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NOT YET RECRUITING
NCT06472466
NA

Sleep and Eating Behaviours in Adolescents

Sponsor: University of Padova

View on ClinicalTrials.gov

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.

Official title: "Healthier and Earlier Through Digital Technology: Towards a Transdiagnostic Staging Model of Eating and Sleep Disorders in Adolescence"

Key Details

Gender

All

Age Range

14 Years - 17 Years

Study Type

INTERVENTIONAL

Enrollment

854

Start Date

2024-09-01

Completion Date

2025-09-30

Last Updated

2024-06-25

Healthy Volunteers

Yes

Interventions

BEHAVIORAL

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.

BEHAVIORAL

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.

Locations (2)

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

Padova, Italy

Department of Human Sciences, Guglielmo Marconi University

Rome, Italy