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Virtual Reality-Based Attention Bias Modification Training for Anorexia Nervosa (AN-VR-ABM)

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ClinicalTrials.gov Identifier: NCT04786951
Recruitment Status : Recruiting
First Posted : March 8, 2021
Last Update Posted : May 19, 2022
Sponsor:
Collaborators:
Hospital Sant Joan de Deu
Hospital San Carlos, Madrid
Hospital Universitari de Bellvitge
Information provided by (Responsible Party):
Jose Gutierrez Maldonado, University of Barcelona

Brief Summary:
Anorexia Nervosa (AN) is considered as one of the most severe subtypes of eating disorders (ED), with important medical complications, high mortality rates, and high comorbidity with other disorders, such as anxiety disorders. Likewise, to what happens in anxiety disorders, several studies have suggested the presence of dysfunctional body-related Attentional Bias (AB) in patients with ED and, specifically, in AN patients. Patients with AN tend to focus their attention on their body, in a dysfunctional way, by showing body checking behaviors, and scrutinizing their general appearance and weight-related body parts. This body-related AB has been associated with higher levels of body dissatisfaction, one of the most important risk factors for the development and maintenance of ED. In addition, body-related AB may be responsible for decreasing the effectiveness of body exposure-based treatments used in patients with AN. For this reason, it is necessary to develop new treatment techniques by adding specific components that aim to reduce body-related AB. It has been proposed to include AB modification techniques within the body exposure therapy, as an effective treatment to reduce body-related AB, body dissatisfaction, and body anxiety. To date, our group has been the first, to use a combination of virtual reality (VR) and eye-tracking (ET) techniques to assess the presence of a body-related AB in non-clinical samples. In order to improve AN-based treatments, this project aims to develop a new AB modification procedure, using ET and VR technologies. In addition, this project aims to integrate this AB modification procedure as a part of a body exposure-based treatment that aims to reduce the fear of weight gain experienced by patients with AN. Finally, this project aims to assess whether adding two separate components of body exposure-based therapy and AB modification training would result in a more effective intervention. It is expected that adding a specific component of VR body exposure procedure in the usual treatment for AN, enhanced through the illusion of ownership toward the virtual body, will result in more effective treatment. In addition, it is expected that adding an AB modification training in the body-exposure-based procedure, will result in a further increase the effectiveness of the treatment.

Condition or disease Intervention/treatment Phase
Anorexia Nervosa Behavioral: Attentional Bias Modification Training Behavioral: VR-based body exposure Behavioral: Cognitive-behavioral therapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Virtual Reality-Based Attention Bias Modification Training for Anorexia Nervosa (AN-VR-ABM)
Actual Study Start Date : December 21, 2021
Estimated Primary Completion Date : February 2023
Estimated Study Completion Date : December 2023

Arm Intervention/treatment
Experimental: Cognitive-behavioral therapy plus VR-based body exposure and Attentional Bias Modification Training.
In this group, five sessions of VRE will be added to the usual CBT, as in the other experimental group, but, in addition, at the beginning of each of the exposure sessions, the training aimed at reducing the attentional bias will be carried out. The training will be developed through the visual selection of geometric figures that fit approximately with specific parts of the body. Each of these figures can have different colors. Specifically, the patient must detect and identify the figures that will appear in different parts of the avatar's body. In half of the trials, the shape of the figure must be discriminated and in the remaining 50%, the discrimination will be based on color. Throughout the training, the geometric figures will appear on weight-related body parts in 45% of the trials, and in another 45% of the trials, it will appear on non-weight-related body parts. In the remaining trials (10%), the test will appear on one of three neutral stimuli located next to the avatar.
Behavioral: Attentional Bias Modification Training
Combine usual cognitive-behavioral treatment (CBT) sessions with additional five VR-based body-exposure therapy sessions and five sessions of Attentional Bias Modification Training.

Behavioral: VR-based body exposure
Combine usual cognitive-behavioral treatment (CBT) sessions with additional five VR-based body-exposure therapy sessions

Behavioral: Cognitive-behavioral therapy
Usual cognitive-behavioral treatment (CBT) sessions.

Experimental: Cognitive-behavioral therapy for anorexia and VR-based body exposure:
Patients assigned to this group will receive the usual CBT from the clinical unit or the hospital where they are, and additionally, five sessions of VR-based body exposure intervention. In these weekly sessions patients will go through a body exposure intervention in which they will own a virtual avatar with their real measurements, that will progressively increase its BMI values throughout the following exposure sessions until a healthy BMI value is reached.
Behavioral: VR-based body exposure
Combine usual cognitive-behavioral treatment (CBT) sessions with additional five VR-based body-exposure therapy sessions

Behavioral: Cognitive-behavioral therapy
Usual cognitive-behavioral treatment (CBT) sessions.

Active Comparator: Cognitive behavioral therapy
Patients assigned to this group will receive the usual treatment from the center in which they are recruited for the study (CBT), and will have to complete the evaluations following the same schedule as the experimental group.
Behavioral: Cognitive-behavioral therapy
Usual cognitive-behavioral treatment (CBT) sessions.




Primary Outcome Measures :
  1. Change in Eating Disorder symptomatology: Eating Disorders Inventory-3 (EDI-3; Garner, 2004) drive for thinness (EDI-DT) scale [ Time Frame: From pre-assessment to post-assessment after 6 weeks , and at the six-month follow-up ]
    Evaluation of the change in drive for thinness, with maximum possible score of 28, where higher scores indicate higher drive for thinness.

