Multimodal Longitudinal and Predictive Modelling to Understand Eating Disorder Development
NCT ID: NCT06050616
Last Updated: 2024-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
23 participants
OBSERVATIONAL
2023-11-15
2024-08-12
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CONTROL
CROSS_SECTIONAL
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
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.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Age of 18 to 30.
* Sufficient in English (due to validity of neuropsychological measures).
* current DSM-5 binge eating disorder.
Exclusion Criteria
* 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.
18 Years
30 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Delosis Limited
UNKNOWN
NeuroSpin
UNKNOWN
King's College London
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Zuo Zhang
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Zuo Zhang, PhD
Role: PRINCIPAL_INVESTIGATOR
King's College London
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Institute of Psychiatry, Psychology & Neuroscience, King's College London
London, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
MRF-058-0014-F-ZHAN-C0866
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
23/NW/0232
Identifier Type: OTHER
Identifier Source: secondary_id
IRAS326571
Identifier Type: -
Identifier Source: org_study_id