Sleep and Eating Behaviours in Adolescents
NCT Number: NCT06472466
Acronym: SANA
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Eating Disorders|Insomnia Disorder
Interventions: BEHAVIORAL: Sleep/eating virtual reality self-help exposure-based intervention|BEHAVIORAL: Sleep/eating self-help written materials.
Sponsor: University of Padova
Collaborators: University of Rome G. Marconi
Sex: ALL
Age: CHILD
Enrollment: 854
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2025-09-30
Locations: Department of General Psychology, University of Padova, Padova, Italy, Padova, 35121, Italy|Department of Human Sciences, Guglielmo Marconi University, Rome, 00193, Italy

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.

Primary Outcome Measures: Percentages of participants at high-risk, no risk, or clinical levels of eating difficulties at baseline, Screening tool for eating disorders (SCOFF), total score (min=1; max=5). The cut-off for at-risk eating disorders behaviours is 3., baseline|Percentages of participants at high-risk, no risk, or clinical levels of sleep difficulties at 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., baseline|Influence of psychological wellbeing on eating difficulties, 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), baseline|Influence of psychological wellbeing on eating disorder symptoms, 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), baseline|influence of psychological wellbeing on sleep difficulties, 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), baseline|influence of psychological wellbeing on insomnia symptoms, 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), baseline|Percentages of participants who developed or worsened eating disorder symptoms over time, Screening tool for eating disorders (SCOFF, total score. min=1; max=5, cut-off 3), baseline, 3- and 6/9 months follow-up|Percentages of participants who developed or worsened insomnia symptoms over time, Insomnia Severity Index (ISI, total score. min=0; max=28, cut-off 8 for high-risk individuals, 15 for clinical levels of insomnia), baseline, 3- and 6/9 months follow-up|predictors of eating disorder difficulties onset or worsening, 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), 3-, and 6/9- months follow-up|predictors of eating disorder symptoms onset or worsening, 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), 3-, and 6/9- months follow-up|predictors of insomnia symptoms onset or worsening, 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), 3-, and 6/9- months follow-up|between-group differences (high-risk or clinical vs. healthy peers) in anxiety scores in the virtual reality environment, scores provided on a visual analogue scale developed by the research team (0-8; higher scores corresponding to higher anxiety levels), 3-months follow-up; data collected before and after the one-session virtual reality exposure|between-group differences (high risk/clinical vs. healthy peers) in behavioural indices of approach and attention towards disease-specific stimuli, number of approach behaviours and eye gazes directed to sleep/eating specific items registered automatically by the Oculus Quest, 3-months follow-up; data collected during the one-session virtual reality exposure
Secondary Outcome Measures: longitudinal evaluation of depression, anxiety, and stress symptoms, 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), 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, 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), 1-week virtual reality intervention period, before and after each exposure|frequency of exposure to the virtual reality environment, number of times participants will have completed the exposure, 1-week virtual reality intervention period|evaluation of the effect of a virtual reality intervention in reducing eating disorders/insomnia, 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)., 1-week virtual reality intervention period|feasibility of virtual reality exposure, 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, at the end of the 1-week virtual reality exposure intervention|acceptability of virtual reality exposure, scores provided on visual analogue scales developed by the research team (0-8) and qualitative data collected through a brief interview, at the end of the 1-week virtual reality self-help exposure-based intervention
Other Outcome Measures: longitudinal evaluation of sleep quality, online ecological momentary assessments (notification via mobile application), 5-minutes length, in the morning. Scores provided on visual analogue scales developed by the research team (0-8) and open-questions, 4-day evaluation at baseline, repeated at 3-, and 6/9- months follow-up|longitudinal evaluation of emotional states, online ecological momentary assessments (notification via mobile application), 5-minutes length, in the evening before bedtime and at three time points in the afternoon. Scores provided on visual analogue scales developed by the research team (0-8), 4-day evaluation at baseline, repeated at 3-, and 6/9- months follow-up|longitudinal evaluation of sleepiness, online ecological momentary assessment (notification via mobile application), 5-minutes length, in the evening before bedtime and at three time points in the afternoon. Scores provided on visual analogue scales developed by the research team (0-8)., 4-day evaluation at baseline, repeated at 3-, and 6/9- months follow-up|longitudinal evaluation of eating disorder symptomatology, online ecological momentary assessments (notification via smartphone application), 5-minutes length, in the evening before bedtime and at three time points in the afternoon. Scores provided on visual analogue scales developed by the research team (0-8)., 4-day evaluation at baseline, repeated at 3-, and 6/9- months follow-up