- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04786951
Virtual Reality-Based Attention Bias Modification Training for Adolescents With Anorexia Nervosa (AN-VR-ABMT)
AN-VR-ABM: Attentional Bias Modification and Body Exposure Using Virtual Reality and Eye-Tracking to Enhance Treatment for Adolescents With Anorexia Nervosa
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.
Study Overview
Status
Conditions
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Barcelona
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Barcelona, Barcelona, Spain, 08950
- Hospital Sant Joan de Déu
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: 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.
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Combine usual treatment with an additional five VR-based body-exposure therapy sessions and five sessions of Attentional Bias Modification Training.
Combine the usual treatment with an additional five VR-based body-exposure therapy sessions
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. |
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Experimental: 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.
|
Combine the usual treatment with an additional five VR-based body-exposure therapy sessions
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. |
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Active Comparator: 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.
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Drive for Thinness (EDI-DT)
Time Frame: Assessed at baseline, at the end of treatment (6 weeks), and at 6-month follow-up.
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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.
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Assessed at baseline, at the end of treatment (6 weeks), and at 6-month follow-up.
|
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Change in Body Dissatisfaction (EDI-BD)
Time Frame: Assessed at baseline, at the end of treatment (6 weeks), and at 6-month follow-up.
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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.
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Assessed at baseline, at the end of treatment (6 weeks), and at 6-month follow-up.
|
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Change in Body Dissatisfaction (BIAS - BD)
Time Frame: Assessed at baseline, at the end of treatment (6 weeks), and at 6-month follow-up.
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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.
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Assessed at baseline, at the end of treatment (6 weeks), and at 6-month follow-up.
|
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Change in Body Distortion (BIAS - BD)
Time Frame: Assessed at baseline, at the end of treatment (6 weeks), and at 6-month follow-up.
|
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.
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Assessed at baseline, at the end of treatment (6 weeks), and at 6-month follow-up.
|
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Change in complete fixation time towards weight-related body parts
Time Frame: Assessed at baseline, at the end of treatment (6 weeks), and at 6-month follow-up.
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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.
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Assessed at baseline, at the end of treatment (6 weeks), and at 6-month follow-up.
|
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Change in the number of fixations towards weight-related body parts
Time Frame: Assessed at baseline, at the end of treatment (6 weeks), and at 6-month follow-up.
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Change in attentional bias towards weight-related body parts, measured as the number of fixations of gaze.
Higher values indicate greater attentional bias.
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Assessed at baseline, at the end of treatment (6 weeks), and at 6-month follow-up.
|
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Change in Body Mass Index values
Time Frame: Assessed at baseline, at the end of treatment (6 weeks), and at 6-month follow-up.
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Change in Body Mass Index was calculated as weight (kg) divided by height (m) squared.
Higher values indicate greater BMI.
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Assessed at baseline, at the end of treatment (6 weeks), and at 6-month follow-up.
|
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Change in Fear of Gaining Weight
Time Frame: Assessed at baseline, at the end of treatment (6 weeks), and at 6-month follow-up.
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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.
|
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Change in Anxiety
Time Frame: 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.
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Change in anxiety, measured using a visual analogue scale (0-100).
Higher scores indicate greater anxiety.
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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.
|
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Change in Body-related Anxiety (PASTAS)
Time Frame: Assessed at baseline, at the end of treatment (6 weeks), and at 6-month follow-up.
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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)
Time Frame: Assessed at baseline, at the end of treatment (6 weeks), and at 6-month follow-up.
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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.
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Assessed at baseline, at the end of treatment (6 weeks), and at 6-month follow-up.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in number of fixations of the gaze towards weight-related body parts
Time Frame: From pre-assessment to post-assessment after 6 weeks
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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.
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From pre-assessment to post-assessment after 6 weeks
|
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Change in complete fixation time of the gaze towards weight-related body parts
Time Frame: From pre-assessment to post-assessment after 6 weeks .
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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
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From pre-assessment to post-assessment after 6 weeks .
|
|
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
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From pre-assessment to post-assessment after 6 weeks , and at the six-month follow-up
|
|
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
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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
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From pre-assessment to post-assessment after 6 weeks , and at the six-month follow-up
|
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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
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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
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From pre-assessment to post-assessment after 6 weeks , and at the six-month follow-up
|
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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
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From pre-assessment to post-assessment after 6 weeks , and at the six-month follow-up
|
|
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
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From pre-assessment to post-assessment after 6 weeks , and at the six-month follow-up
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
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Visual analogue scale from 0 to 100, with higher scores indicating higher body-related anxiety
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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
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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 ]
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Visual analogue scale from 0 to 100, with higher scores indicating higher fear of gaining weight
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Up to 40 minutes. Baseline (prior to beginning the body exposure session) and at the end of the body exposure session ]
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: José Gutiérrez-Maldonado, jgutierrezm@ub.edu
Publications and helpful links
General Publications
- 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
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PID2019-108657RB-I00
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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