  2. Change in Eating Disorder symptomatology: Eating Disorders Inventory-3 (EDI-3; Garner, 2004) body dissatisfaction (EDI-BD) scale. [ Time Frame: From pre-assessment to post-assessment after 6 weeks , and at the six-month follow-up ]
    Evaluation of the change in body dissatisfaction, with maximum possible score of 40, where higher scores indicate higher body dissatisfaction.

  3. Change in body mass index values [ Time Frame: From pre-assessment to post-assessment after 6 weeks , and at the six-month follow-up ]
    Evaluation of change in Body Mass Index values


Secondary Outcome Measures :
  1. Change in number of fixations of the gaze towards weight-related body parts [ Time Frame: From pre-assessment to post-assessment after 6 weeks ]
    Evaluation of the attentional bias towards the body using complete fixation time (evaluated in milliseconds) of the gaze towards weight-related body parts, with higher values indicating a greater attentional bias.

  2. Change in complete fixation time of the gaze towards weight-related body parts [ Time Frame: From pre-assessment to post-assessment after 6 weeks . ]
    Evaluation of the attentional bias towards the body using number of fixations of the gaze towards weight-related body parts, with higher values indicating a greater attentional bias

  3. Change in complete fixation time of the gaze towards weight-related body parts [ Time Frame: From pre-assessment to post-assessment after 6 weeks , and at the six-month follow-up ]
    Evaluation of the attentional bias towards the body using number of fixations of the gaze towards weight-related body parts, with higher values indicating a greater attentional bias

  4. Figural Drawing Scale for Body Image Assessment (BIAS-BD) body distortion scores [ Time Frame: From pre-assessment to post-assessment after 6 weeks , and at the six-month follow-up ]
    Evaluation of the change in body distortion using the BIAS-BD body distortion scores, ranging from -80 to 80, with higher scores indicating higher body distortion

  5. Figural Drawing Scale for Body Image Assessment (BIAS-BD) body dissatisfaction scores [ Time Frame: From pre-assessment to post-assessment after 6 weeks , and at the six-month follow-up ]
    Evaluation of the change in body dissatisfaction using the BIAS-BD body distortion scores, ranging from -80 to 80, with higher scores indicating higher body distortion

  6. Change in Physical Appearance State Anxiety Scale (PASTAS) [ Time Frame: From pre-assessment to post-assessment after 6 weeks , and at the six-month follow-up ]
    Evaluation of body-related anxiety using the PASTAS, with a maximum score of 32, with higher scores indicating higher body-related anxiety

  7. Change in Body Appreciation Scale (BAS) [ Time Frame: From pre-assessment to post-assessment after 6 weeks , and at the six-month follow-up ]
    Evaluation of the change in body appreciation using the BAS, with a scale of possible scores ranging from 13-65, where higher scores indicate higher body appreciation


Other Outcome Measures:
  1. Body-related anxiety [ Time Frame: Up to 40 minutes. Baseline (prior to beginning the body exposure session), every two minutes during the exposure, and at the end of the body exposure session ]
    Visual analogue scale from 0 to 100, with higher scores indicating higher body-related anxiety

  2. Fear of gaining weight [ Time Frame: Up to 40 minutes. Baseline (prior to beginning the body exposure session) and at the end of the body exposure session ] ]
    Visual analogue scale from 0 to 100, with higher scores indicating higher fear of gaining weight

  3. Full body illusion [ Time Frame: Up to 40 minutes. Baseline (prior to beginning the body exposure session) ]
    Visual analogue scale from 0 to 100, with higher scores indicating higher body ownership illusion



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Ages Eligible for Study:   14 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with a primary diagnosis of anorexia nervosa (DSM-V)
  • from the age of 14 years
  • with BMI <18.5
  • subsyndromal patients will also be included, understood as those patients who fulfill all the criteria of anorexia nervosa with the exception of two at most

Exclusion Criteria:

  • visual deficits
  • epilepsy or neuroleptic medication
  • psychotic disorder
  • bipolar disorder
  • medical complications
  • pregnancy
  • clinical cardiac arrhythmia

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04786951


Contacts
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Contact: José Gutiérrez-Maldonado 93 312 51 24 ext +34 jgutierrezm@ub.edu
Contact: Marta Ferrer-Garcia 667287894 ext +34 martaferrerg@ub.edu

Locations
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Spain
Hospital Sant Joan de Déu Recruiting
Barcelona, Spain, 08950
Contact: Eduard Serrano-Troncoso       eduardo.serrano@sjd.es   
Sponsors and Collaborators
University of Barcelona
Hospital Sant Joan de Deu
Hospital San Carlos, Madrid
Hospital Universitari de Bellvitge
Investigators
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Principal Investigator: José Gutiérrez-Maldonado jgutierrezm@ub.edu
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Responsible Party: Jose Gutierrez Maldonado, Prof. Dr., University of Barcelona
ClinicalTrials.gov Identifier: NCT04786951    
Other Study ID Numbers: PID2019-108657RB-I00
First Posted: March 8, 2021    Key Record Dates
Last Update Posted: May 19, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The data presented in this study will be available on request from the corresponding author. The data are not publicly available due to patients' privacy restrictions.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jose Gutierrez Maldonado, University of Barcelona:
Attentional bias
Virtual Reality
Body exposure procedure
Attentional bias modification training
Additional relevant MeSH terms:
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Anorexia
Anorexia Nervosa
Signs and Symptoms, Digestive
Feeding and Eating Disorders
Mental Disorders