Sleep and Eating Behaviours in Adolescents

ConditionsEating Disorders Insomnia Disorder

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age14-17

SponsorUniversity of Padova

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

age ≥ 14; ≤ 17 years old

knowledge of Italian language

own a device with internet connection

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

Sleep/eating virtual reality self-help exposure-based intervention
Behavioral
Participants will receive one of two possible interventions: 1. A virtual reality kitchen with foods with different caloric contents. Participants will be invited to explore the environment and interact with the stimuli they feel most comfortable with. Depending on their preference, they will be able to access the virtual kitchen in one of three different conditions: alone, accompanied by a pink elephant (designed to induce positive mood), or accompanied by a reassuring voice that will encourage them to interact with the food and face their fears. 2. A virtual reality bedroom with several objects, some of which will have a neutral valence for people with sleep difficulties, and others that will be related to insomnia, such as a mobile phone, electronic devices and a clock marking 3:00. Participants will be first told to move in the environment and they could not fall asleep. Then, they will receive specific instructions to cope with sleeping difficulties.
Sleep/eating self-help written materials.
Behavioral
Participants allocated to the control condition will be invited to download self-help written materials about eating and sleep difficulties and helpful ways to cope with these.

Treatment groups

854 Participants

are divided into 2 treatment groups

Group A: Intervention group - VR scenarioExperimental treatment 1 intervention

Group B: Control conditionActive comparator 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

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.

Time frame

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)

Time frame

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)

Time frame

baseline

Secondary outcomes

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)

Time frame

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)

Time frame

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

Time frame

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).

Time frame

1-week virtual reality intervention period

Other outcomes

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

Time frame

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)

Time frame

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).

Time frame

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).

Time frame

4-day evaluation at baseline, repeated at 3-, and 6/9- months follow-up

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Padova

Lead sponsor

University of Rome G. Marconi

Collaborator

Source ClinicalTrials.gov

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