Eating DisordersNCT06103929
Adult Eating Disorder Assessment Study
An observational study of Eating Disorders, run by University of Leicester at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Eating Disorders
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Jan 2024to May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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- Participants who lose capacity during their participation will be withdrawn from the study (with data collected up until the point of withdrawal being retained).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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Associate Professor of Psychiatry & Honorary Consultant Psych, MRCPsych,PhD contact
United Kingdom1 site, 1 recruiting
- Recruiting
Leicestershire Partnership NHS Trust
Leicester, LE4 8BL
Dave Clarke, PhD, +44 (0) 7900053538, dave.clarke6@nhs.net
About this study
Official title: Evaluation of Eating Difficulties Assessment Measures in Clinical Practice and in Epidemiological Surveys
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).
Read the 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
- Keywords
- Eating disorders, Adult psychiatry, Epidemiology, Calibration, Public health, Anorexia nervosa, Bulimia nervosa, Binge eating disorder
- Medical subject headings
- Feeding and Eating Disorders, Anorexia Nervosa, Bulimia Nervosa, Binge-Eating Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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 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.
Measured: 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 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.
Measured: 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
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.
Measured: 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 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
Measured: 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 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.
Measured: The SCOFF (1.3 minutes) and basic demographic details form (3.7 minutes), completed by each participant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2023
- Study start15 Jan 2024
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Eating DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Leicester
- Sponsor type
- University, hospital or other
- Collaborators
- Leicestershire Partnership NHS Trust, City, University of London, National Centre for Social Research, London, UK, University of London
- Responsible party
- Principal investigator, Sam Tromans, University of Leicester
- Investigators
- Samuel J. Tromans, Principal investigator, University of Leicester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06103929
- Sponsor's protocol ID
- 0897
- Status last verified
- Feb 2024
- First submitted
- 25 Jul 2023
- Last updated
- 14 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Upon completion of the study, the data that support the findings of this study will be available to other researchers in deidentified form from the NHS Data Access Request Service or from another official data depository as yet to be determined.
Publications
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.
PubMed 11055457Brugha 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.
PubMed 21798110Fairburn CG, Cooper Z, O'Connor M. The eating disorder examination. 1993;6:1-8.
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.
PubMed 31725160Gideon 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.
PubMed 27138364Morgan 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.
PubMed 18751246American Psychiatric Association D, Association AP. Diagnostic and statistical manual of mental disorders: DSM-5. American psychiatric association Washington, DC; 2013.
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.
PubMed 19343793
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Eating Difficulties Assessment Measures in Clinical Practice and in Epidemiological Surveys
- ClinicalTrials.gov ID
- NCT06103929
- Acronym / sponsor ID
- 0897
- Conditions
- Eating Disorders
- Keywords
- Eating disorders, Adult psychiatry, Epidemiology, Calibration, Public health, Anorexia nervosa, Bulimia nervosa, Binge eating disorder
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of LeicesterUniversity, hospital or other
- Collaborators
- Leicestershire Partnership NHS Trust, City, University of London, National Centre for Social Research, London, UK, University of London
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 27 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
5 secondary outcomes
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 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
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 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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2024.
- Background: PubMed 11055457Lord 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.
- Background: PubMed 21798110Brugha 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.
- BackgroundFairburn CG, Cooper Z, O'Connor M. The eating disorder examination. 1993;6:1-8.
- Background: PubMed 31725160McManus 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.
- Background: PubMed 27138364Gideon 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.
- Background: PubMed 18751246Morgan 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.
- BackgroundAmerican Psychiatric Association D, Association AP. Diagnostic and statistical manual of mental disorders: DSM-5. American psychiatric association Washington, DC; 2013.
- Background: PubMed 19343793Hill 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.
- Individual participant dataSharing planned: Yes. Upon completion of the study, the data that support the findings of this study will be available to other researchers in deidentified form from the NHS Data Access Request Service or from another official data depository as yet to be determined.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Associate Professor of Psychiatry & Honorary Consultant Psych, MRCPsych,PhD contact
Samuel J. Tromans principal investigator
University of Leicester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Eating Disorders, run by University of Leicester at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Associate Professor of Psychiatry & Honorary Consultant Psych, MRCPsych,PhD (+44 (0)116 252 5451, st386@leicester.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06103929, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2024.