Virtual Reality-Based Attention Bias Modification Training for Adolescents With Anorexia Nervosa

NCT04786951 | Completed

• 1 other identifier: PID2019-108657RB-I00
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

Anorexia Nervosa (AN) is considered one of the most severe subtypes of eating disorders (EDs), characterized by significant medical complications, high mortality rates, and high comorbidity with other disorders, such as anxiety disorders. Similarly to what occurs in anxiety disorders, several studies have suggested the presence of dysfunctional body-related attentional bias (AB) in patients with EDs, and specifically in patients with AN. Individuals with AN tend to focus their attention on their body in a dysfunctional manner, engaging in body-checking behaviors and excessively scrutinizing their general appearance and weight-related body parts. This body-related AB has been associated with higher levels of body dissatisfaction, which represents one of the most important risk factors for the development and maintenance of EDs. Moreover, body-related AB may contribute to reducing the effectiveness of body exposure-based treatments used in patients with AN. For this reason, it is necessary to develop new treatment techniques by incorporating specific components aimed at reducing body-related AB. It has been proposed that attentional bias modification techniques could be integrated into body exposure therapy as an effective approach to reduce body-related AB, body dissatisfaction, and body anxiety. To date, our research group has been the first to use a combination of virtual reality (VR) and eye-tracking (ET) technologies to assess the presence of body-related AB in non-clinical samples. In order to improve treatments for AN, the present project aims to develop a novel attentional bias modification procedure using ET and VR technologies. In addition, this project seeks to integrate this AB modification procedure into a body exposure-based treatment designed to reduce the fear of weight gain experienced by patients with AN. Finally, the project aims to evaluate whether combining two distinct components-body exposure-based therapy and attentional bias modification training-results in a more effective intervention. It is expected that the inclusion of a VR-based body exposure procedure in standard AN treatment, enhanced through the illusion of ownership over a virtual body, will lead to improved treatment outcomes. Furthermore, it is anticipated that the addition of attentional bias modification training to the body exposure-based procedure will further enhance treatment effectiveness.

Conditions

Anorexia Nervosa

Keywords

Attentional bias; Virtual Reality; Body exposure procedure; Attentional bias modification training

Outcome Measures

Primary Outcomes (11)

• Change in Drive for Thinness (EDI-DT)

  Change in drive for thinness scores as measured by the Eating Disorder Inventory-3 - drive for thinness (EDI-DT) scale. Scores range from 0 to 28, with higher scores indicating greater drive for thinness.

  Assessed at baseline, at the end of treatment (6 weeks), and at 6-month follow-up.

• Change in Body Dissatisfaction (EDI-BD)

  Change in body dissatisfaction scores as measured by the Eating Disorder Inventory-3 - body dissatisfaction (EDI-BD) scale. Scores range from 0 to 40, with higher scores indicating greater body dissatisfaction.

  Assessed at baseline, at the end of treatment (6 weeks), and at 6-month follow-up.

• Change in Body Dissatisfaction (BIAS - BD)

  Body dissatisfaction scores were assessed using the Figural Drawing Scale for Body Image Assessment (BIAS-BD). Scores range from -80 to 80, with higher absolute values indicating greater body dissatisfaction.

  Assessed at baseline, at the end of treatment (6 weeks), and at 6-month follow-up.

• Change in Body Distortion (BIAS - BD)

  Body distortion scores were assessed using the Figural Drawing Scale for Body Image Assessment (BIAS-BD). Scores range from -80 to 80, with higher absolute values indicating greater body distortion.

  Assessed at baseline, at the end of treatment (6 weeks), and at 6-month follow-up.

• Change in complete fixation time towards weight-related body parts

  Change in attentional bias towards weight-related body parts, measured as the total fixation time of gaze (evaluated in milliseconds). Higher values indicate greater attentional bias.

  Assessed at baseline, at the end of treatment (6 weeks), and at 6-month follow-up.

• Change in the number of fixations towards weight-related body parts

  Change in attentional bias towards weight-related body parts, measured as the number of fixations of gaze. Higher values indicate greater attentional bias.

  Assessed at baseline, at the end of treatment (6 weeks), and at 6-month follow-up.

