Eating DisordersU-SEEDNCT06592963
Unfolding Severe and Enduring Eating Disorders (U-SEED)
An observational study of Eating Disorders and Anorexia Nervosa, run by Uppsala University Hospital at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Eating Disorders, Anorexia Nervosa, Bulimia Nervosa
- How many people
- 50 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jun 2024to Apr 2026
- How long will I take part?
- 2 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Uppsala University Hospital
Uppsala, Uppsala County, 75185
Martina Isaksson, PhD, +46706954108, martina.isaksson@uu.se
Mia Ramklint, PhD, +46730949181, mia.ramklint@uu.se
About this study
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:
- 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).
- 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).
- 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).
- explore participants perspectives on their symptoms and received care (the ongoing SEED sample).
Read the detailed description
BACKGROUND, AIMS AND HYPOTHESES
Clinical factors such as psychiatric comorbidity and personality disorders, psychological and personality characteristics related to dysfunctional emotion regulation and loneliness, and biological factors such as dysregulation of the immune system, may all play a role in the developement, maintenance, and relapse of eating disorders. However, research in this field is scarce.
This projects aims is to increase our knowledge about risk factors for a severe course in eating disorders.
Hypotheses are:
- Personality disorders, comorbid psychiatric disorders and a high symptom load (generally and specifically for eating disorder symptoms) will be related to the development of SEED in the register based cohort
- The relation between SEED and personality disorders, comorbid psychiatric disorders and a high symptom load in the register based cohort will be replicated in the ongoing SEED sample
- In the ongoing SEED sample, symptom severity and functional impairment will be related to
- Personality traits
- Emotion dysregulation, maladaptive overcontrol and maladaptive undercontrol
- Increased inflammation
- More pronounced loneliness
- Cognitive inflexibility
Primary outcomes are
- for aim 1: SEED at follow-up.
- for aim 2: factors identified from the register based study (aim 1). Thus, primary outcomes for aim 2 will be added to the protocol after analyses for aim 1 has been conducted.
- for aim 3: symptom severity and functional impairment
- for aim 4: patient perspectives of their symptoms and received care
Secondary outcomes are
- for aim 1: functional impairment, psychiatric and somatic comorbidity
- for aim 3: personality traits, emotion dysregulation, maladaptive overcontrol and maladaptive undercontrol, increased inflammation, more pronounced loneliness, cognitive inflexibility
PROCEDURE
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. They were diagnosed according to gold standard including PD diagnoses, and thoroughly characterized in respect to clinical characteristics. They will be followed in national registries held by Statistics Sweden and the National Board of Health and Welfare, and these registers include the Swedish National Inpatient Register (IPR), the Longitudinal integrated database for health insurance and labour market studies (LISA) and the Registry of household statistics and the Swedish Medical Birth Register. By using registers both medical and social outcome can be examined. Factors from baseline can be related to outcome.
Tho ongoing SEED sample: Adult participants with SE-ED will be recruited through the ordinary staff that sees the participants at the Eating Disorder Unit at the Uppsala Department of Psychiatry combined with flyers and posters at the ED unit, through patient organizations, through the Uppsala University homepage, and through media. Those who themselves identify as having at least seven years duration of their ED and shown no or little response to treatment (SE-ED) who are interested in the study, will be guided to a web link were screening questions are provided. Inclusion criteria are having more than seven years of ED duration, having at least one evidence-based treatment without remission or resulting in relapse. Those completing the screening will be contacted, informed verbally in writing about the study and those fulfilling inclusion criteria will be invited to participate and sign an informed consent form. The investigators plan to include 50 participants. All participants will be invited to undergo a systematic diagnostic evaluation. The systematic evaluation consists of a clinical anamnestic history and three structured diagnostic interviews; either the MINI for DSM 5 or the Structured Clinical Interview for DSM-5 Axis I Disorders- Clinical Version (SCID-I CV) and Structured Clinical Interview for DSM-5 Personality Disorders (SCID-5-PD) assessing personality disorders. Participants also undergo the Eating Disorder Examination interview (EDE). Participants are also weighed and measured. All diagnostic assessments are conducted by psychologists physicians or trained students, who have received training in the procedure and who are co-rated. Participants will also be asked about collection of biomarkers through Uppsala psychiatric patient samples (UPP), which is an infrastructure for the collection of biological materials at the Department of psychiatry at Uppsala University Hospital. All participants will be invited to take blood samples and inflammatory markers will be analyzed in accordance with the informed consent for UPP. After the structured evaluation, they will be interviewed about their perspectives on their symptoms and received care using a semi-structured interview guide. All interviews will be audio taped and transcribed verbatim.
