Sleep and Eating Behaviours in Adolescents

Not Applicable

Not yet recruiting

• Conditions: Insomnia Disorder; Eating Disorders

• Registration Number: NCT06472466
• Lead Sponsor: University of Padova

Brief Summary

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.

Detailed Description

The present study aims:

1. 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;

2. 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;

3. 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.

Assessment phase.

Students whose parents will have given informed consent to participate in the study will complete the baseline assessment through the App and provide information on:

* gender, age, family composition, and history of mental health disorders;

* sleep behaviours and insomnia symptoms: Insomnia Severity Index (ISI); Sleep Health Dimensions Questionnaire

* eating behaviours and symptoms: Screening Tool for Eating Disorders (SCOFF); Eating Disorder Examination Questionnaire (EDE-Q 6.0)

* history of weight-based victimization

* depression, anxiety, and stress symptoms: Depression, Anxiety and Stress Scales (DASS-21)

* strengths and difficulties regarding emotional functioning: Cognitive Emotion Regulation Questionnaire (CERQ-IS)

* emotional, behavioural and interpersonal difficulties and prosociality: Strengths and Difficulties Questionnaire (SDQ)

* social media usage: Bergen Social Media Addiction Scale (BSMAS).

They will also undergo a 4-day EMA to assess sleep and eating behaviours, sleepiness, eating disorder symptoms, and emotional states multiple times/day.

At three- and six-to-nine months follow-up, participants will complete a subset of measures completed at baseline:

* Insomnia Severity Index (ISI)

* Eating Disorder Examination Questionnaire (EDE-Q 6.0)

* Screening Tool for Eating Disorders (SCOFF)

* Depression, Anxiety and Stress Scales (DASS-21)

* 4-day Ecological Momentary Assessment; EMAs

Self-help written materials have been developed by the research team for the purposes of the present study. They consist of a short booklet about sleep and eating behaviours and disorders, providing strategies to cope with them. Contents will be available to participants from the beginning of the study. They will be able to both read and download them directly from the application on their mobile devices.

Individuals identified as at high-risk for, or with insomnia (ISI, total score min=0; max=28, cut-off= 8 for high-risk individuals, cut-off=15 for clinical levels of insomnia)/eating disorder symptoms (SCOFF, total score min=1; max=5, cut-off 3) at baseline and at 3 months will be invited to take part in a 15-min virtual reality exposure session to measure emotional reactivity to eating and/or sleep-related stimuli. Individuals at high-risk for/with insomnia will be exposed to a virtual bedroom, while individuals at high-risk for/with eating disorders will be exposed to a virtual kitchen. A control group (with no symptoms of eating disorders or insomnia) will also be recruited and exposed to both the virtual bedroom and virtual kitchen in randomized order.

Intervention phase. Participants in the high-risk/clinical group (approximately N=100) will be randomly allocated to an intervention or a control condition. Those in the intervention condition will be asked to use the virtual reality scenario for a week, at home, with the aim of reducing emotional reactivity associated with sleep or eating-related stimuli. Those in the control condition will only have received access to the self-help written materials. Visual analogue scales will be presented to evaluate anxiety levels before and after the exposure. Feasibility and acceptability of the virtual reality environments will be assessed through visual analogue scales and a qualitative interview. Participants across groups will also complete EMAs of eating and/or sleep behaviours during the week.

Study Timeline

• Status Verified: 2024-06
• Study First Submitted: 2024-06-07
• Study First Submitted QC: 2024-06-17
• Last Update Submitted: 2024-06-17
• Study First Posted: 2024-06-25
• Last Update Posted: 2024-06-25
• Study Start: 2024-09-01
• Primary Completion: 2025-01-01
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 854

Inclusion Criteria

• age ≥ 14; ≤ 17 years old
• knowledge of Italian language
• own a device with internet connection

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Percentages of participants at high-risk, no risk, or clinical levels of sleep difficulties at baseline	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	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	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	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	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	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	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	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	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	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	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	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	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)

Secondary Outcome Measures

Name	Time	Method
frequency of exposure to the virtual reality environment	1-week virtual reality intervention period	number of times participants will have completed the exposure
evaluation of the effect of a virtual reality intervention in reducing eating disorders/insomnia	1-week virtual reality intervention period	between-group comparison of frequency of eating/sleep problems (intervention condition vs. self-help condition) collected through EMAs (visual analogue scales developed by the research team 0-8).
longitudinal evaluation of depression, anxiety, and stress symptoms	baseline; 3-, and 6-9- month follow-up	Depression, Anxiety and Stress Scales (DASS-21; 3 subscales. Stress subscale: Normal: 0-10; Mild: 11-18; Moderate: 19-26; Severe: 27-34; Extremely severe: 35-42. Anxiety: Normal : 0-6, Mild : 7-9, Moderate:10-14, Severe: 15-19, Extremely severe: 20-42. Depression: Normal: 0-9, Mild : 10-12, Moderate : 13-20, Severe : 21-27, Extremely severe: 28-42)
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	ratings of cue-related anxiety collected at the beginning and at the end of each virtual reality exposure measured by means of a visual analogue scale developed by the research team (0-8; higher scores corresponding to higher anxiety levels)
feasibility of virtual reality exposure	at the end of the 1-week virtual reality exposure intervention	scores provided on visual analogue scales developed by the research team (0-8; higher scores corresponding to higher ) and qualitative data collected through a brief interview
acceptability of virtual reality exposure	at the end of the 1-week virtual reality self-help exposure-based intervention	scores provided on visual analogue scales developed by the research team (0-8) and qualitative data collected through a brief interview

Trial Locations

Locations (2)

Department of General Psychology, University of Padova, Padova, Italy; 🇮🇹 Padova, Italy

Department of Human Sciences, Guglielmo Marconi University; 🇮🇹 Rome, Italy