Adult Eating Disorder Assessment Study

NCT ID: NCT06103929

Last Updated: 2024-02-14

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-01-15
• Study Completion Date: 2027-05-31

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).

Detailed Description

Study Analysis Plan

Work Package 1 (WP1) relates to assessment of the entire study clinical population (n = 100). For WP1, the threshold for diagnosis of common forms of eating disorders (anorexia nervosa, bulimia nervosa, binge-eating disorder, and any eating disorder) by clinicians will be used as the reference (criterion) standard, and 95% confidence intervals will be performed for all estimates. Receiver-operating characteristic (ROC) curves and areas under the curve (AUC) will be calculated for all measurement tools (SCANv3s9, EDE-QS, and SCOFF), with reference to the criterion standard, as well as sensitivity, specificity, positive predictive value, and negative predictive values for a range of cut-off scores for these tools. Additionally, correlation coefficients will be calculated with respect to SCANv3s9, EDE-QS, and SCOFF findings, relative to those of the reference standard.

To calibrate the SCANv3s9 interview, symptom findings from the researcher-assessed SCANv3s9 will be compared with NHS clinician's diagnostic thresholds. However, the research team may modify the SCANv3s9 diagnostic algorithms in the event that they diverge substantially from clinician judgment, an approach that has previously been employed when calibrating the Autism Diagnostic Observation Schedule (ADOS) against clinical opinion. Work Package 2 (WP2) relates to retesting of a subsample of the WP1 population (n = 25). For WP2, test-retest reliability will be assessed using Cohen's kappa coefficient (κ), as well as simple percentage agreement calculations.

Conditions

Eating Disorders

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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.

No interventions assigned to this group

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.

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Leicestershire Partnership NHS Trust

OTHER

Sponsor Role: collaborator

City, University of London

OTHER

Sponsor Role: collaborator

National Centre for Social Research, London, UK

UNKNOWN

Sponsor Role: collaborator

University of London

OTHER

Sponsor Role: collaborator

University of Leicester

OTHER

Sponsor Role: lead

Responsible Party

Sam Tromans

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Samuel J. Tromans

Role: PRINCIPAL_INVESTIGATOR

University of Leicester

Locations

Leicestershire Partnership NHS Trust

Leicester, , United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Central Contacts

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

Role: CONTACT

st386@leicester.ac.uk

+44 (0)116 252 5451

Traolach S. Brugha, FRCPsych,MD

Role: CONTACT

tsb@leicester.ac.uk

+44 (0)116 252 3211

Facility Contacts

Dave Clarke, PhD

Role: primary

dave.clarke6@nhs.net

+44 (0) 7900053538

References

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.

Reference Type: BACKGROUND

PMID: 11055457 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21798110 (View on PubMed)

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

Reference Type: 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.

Reference Type: BACKGROUND

PMID: 31725160 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27138364 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18751246 (View on PubMed)

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

Reference Type: 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.

Reference Type: BACKGROUND

PMID: 19343793 (View on PubMed)

Study Documents

Document Type: Individual Participant Data Set

View Document

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

0897

Identifier Type: -

Identifier Source: org_study_id