DATA ANALYSES
For aim 1: Stratified Cox regression models will be estimated with year 2005 as entry time. Hazard ratios (HR) and corresponding 95% confidence intervals (CIs) will be calculated. Cumulative indices will be calculated and illustrated with Kaplan-Meier curves.
For aim 2: Descriptive statistics and generalized linear models will be performed comparing three groups: non-SEED and SEED from the register based cohort and SEED from the ongoing sample according to psychiatric symptoms, severity, comorbidity, personality disorders.
For aim 3: For the primary outcomes, generalized linear models will be used to analyze if more pronounced symptom severity and lower level of functioning will be explained by personality traits, emotion dysregulation, maladaptive overcontrol and maladaptive undercontrol, increased inflammation, more pronounced loneliness, cognitive inflexibility. Participants will be asked about collection of biomarkers through Uppsala Psychiatric Patient samples (UPP) (ethics approval Dnr 2012/081), which is an infrastructure for the collection of biological materials at the Department of Psychiatry at Uppsala University Hospital. All participants will be invited to participate in UPP and inflammatory markers will be analyzed in accordance with the informed consent for UPP. Inflammatory markers will be analyzed using an electrochemilumine scence sandwich immunoassay, Meso Scale Discovery (K15049D and K15198D, Rockville, MD, USA) a multiplex platform. For protein hormones, such as plasma adiponectin and leptin, a solid phase sandwich enzyme linked immunosorbent assay (ELISA) (Mercodia AB, Uppsala, Sweden) will be used. For the secondary outcomes, descriptive statistics will be presented.
For aim 4: Participant perspectives will be analysed qualitatively with thematic analyses
- Conditions
- Eating Disorders, Anorexia Nervosa, Bulimia Nervosa, Binge-Eating Disorder, Personality Disorders
- Keywords
- Registers, Severe and Enduring Eating Disorders
- Medical subject headings
- Feeding and Eating Disorders, Anorexia Nervosa, Bulimia Nervosa, Binge-Eating Disorder, Personality Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: One hour
Secondary outcomes (30)
Functional impairment during follow-up in registers (secondary outcome for aim 1)
Demographic data describing level of education.
Measured: Registry data is retrieved autumn 2024
Functional impairment during follow-up in registers (secondary outcome for aim 1)
Demographic data describing civil status.
Measured: Registry data is retrieved autumn 2024
Functional impairment during follow-up in registers (secondary outcome for aim 1)
Demographic data describing number of children.
Measured: Registry data is retrieved autumn 2024
Functional impairment during follow-up in registers (secondary outcome for aim 1)
Demographic data describing occupation.
Measured: Registry data is retrieved autumn 2024
Functional impairment during follow-up in registers (secondary outcome for aim 1)
Demographic data describing level of income.
Measured: Registry data is retrieved autumn 2024
Functional impairment during follow-up in registers (secondary outcome for aim 1)
Demographic data describing welfare benefit.
Measured: Registry data is retrieved autumn 2024
Functional impairment during follow-up in registers (secondary outcome for aim 1)
Demographic data describing number of days in hospital care.
Measured: Registry data is retrieved autumn 2024
Functional impairment during follow-up in registers (secondary outcome for aim 1)
Demographic data describing compulsory care.
Measured: Registry data is retrieved autumn 2024
Psychiatric and somatic comorbidity during follow-up in registers (secondary outcome for aim 1)
Data describing psychiatric and somatic diagnosis.
Measured: Registry data is retrieved autumn 2024
Psychiatric and somatic comorbidity during follow-up in registers (secondary outcome for aim 1)
Data describing dental care.
Measured: Registry data is retrieved autumn 2024
Psychiatric and somatic comorbidity during follow-up in registers (secondary outcome for aim 1)
Data describing premature death.
Measured: Registry data is retrieved autumn 2024
Psychiatric and somatic comorbidity during follow-up in registers (secondary outcome for aim 1)
Data describing cause of death.
Measured: Registry data is retrieved autumn 2024
The Mini-International Neuropsychiatric Interview (M.I.N.I) (secondary outcome for aim 3)
M.I.N.I. is a structured diagnostic psychiatric interview designed to assess psychiatric disorders according to the DSM. It consists of a series of standardized questions and probes to elicit information about symptoms, duration, and severity of various psychiatric conditions such as mood disorders, anxiety disorders, substance use disorders, and psychotic disorders.
