls

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• King's College London: lead
• Delosis Limited: collaborator
• NeuroSpin: collaborator

Study Sites (1)

Institute of Psychiatry, Psychology & Neuroscience, King's College London

London, SE5 8AF, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

Two EDTA tubes and 2 Tempus tubes of blood will be collected. A urine sample (stored in 2 x 10ml tubes) will be collected.

MeSH Terms

Conditions

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

Interventions

Magnetic Resonance Spectroscopy; Blood Specimen Collection

Condition Hierarchy (Ancestors)

Mental Disorders; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative

Study Officials

• Zuo Zhang, PhD

  King's College London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 6, 2023
• First Posted: September 22, 2023
• Study Start: November 15, 2023
• Primary Completion: August 12, 2024
• Study Completion: August 12, 2024
• Last Updated: December 11, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: starting 6 months after publication of the research findings
• Access Criteria: A short data access application must be submitted to the principle investigator, including specific research questions, choice of variables, and plans for analysis and publication. The principle investigator will discuss with the STRATIFY Executive Committee (chaired by the Centre for Population Neuroscience and Stratified Medicine, Charité - Universitätsmedizin Berlin) about the application, and inform the applicant of the outcome.

Locations

GB (1)