Unfolding Severe and Enduring Eating Disorders (U-SEED)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Eating disorder diagnosis during follow-up in registers (primary outcome for aim 1)
研究概览
简要总结
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).
详细描述
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
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Eating disorder diagnosis during follow-up in registers (primary outcome for aim 1)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: One hour
A qualitative interview performed individually with each participant following a semi-structured interview guide.
次要结局
- Functional impairment during follow-up in registers (secondary outcome for aim 1)(Registry data is retrieved autumn 2024)
- Psychiatric and somatic comorbidity during follow-up in registers (secondary outcome for aim 1)(Registry data is retrieved autumn 2024)
- The Mini-International Neuropsychiatric Interview (M.I.N.I) (secondary outcome for aim 3)(One hour)
- The Structured Clinical Interview for DSM-5 Personality Disorders (SCID-5-PD) (secondary outcome for aim 3)(One hour)
- Blood pressure (secondary outcome for aim 3)(30 minutes)
- BMI (secondary outcome for aim 3)(30 minutes)
- EQ-Visual Analogue Scale (EQ-VAS) (secondary outcome for aim 3)(5 minutes)
- The Avoidance and Fusion Questionnaire for Youth (AFQ-Y) (secondary outcome for aim 3)(10 minutes)
- Social safeness and pleasure scale (SSPS) (secondary outcome for aim 3)(10 minutes)
- Loneliness scale (secondary outcome for aim 3)(10 minutes)
- Demographic characteristics (secondary outcome for aim 3)(10 minutes)
- Emotion Regulation Questionnaire (ERQ) (secondary outcome for aim 3)(10 minutes)
- Ego Undercontrol Scale-13 (EUC-13) (secondary outcome for aim 3)(10 minutes)
- Montgomery Åsberg Depression Scale (MADRS-S) (secondary outcome for aim 3)(10 minutes)
- UCLA Loneliness Scale (secondary outcome for aim 3)(5 minutes)
- Swedish universities Scale of Personality (SSP) (secondary outcome for aim 3)(20 minutes)
- Ghrelin (secondary outcome for aim 3)(15 minutes)
- Leptin (secondary outcome for aim 3)(15 minutes)
- Adinopectin (secondary outcome for aim 3)(15 minutes)
- Inflammatory markers (secondary outcome for aim 3)(15 minutes)
研究者
Martina Isaksson
licensed psychologist, PhD, clinical researcher
Uppsala University Hospital