Measured: One hour
The Structured Clinical Interview for DSM-5 Personality Disorders (SCID-5-PD) (secondary outcome for aim 3)
Number, type and proportion of personality disorder diagnoses will be assessed by SCID-5-PD. It is a semistructured diagnostic interview for clinicians and researchers to assess the 10 DSM-5 Personality Disorders across Clusters A, B, C and Other Specified Personality Disorder. The SCID-5-PD includes the interview and the self-report screening questionnaire, the Structured Clinical Interview for DSM-5 Screening Personality Questionnaire (SCID-5-SPQ). SCID-5-SPQ will be used to screen for PDs before conducting the interview.
Measured: One hour
Blood pressure (secondary outcome for aim 3)
Blood pressure will be assessed with a valid and reliable device in a standardized procedure.
Measured: 30 minutes
BMI (secondary outcome for aim 3)
Weight and height will be combined to report BMI in kg/m^2, assessed with a valid and reliable device in a standardized procedure.
Measured: 30 minutes
EQ-Visual Analogue Scale (EQ-VAS) (secondary outcome for aim 3)
The EQ-VAS is a vertical visual analogue scale that takes values between 100 (best imaginable health) and 0 (worst imaginable health), on which patients provide a global assessment of their health.
Measured: 5 minutes
The Avoidance and Fusion Questionnaire for Youth (AFQ-Y) (secondary outcome for aim 3)
The AFQ-Y is a self-rating instrument that measures psychological inflexibility. Participants rate their level of agreement on eight items on a 5-point Likert measuring one single factor. Score range is 0-24 and higher scores indicate a higher level of psychological inflexibility.
Measured: 10 minutes
Social safeness and pleasure scale (SSPS) (secondary outcome for aim 3)
The SSPS is an 11-item self-rating instrument that assesses the extent to which people experience their world as safe, warm, and soothing, and how connected they feel to others. Participants indicate their answers on a five-point Likert scale, ranging from 1 (almost never) to 5 (almost all the time). Scores are added together to produce a total score in the range 11-55, with higher scores representing higher perceived social safeness and connectedness to others.
Measured: 10 minutes
Loneliness scale (secondary outcome for aim 3)
The Loneliness scale is an 11-item self-rating instrument includes a 6-item emotional subscale and a 5-item social subscale. Respondents are presented with a series of statements and asked to indicate the extent to which the statement applies to their situation on a four-point Likert scale. The total score can range between 0-11 with higher scores indicating greater feelings of loneliness.
Measured: 10 minutes
Demographic characteristics (secondary outcome for aim 3)
Gender, age, age at ED onset and treatment, and socio-demographic characteristics will be assessed.
Measured: 10 minutes
Emotion Regulation Questionnaire (ERQ) (secondary outcome for aim 3)
The ERQ is a self-rating instrument designed to assess individual differences in the use of emotion regulation strategies. It is composed of ten items divided into two factors: cognitive reappraisal and expressive suppression. Participants indicate their answers on a 7-point Likert-scale ranging from 1 (total disagreement) to 7 (total agreement).
Measured: 10 minutes
Ego Undercontrol Scale-13 (EUC-13) (secondary outcome for aim 3)
EUC-13 is a 13 item self-rating instrument designed to assess personality types based on how people inhibit or express their emotional impulses, identifying over- and undercontrolled personality styles. It is answered on a four-point Likert-scale ranging from Disagree very strongly to Agree very strongly. The total score can range between 1-4, with higher scores indicating higher undercontrol and lower scores indicating higher overcontrol.
Measured: 10 minutes
Montgomery Åsberg Depression Scale (MADRS-S) (secondary outcome for aim 3)
MADRS-S is a 9-item widely used self-rating measure of depressive severity. The intention of the scale is to give an image of the patients current state of mind. The patient grades how he/she felt during the last three days. Items are rated on a seven-point Likert scale, providing a total score between 0-54, with higher scores reflecting greater depression severity.
Measured: 10 minutes
UCLA Loneliness Scale (secondary outcome for aim 3)
UCLA Loneliness scale is a self-rating scale designed to measure ones subjective feelings of loneliness as well as feelings of social isolation. The scale comprises three questions that measure three dimensions of loneliness: relational connectedness, social connectedness and self-perceived isolation. Participants indicate their answers on a four-point Likert scale, providing a total score between 4-16, with higher scores indicating greater feelings of loneliness.
