Stages, progression, and recovery of eating disorders in youth
| ISRCTN | ISRCTN17301762 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17301762 |
| IRAS number | 325803 |
| Secondary identifying numbers | IRAS 325803, CPMS 58055 |
- Submission date
- 15/08/2023
- Registration date
- 29/08/2023
- Last edited
- 02/07/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Eating disorders (EDs, including anorexia nervosa [AN], bulimia nervosa [BN], binge eating disorder [BED], amongst others) are serious and disabling mental illness that most commonly onset during adulthood and can affect anyone regardless of gender, ethnicity, sexuality, and life circumstances. There is more and more evidence suggesting that EDs are progressive disorders, yet the understanding of how symptom profiles differ between earlier- and later-stage presentations, and how symptoms may change over time, is limited. In addition, though recovery from EDs is always possible, our understanding of the factors that help or hinder the process is also underdeveloped.
This study involves repeated online assessments (i.e. questionnaires) and continuous data collection via a smartphone and (optionally) a wearable device. By following individuals with different EDs and illness durations for the duration of the study, the study aims to investigate how symptom profiles differ across different stages of illness and the factors that help or hinder progression within and recovery from EDs in young people. Ultimately, a greater understanding of illness stages, progression, and recovery in EDs is an important step in developing more personalised and effective interventions.
Who can participate?
Individuals aged between 16 and 25 years who have an eating disorder diagnosis or suspect that they have one, or individuals aged 16-25 years with no history of an eating disorder or any other mental disorder.
What does the study involve?
Being a participant involves completing several assessment measures at different time points over the course of 2 years. When a participant joins the study, they will complete a series of online questionnaires about different aspects of their life, including their mental health and well-being and their social environment. These questionnaires are then repeated at 6-, 12-, and 24-month follow-up points. Participants will also download two apps onto their smartphone (or onto a smartphone given to them by the study team if they do not have an Android smartphone). These apps will continuously collect data throughout the study, both in the background and more frequent, short questionnaires.
Participants can also choose to come to King's College London or the University of Edinburgh (if they live locally) to complete some psychological tasks in person and/or have a brain scan. These take place at the start of the study and at 12- and 24-months follow-ups. Additionally, participants can choose to wear a smart ring for the duration of the study which will measure things such as heart rate and sleep quality. All data will be anonymised and participants will not be able to access any of the feedback.
What are the possible benefits and risks of participating?
This is an observational study and does not involve any clinical intervention and therefore will not benefit or detract from the participant's treatment (if they are currently receiving treatment). There may be some discomfort associated with completing questionnaires, although all the questionnaires given are very widely used and usually do not cause distress.
Participants can receive up to £175 if they complete all components of the study. Participants can also keep the study smartphone after the study ends, if received. This study should allow for a better understanding of how eating disorders progress and how people recover from eating disorders to be gained which in turn will aid the development of more personalised treatment in the future. Participating in the study will help other people in the future who experience similar symptoms - which can be experienced as enriching.
Where is the study run from?
King's College London and the University of Edinburgh (UK)
When is the study starting and how long is it expected to run for?
July 2022 to August 2025
Who is funding the study?
UK Research and Innovation (UKRI)
Who is the main contact?
