Adult Eating Disorder Assessment Study

NCT06103929 | Recruiting

• 1 other identifier: 0897
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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).

Conditions

Eating Disorders

Keywords

Eating disorders; Adult psychiatry; Epidemiology; Calibration; Public health; Anorexia nervosa; Bulimia nervosa; Binge eating disorder

Outcome Measures

Primary Outcomes (1)

• The threshold on the questionnaires and SCAN examination output algorithm scores calibrated against the clinician diagnostic thresholds for eating disorder, taking account of the level of agreement between the questionnaires and SCAN

  The SCAN assesses most forms of mental and neurodevelopmental disorders. SCANv3s9 is designed to measure eating disorder symptoms and the output numerical scores will be calibrated against clinician diagnostic thresholds for eating disorder (the criterion standard). The study will also ask about history of mental and physical health conditions

  The WP1 SCAN interview battery (60-84 minutes)

Secondary Outcomes (5)

• The threshold on the EDE-QS examination output algorithm scores calibrated against the clinician diagnostic thresholds for eating disorder, taking account of the level of agreement between the EDE-QS and SCAN

  The EDE-QS will take about 2.7 minutes to be completed

• The threshold on the SCOFF examination output algorithm scores calibrated against the clinician diagnostic thresholds for eating disorder, taking account of the level of agreement between the SCOFF and SCAN

  The SCOFF (1.3 minutes) and basic demographic details form (3.7 minutes), completed by each participant

• A retest comparison of findings from the SCAN among a subgroup of participants subject to repeated assessment

  The reduced time of assessment due to repeat SCAN testing with SCANv3s0 and SCANv3s9, will take 20-28 minutes.

• A retest comparison of findings from the EDE-QS among a subgroup of participants subject to repeated assessment

  The EDE-QS will take about 2.7 minutes to be completed

• A retest comparison of findings from the SCOFF among a subgroup of participants subject to repeated assessment

  The SCOFF (1.3 minutes) and basic demographic details form (3.7 minutes), completed by each participant

Study Arms (1)

Adults referred to eating disorder services

A cohort of adults referred to a specialist adult eating disorders service will be recruited. A stratified sample of patients will be approached about participating in the study, providing the study inclusion criteria are met, and their responsible clinician does not express concerns about their participation. All study participants will be assessed with the SCAN semi-structured interview (including version 2 of the SCAN, SCANv3s0, SCANv3s1, and SCANv3s9) and will also complete two self-completion measures, the EDE-QS and the SCOFF, randomly ordered. The SCAN items will be asked about in the context of the past 4 weeks and the directly preceding 11 months (i.e., the past year), unless otherwise stated. Additionally, a subset of study participants (n = 25) will be reassessed with the SCANv3s0, SCANv3s1, SCANv3s9, EDE-QS, and SCOFF, for test-retest reliability.

Eligibility Criteria

• Age: 16 Years+
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adults resident in the UK who have been referred to NHS Leicestershire Partnership Trust. The study aims to collect data on accepted referrals, which will represent the clinical population, and referrals not accepted into treatment which will represent people more likely to describe eating difficulties in community surveys.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Leicester: lead
• Leicestershire Partnership NHS Trust: collaborator
• City, University of London: collaborator
• National Centre for Social Research, London, UK: collaborator
• University of London: collaborator

Study Sites (1)

Leicestershire Partnership NHS Trust

Leicester, LE4 8BL, United Kingdom

RECRUITING

Related Publications (8)

• Lord C, Risi S, Lambrecht L, Cook EH Jr, Leventhal BL, DiLavore PC, Pickles A, Rutter M. The autism diagnostic observation schedule-generic: a standard measure of social and communication deficits associated with the spectrum of autism. J Autism Dev Disord. 2000 Jun;30(3):205-23.

  PMID: 11055457 BACKGROUND

• Brugha TS, McManus S, Smith J, Scott FJ, Meltzer H, Purdon S, Berney T, Tantam D, Robinson J, Radley J, Bankart J. Validating two survey methods for identifying cases of autism spectrum disorder among adults in the community. Psychol Med. 2012 Mar;42(3):647-56. doi: 10.1017/S0033291711001292. Epub 2011 Jul 29.

  PMID: 21798110 BACKGROUND

• Fairburn CG, Cooper Z, O'Connor M. The eating disorder examination. 1993;6:1-8.

  BACKGROUND

• McManus S, Bebbington PE, Jenkins R, Morgan Z, Brown L, Collinson D, Brugha T. Data Resource Profile: Adult Psychiatric Morbidity Survey (APMS). Int J Epidemiol. 2020 Apr 1;49(2):361-362e. doi: 10.1093/ije/dyz224. No abstract available.

  PMID: 31725160 BACKGROUND

• Gideon N, Hawkes N, Mond J, Saunders R, Tchanturia K, Serpell L. Development and Psychometric Validation of the EDE-QS, a 12 Item Short Form of the Eating Disorder Examination Questionnaire (EDE-Q). PLoS One. 2016 May 3;11(5):e0152744. doi: 10.1371/journal.pone.0152744. eCollection 2016.

  PMID: 27138364 BACKGROUND

• Morgan JF, Reid F, Lacey JH. The SCOFF questionnaire: a new screening tool for eating disorders. West J Med. 2000 Mar;172(3):164-5. doi: 10.1136/ewjm.172.3.164. No abstract available.

  PMID: 18751246 BACKGROUND

• American Psychiatric Association D, Association AP. Diagnostic and statistical manual of mental disorders: DSM-5. American psychiatric association Washington, DC; 2013.

  BACKGROUND

• Hill LS, Reid F, Morgan JF, Lacey JH. SCOFF, the development of an eating disorder screening questionnaire. Int J Eat Disord. 2010 May;43(4):344-51. doi: 10.1002/eat.20679.

  PMID: 19343793 BACKGROUND

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

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

Study Officials

• Samuel J. Tromans

  University of Leicester

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Associate Professor of Psychiatry & Honorary Consultant Psych, MRCPsych,PhD

CONTACT

+44 (0)116 252 5451; st386@leicester.ac.uk

Traolach S. Brugha, FRCPsych,MD

CONTACT

+44 (0)116 252 3211; tsb@leicester.ac.uk

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 25, 2023
• First Posted: October 27, 2023
• Study Start: January 15, 2024
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: February 14, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: This will be made available starting January 2026

Locations

GB (1)