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

NCT ID: NCT04786951

Last Updated: 2026-01-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-21

Study Completion Date

2024-02-29

Brief Summary

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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.

Detailed Description

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Attentional bias (AB) refers to the tendency to allocate greater attention to certain types of stimuli or information (e.g., disorder-relevant information) over other types of information. Adolescent patients with Anorexia Nervosa (AN) have been shown to focus more on self-perceived unattractive body parts than on other body parts. Dysfunctional body-related AB is thought to maintain body image disturbances commonly reported by adolescents with AN by selectively processing body-related information that is consistent with dysfunctional cognitive schemas (e.g., "I am getting a fatter belly"), while schema-inconsistent information (e.g., "I am getting thinner") receives less attention and is often visually neglected.

Dysfunctional body-related AB may also contribute to the reduced effectiveness of body exposure-based treatments for adolescents with AN. Therefore, there is a need to develop novel treatment approaches by incorporating specific components aimed at reducing body-related AB in this population. In a previous project conducted by our group, preliminary evidence supported the effectiveness of body-related AB modification in adolescent patients with AN following a virtual reality (VR)-based mirror exposure intervention. A key factor underlying these results may lie in the structure of the procedure, in which patients were required to sequentially focus on different parts of a virtual body (from head to feet) and verbally express their thoughts and emotions related to each body area.

Building on these findings, the present project aims to further advance this line of research by integrating attentional bias modification techniques into body exposure therapy as an effective approach to reducing body-related AB, body dissatisfaction, and body anxiety in adolescents with AN. To date, our research group has been among the first to combine virtual reality (VR) and eye-tracking (ET) technologies to assess body-related AB in both clinical and non-clinical samples. Specifically, this project seeks to determine whether the addition of attentional bias modification training to body exposure-based therapy results in a more effective intervention for adolescents diagnosed with AN.

It is hypothesized that incorporating AB modification training into the body exposure-based procedure (experimental group) will lead to greater treatment efficacy compared with treatment as usual (control group). Specifically, adolescents in the experimental group are expected to show a significant increase in body mass index (BMI) and a significant reduction in core AN symptomatology (e.g., fear of weight gain, body image disturbances), as well as a reduction in body-related AB, from pre- to post-treatment, compared with the control group. These improvements are also expected to be maintained at the six-month follow-up.

The project will be conducted at the Eating Disorders Units of Hospital Sant Joan de Déu (Barcelona, Spain), which specializes in the treatment of adolescents with eating disorders.

Adolescent patients with AN will be exposed to an immersive virtual environment using a VR head-mounted display (HTC Pro Eye) equipped with integrated eye-tracking. In addition to the two controllers typically provided with the HTC Pro Eye system, three additional body trackers will be used to enable full-body motion tracking. The virtual environment will consist of a room featuring a large mirror positioned on the front wall, approximately 1.5 m in front of the participant, and large enough to reflect the entire body. A young female avatar wearing a basic white T-shirt, blue jeans, and black trainers will be created for the intervention.

Regarding the treatment protocol, all sessions will last approximately one hour and will be conducted once per week. Each session will begin with the induction of the full-body illusion (FBI) and the assessment of visual analogue scales (VASs). Body exposure will initially involve a virtual body with the same BMI as the adolescent patient. The attentional bias modification training will be based on an adaptation of the AB induction procedure proposed by Smeets, Jansen, and Roefs (2011). The training will involve the visual selection of geometric figures (e.g., squares, rectangles, circles) that approximately correspond to specific body parts, with each figure presented in different colors. Participants will be required to detect and identify figures appearing on different parts of the avatar's body. In 50% of the trials, discrimination will be based on shape, while 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 and on non-weight-related body parts in another 45% of the trials. In the remaining 10% of trials, figures will appear on one of three neutral stimuli positioned next to the avatar.

Raw eye-tracking data will be processed using Ogama (Open Gaze and Mouse Analyzer) software to obtain quantitative measures of visual attention. Weight-related and non-weight-related areas of interest (AOIs) will be defined a priori. Weight-related AOIs will be determined based on the weight-related body items of the PASTAS questionnaire and mapped onto a frontal-view image of a female avatar. These weight-related AOIs will include the legs, thighs, buttocks, hips, abdomen, and waist. All remaining body parts (head, neck, chest, shoulders, arms, and feet) will be classified as non-weight-related AOIs. Selective visual attention will be assessed using total fixation duration and the number of fixations within each AOI.

Conditions

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Anorexia Nervosa

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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

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.

Group Type EXPERIMENTAL

Attentional Bias Modification Training

Intervention Type BEHAVIORAL

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

VR-based body exposure

Intervention Type BEHAVIORAL

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

Usual Care for Eating Disorders

Intervention Type 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 + VR-based body exposure

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.

Group Type EXPERIMENTAL

VR-based body exposure

Intervention Type BEHAVIORAL

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

Usual Care for Eating Disorders

Intervention Type 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

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.

Group Type ACTIVE_COMPARATOR

Usual Care for Eating Disorders

Intervention Type 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.

Interventions

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Attentional Bias Modification Training

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

Intervention Type BEHAVIORAL

VR-based body exposure

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

Intervention Type BEHAVIORAL

Usual Care for Eating Disorders

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

12 Years

Maximum Eligible Age

17 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Barcelona

OTHER

Sponsor Role lead

Hospital Sant Joan de Deu

OTHER

Sponsor Role collaborator

Responsible Party

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Jose Gutierrez Maldonado

Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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José Gutiérrez-Maldonado

Role: PRINCIPAL_INVESTIGATOR

[email protected]

Locations

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Hospital Sant Joan de Déu

Barcelona, Barcelona, Spain

Site Status

Countries

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Spain

References

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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

Reference Type 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.

Reference Type BACKGROUND
PMID: 21553980 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27116714 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28133705 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26714279 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15383683 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15629749 (View on PubMed)

Other Identifiers

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PID2019-108657RB-I00

Identifier Type: -

Identifier Source: org_study_id

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