Sleep and Eating Behaviours in Adolescents

NCT06472466 | Not Yet Recruiting

• 1 other identifier: P2022C7XFJ
• Study Type: interventional
• Target: 854
• Locations: 1 country
• Sites: 2

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.

Conditions

Eating Disorders; Insomnia Disorder

Keywords

Mental health; Adolescence; Eating; Sleep Health; Insomnia; Virtual Reality; Longitudinal

Outcome Measures

Primary Outcomes (13)

• 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 Outcomes (6)

• longitudinal evaluation of depression, anxiety, and stress symptoms

  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

  1-week virtual reality intervention period, before and after each exposure

• frequency of exposure to the virtual reality environment

  1-week virtual reality intervention period

• evaluation of the effect of a virtual reality intervention in reducing eating disorders/insomnia

  1-week virtual reality intervention period

• feasibility of virtual reality exposure

  at the end of the 1-week virtual reality exposure intervention

Other Outcomes (4)

• longitudinal evaluation of sleep quality

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

• longitudinal evaluation of emotional states

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

• longitudinal evaluation of sleepiness

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

Study Arms (2)

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.

Behavioral: Sleep/eating virtual reality self-help exposure-based intervention

Control condition

ACTIVE COMPARATOR

Participants will all have access to self-help written materials.

Behavioral: Sleep/eating self-help written materials.

Interventions

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.

Intervention group - VR scenario

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.

Control condition

Eligibility Criteria

• Age: 14 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

Sponsors & Collaborators

• University of Padova: lead
• University of Rome G. Marconi: collaborator

Study Sites (2)

Department of General Psychology, University of Padova, Padova, Italy

Padua, 35121, Italy

Location

Department of Human Sciences, Guglielmo Marconi University

Rome, 00193, Italy

Location

Related Publications (14)

• 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.

  PMID: 34279064 BACKGROUND

• 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.

  PMID: 23809904 BACKGROUND

• 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.

  PMID: 11438246 BACKGROUND

• 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.

  PMID: 25933937 BACKGROUND

• 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.

  PMID: 27039107 BACKGROUND

• 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.

  PMID: 36546957 BACKGROUND

• 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.

  PMID: 34014507 BACKGROUND

• 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.

  PMID: 12601558 BACKGROUND

• 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.

  PMID: 33601324 BACKGROUND

• 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.

  PMID: 28494648 BACKGROUND

• 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.

  PMID: 10582927 BACKGROUND

• 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.

  PMID: 16956166 BACKGROUND

• 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.

  PMID: 21400638 BACKGROUND

• 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.

  PMID: 31157534 BACKGROUND

MeSH Terms

Conditions

Feeding and Eating Disorders; Sleep Initiation and Maintenance Disorders; Psychological Well-Being

Interventions

Sleep

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Personal Satisfaction; Behavior

Intervention Hierarchy (Ancestors)

Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Valentina Cardi, PhD

  Department of General Psychology, University of Padova, Padova, Italy

  STUDY DIRECTOR

Central Study Contacts

Valentina Cardi, PhD

CONTACT

+39049827; valentina.cardi@unipd.it

Chiara Baglioni, PhD

CONTACT

c.baglioni@unimarconi.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Each participant will be assigned an identification code (ID-code) randomly generated by a computer. The outcome assessors will be blind to which group (intervention or control) conditions 1 and 2 will correspond to.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: June 7, 2024
• First Posted: June 25, 2024
• Study Start: September 1, 2024
• Primary Completion: January 1, 2025
• Study Completion: September 30, 2025
• Last Updated: June 25, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)