Dr Başak İnce Çağlar, basak.ince@kcl.ac.uk
Contact information
Principal Investigator
Institute of Psychiatry, Psychology and Neuroscience
Centre for Research in Eating And Weight Disorders (CREW)
103 Denmark Hill
London
SE5 8AZ
United Kingdom
 ORCID ID |
0000-0003-1335-1937 |
|---|---|
| Phone | +44 (0)20 7848 0181 |
| ulrike.schmidt@kcl.ac.uk |
Scientific
Institute of Psychiatry, Psychology and Neuroscience
Centre for Research in Eating And Weight Disorders (CREW)
103 Denmark Hill
London
SE5 8AZ
United Kingdom
| ORCID ID |
0000-0003-1177-3490 |
|---|---|
| Phone | +44 (0)20 7848 5608 |
| basak.ince@kcl.ac.uk |
Public
Institute of Psychiatry, Psychology and Neuroscience
Centre for Research in Eating And Weight Disorders (CREW)
103 Denmark Hill
London
SE5 8AZ
United Kingdom
| Phone | +44 (0)20 7848 5608 |
|---|---|
| basak.ince@kcl.ac.uk |
Study information
| Study design | STORY is a prospective cohort non-randomised non-interventional study using wearable technology and smartphone sensors. |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Home, Internet/virtual, University/medical school/dental school |
| Study type | Other |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Characterising illness stages, progression, and recovery trajectories of eating disorders in young people |
| Study acronym | STORY |
| Study objectives | The first main aim (objectives 1-3 below) is to understand the details of the recovery process from Eating Disorders (EDs) by unobtrusively measuring behaviour, physiology, and daily experiences of young people (YP) in real-time via smartphone apps and inbuilt sensors in smartphones and wearable devices. The second main aim (objectives 4-6 below) is to investigate how biopsychosocial symptom profiles, behavioural and brain responses differ between earlier- and later-stage EDs and what factors predict outcome. Objective 1: Using biological and psychological Remote Measurement Technology (RMT) measures to compare young people (YP) presenting with a 1st ED episode with healthy control YP. Objective 2: Assessing differences in recovery trajectories within and across ED groups. Objective 3: Identifying early RMT predictors of ED recovery or lack of recovery at 12 months. Objective 4: Using a multi-modal assessment protocol to cross-sectionally and longitudinally compare YP with early and later illness stages in terms of their biopsychosocial profiles and how these change over time. This will be done within and across ED diagnostic groups. Objective 5: Identifying baseline biopsychosocial predictors of outcome at 6 and 12 months within and across ED diagnostic groups and illness duration groups. Objective 6: Using cognitive tasks with illness-relevant stimuli to compare YP with early and later stage illness in terms of their cognitive profiles and changes in these over time within and across ED diagnostic groups and illness duration groups. The STORY study is exploratory in nature and therefore will not use directional hypotheses. |
| Ethics approval(s) |
Approved 25/10/2023, London – Bloomsbury (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 (0)207104828, (0)207 104 8256, (0)207 104 8276; bloomsbury.rec@hra.nhs.uk), ref: 23/PR/0927 |
| Health condition(s) or problem(s) studied | Eating disorders (including but not limited to anorexia nervosa, bulimia nervosa, binge eating disorder, avoidant restrictive food intake disorder, other specified feeding and eating disorder) |
| Intervention | STORY is an observational study, involving no intervention or change to a participant's usual standard of care. Being a participant in STORY involves completing several assessment measures at different timepoints over the course of 2 years. When a participant joins the study, they will complete a series of online questionnaires about different aspects of their life, including their mental health and well-being and their social environment. These questionnaires are then repeated at 6-, 12-, and 24-month follow-up points. Participants will also download two apps onto their smartphone (or onto a smartphone given to them by the study team if they do not have an Android smartphone). These apps will continuously collect data throughout the study, both in the background and more frequent, short questionnaires. Participants can also choose to come to King's College London or the University of Edinburgh (if they live locally) to complete some psychological tasks in person and/or have a brain scan. These take place at the start of the study and at 12- and 24-months follow-ups. Additionally, participants can choose to wear a smart ring for the duration of the study which will measure things such as heart rate and sleep quality. All data will be anonymised and participants will not be able to access any of the feedback. |
| Intervention type | Other |
| Primary outcome measure | Eating disorder symptoms are measured using the Eating Disorder Examination Questionnaire (EDE-Q) global score at baseline, 3, 6, 12 and 24 months |