Measured: 5 minutes
Swedish universities Scale of Personality (SSP) (secondary outcome for aim 3)
SSP is a self-report instrument assessing personality traits corresponding to biological correlates. It contains 91 items divided into 13 subscales. The scale can also be divided into a three-factor solution with Factor 1 reflecting Neuroticism; Factor 2 reflecting Aggressiveness; and Factor 3 reflecting Extraversion. Each item is given as a statement with a four-point response format, ranging from does not apply at all to applies completely. It is presented in standardized t-score ranging from 0-100 (mean 50 and standard deviation 10). Higher scorer indicate more pronounced characteristics of that specific trait.
Measured: 20 minutes
Ghrelin (secondary outcome for aim 3)
Ghrelin will be analysed from blood samples. A solid phase sandwich enzyme linked immunosorbent assay (ELISA) (Mercodia AB, Uppsala, Sweden) will be used for the analyses.
Measured: 15 minutes
Leptin (secondary outcome for aim 3)
Leptin will be analysed from blood samples. A solid phase sandwich enzyme linked immunosorbent assay (ELISA) (Mercodia AB, Uppsala, Sweden) will be used for the analyses
Measured: 15 minutes
Adinopectin (secondary outcome for aim 3)
Adinopectin will be analysed from blood samples. A solid phase sandwich enzyme linked immunosorbent assay (ELISA) (Mercodia AB, Uppsala, Sweden) will be used for the analyses
Measured: 15 minutes
Inflammatory markers (secondary outcome for aim 3)
Inflammatory markers will be analysed from blood samples. A panel of 100 different markers, will be anlyzed using an electrochemilumine-scence sandwich immunoassay, Meso Scale Discovery (K15049D and K15198D, Rockville, MD, USA) a multiplex platform.
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Jun 2024
- Primary completionApr 2026 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
- Target duration
- 2 Weeks
Sponsor and investigators
- Lead sponsor
- Uppsala University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Söderström König Foundation, Forte
- Responsible party
- Principal investigator, Martina Isaksson, Uppsala University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06592963
- Sponsor's protocol ID
- U-SEED
- Acronym
- U-SEED
- Status last verified
- Aug 2024
- First submitted
- 23 Aug 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will not be made publicly available due to confidentiality but can be provided upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unfolding Severe and Enduring Eating Disorders (U-SEED)
- ClinicalTrials.gov ID
- NCT06592963
- Acronym / sponsor ID
- U-SEED / U-SEED
- Conditions
- Eating Disorders, Anorexia Nervosa, Bulimia Nervosa, Binge-Eating Disorder, Personality Disorders
- Keywords
- Registers, Severe and Enduring Eating Disorders
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Uppsala University HospitalUniversity, hospital or other
- Collaborators
- The Söderström König Foundation, Forte
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 19 Sep 2024 (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 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:
- 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).
- 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).
- 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).
- explore participants perspectives on their symptoms and received care (the ongoing SEED sample).
Detailed description
BACKGROUND, AIMS AND HYPOTHESES
Clinical factors such as psychiatric comorbidity and personality disorders, psychological and personality characteristics related to dysfunctional emotion regulation and loneliness, and biological factors such as dysregulation of the immune system, may all play a role in the developement, maintenance, and relapse of eating disorders. However, research in this field is scarce.
This projects aims is to increase our knowledge about risk factors for a severe course in eating disorders.
Hypotheses are:
- Personality disorders, comorbid psychiatric disorders and a high symptom load (generally and specifically for eating disorder symptoms) will be related to the development of SEED in the register based cohort
- The relation between SEED and personality disorders, comorbid psychiatric disorders and a high symptom load in the register based cohort will be replicated in the ongoing SEED sample
- In the ongoing SEED sample, symptom severity and functional impairment will be related to
- Personality traits
- Emotion dysregulation, maladaptive overcontrol and maladaptive undercontrol
- Increased inflammation
- More pronounced loneliness
- Cognitive inflexibility
Primary outcomes are
- for aim 1: SEED at follow-up.
- for aim 2: factors identified from the register based study (aim 1). Thus, primary outcomes for aim 2 will be added to the protocol after analyses for aim 1 has been conducted.
