A Longitudinal Study of Severe and Enduring Eating Disorders

NCT06752304 | Recruiting

• 1 other identifier: Long-SEED
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational longitudinal study is to investigate characteristics and factors associated with the development of Severe and Enduring Eating Disorders (SEED). In this project, the researchers will follow two prospective cohorts of patients with eating disorders (ED), one adolescent (ages 14-17) and one adult (ages 18+), in terms of change in and impact of clinical, psychological, and biological risk factors. Data will be collected at baseline, after treatment, two years after baseline, and thereafter five, 10 and 20 years after baseline. Participants will be asked to undergo a physical examination, leave blood samples, be interviewed, and fill in questionnaires. If the participants are minors, their care takers will also fill in the questionnaires. The study aims to explore how clinical, psychological, and biological risk factors-including comorbidity, personality characteristics, difficulties with emotion regulation (ER), cognitive inflexibility, loneliness, severe ED symptoms, and inflammatory activation-contribute to a chronic course of the disorder.

Conditions

Eating Disorders; Anorexia Nervosa; Bulimia Nervosa; Binge Eating Disorder; Other Specified Feeding or Eating Disorder

Outcome Measures

Primary Outcomes (5)

• Eating disorder examination interview (EDE-I)

  EDE-I is a semi-structured interview for assessing symptoms of and diagnosing eating disorders, including providing information for grading severity according to e.g., the DSM 5. The EDE-I assesses a variety of eating disorder behaviors, weight control behaviors, and behavioral and cognitive features of eating disorder psychopathology.

  At baseline and at two-year follow up

• Eating disorder Examination Questionnaire (EDE-Q)

  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.

  At baseline, follow-up after treatment, and at 2, 5, 10, and 20 years follow-up.

• Eating Disorder-15 (ED-15) and for parents/caregivers (ED-15-P)

  ED-15 assesses eating disorder attitudes and behaviors on a 15-item Likert scale, which includes 10 attitudinal items (scored from 0-6) and 5 items for frequency grading. ED-15-P include the same items but is answered by the youths caregiver instead. The ED-15 includes two attitudinal subscales: Weight \& shape concerns and Eating concerns. The Overall attitudinal score is the mean of the scores on all ten items. Higher scores indicate more severe eating disorder symptoms.

  ED-15 at baseline, follow-up after treatment, and at 2, 5, 10, and 20 years follow-up (youth cohort only). ED-15-P At baseline, follow-up after treatment, and at 2 years follow-up.

• Clinical Global Impression-Severity (CGI-S)

  Global clinical rating of symptom severity on an 8-grade Likert scale (scored between 0-7). The CGI offers a clinician-determined summary that incorporates all available information, including the patient's history, psychosocial context, symptoms, behavior, and the impact of these symptoms on their functional ability. A higher score indicates a more severe psychopathology.

  At baseline and at 2 year follow-up (youth cohort only).

• Eating disorder diagnosis during follow-up in registers

  Eating disorder diagnosis (AN, BN, BED, EDNOS, OSFED, UFED), collected from the National registries held by the National Board of Health and Welfare.

  Registry data is retrieved at follow-up 5, 10 and 20 years

Secondary Outcomes (18)

• Clinical Impairment Assessment questionnaire (CIA)

  At baseline, follow-up after treatment, and at 2, 5, 10, and 20 years follow-up.

• WHO Disability Assessment Schedule (WHODAS 2.0)

  At baseline, follow-up after treatment, and at 2, 5, 10, and 20 years follow-up (adult cohort only).

• Uppsala scale of Functional Impairment in Daily life (UFID and UFID-P for parents)

  UFID: At baseline, follow-up after treatment, and at 2, 5, 10, and 20 years follow-up (youth cohort only). UFID-P: At baseline, follow-up after treatment, and at 2 year follow-up.

• Children's Global Assessment Scale (CGAS)

  At baseline and at 2 year follow-up (youth cohort only).

• EQ-Visual Analogue Scale (EQ-VAS)

  At baseline, follow-up after treatment, and at 2, 5, 10, and 20 years follow-up.

Other Outcomes (15)

• The Avoidance and Fusion Questionnaire for Youth (AFQ-Y)

  At baseline, follow-up after treatment, and at 2, 5, 10, and 20 years follow-up.

• Emotion Regulation Questionnaire (ERQ)

  At baseline, follow-up after treatment, and at 2, 5, 10, and 20 years follow-up.

• Swedish universities Scale of Personality (SSP)

  At baseline and at 2, 5, 10, and 20 years follow-up (adult cohort only).

Study Arms (2)

Adolescent ED cohort

Adult ED cohort

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Two prospective cohorts of patients with ED, one adolescent and one adult, will be followed in terms of change in and impact of clinical factors, personality style, ER difficulties, loneliness, and biomarkers from baseline, after treatment, two years after baseline, and after five, 10 and 20 years. These cohorts will be consecutively recruited from 2024 onwards from the Eating Disorder Unit at the Uppsala Department of Child and Adolescent Psychiatry (CAP), from 14 to17 years of age, and the Uppsala Department of Psychiatry (P), from 18 years of age.

You may qualify if:

• found to meet the criteria for an eating disorder
• being in need of treatment
• having provided written informed consent (for minors, this includes consent from all caregivers and the minors themselves).

