Unfolding Severe and Enduring Eating Disorders (U-SEED)

NCT06592963 | Recruiting

• 1 other identifier: U-SEED
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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. 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. 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. 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. 4.explore participants perspectives on their symptoms and received care (the ongoing SEED sample).

Conditions

Eating Disorders; Anorexia Nervosa; Bulimia Nervosa; Binge-Eating Disorder; Personality Disorders

Keywords

Registers; Severe and Enduring Eating Disorders

Outcome Measures

Primary Outcomes (7)

• 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.

  Registry data is retrieved autumn 2024

• 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.

  Registry data is retrieved autumn 2024. Interviews and examinations performed with the ongoing SEED-sample for six hours.

• 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.

  One hour

• 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.

  20 minutes

• Clinical Impairment Assessment questionnaire (CIA) (Primary outcome for aim 3)

  The CIA is a 16-item self-report measure of the severity of psychosocial impairment due to eating disorder features, Each item is rated on a four-point Likert scale ranging from 'Not at all' to 'A lot'. The minimun score is zero and the maximum score is 48, with higher scores indicating a more severe impairment.

  10 minutes

• WHO Disability Assessment Schedule (WHODAS 2.0) (Primary outcome for aim 3)

  WHODAS 2.0 measure individual dysfunction in six domains of daily activities (cognition, mobility, self-care, relationships with people, life activities, and participation). It is measured on a five-point Likert scale ranging from no difficulty, to extreme difficulty. The score is calculated by dividing the total score with the number of items, resulting in a minimum score of zero and maximum score of 4. Higher scores indicate higher disability.

  15 minutes

• Participants expressed views and experiences of their symptoms and received care (primary outcome for aim 4)

  A qualitative interview performed individually with each participant following a semi-structured interview guide.

  One hour

Secondary Outcomes (30)

• Functional impairment during follow-up in registers (secondary outcome for aim 1)

  Registry data is retrieved autumn 2024

• Functional impairment during follow-up in registers (secondary outcome for aim 1)

  Registry data is retrieved autumn 2024

• Functional impairment during follow-up in registers (secondary outcome for aim 1)

  Registry data is retrieved autumn 2024

• Functional impairment during follow-up in registers (secondary outcome for aim 1)

  Registry data is retrieved autumn 2024

• Functional impairment during follow-up in registers (secondary outcome for aim 1)

  Registry data is retrieved autumn 2024

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

For aim 1 (register based cohort): Incl. criteria: Attended care for eating disorders at Uppsala University Hospital between 2005 and 2007 and accepted to be included in a local quality register. Excl. criteria: None For aim 2 (ongoing SEED sample and register based cohort) Incl. criteria: * 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. Excl. criteria: * 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. For aim 3 and 4 (the ongoing SEED sample). See above.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Uppsala University Hospital: lead
• The Söderström König Foundation: collaborator
• Forte: collaborator

Study Sites (1)

Uppsala University Hospital

Uppsala, Uppsala County, 75185, Sweden

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Samples retained, with potential for extraction of DNA from at least one of the types of samples retained (e.g., frozen tissue, whole blood)

MeSH Terms

Conditions

Feeding and Eating Disorders; Anorexia Nervosa; Bulimia Nervosa; Binge-Eating Disorder; Personality Disorders

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Central Study Contacts

Martina Isaksson

CONTACT

0706954108; martina.isaksson@uu.se

Mia Ramklint

CONTACT

0730949181; mia.ramklint@uu.se

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Target Duration: 2 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: licensed psychologist, PhD, clinical researcher

Study Record Dates

• First Submitted: August 23, 2024
• First Posted: September 19, 2024
• Study Start: June 1, 2024
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: September 19, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)