Unfolding Severe and Enduring Eating Disorders (U-SEED)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUppsala University Hospital
About this trial
The main aim of this study is to identify biological and psychological characteristics as risk factors in individuals with severe and enduring eating disorders (SEED).
Specifically, the investigators aim to:
1. in a cohort of well-diagnosed eating disorder patients from 2005 followed up in National health registers, explore risk factors at baseline (recorded 2005-2007) for development of later SEED (the registry based cohort). 2. replicate the findings in a new sample of 50 adults with ongoing SEED. Participants will be assessed diagnostically and physically, and asked to fill out questionnaires and leave blood samples (the ongoing SEED sample compared with the register based cohort). 3. in a sample of 50 adults with SEED, explore demographic, biological, clinical, and psychological factors and examine the relation between these factors and symptom severity and functional impairment (the ongoing SEED sample). 4. explore participants perspectives on their symptoms and received care (the ongoing SEED sample).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
For ongoing SEED sample: Minimum age of 18, impairing eating disorder symptoms for at least seven years, and having at least one evidence-based treatment without remission or resulting in relapse.
For register based cohort, see above.
For ongoing SEED sample: Eating disorders symptoms in need of emergency care, high risk for suicide, and an inability to respond to the questionnaires due to lack of knowledge in Swedish.
Disqualifiers
None
Trial population
The register based cohort: This adult cohort was consecutively recruited at the Eating Disorder Unit at the Uppsala Department of Psychiatry between 2005 and 2007. Of all 297 patients who came to the unit 218 (73%) participated in the study. They were diagnosed according to gold standard including PD diagnoses, and thoroughly characterized in respect to clinical characteristics. The ongoing SEED sample: Study population are individuals that themselves experience that their eating disorder have affected them in a significant way during at least the last seven years, who report having gone through at least one evidence-based treatment attempt, and that are willing to participate in the study. This adult sample will be recruited from the Eating Disorder Unit at the Uppsala Department of Psychiatry, via advertisement, through patient organizations, and through media. We plan to include 50 patients.
Trial design
Design model
Case-only
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Eating disorder diagnosis during follow-up in registers (primary outcome for aim 1)
Eating disorder diagnosis (AN, BN, BED, EDNOS, OSFED, UFED), collected from the National registries held by the National Board of Health and Welfare, from 2005 to 2024.
Time frame
Registry data is retrieved autumn 20242
Findings identified from aim 1 - the register based study (primary outcome for aim 2)
Primary outcome for aim 2 will be added to the protocol when the register study/aim 1 has been analysed, as the findings from those analyses will decide the primary outcome for aim 2.
Time frame
Registry data is retrieved autumn 2024. Interviews and examinations performed with the ongoing SEED-sample for six hours.3
Eating disorder examination interview (EDE-I) (Primary outcome for aim 3)
EDE-I is a semi-structured interview for assessing symptoms of and diagnosing eating disorders. The EDE-I assesses a variety of eating disorder behaviors, weight control behaviors, and behavioral and cognitive features of eating disorder psychopathology.
Time frame
One hour4
Eating disorder Examination Questionnaire (EDE-Q) (Primary outcome for aim 3)
EDE-Q is a 28-item self-report questionnaire, designed to assess the range, frequency and severity of behaviors associated with an eating disorder. It is categorized into four sub-scales: Restraint, Eating Concern, Shape Concern and Weight Concern, and an overall global score. The score is obtained by calculating the mean for the total score and the subscales respectively (min = 0, max =6), higher scores indicate more severe eating disorder symptoms.
Time frame
20 minutesSecondary outcomes
1
Functional impairment during follow-up in registers (secondary outcome for aim 1)
Demographic data describing level of education.
Time frame
Registry data is retrieved autumn 20242
Functional impairment during follow-up in registers (secondary outcome for aim 1)
Demographic data describing civil status.
Time frame
Registry data is retrieved autumn 20243
Functional impairment during follow-up in registers (secondary outcome for aim 1)
Demographic data describing number of children.
Time frame
Registry data is retrieved autumn 20244
Functional impairment during follow-up in registers (secondary outcome for aim 1)
Demographic data describing occupation.
Time frame
Registry data is retrieved autumn 2024Sponsors and contacts
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Source ClinicalTrials.gov