Eating DisordersSANANCT06472466
Sleep and Eating Behaviours in Adolescents
A study testing Sleep/eating virtual reality self-help exposure-based intervention and Sleep/eating self-help written materials. in people with Eating Disorders and Insomnia Disorder, run by University of Padova at 2 sites in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 14 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Eating Disorders, Insomnia Disorder
- What is being tested?
- Sleep/eating virtual reality self-help exposure-based intervention and Sleep/eating self-help written materials.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 854 participants
- Where
- 2 sitesItaly
- Study dates
- 1 Sep 2024to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- age ≥ 14; ≤ 17 years old
- knowledge of Italian language
- own a device with internet connection
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
Chiara Baglioni, PhD contact
Italy2 sites
Department of General Psychology, University of Padova, Padova, Italy
Padova, 35121
Valentina Cardi, PhD, +39049827, valentina.cardi@unipd.it
Chiara Tosi, MsC, chiara.tosi@unipd.it
Department of Human Sciences, Guglielmo Marconi University
Rome, 00193
Chiara Baglioni, PhD, +49 (0) 76127065970, c.baglioni@unimarconi.it
Chiara Baglioni, PhD
About this study
Official title: "Healthier and Earlier Through Digital Technology: Towards a Transdiagnostic Staging Model of Eating and Sleep Disorders in Adolescence"
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.
Read the detailed description
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.
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
- Eating Disorders, Insomnia Disorder
- Being tested
- Sleep/eating virtual reality self-help exposure-based intervention, Sleep/eating self-help written materials.
- Keywords
- Mental health, Adolescence, Eating, Sleep Health, Insomnia, Virtual Reality, Longitudinal
- Medical subject headings
- Feeding and Eating Disorders, Sleep Initiation and Maintenance Disorders, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep/eating virtual reality self-help exposure-based interventionBehavioural
Participants will receive one of two possible interventions:
- 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.
- 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.Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group - VR scenario | Experimental | 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. Receives: Behavioral: Sleep/eating virtual reality self-help exposure-based intervention |
| Control condition | Active comparator | Participants will all have access to self-help written materials. Receives: Behavioral: Sleep/eating self-help written materials. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 3-months follow-up; data collected during the one-session virtual reality exposure
Secondary outcomes (6)
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)
Measured: 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)
Measured: 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
Measured: 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).
Measured: 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
Measured: 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
Measured: at the end of the 1-week virtual reality self-help exposure-based intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2024
- Study start1 Sep 2024 (estimated)
- Primary completion1 Jan 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Eating DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Data collected throughout the first phase of the study, will allow to identify participants at high-risk for or with insomnia and/or eating disorder symptoms. Based on these data: 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 854 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Padova
- Sponsor type
- University, hospital or other
- Collaborators
- University of Rome G. Marconi
- Responsible party
- Principal investigator, CARDI VALENTINA, University of Padova
- Investigators
- Valentina Cardi, PhD, Study director, Department of General Psychology, University of Padova, Padova, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06472466
- Sponsor's protocol ID
- P2022C7XFJ
- Acronym
- SANA
- Status last verified
- Jun 2024
- First submitted
- 7 Jun 2024
- Last updated
- 25 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: a plan will be established by the research team for data sharing following publication of the first manuscript
Publications
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.
PubMed 34279064Baglioni 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.
PubMed 23809904Bastien 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.
PubMed 11438246Bottesi 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.
PubMed 25933937Calugi 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.
PubMed 27039107Cerolini 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.
PubMed 36546957D'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.
PubMed 34014507Muris 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.
PubMed 12601558Meltzer 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.
PubMed 33601324Monacis 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.
PubMed 28494648Morgan 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.
PubMed 10582927Young 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.
PubMed 16956166Pannocchia 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.
PubMed 21400638Puhl 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.
