Study Results
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Basic Information
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NOT_YET_RECRUITING
NA
854 participants
INTERVENTIONAL
2024-09-01
2025-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
Participants with eating/insomnia disorder symptoms will be randomized to one of two conditions:
1. repeated exposure to the virtual kitchen/bedroom scenario respectively (intervention condition);
2. self-help written materials (control condition).
Participants allocated to the intervention condition will be asked to use the virtual reality scenario for one week, for a minimum of three times in total and to rate their level of perceived anxiety at the beginning and at the end of each exposure session. To evaluate the feasibility and acceptability of the virtual environments, they will be asked to complete a series of visual analogue scales, EMAs of eating and/or sleep behaviours, and will participate in a brief interview to collect qualitative data on their experience.
TREATMENT
SINGLE
Study Groups
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Intervention group - VR scenario
Virtual reality immersive intervention: 1-week virtual reality self-help exposure-based intervention. Participants will be asked to use the assigned virtual environment for a minimum of three times in total over the week, at home.
Sleep/eating virtual reality self-help exposure-based intervention
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.
Control condition
Participants will all have access to self-help written materials.
Sleep/eating self-help written materials.
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.
Interventions
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Sleep/eating virtual reality self-help exposure-based intervention
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.
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.
Eligibility Criteria
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Inclusion Criteria
* knowledge of Italian language
* own a device with internet connection
14 Years
17 Years
ALL
Yes
Sponsors
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University of Rome G. Marconi
OTHER
University of Padova
OTHER
Responsible Party
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CARDI VALENTINA
Professor
Principal Investigators
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Valentina Cardi, PhD
Role: STUDY_DIRECTOR
Department of General Psychology, University of Padova, Padova, Italy
Locations
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Department of General Psychology, University of Padova, Padova, Italy
Padua, , Italy
Department of Human Sciences, Guglielmo Marconi University
Rome, , Italy
Countries
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Central Contacts
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Facility Contacts
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References
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Bacaro V, Curati S, Baglioni C. Validation study of the Italian version of the Sleep Hygiene Index. J Sleep Res. 2022 Feb;31(1):e13445. doi: 10.1111/jsr.13445. Epub 2021 Jul 19.
Baglioni C, Regen W, Teghen A, Spiegelhalder K, Feige B, Nissen C, Riemann D. Sleep changes in the disorder of insomnia: a meta-analysis of polysomnographic studies. Sleep Med Rev. 2014 Jun;18(3):195-213. doi: 10.1016/j.smrv.2013.04.001.
Bastien CH, Vallieres A, Morin CM. Validation of the Insomnia Severity Index as an outcome measure for insomnia research. Sleep Med. 2001 Jul;2(4):297-307. doi: 10.1016/s1389-9457(00)00065-4.
Bottesi G, Ghisi M, Altoe G, Conforti E, Melli G, Sica C. The Italian version of the Depression Anxiety Stress Scales-21: Factor structure and psychometric properties on community and clinical samples. Compr Psychiatry. 2015 Jul;60:170-81. doi: 10.1016/j.comppsych.2015.04.005. Epub 2015 Apr 15.
Calugi S, Milanese C, Sartirana M, El Ghoch M, Sartori F, Geccherle E, Coppini A, Franchini C, Dalle Grave R. The Eating Disorder Examination Questionnaire: reliability and validity of the Italian version. Eat Weight Disord. 2017 Sep;22(3):509-514. doi: 10.1007/s40519-016-0276-6. Epub 2016 Apr 2.
Cerolini S, Zagaria A, Vacca M, Spinhoven P, Violani C, Lombardo C. Cognitive Emotion Regulation Questionnaire-Short: Reliability, Validity, and Measurement Invariance of the Italian Version. Behav Sci (Basel). 2022 Nov 24;12(12):474. doi: 10.3390/bs12120474.
D'Anna G, Lazzeretti M, Castellini G, Ricca V, Cassioli E, Rossi E, Silvestri C, Voller F. Risk of eating disorders in a representative sample of Italian adolescents: prevalence and association with self-reported interpersonal factors. Eat Weight Disord. 2022 Mar;27(2):701-708. doi: 10.1007/s40519-021-01214-4. Epub 2021 May 20.
Muris P, Meesters C, van den Berg F. The Strengths and Difficulties Questionnaire (SDQ)--further evidence for its reliability and validity in a community sample of Dutch children and adolescents. Eur Child Adolesc Psychiatry. 2003 Jan;12(1):1-8. doi: 10.1007/s00787-003-0298-2.
Meltzer LJ, Williamson AA, Mindell JA. Pediatric sleep health: It matters, and so does how we define it. Sleep Med Rev. 2021 Jun;57:101425. doi: 10.1016/j.smrv.2021.101425. Epub 2021 Jan 19.
Monacis L, de Palo V, Griffiths MD, Sinatra M. Social networking addiction, attachment style, and validation of the Italian version of the Bergen Social Media Addiction Scale. J Behav Addict. 2017 Jun 1;6(2):178-186. doi: 10.1556/2006.6.2017.023. Epub 2017 May 11.
Morgan JF, Reid F, Lacey JH. The SCOFF questionnaire: assessment of a new screening tool for eating disorders. BMJ. 1999 Dec 4;319(7223):1467-8. doi: 10.1136/bmj.319.7223.1467. No abstract available.
Young AF, Powers JR, Bell SL. Attrition in longitudinal studies: who do you lose? Aust N Z J Public Health. 2006 Aug;30(4):353-61. doi: 10.1111/j.1467-842x.2006.tb00849.x.
Pannocchia L, Fiorino M, Giannini M, Vanderlinden J. A psychometric exploration of an Italian translation of the SCOFF questionnaire. Eur Eat Disord Rev. 2011 Jul-Aug;19(4):371-3. doi: 10.1002/erv.1105.
Puhl RM, Himmelstein MS, Watson RJ. Weight-based victimization among sexual and gender minority adolescents: Implications for substance use and mental health. Health Psychol. 2019 Aug;38(8):727-737. doi: 10.1037/hea0000758. Epub 2019 Jun 3.
Other Identifiers
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P2022C7XFJ
Identifier Type: -
Identifier Source: org_study_id
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