"Healthier and Earlier Through Digital Technology: Towards a Transdiagnostic Staging Model of Eating and Sleep Disorders in Adolescence"
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 854
- 试验地点
- 4
- 主要终点
- Percentages of participants at high-risk, no risk, or clinical levels of sleep difficulties at baseline
研究概览
简要总结
Insomnia and eating disorders are highly prevalent among adolescents, often co-occur, and are associated with somatic and mental comorbidities and functional impairment. The first aim of this project is to longitudinally monitor psychological functioning and sleep- and eating-related behaviours in a large sample of students aged 14-17 yrs. (N = 854), to identify the variables that predict transition from a prodromal phase to a clinical stage, and signpost individuals at risk or with clinical symptoms to self-help materials and clinical support. The second aim is to test whether increased emotional reactivity to disease-related stimuli (stimuli related to sleep or eating) in a virtual reality environment can discriminate between individuals at risk or with clinical symptoms and healthy peers. The third goal is to conduct a pilot randomized controlled trial to test a virtual reality self-help exposure-based intervention to remediate eating or sleep difficulties in individuals at risk or exhibiting clinical symptoms of eating disorders or insomnia.
详细描述
The present study aims:
- To measure eating- and sleep-related behaviours and psychological functioning over time (6-9 months) in a large sample of secondary school students aged 14 to 17 years old and identify individuals at risk or exhibiting clinical symptoms in order to signpost them to self-help written materials and clinical support;
- To establish whether increased emotional reactivity to disease-related stimuli (sleep- or eating-related) in a virtual reality environment discriminates between individuals at risk or with clinical levels of eating and/or insomnia and healthy peers;
- To conduct a pilot randomized controlled trial to test a virtual reality self-help exposure-based intervention for eating or sleep difficulties, targeting increased emotional reactivity to disease-related stimuli.
A minimum of 854 adolescents will be recruited and assessed at baseline, 3- and 6-to-9 months follow-up.
A mobile application has been specifically designed for this study, incorporating gamified elements to enhance engagement and adherence. The app can be downloaded for free on participants' mobile devices and will play a crucial role throughout the study, serving multiple purposes. It will be first used as an assessment tool: participants will complete baseline and follow-up questionnaires. Moreover, they will receive notifications to collect Ecological Momentary Assessment (EMA) data. Finally, it will provide access to self-help written materials on sleep and eating habits and disorders that participants will be able to read and download from the beginning of the study.
The sample size was estimated based on the recommendations for sample size calculation in prevalence studies. The calculation was performed using the Scalex sample size calculator and was based on four parameters: level of confidence, which was set at 95%; level of precision of the estimated prevalence, which was set at 3%, the recommended threshold for large scale studies likely to gain attention from policy makers; estimated prevalence of the disorder, which was established at 20% based on prevalence of sleep and eating problems among Italian adolescents; anticipated loss, which was set at 20% based on the loss of data at six months in previous studies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Each participant will be assigned an identification code (ID-code) randomly generated by a computer. The outcome assessors will be blind to which group (intervention or control) conditions 1 and 2 will correspond to.
入排标准
- 年龄范围
- 14 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age ≥ 14; ≤ 17 years old
- •knowledge of Italian language
- •own a device with internet connection
排除标准
- 未提供
结局指标
主要结局
Percentages of participants at high-risk, no risk, or clinical levels of sleep difficulties at baseline
时间窗: baseline
Insomnia Severity Index (ISI), total score (min=0; max=28). The cut-off to detect individuals at high-risk is 8. The cut-off to detect individuals with clinical levels of insomnia is 15.
