Treating the Fear of Gaining Weight in Anorexia Nervosa

November 13, 2020 updated by: Jose Gutierrez Maldonado, University of Barcelona

Treating the Fear of Gaining Weight. A Randomized Controlled Clinical Trial for Patients With Anorexia Nervosa

The main aim of this study is to develop a virtual reality (VR) embodiment-based exposure technique to improve the treatment of anorexia nervosa (AN). A systematic and hierarchical body exposure intervention in which the patient owns a virtual avatar is proposed. At first, the virtual body matches with the real measurements of the patient, then the experimenter will progressively increase Body Mass Index (BMI) values of the virtual body during the exposure sessions until a healthy BMI value is reached (e.g. BMI score of 20). In this study a VR embodiment-based technique that combines visuo-motor and a visuo-tactile stimulation procedures is proposed in order to increase illusory feelings of ownership over the virtual body. It is hypothesised that adding a VR-based body exposure intervention to the classical cognitive behavioral therapy (CBT) will significantly reduce symptomatology in AN patients.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

In order to evaluate the efficacy of the addition of a VR body exposure component to the usual treatment, a randomized controlled clinical trial will be conducted. 54 patients with a primary diagnosis of anorexia nervosa and a BMI > 18.5 will be randomly assigned to the experimental group receiving VR body exposure in addition to cognitive behavioral therapy or control group, which receives cognitive behavioral therapy only. Data regarding eating disorder symptomatology and body related attention will be collected before and at the end of the intervention, as well as after six months of follow-up. In the systematic and hierarchical VR body exposure intervention, which consists of 5 weekly exposure sessions, patients will gradually be exposed to increases in the BMI of their virtual avatar. Each session starts by inducing illusory feelings of ownership over the virtual body by the means of visuo-tactile and visuo-motor stimulation. Then patients are exposed to their virtual bodies in order to achieve the habituation or extinction of the anxiety response to their body image and, consequently, reduce the fear of gaining weight. During exposure, patients will be asked to focus on different parts of the virtual body, by asking what they think and feel about them. Body ownership illusion, body-related anxiety and fear of gaining weight will be assessed within each session by means of visual analogue scales.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
35

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08035
        • Universitat de Barcelona

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

10 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients with primary diagnosis of anorexia nervosa (DSM-V)
  • from the age of 14 years
  • with BMI <18.5

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Cognitive-behavioral therapy plus 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, six sessions of VR-based body exposure intervention. In these weekly sessions patients will go through a body exposure intervention in which the 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: Cognitive-behavioral therapy plus VR-based body exposure
Combine usual cognitive-behavioral treatment (CBT) sessions with additional five VR-based body-exposure therapy sessions.
Active Comparator: Cognitive behavioral therapy
Patients assigned to this group will receive the usual treatment from the centre 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 CBT

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Body Mass Index
Time Frame: from pre-assessment to post-assessment after 6 weeks
Evaluation of change in Body Mass Index
from pre-assessment to post-assessment after 6 weeks
Change in Eating Disorders Inventory-3 (EDI-3) drive for thinness (EDI-DT) scale
Time Frame: from pre-assessment to post-assessment after 6 weeks
Evaluation of the change in drive for thinness, with maximum possible score of 28, where higher scores indicate higher drive for thinness
from pre-assessment to post-assessment after 6 weeks
Change in Eating Disorders Inventory-3 (EDI-3) body dissatisfaction (EDI-BD) scale
Time Frame: from pre-assessment to post-assessment after 6 weeks
Evaluation of the change in body dissatisfaction, with maximum possible score of 40, where higher scores indicate higher body dissatisfaction
from pre-assessment to post-assessment after 6 weeks
Change in Silhouette Test for Adolescents (TSA) body distortion scores
Time Frame: from pre-assessment to post-assessment after 6 weeks
Evaluation of the change in body distortion in adolescents using the TSA body distortion scores, which can range from -3 to 3, with higher values indicating higher body distortion
from pre-assessment to post-assessment after 6 weeks
Change in Silhouette Test for Adolescents (TSA) body dissatisfaction scores
Time Frame: from pre-assessment to post-assessment after 6 weeks
Evaluation of the change in body dissatisfaction in adolescents using the TSA body dissatisfaction scores, which can range from -3 to 3, with lower scores indicating higher body dissatisfaction
from pre-assessment to post-assessment after 6 weeks
Figural Drawing Scale for Body Image Assessment (BIAS-BD) body distortion scores
Time Frame: from pre-assessment to post-assessment after 6 weeks
Evaluation of the change in body distortion in adults using the BIAS-BD body distortion scores, ranging from -80 to 80, with higher scores indicating higher body distortion
from pre-assessment to post-assessment after 6 weeks
Figural Drawing Scale for Body Image Assessment (BIAS-BD) body dissatisfaction scores
Time Frame: from pre-assessment to post-assessment after 6 weeks
Evaluation of the change in body dissatisfaction in adults using the BIAS-BD body dissatisfaction scores, ranging from -80 to 80, with higher scores indicating higher body dissatisfaction
from pre-assessment to post-assessment after 6 weeks
Change in Physical Appearance State Anxiety Scale (PASTAS)
Time Frame: from pre-assessment to post-assessment after 6 weeks
Evaluation of body-related anxiety using the PASTAS, with a maximum score of 32, with higher scores indicating higher body-related anxiety
from pre-assessment to post-assessment after 6 weeks
Change in Body Appreciation Scale (BAS)
Time Frame: from pre-assessment to post-assessment after 6 weeks
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
from pre-assessment to post-assessment after 6 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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 complete fixation time (evaluated in milliseconds) of the gaze towards weight-related body parts, with higher values indicating a greater attentional bias
from pre-assessment to post-assessment after 6 weeks
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 the number of fixations of the gaze towards weight-related body parts, with higher values indicating a greater attentional bias
from pre-assessment to post-assessment after 6 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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
Visual analogue scale from 0 to 100, with higher scores indicating higher body-related anxiety
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
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
Up to 40 minutes. Baseline (prior to beginning the body exposure session) and at the end of the body exposure session
Body ownership illusion
Time Frame: Baseline (prior to beginning the body exposure session)
Visual analogue scale from 0 to 100, with higher scores indicating higher body ownership illusion
Baseline (prior to beginning the body exposure session)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Barcelona

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Hospital Clinic of Barcelona
Hospital Universitari de Bellvitge
Istituto Auxologico Italiano
Hospital San Carlos, Madrid
Hospital Sant Joan de Deu

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: José Gutiérrez-Maldonado, Prof. Dr., University of Barcelona

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 25, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 30, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 16, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 19, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 22, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 17, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 13, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PSI2015-70389-R

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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