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NCT Number: NCT06103929

Adult Eating Disorder Assessment Study

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).

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Key information

Conditions

Eating Disorders Anorexia Nervosa Binge-Eating Disorder Bulimia Nervosa Feeding and Eating Disorders Mental Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Leicestershire Partnership NHS Trust

Leicester, LE4 8BL, United Kingdom

Location status: Recruiting

Location contact

Dave Clarke, PhD

CONTACT

[email protected]

+44 (0) 7900053538

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

    Time frame: The WP1 SCAN interview battery (60-84 minutes)

    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

Secondary outcomes

  1. 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

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

    The Eating Disorder Examination Short (EDE-QS) is a 12-item self-report questionnaire on eating disorder symptoms, and providing an overall numerical score. It showed high internal consistency, with reduced administration time.

  2. 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

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

    The SCOFF questionnaire was used in the APMS survey in 2007, to screen for eating disorders. It is a 5-item measure, designed to detect eating disorders within a primary care setting.

    Please note that the respective measures of eating problems (SCAN, EDE-QS, and SCOFF) will be compared against the criterion standard (clinical diagnostic thresholds), but will not be aggregated to arrive at a singular reported value.

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

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

    A total of 25 participants will take part in WP2, all of whom will have previously participated in WP1. Most WP2 assessment will take place within 2-3 weeks of WP1 assessment. Although the WP2 research team assessments will also take place either in a clinical setting or the participant's home, as described in WP1, the participant in WP2 will be assessed by a different research team member than they were for WP1.

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

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

    The Eating Disorder Examination Questionnaire (EDE-Q) is a 28-item self-report questionnaire, comprising fixed worded questions on eating disorder symptoms, and providing an overall score. A shortened version, the 12-item Eating Disorder Examination Short (EDE-QS) will be used

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

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

    The SCOFF questionnaire is a 5-item measure, designed to detect eating disorders within a primary care setting, with good validity when compared (for accuracy) with clinical diagnosis (DSM-IV).

    Please note that the respective measures of eating problems (SCAN, EDE-QS, and SCOFF) will be compared against the criterion standard (clinical diagnostic thresholds), but will not be aggregated to arrive at a singular reported value.

Study contacts

Contact information is provided by the study sponsor or research team.

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

CONTACT

[email protected]

+44 (0)116 252 5451

Traolach S. Brugha, FRCPsych,MD

CONTACT

[email protected]

+44 (0)116 252 3211

Sponsors and collaborators

Lead sponsor

University of Leicester

Other

Collaborators

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

Registry information

Official study title

Evaluation of Eating Difficulties Assessment Measures in Clinical Practice and in Epidemiological Surveys

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Oct 27, 2023
Registry last updated
Feb 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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