- for aim 3: symptom severity and functional impairment
- for aim 4: patient perspectives of their symptoms and received care
Secondary outcomes are
- for aim 1: functional impairment, psychiatric and somatic comorbidity
- for aim 3: personality traits, emotion dysregulation, maladaptive overcontrol and maladaptive undercontrol, increased inflammation, more pronounced loneliness, cognitive inflexibility
PROCEDURE
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. They were diagnosed according to gold standard including PD diagnoses, and thoroughly characterized in respect to clinical characteristics. They will be followed in national registries held by Statistics Sweden and the National Board of Health and Welfare, and these registers include the Swedish National Inpatient Register (IPR), the Longitudinal integrated database for health insurance and labour market studies (LISA) and the Registry of household statistics and the Swedish Medical Birth Register. By using registers both medical and social outcome can be examined. Factors from baseline can be related to outcome.
Tho ongoing SEED sample: Adult participants with SE-ED will be recruited through the ordinary staff that sees the participants at the Eating Disorder Unit at the Uppsala Department of Psychiatry combined with flyers and posters at the ED unit, through patient organizations, through the Uppsala University homepage, and through media. Those who themselves identify as having at least seven years duration of their ED and shown no or little response to treatment (SE-ED) who are interested in the study, will be guided to a web link were screening questions are provided. Inclusion criteria are having more than seven years of ED duration, having at least one evidence-based treatment without remission or resulting in relapse. Those completing the screening will be contacted, informed verbally in writing about the study and those fulfilling inclusion criteria will be invited to participate and sign an informed consent form. The investigators plan to include 50 participants. All participants will be invited to undergo a systematic diagnostic evaluation. The systematic evaluation consists of a clinical anamnestic history and three structured diagnostic interviews; either the MINI for DSM 5 or the Structured Clinical Interview for DSM-5 Axis I Disorders- Clinical Version (SCID-I CV) and Structured Clinical Interview for DSM-5 Personality Disorders (SCID-5-PD) assessing personality disorders. Participants also undergo the Eating Disorder Examination interview (EDE). Participants are also weighed and measured. All diagnostic assessments are conducted by psychologists physicians or trained students, who have received training in the procedure and who are co-rated. Participants will also be asked about collection of biomarkers through Uppsala psychiatric patient samples (UPP), which is an infrastructure for the collection of biological materials at the Department of psychiatry at Uppsala University Hospital. All participants will be invited to take blood samples and inflammatory markers will be analyzed in accordance with the informed consent for UPP. After the structured evaluation, they will be interviewed about their perspectives on their symptoms and received care using a semi-structured interview guide. All interviews will be audio taped and transcribed verbatim.
DATA ANALYSES
For aim 1: Stratified Cox regression models will be estimated with year 2005 as entry time. Hazard ratios (HR) and corresponding 95% confidence intervals (CIs) will be calculated. Cumulative indices will be calculated and illustrated with Kaplan-Meier curves.
For aim 2: Descriptive statistics and generalized linear models will be performed comparing three groups: non-SEED and SEED from the register based cohort and SEED from the ongoing sample according to psychiatric symptoms, severity, comorbidity, personality disorders.
For aim 3: For the primary outcomes, generalized linear models will be used to analyze if more pronounced symptom severity and lower level of functioning will be explained by personality traits, emotion dysregulation, maladaptive overcontrol and maladaptive undercontrol, increased inflammation, more pronounced loneliness, cognitive inflexibility. Participants will be asked about collection of biomarkers through Uppsala Psychiatric Patient samples (UPP) (ethics approval Dnr 2012/081), which is an infrastructure for the collection of biological materials at the Department of Psychiatry at Uppsala University Hospital. All participants will be invited to participate in UPP and inflammatory markers will be analyzed in accordance with the informed consent for UPP. Inflammatory markers will be analyzed using an electrochemilumine scence sandwich immunoassay, Meso Scale Discovery (K15049D and K15198D, Rockville, MD, USA) a multiplex platform. For protein hormones, such as plasma adiponectin and leptin, a solid phase sandwich enzyme linked immunosorbent assay (ELISA) (Mercodia AB, Uppsala, Sweden) will be used. For the secondary outcomes, descriptive statistics will be presented.
For aim 4: Participant perspectives will be analysed qualitatively with thematic analyses
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 2 Weeks
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
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
Eating disorder diagnosis during follow-up in registers (primary outcome for aim 1)
Time frame: Registry data is retrieved autumn 2024
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.
Findings identified from aim 1 - the register based study (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.
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.
Eating disorder examination interview (EDE-I) (Primary outcome for aim 3)
Time frame: One hour
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.