PubMed 31157534
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Healthier and Earlier Through Digital Technology: Towards a Transdiagnostic Staging Model of Eating and Sleep Disorders in Adolescence"
- ClinicalTrials.gov ID
- NCT06472466
- Acronym / sponsor ID
- SANA / P2022C7XFJ
- Conditions
- Eating Disorders, Insomnia Disorder
- Keywords
- Mental health, Adolescence, Eating, Sleep Health, Insomnia, Virtual Reality, Longitudinal
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 854 participants (estimated)
- Lead sponsor
- University of PadovaUniversity, hospital or other
- Collaborators
- University of Rome G. Marconi
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 25 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Data collected throughout the first phase of the study, will allow to identify participants at high-risk for or with insomnia and/or eating disorder symptoms. Based on these data: 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention group - VR scenario | Experimental | Behavioral: Sleep/eating virtual reality self-help exposure-based interventionVirtual 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. |
| Control condition | Active comparator | Behavioral: Sleep/eating self-help written materials.Participants will all have access to self-help written materials. |
Who may qualify
- Ages
- 14 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- age ≥ 14; ≤ 17 years old
- knowledge of Italian language
- own a device with internet connection
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sleep/eating virtual reality self-help exposure-based interventionParticipants 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. | Behavioural | Intervention group - VR scenario |
| 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. | Behavioural | Control condition |
Primary outcome
Percentages of participants at high-risk, no risk, or clinical levels of eating difficulties at baseline
Time frame: baseline
Screening tool for eating disorders (SCOFF), total score (min=1; max=5). The cut-off for at-risk eating disorders behaviours is 3.
Percentages of participants at high-risk, no risk, or clinical levels of sleep difficulties at baseline
Time frame: 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 eating difficulties
Time frame: 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
Time frame: 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)
influence of psychological wellbeing on sleep difficulties
Time frame: 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)
influence of psychological wellbeing on insomnia symptoms
Time frame: 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)
Percentages of participants who developed or worsened eating disorder symptoms over time
Time frame: baseline, 3- and 6/9 months follow-up
Screening tool for eating disorders (SCOFF, total score. min=1; max=5, cut-off 3)
Percentages of participants who developed or worsened insomnia symptoms over time
Time frame: 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 eating disorder difficulties onset or worsening
Time frame: 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)
predictors of eating disorder symptoms onset or worsening
Time frame: 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)
predictors of insomnia symptoms onset or worsening
Time frame: 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)
between-group differences (high-risk or clinical vs. healthy peers) in anxiety scores in the virtual reality environment
Time frame: 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
Time frame: 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
6 secondary outcomes
longitudinal evaluation of depression, anxiety, and stress symptoms
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
Time frame: 1-week virtual reality intervention period, before and after each exposure
frequency of exposure to the virtual reality environment
Time frame: 1-week virtual reality intervention period
evaluation of the effect of a virtual reality intervention in reducing eating disorders/insomnia
Time frame: 1-week virtual reality intervention period
feasibility of virtual reality exposure
Time frame: at the end of the 1-week virtual reality exposure intervention
acceptability of virtual reality exposure
Time frame: at the end of the 1-week virtual reality self-help exposure-based intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2024.
- Background: PubMed 34279064Bacaro 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.
- Background: PubMed 23809904Baglioni 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.
- Background: PubMed 11438246Bastien 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.
- Background: PubMed 25933937Bottesi 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.
- Background: PubMed 27039107Calugi 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.
- Background: PubMed 36546957Cerolini 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.
- Background: PubMed 34014507D'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.
- Background: PubMed 12601558Muris 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.
- Background: PubMed 33601324Meltzer 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.
- Background: PubMed 28494648Monacis 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.
- Background: PubMed 10582927Morgan 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.
- Background: PubMed 16956166Young 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.
- Individual participant dataSharing planned: No. a plan will be established by the research team for data sharing following publication of the first manuscript
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chiara Baglioni, PhD contact
Valentina Cardi, PhD study director
Department of General Psychology, University of Padova, Padova, Italy
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep/eating virtual reality self-help exposure-based intervention and Sleep/eating self-help written materials. in people with Eating Disorders and Insomnia Disorder, run by University of Padova at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Valentina Cardi, PhD (+39049827, valentina.cardi@unipd.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentages of participants at high-risk, no risk, or clinical levels of eating difficulties at baseline (time frame: baseline). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06472466, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2024.