| Secondary outcome measures | 1. Eating disorder symptom changes and related clinical outcomes are measured using brief clinical symptom questionnaires and visual analogue scales (VAS) every 2 weeks for 1 year, and at 24-month follow-up 2. Other related psychological, social, and functional outcomes are measured using scores on validated questionnaires and VAS at baseline, 6-, 12- and 24-month follow-up 3. Speech prosody is measured using a speech task every month for 1 year 4. Real-time experiences, mood changes and stressors in daily life are measured using an Experience Sampling Methodology (ESM) protocol every 12 weeks, for 6 consecutive days, at 6 times per day, for 1 year 5. Digital biomarkers of ED symptom changes are measured using ongoing remote monitoring via purpose-built smartphone applications and wearable devices for 1 year 6. Neurocognitive functioning is measured using performance on tasks involving food-related attentional bias, decision making, impulse control, temporal discounting, and emotion regulation at baseline, 12- and 24-month follow-up |
| Overall study start date | 01/07/2022 |
| Completion date | 28/02/2026 |
Eligibility
| Participant type(s) | Healthy volunteer, Patient, Population, Service user, Other |
|---|---|
| Age group | Mixed |
| Lower age limit | 16 Years |
| Upper age limit | 25 Years |
| Sex | Both |
| Target number of participants | 840 |
| Key inclusion criteria | 1. Aged 16-25 years – all genders, all ethnicities 2. Ability to give informed consent 3. Access and ability to complete the self-reported assessments via smartphone and/or computer 4. Willingness to use either their own Android smartphone or a provided Android study smartphone as their only smartphone during the data collection period of 12 months 5. Willingness and ability to install a RADAR Passive App and RADAR Active App on the study smartphone provided, during the data collection period of 12 months |
| Key exclusion criteria | 1. Insufficient knowledge of English to complete study assessments 2. Severe learning disabilities 3. Any other major medical condition which might impact the patient’s ability to participate in normal daily activities (e.g., due to hospitalisations) 4. Residing outside the UK |
| Date of first enrolment | 20/11/2023 |
| Date of final enrolment | 31/08/2025 |
Locations
Countries of recruitment
- England
- Scotland
- United Kingdom
Study participating centres
Teviot Place
Edinburgh
EH8 9AG
United Kingdom
Monks Orchard Road
Beckenham
BR3 3BX
United Kingdom
St Ann's Hospital
St Ann's Road
London
N15 3TH
United Kingdom
Warneford Lane
Headington
Oxford
OX3 7JX
United Kingdom
Victoria Road
Saltaire
Shipley
BD18 3LD
United Kingdom
2-4 Waterloo Place
Edinburgh
EH1 3EG
United Kingdom
Jubilee Road
Gosforth
Newcastle upon Tyne
NE3 3XT
United Kingdom
350 Euston Road
Regents PLACE
London
NW1 3AX
United Kingdom
Dryden Road
Exeter
EX2 5AF
United Kingdom
Kingsway Hospital
Kingsway Derby
DE22 3LZ
United Kingdom
Sponsor information
University/education
c/o Professor Bashir Al-Hashimi
King’s College London
Room 8.11, 8th Floor Melbourne House
44-46 Aldwych
London
WC2B 4LL
England
United Kingdom
| Phone | +44 (0)20 7848 7306 |
|---|---|
| vpri@kcl.ac.uk | |
| Website | http://www.kcl.ac.uk/index.aspx |
"ROR" |
https://ror.org/0220mzb33 |
Hospital/treatment centre
Institute of Psychiatry, Psychology and Neuroscience
R&D Department, W1.08
16 De Crespigny Park
London
SE5 8AF
England
United Kingdom
| Phone | +44 (0) 2078480339 |
|---|---|
| slam-ioppn.research@kcl.ac.uk | |
| Website | http://www.slam.nhs.uk/ |
|
"ROR" |
https://ror.org/015803449 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- UKRI
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/09/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | It is planned the the results of STORY, as well as a study protocol, will be disseminated primarily via publications in peer-reviewed high-impact journals. |
| IPD sharing plan | The datasets generated and/or analysed during the current study will be available on request from Prof. Ulrike Schmidt (ulrike.schmidt@kcl.ac.uk) or Dr Başak İnce Çağlar (basak.ince@kcl.ac.uk). The anonymised data created in STORY will be fully suitable for sharing and all participants will be asked for consent to this. Timely and fair data sharing will be offered after a 2-year period of exclusive use of data by the investigators, to allow publication of main findings and key secondary findings. External users of data will be required to sign data sharing agreements providing assurances about ethical and lawful storage and processing of data. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 30/05/2024 | 28/10/2024 | Yes | No |
Editorial Notes
02/07/2025: The following changes were made to the trial record:
1. The date of final enrolment was changed from 01/07/2025 to 31/08/2025.
2. The completion date was changed from 31/08/2025 to 28/02/2026.
3. The plain English summary was updated to reflect these changes.
28/10/2024: Publication reference added.
06/11/2023: The following changes were made to the trial record:
1. The ethics approval was added.
2. The recruitment start date was changed from 01/11/2023 to 20/11/2023.
04/10/2023: The Research Ethics Committee was updated.
18/09/2023: The recruitment start date was changed from 18/09/2023 to 01/11/2023.
05/09/2023: Internal review.
17/08/2023: Study's existence confirmed by the HRA.
