Multimodal Longitudinal and Predictive Modelling to Understand Eating Disorder Development (ESTRA-BED)
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| ClinicalTrials.gov Identifier: NCT06050616 |
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Recruitment Status :
Recruiting
First Posted : September 22, 2023
Last Update Posted : May 9, 2024
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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.
| Condition or disease | Intervention/treatment |
|---|---|
| Binge-Eating Disorder Anorexia Nervosa Bulimia Nervosa | Other: MRI scans Other: Psychological measures Other: Life experiences Biological: Blood and urine samples Other: Mental health symptoms |
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.
| Study Type : | Observational |
| Estimated Enrollment : | 30 participants |
| Observational Model: | Case-Control |
| Time Perspective: | Cross-Sectional |
| Official Title: | Multimodal Longitudinal and Machine Learning-based Predictive Modelling to Understand the Development of Eating Disorders |
| Actual Study Start Date : | November 15, 2023 |
| Estimated Primary Completion Date : | December 2024 |
| Estimated Study Completion Date : | December 2024 |
| Group/Cohort | Intervention/treatment |
|---|---|
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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.
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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. Other: 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. Other: 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. |
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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.
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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. Other: 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. Other: 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. |
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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.
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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. Other: 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. Other: 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. |
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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.
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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. Other: 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. Other: 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. |
- Eating disorder diagnosis [ Time Frame: Administered at the screening phase and within two weeks of the other assessments. ]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.
Biospecimen Retention: Samples With DNA
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| Ages Eligible for Study: | 18 Years to 30 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06050616
| Contact: Zuo Zhang, PhD | +44 (0)20 7848 7883 | zuo.zhang@kcl.ac.uk |
| United Kingdom | |
| Institute of Psychiatry, Psychology & Neuroscience, King's College London | Recruiting |
| London, United Kingdom, SE5 8AF | |
| Contact: Zuo Zhang, PhD | |
| Principal Investigator: | Zuo Zhang, PhD | King's College London |
| Responsible Party: | Zuo Zhang, Principal Investigator, King's College London |
| ClinicalTrials.gov Identifier: | NCT06050616 |
| Other Study ID Numbers: |
IRAS326571 MRF-058-0014-F-ZHAN-C0866 ( Other Grant/Funding Number: Medical Research Foundation, UK ) 23/NW/0232 ( Other Identifier: NorthWest-Greater Manchester South Research Ethics Committee ) |
| First Posted: | September 22, 2023 Key Record Dates |
| Last Update Posted: | May 9, 2024 |
| Last Verified: | May 2024 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | All collected individual participant data are to be shared. Data will be pseudonymised before sharing. |
| Supporting Materials: |
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. |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Eating Disorders Binge-Eating Disorder Anorexia Nervosa Bulimia Nervosa Neuroimaging |
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Anorexia Bulimia Feeding and Eating Disorders Anorexia Nervosa Binge-Eating Disorder |
Bulimia Nervosa Mental Disorders Signs and Symptoms, Digestive Hyperphagia |