| NCT ID | NCT06103929 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Leicester |
| Condition | Eating Disorders |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-01-15 |
| Primary Completion | 2027-05 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2024-01-15 with a primary completion date of 2027-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The hypothesis of the study is that low-cost self-completion questionnaires relating to eating disorder symptoms will predict the subsequent results of a detailed, semi-structured interview assessment of eating disorder symptoms that has been calibrated according to expert clinical diagnostic case thresholds. Eating disorders are recognised as a research priority among healthcare professionals, adults with lived experience, and their carers alike. There is a need for measurement methods that can reliably and systematically identify symptoms of common forms of eating disorder, including those fulfilling agreed diagnostic criteria for anorexia nervosa, bulimia nervosa, and binge-eating disorder. Effective diagnostic interview tools can facilitate early detection of eating disorders. To develop rules for determining whether diagnostic criteria for eating disorders are met, a study involving adults referred to specialist eating disorder services is required. In this study, assessments by eating disorder clinicians will be compared with researcher assessments using a semi-structured interview assessment, the Schedules for Clinical Assessment in Neuropsychiatry version 3 section 9 (SCANv3s9). The study population will consist of 100 adult patients referred to specialist eating disorder services, including patients whose referrals are accepted by these services, as well as those who are not. Clinical assessments and structured interview assessment findings will also be compared with those from widely used screening tools for eating disorders, the Eating Disorder Examination Questionnaire short-form and the SCOFF (Sick, Control, One, Fat, Food) questionnaire. The aim of this study is to evaluate the accuracy of the Eating Disorder Examination Questionnaire Short-Form (EDE-QS) and the SCOFF (Sick, Control, One, Fat, Food) questionnaire in adults referred to specialist eating disorder services, in a comparison with the Schedules for Clinical Assessment in Neuropsychiatry subsection on eating disorders and specialist NHS clinician assessments of the probability of eating disorder. This will help develop appropriate and accurate benchmarks for estimating the prevalence of eating disorder symptoms and clinical diagnoses, in adults referred to specialist eating disorder services, as well as the wider population (through combining the findings from this study with those of the community 2023 Adult Psychiatric Morbidity Survey).
Eligibility Criteria
Inclusion Criteria: * Individuals aged 16 years or older (on the date of referral to specialist eating disorder services) * Individuals referred to specialist adult eating disorder services during the study period Exclusion Criteria: * Patients under 16 years old and having not been referred to specialist eating disorder services. * Patients with a clinical diagnosis of intellectual disability will be excluded on the basis that the SCAN is not intended for use in this patient group. * Patients lacking capacity to consent to take part. * Participants who lose capacity during their participation will be withdrawn from the study (with data collected up until the point of withdrawal being retained). * Participants who are unable to understand written and verbal English.
Contact & Investigator
Associate Professor of Psychiatry & Honorary Consultant Psych, MRCPsych,PhD
✉ st386@leicester.ac.uk📞 +44 (0)116 252 5451
Samuel J. Tromans
PRINCIPAL INVESTIGATOR
University of Leicester
Frequently Asked Questions
Who can join the NCT06103929 clinical trial?
This trial is open to participants of all sexes, aged 16 Years or older, studying Eating Disorders. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06103929 currently recruiting?
Yes, NCT06103929 is actively recruiting participants. Contact the research team at st386@leicester.ac.uk for enrollment information.
Where is the NCT06103929 trial being conducted?
This trial is being conducted at Leicester, United Kingdom.
Who is sponsoring the NCT06103929 clinical trial?
NCT06103929 is sponsored by University of Leicester. The principal investigator is Samuel J. Tromans at University of Leicester. The trial plans to enroll 100 participants.