influence of psychological wellbeing on sleep difficulties
时间窗: baseline
Regression model to evaluate the impact of psychological wellbeing variables on the Sleep Health Dimensions Questionnaire; (SHDQ-A; higher scores indicating higher severity of insomnia)
Percentages of participants who developed or worsened insomnia symptoms over time
时间窗: baseline, 3- and 6/9 months follow-up
Insomnia Severity Index (ISI, total score. min=0; max=28, cut-off 8 for high-risk individuals, 15 for clinical levels of insomnia)
predictors of insomnia symptoms onset or worsening
时间窗: 3-, and 6/9- months follow-up
A multivariate proportional hazard model will be calculated to predict the likelihood conversion of insomnia symptoms in insomnia based on participants' responses to the questionnaires evaluating psychological wellbeing at baseline and scores at follow-up to the Insomnia Severity Index (ISI, total score. min=0; max=28, cut-off 8 for high-risk individuals, 15 for clinical levels of insomnia)
Percentages of participants at high-risk, no risk, or clinical levels of eating difficulties at baseline
时间窗: baseline
Screening tool for eating disorders (SCOFF), total score (min=1; max=5). The cut-off for at-risk eating disorders behaviours is 3.
influence of psychological wellbeing on insomnia symptoms
时间窗: baseline
Regression model to evaluate the impact of psychological wellbeing variables on the Insomnia Severity Index (ISI; total score. min=0; max=28, cut-off 8 for high-risk individuals, 15 for clinical levels of insomnia)
Influence of psychological wellbeing on eating difficulties
时间窗: baseline
Regression model to evaluate the impact of psychological wellbeing variables on the Eating Disorder Examination Questionnaire (EDE-Q; total score. min=0; max=6, cut-off 4)
Influence of psychological wellbeing on eating disorder symptoms
时间窗: baseline
Regression model to evaluate the impact of psychological wellbeing variables on the Screening tool for eating disorders (SCOFF; total score. min=1; max=5, cut-off 3)
Percentages of participants who developed or worsened eating disorder symptoms over time
时间窗: baseline, 3- and 6/9 months follow-up
Screening tool for eating disorders (SCOFF, total score. min=1; max=5, cut-off 3)
predictors of eating disorder difficulties onset or worsening
时间窗: 3-, and 6/9- months follow-up
A multivariate proportional hazard model will be calculated to predict the likelihood conversion of eating disorder symptoms in eating disorders based on participants' responses to the questionnaires evaluating psychological wellbeing at baseline and scores at follow-up to the Eating Disorder Examination Questionnaire (EDE-Q 6.0, total score. min=0; max=6, cut-off 4)
between-group differences (high-risk or clinical vs. healthy peers) in anxiety scores in the virtual reality environment
时间窗: 3-months follow-up; data collected before and after the one-session virtual reality exposure
scores provided on a visual analogue scale developed by the research team (0-8; higher scores corresponding to higher anxiety levels)
between-group differences (high risk/clinical vs. healthy peers) in behavioural indices of approach and attention towards disease-specific stimuli
时间窗: 3-months follow-up; data collected during the one-session virtual reality exposure
number of approach behaviours and eye gazes directed to sleep/eating specific items registered automatically by the Oculus Quest
predictors of eating disorder symptoms onset or worsening
时间窗: 3-, and 6/9- months follow-up
A multivariate proportional hazard model will be calculated to predict the likelihood conversion of eating disorder symptoms in eating disorders based on participants' responses to the questionnaires evaluating psychological wellbeing at baseline and scores at follow-up to the Screening tool for eating disorders (SCOFF, total score. min=1; max=5, cut-off 3)
次要结局
- frequency of exposure to the virtual reality environment(1-week virtual reality intervention period)
- evaluation of the effect of a virtual reality intervention in reducing eating disorders/insomnia(1-week virtual reality intervention period)
- longitudinal evaluation of depression, anxiety, and stress symptoms(baseline; 3-, and 6-9- month follow-up)
- effect size of changes in anxiety over time in participants allocated to the virtual reality exposure condition over a week(1-week virtual reality intervention period, before and after each exposure)
- feasibility of virtual reality exposure(at the end of the 1-week virtual reality exposure intervention)
- acceptability of virtual reality exposure(at the end of the 1-week virtual reality self-help exposure-based intervention)
研究者
CARDI VALENTINA
Professor
University of Padova