Virtual Reality Exposure to Reduce Food Related Anxiety in Anorexia Nervosa

NCT06795555 | Recruiting

• 1 other identifier: 6048/AO/24
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Exposure to food stimuli often elicit aversive emotions in patients with anorexia nervosa, which can perpetuate eating-related avoidance. Exposure therapy has been shown to effectively reduce anxiety toward, and avoidance of, feared stimuli in several psychiatric disorders. Digital technologies, such as virtual reality (VR) have been employed to implement exposure therapy in situations where in vivo exposure is unfeasible, challenging, or perceived as threatening by patients. VR has also the potential to be used by individuals repeatedly in their own time and environment, to consolidate new learning. This pilot randomised controlled study evaluates the feasibility and clinical impact of repeated VR exposure to food stimuli in patients with anorexia nervosa attending intensive daycare treatment (treatment as usual, TAU). VR food exposure will be compared to the use of a relaxation-focused VR scenario (natural environment) and a control condition (no use of VR). Patients in all groups will receive TAU.

Conditions

Anorexia Nervosa

Keywords

mental health; eating disorders; exposure therapy; virtual reality

Outcome Measures

Primary Outcomes (2)

• Change from baseline to end of intervention in meal related anxiety

  Meal related anxiety is assessed on a Likert scale from 0 (no anxiety) to 10 (extreme anxiety)

  Measurements at baseline and day 5

• Feasibility of exposure to the virtual reality environments

  Percentage of participants who interrupt exposure to the virtual reality environment before completion. Discomfort associated to the virtual reality exposure session, rated at the end of each session on a visual analogue scale (0-100).

  Following each of five exposure sessions, over a time period of five days

Secondary Outcomes (4)

• Change from baseline to end of treatment in positive and negative affect

  Measurements at baseline and day 5

• Change from baseline to end of intervention in state anxiety

  Measurements at baseline and day 5

• Change from baseline to end of intervention in food pictures evaluation

  Measurements at baseline and day 5

• Effect sizes of changes in anxiety and meal related anxiety from before to after virtual reality exposure

  Measurements before and after each exposure session, over five days

Study Arms (3)

Virtual Reality Food Exposure

EXPERIMENTAL

Five sessions of exposure to a virtual kitchen (one session/day, over a week). Participants in this arm will continue receiving treatment as usual for their eating disorder at the treatment center

Behavioral: Virtual reality food exposure

Virtual Reality Nature Exposure

ACTIVE COMPARATOR

Five sessions of exposure to a virtual natural environment (one session/day, over a week). Participants in this arm will continue receiving treatment as usual for their eating disorder at the treatment center

Behavioral: Virtual Reality Nature Exposure

Treatment as usual

NO INTERVENTION

Patients in this condition will receive treatment as usual only

Interventions

Virtual reality food exposure BEHAVIORAL

Patients in this condition are exposed to a virtual kitchen environment once/day, for 5 consecutive days (from Monday, day 1, to Friday, day 5). Each session lasts 5 minutes. The VR environment was specifically developed by the study team (Natali et al, 2024) and it consists of a kitchen with foods of different calorie contents. Patients are invited to explore the environment; they can freely move, open the cupboards and the fridge, and grab and hold the foods. Participants can choose to interact with one of three versions of the virtual kitchen environment: a) a kitchen alone, b) a kitchen with a virtual pet which participants can interact with (and aimed at inducing positive mood) and c) a kitchen with a compassionate avatar which motivates the participant to face food-related fears.

Virtual Reality Food Exposure

Virtual Reality Nature Exposure BEHAVIORAL

Patients in this condition complete a session of VR exposure to a natural scenario (from the NatureTreksVR app) for 5 consecutive days (from Monday to Friday), one session/day. Each session lasts 5 minutes. Participants can choose exposure to one of three different natural environments, at the start of each session: a white sand beach ("Blue Ocean"), a snowy mountain ("White Winter"), or a forest in autumn foliage ("Red Fall").

Virtual Reality Nature Exposure

Eligibility Criteria

• Age: 14 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• current diagnosis of anorexia nervosa according to DSM-5 criteria
• years or older.

You may not qualify if:

• diagnosis of neurological disorders
• diagnosis of psychosis or substance abuse disorders
• visual/hearing impairments not corrected by glasses/ear implants
• non-tolerance of exposure to VR (i.e., cybersickness, dizziness)

Sponsors & Collaborators

• University of Padova: lead
• University of Salerno, Italy: collaborator
• Ospedale S.Bortolo -Vicenza, Italy: collaborator

Study Sites (1)

University Hospital of Padova

Padua, Italy, 35121, Italy

RECRUITING

Related Publications (4)

• Gratz, K.L., Roemer, L. Multidimensional Assessment of Emotion Regulation and Dysregulation: Development, Factor Structure, and Initial Validation of the Difficulties in Emotion Regulation Scale. Journal of Psychopathology and Behavioral Assessment 26, 41-54 (2004). https://doi.org/10.1023/B:JOBA.0000007455.08539.94

  BACKGROUND

• Terracciano A, McCrae RR, Costa PT Jr. Factorial and construct validity of the Italian Positive and Negative Affect Schedule (PANAS). Eur J Psychol Assess. 2003;19(2):131-141. doi: 10.1027//1015-5759.19.2.131.

  PMID: 20467578 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

MeSH Terms

Conditions

Anorexia Nervosa; Psychological Well-Being; Feeding and Eating Disorders

Condition Hierarchy (Ancestors)

Mental Disorders; Personal Satisfaction; Behavior; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Valentina Cardi, PhD

CONTACT

+39 3713759534; valentina.cardi@unipd.it

Valentina Meregalli, PhD

CONTACT

+39 320 744 2384; valentina.meregalli@unipd.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Patients are randomly assigned to one of three conditions: (1) treatment as usual + virtual food exposure; (2) treatment as usual + virtual nature exposure; (3) treatment as usual

Study Record Dates

• First Submitted: January 21, 2025
• First Posted: January 28, 2025
• Study Start: March 1, 2024
• Primary Completion: September 1, 2025
• Study Completion: December 1, 2025
• Last Updated: January 29, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)