Eating disorder Examination Questionnaire (EDE-Q) (Primary outcome for aim 3)
Time frame: 20 minutes
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.
Clinical Impairment Assessment questionnaire (CIA) (Primary outcome for aim 3)
Time frame: 10 minutes
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.
WHO Disability Assessment Schedule (WHODAS 2.0) (Primary outcome for aim 3)
Time frame: 15 minutes
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.
Participants expressed views and experiences of their symptoms and received care (primary outcome for aim 4)
Time frame: One hour
A qualitative interview performed individually with each participant following a semi-structured interview guide.
30 secondary outcomes
Functional impairment during follow-up in registers (secondary outcome for aim 1)
Time frame: Registry data is retrieved autumn 2024
Functional impairment during follow-up in registers (secondary outcome for aim 1)
Time frame: Registry data is retrieved autumn 2024
Functional impairment during follow-up in registers (secondary outcome for aim 1)
Time frame: Registry data is retrieved autumn 2024
Functional impairment during follow-up in registers (secondary outcome for aim 1)
Time frame: Registry data is retrieved autumn 2024
Functional impairment during follow-up in registers (secondary outcome for aim 1)
Time frame: Registry data is retrieved autumn 2024
Functional impairment during follow-up in registers (secondary outcome for aim 1)
Time frame: Registry data is retrieved autumn 2024
Functional impairment during follow-up in registers (secondary outcome for aim 1)
Time frame: Registry data is retrieved autumn 2024
Functional impairment during follow-up in registers (secondary outcome for aim 1)
Time frame: Registry data is retrieved autumn 2024
Psychiatric and somatic comorbidity during follow-up in registers (secondary outcome for aim 1)
Time frame: Registry data is retrieved autumn 2024
Psychiatric and somatic comorbidity during follow-up in registers (secondary outcome for aim 1)
Time frame: Registry data is retrieved autumn 2024
Psychiatric and somatic comorbidity during follow-up in registers (secondary outcome for aim 1)
Time frame: Registry data is retrieved autumn 2024
Psychiatric and somatic comorbidity during follow-up in registers (secondary outcome for aim 1)
Time frame: Registry data is retrieved autumn 2024
The Mini-International Neuropsychiatric Interview (M.I.N.I) (secondary outcome for aim 3)
Time frame: One hour
The Structured Clinical Interview for DSM-5 Personality Disorders (SCID-5-PD) (secondary outcome for aim 3)
Time frame: One hour
Blood pressure (secondary outcome for aim 3)
Time frame: 30 minutes
BMI (secondary outcome for aim 3)
Time frame: 30 minutes
EQ-Visual Analogue Scale (EQ-VAS) (secondary outcome for aim 3)
Time frame: 5 minutes
The Avoidance and Fusion Questionnaire for Youth (AFQ-Y) (secondary outcome for aim 3)
Time frame: 10 minutes
Social safeness and pleasure scale (SSPS) (secondary outcome for aim 3)
Time frame: 10 minutes
Loneliness scale (secondary outcome for aim 3)
Time frame: 10 minutes
Demographic characteristics (secondary outcome for aim 3)
Time frame: 10 minutes
Emotion Regulation Questionnaire (ERQ) (secondary outcome for aim 3)
Time frame: 10 minutes
Ego Undercontrol Scale-13 (EUC-13) (secondary outcome for aim 3)
Time frame: 10 minutes
Montgomery Åsberg Depression Scale (MADRS-S) (secondary outcome for aim 3)
Time frame: 10 minutes
UCLA Loneliness Scale (secondary outcome for aim 3)
Time frame: 5 minutes
Swedish universities Scale of Personality (SSP) (secondary outcome for aim 3)
Time frame: 20 minutes
Ghrelin (secondary outcome for aim 3)
Time frame: 15 minutes
Leptin (secondary outcome for aim 3)
Time frame: 15 minutes
Adinopectin (secondary outcome for aim 3)
Time frame: 15 minutes
Inflammatory markers (secondary outcome for aim 3)
Time frame: 15 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No. Data will not be made publicly available due to confidentiality but can be provided upon reasonable request.
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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. This study is not recruiting at the moment.
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 and Anorexia Nervosa, run by Uppsala University Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: status not confirmed, as of the sponsor's last update on 19 Sep 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 Sweden. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Martina Isaksson (0706954108, martina.isaksson@uu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eating disorder diagnosis during follow-up in registers (primary outcome for aim 1) (time frame: Registry data is retrieved autumn 2024). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Sep 2024.