• Change in Body Mass Index values

  Change in Body Mass Index was calculated as weight (kg) divided by height (m) squared. Higher values indicate greater BMI.

  Assessed at baseline, at the end of treatment (6 weeks), and at 6-month follow-up.

• Change in Fear of Gaining Weight

  Change in fear of gaining weight, measured using a visual analogue scale (0-100). Higher scores indicate greater fear of gaining weight.

  Assessed at baseline, at the end of treatment (6 weeks), and at 6-month follow-up.

• Change in Anxiety

  Change in anxiety, measured using a visual analogue scale (0-100). Higher scores indicate greater anxiety.

  Assessed at baseline (before the body exposure session); every 2 minutes during the exposure session; at the end of the exposure session; at the end of treatment (6 weeks); and at 6-month follow-up.

• Change in Body-related Anxiety (PASTAS)

  Change in body-related anxiety as measured by the Physical Appearance State Anxiety Scale (PASTAS). Total scores range from 0 to 32, with higher scores indicating greater body-related anxiety.

  Assessed at baseline, at the end of treatment (6 weeks), and at 6-month follow-up.

• Change in Body Appreciation (BAS)

  Change in body appreciation as measured by the Body Appreciation Scale (BAS), with scores ranging from 13 to 65; higher scores indicate greater body appreciation.

  Assessed at baseline, at the end of treatment (6 weeks), and at 6-month follow-up.

Study Arms (3)

Treatment as usual + VR-based body + Attentional Bias Modification Training.

EXPERIMENTAL

In this group, five sessions of VR-based body exposure will be added to the usual treatment, as in the other experimental group. Additionally, at the beginning of each exposure session, participants will undergo attentional bias modification training. The training involves the visual selection of geometric figures that approximately correspond to specific body parts, with each figure presented in different colors. Participants must detect and identify figures appearing on different parts of the avatar's body. In 50% of the trials, discrimination will be based on shape, and in the remaining 50%, it will be based on color. Throughout the training, figures will appear on weight-related body parts in 45% of the trials, on non-weight-related body parts in another 45% of the trials, and on one of three neutral stimuli located next to the avatar in the remaining 10% of trials.

Behavioral: Attentional Bias Modification Training; Behavioral: VR-based body exposure; Behavioral: Usual Care for Eating Disorders

Treatment as usual + VR-based body exposure

EXPERIMENTAL

Patients assigned to this group will receive the usual treatment provided by their clinical unit, in addition to five weekly sessions of a VR-based body exposure intervention. During these sessions, participants will undergo body exposure using a virtual avatar representing their actual body measurements. The avatar's BMI will be progressively increased across sessions until a healthy BMI is reached.

Behavioral: VR-based body exposure; Behavioral: Usual Care for Eating Disorders

Treatment as usual

ACTIVE COMPARATOR

Patients assigned to this group will receive the usual treatment from the center where they are recruited for the study and will be required to complete the evaluations according to the same schedule as the experimental group.

Behavioral: Usual Care for Eating Disorders

Interventions

Attentional Bias Modification Training BEHAVIORAL

Combine usual treatment with an additional five VR-based body-exposure therapy sessions and five sessions of Attentional Bias Modification Training.

Treatment as usual + VR-based body + Attentional Bias Modification Training.

VR-based body exposure BEHAVIORAL

Combine the usual treatment with an additional five VR-based body-exposure therapy sessions

Treatment as usual + VR-based body + Attentional Bias Modification Training.; Treatment as usual + VR-based body exposure

Usual Care for Eating Disorders BEHAVIORAL

Participants were recruited from the day-patient and home-treatment programs of the eating disorders unit. The day-patient program followed a cognitive-behavioral therapy model and included nutritional rehabilitation, behavioral strategies for improving eating and weight gain, individual and group psychotherapy, and parental support. Attendance ranged from 6 to 11 hours per day, depending on patient risk. The home-treatment program served as transitional care between hospitalization and outpatient treatment and focused on medical stabilization, weight restoration, family involvement, psychoeducation, emotional regulation, and social skills development. Both cognitive-behavioral therapy and family-based therapy were delivered either in person or remotely. Standard treatment procedures for eating disorders were applied across all groups.