You may not qualify if:

• Eating disorders symptoms in need of emergency care
• High risk for suicide
• An inability to respond to the questionnaires due to e.g., lack of knowledge in Swedish.

Sponsors & Collaborators

• Uppsala University Hospital: lead
• Forte: collaborator
• The Söderström König Foundation: collaborator
• Fonden för psykisk hälsa: collaborator

Study Sites (1)

Uppsala University Hospital

Uppsala, 75185, Sweden

RECRUITING

Related Publications (13)

• Isaksson M, Ghaderi A, Wolf-Arehult M, Ramklint M. Overcontrolled, undercontrolled, and resilient personality styles among patients with eating disorders. J Eat Disord. 2021 Apr 16;9(1):47. doi: 10.1186/s40337-021-00400-0.

  PMID: 33863394 BACKGROUND

• Gibson D, Mehler PS. Anorexia Nervosa and the Immune System-A Narrative Review. J Clin Med. 2019 Nov 8;8(11):1915. doi: 10.3390/jcm8111915.

  PMID: 31717370 BACKGROUND

• Solmi M, Veronese N, Favaro A, Santonastaso P, Manzato E, Sergi G, Correll CU. Inflammatory cytokines and anorexia nervosa: A meta-analysis of cross-sectional and longitudinal studies. Psychoneuroendocrinology. 2015 Jan;51:237-52. doi: 10.1016/j.psyneuen.2014.09.031. Epub 2014 Oct 8.

  PMID: 25462897 BACKGROUND

• Santini ZI, Pisinger VSC, Nielsen L, Madsen KR, Nelausen MK, Koyanagi A, Koushede V, Roffey S, Thygesen LC, Meilstrup C. Social Disconnectedness, Loneliness, and Mental Health Among Adolescents in Danish High Schools: A Nationwide Cross-Sectional Study. Front Behav Neurosci. 2021 Apr 12;15:632906. doi: 10.3389/fnbeh.2021.632906. eCollection 2021.

  PMID: 33927599 BACKGROUND

• Hempel R, Vanderbleek E, Lynch TR. Radically open DBT: Targeting emotional loneliness in Anorexia Nervosa. Eat Disord. 2018 Jan-Feb;26(1):92-104. doi: 10.1080/10640266.2018.1418268.

  PMID: 29384459 BACKGROUND

• Oldershaw A, Lavender T, Sallis H, Stahl D, Schmidt U. Emotion generation and regulation in anorexia nervosa: a systematic review and meta-analysis of self-report data. Clin Psychol Rev. 2015 Jul;39:83-95. doi: 10.1016/j.cpr.2015.04.005. Epub 2015 May 2.

  PMID: 26043394 BACKGROUND

• Prefit AB, Candea DM, Szentagotai-Tatar A. Emotion regulation across eating pathology: A meta-analysis. Appetite. 2019 Dec 1;143:104438. doi: 10.1016/j.appet.2019.104438. Epub 2019 Aug 31.

  PMID: 31479694 BACKGROUND

• Martinussen M, Friborg O, Schmierer P, Kaiser S, Overgard KT, Neunhoeffer AL, Martinsen EW, Rosenvinge JH. The comorbidity of personality disorders in eating disorders: a meta-analysis. Eat Weight Disord. 2017 Jun;22(2):201-209. doi: 10.1007/s40519-016-0345-x. Epub 2016 Dec 19.

  PMID: 27995489 BACKGROUND

• Wentz E, Gillberg IC, Anckarsater H, Gillberg C, Rastam M. Adolescent-onset anorexia nervosa: 18-year outcome. Br J Psychiatry. 2009 Feb;194(2):168-74. doi: 10.1192/bjp.bp.107.048686.

  PMID: 19182181 BACKGROUND

• Culbert KM, Racine SE, Klump KL. Research Review: What we have learned about the causes of eating disorders - a synthesis of sociocultural, psychological, and biological research. J Child Psychol Psychiatry. 2015 Nov;56(11):1141-64. doi: 10.1111/jcpp.12441. Epub 2015 Jun 19.

  PMID: 26095891 BACKGROUND

• Keel PK, Brown TA. Update on course and outcome in eating disorders. Int J Eat Disord. 2010 Apr;43(3):195-204. doi: 10.1002/eat.20810.

  PMID: 20186717 BACKGROUND

• Keski-Rahkonen A, Mustelin L. Epidemiology of eating disorders in Europe: prevalence, incidence, comorbidity, course, consequences, and risk factors. Curr Opin Psychiatry. 2016 Nov;29(6):340-5. doi: 10.1097/YCO.0000000000000278.

  PMID: 27662598 BACKGROUND

• Treasure J, Duarte TA, Schmidt U. Eating disorders. Lancet. 2020 Mar 14;395(10227):899-911. doi: 10.1016/S0140-6736(20)30059-3.

  PMID: 32171414 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples for analyses of hormones and inflammatory markers.

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Martina Isaksson, PhD

CONTACT

0046-706954108; martina.isaksson@uu.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 20 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, clinical researcher

Study Record Dates

• First Submitted: December 20, 2024
• First Posted: December 30, 2024
• Study Start: September 1, 2024
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 1, 2048
• Last Updated: December 31, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)