Treatment as usual; Treatment as usual + VR-based body + Attentional Bias Modification Training.; Treatment as usual + VR-based body exposure

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Female adolescents aged 12-17 years.
• Primary diagnosis of anorexia nervosa according to DSM-5 criteria.
• Body weight below the expected range for height, age, and sex.
• Ability to understand and communicate in Spanish.

You may not qualify if:

• Presence of severe mental disorders other than anorexia nervosa.
• Significant cognitive impairment that would interfere with participation.
• Visual or auditory deficits that could interfere with VR-based body exposure therapy.
• Epilepsy.
• Pregnancy.
• Cardiac arrhythmia.

Sponsors & Collaborators

• Hospital Sant Joan de Deu: collaborator
• University of Barcelona: lead

Study Sites (1)

Hospital Sant Joan de Déu

Barcelona, Barcelona, 08950, Spain

Location

Related Publications (7)

• Reed, D. L., Thompson, J. K., Brannick, M. T., & Sacco, W. P. (1991). Development and validation of the Physical Appearance State and Trait Anxiety Scale (PASTAS). Journal of Anxiety Disorders, 5(4), 323-332. https://doi.org/10.1016/0887-6185(91)90032-O

  BACKGROUND

• Smeets E, Jansen A, Roefs A. Bias for the (un)attractive self: on the role of attention in causing body (dis)satisfaction. Health Psychol. 2011 May;30(3):360-7. doi: 10.1037/a0022095.

  PMID: 21553980 BACKGROUND

• Rodgers RF, DuBois RH. Cognitive biases to appearance-related stimuli in body dissatisfaction: A systematic review. Clin Psychol Rev. 2016 Jun;46:1-11. doi: 10.1016/j.cpr.2016.04.006. Epub 2016 Apr 12.

  PMID: 27116714 BACKGROUND

• Bauer A, Schneider S, Waldorf M, Braks K, Huber TJ, Adolph D, Vocks S. Selective Visual Attention Towards Oneself and Associated State Body Satisfaction: an Eye-Tracking Study in Adolescents with Different Types of Eating Disorders. J Abnorm Child Psychol. 2017 Nov;45(8):1647-1661. doi: 10.1007/s10802-017-0263-z.

  PMID: 28133705 BACKGROUND

• Tuschen-Caffier B, Bender C, Caffier D, Klenner K, Braks K, Svaldi J. Selective Visual Attention during Mirror Exposure in Anorexia and Bulimia Nervosa. PLoS One. 2015 Dec 29;10(12):e0145886. doi: 10.1371/journal.pone.0145886. eCollection 2015.

  PMID: 26714279 BACKGROUND

• Williamson DA, White MA, York-Crowe E, Stewart TM. Cognitive-behavioral theories of eating disorders. Behav Modif. 2004 Nov;28(6):711-38. doi: 10.1177/0145445503259853.

  PMID: 15383683 BACKGROUND

• Jansen A, Nederkoorn C, Mulkens S. Selective visual attention for ugly and beautiful body parts in eating disorders. Behav Res Ther. 2005 Feb;43(2):183-96. doi: 10.1016/j.brat.2004.01.003.

  PMID: 15629749 BACKGROUND

MeSH Terms

Conditions

Anorexia Nervosa

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders

Study Officials

• José Gutiérrez-Maldonado

  jgutierrezm@ub.edu

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Model Details: Participants were partially randomly assigned to three study groups. To address recruitment challenges due to the limited availability of new adolescent patients and delays in ABMT software development, historical data from a previous randomized controlled trial conducted by the same research team were incorporated. Only participants who met the current study's inclusion and exclusion criteria were included to ensure comparability, as the previous trial employed the same design, assessments, and treatment-as-usual procedures. The historical dataset comprised 21 participants. Newly recruited participants were randomly assigned to one of three groups using block randomization with a computer-generated sequence to ensure balanced group sizes.

Study Record Dates

• First Submitted: February 25, 2021
• First Posted: March 8, 2021
• Study Start: December 21, 2021
• Primary Completion: February 2, 2023
• Study Completion: February 29, 2024
• Last Updated: January 16, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)