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Treating the Fear of Gaining Weight in Anorexia Nervosa

Primary Purpose

Anorexia Nervosa

Status
Terminated
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Cognitive-behavioral therapy plus VR-based body exposure
Cognitive behavioral therapy
Sponsored by
University of Barcelona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anorexia Nervosa

Eligibility Criteria

14 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Universitat de Barcelona

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cognitive-behavioral therapy plus VR-based body exposure

Cognitive behavioral therapy

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in Body Mass Index
Evaluation of change in Body Mass Index
Change in Eating Disorders Inventory-3 (EDI-3) drive for thinness (EDI-DT) scale
Evaluation of the change in drive for thinness, with maximum possible score of 28, where higher scores indicate higher drive for thinness
Change in Eating Disorders Inventory-3 (EDI-3) body dissatisfaction (EDI-BD) scale
Evaluation of the change in body dissatisfaction, with maximum possible score of 40, where higher scores indicate higher body dissatisfaction
Change in Silhouette Test for Adolescents (TSA) body distortion scores
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
Change in Silhouette Test for Adolescents (TSA) body dissatisfaction scores
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
Figural Drawing Scale for Body Image Assessment (BIAS-BD) body distortion scores
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
Figural Drawing Scale for Body Image Assessment (BIAS-BD) body dissatisfaction scores
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
Change in Physical Appearance State Anxiety Scale (PASTAS)
Evaluation of body-related anxiety using the PASTAS, with a maximum score of 32, with higher scores indicating higher body-related anxiety
Change in Body Appreciation Scale (BAS)
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

Secondary Outcome Measures

Change in complete fixation time of the gaze towards weight-related body parts
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
Change in number of fixations of the gaze towards weight-related body parts
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

Full Information

First Posted
July 16, 2019
Last Updated
November 13, 2020
Sponsor
University of Barcelona
Collaborators
Hospital Sant Joan de Deu, Hospital Clinic of Barcelona, Hospital San Carlos, Madrid, Hospital Universitari de Bellvitge, Istituto Auxologico Italiano
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1. Study Identification

Unique Protocol Identification Number
NCT04028635
Brief Title
Treating the Fear of Gaining Weight in Anorexia Nervosa
Official Title
Treating the Fear of Gaining Weight. A Randomized Controlled Clinical Trial for Patients With Anorexia Nervosa
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Terminated
Why Stopped
The study was terminated with a total of 35 patients finally enrolled, due to the Sars-Cov-2 (COVID-19) global pandemic breakout and the confinement measures considered.
Study Start Date
February 25, 2019 (Actual)
Primary Completion Date
April 30, 2020 (Actual)
Study Completion Date
July 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Barcelona
Collaborators
Hospital Sant Joan de Deu, Hospital Clinic of Barcelona, Hospital San Carlos, Madrid, Hospital Universitari de Bellvitge, Istituto Auxologico Italiano

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anorexia Nervosa

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cognitive-behavioral therapy plus VR-based body exposure
Arm Type
Experimental
Arm Description
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.
Arm Title
Cognitive behavioral therapy
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive-behavioral therapy plus VR-based body exposure
Intervention Description
Combine usual cognitive-behavioral treatment (CBT) sessions with additional five VR-based body-exposure therapy sessions.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive behavioral therapy
Intervention Description
Usual CBT
Primary Outcome Measure Information:
Title
Change in Body Mass Index
Description
Evaluation of change in Body Mass Index
Time Frame
from pre-assessment to post-assessment after 6 weeks
Title
Change in Eating Disorders Inventory-3 (EDI-3) drive for thinness (EDI-DT) scale
Description
Evaluation of the change in drive for thinness, with maximum possible score of 28, where higher scores indicate higher drive for thinness
Time Frame
from pre-assessment to post-assessment after 6 weeks
Title
Change in Eating Disorders Inventory-3 (EDI-3) body dissatisfaction (EDI-BD) scale
Description
Evaluation of the change in body dissatisfaction, with maximum possible score of 40, where higher scores indicate higher body dissatisfaction
Time Frame
from pre-assessment to post-assessment after 6 weeks
Title
Change in Silhouette Test for Adolescents (TSA) body distortion scores
Description
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
Time Frame
from pre-assessment to post-assessment after 6 weeks
Title
Change in Silhouette Test for Adolescents (TSA) body dissatisfaction scores
Description
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
Time Frame
from pre-assessment to post-assessment after 6 weeks
Title
Figural Drawing Scale for Body Image Assessment (BIAS-BD) body distortion scores
Description
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
Time Frame
from pre-assessment to post-assessment after 6 weeks
Title
Figural Drawing Scale for Body Image Assessment (BIAS-BD) body dissatisfaction scores
Description
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
Time Frame
from pre-assessment to post-assessment after 6 weeks
Title
Change in Physical Appearance State Anxiety Scale (PASTAS)
Description
Evaluation of body-related anxiety using the PASTAS, with a maximum score of 32, with higher scores indicating higher body-related anxiety
Time Frame
from pre-assessment to post-assessment after 6 weeks
Title
Change in Body Appreciation Scale (BAS)
Description
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
Time Frame
from pre-assessment to post-assessment after 6 weeks
Secondary Outcome Measure Information:
Title
Change in complete fixation time of the gaze towards weight-related body parts
Description
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
Time Frame
from pre-assessment to post-assessment after 6 weeks
Title
Change in number of fixations of the gaze towards weight-related body parts
Description
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
Time Frame
from pre-assessment to post-assessment after 6 weeks
Other Pre-specified Outcome Measures:
Title
Body-related anxiety
Description
Visual analogue scale from 0 to 100, with higher scores indicating higher 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
Title
Fear of gaining weight
Description
Visual analogue scale from 0 to 100, with higher scores indicating higher 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
Title
Body ownership illusion
Description
Visual analogue scale from 0 to 100, with higher scores indicating higher body ownership illusion
Time Frame
Baseline (prior to beginning the body exposure session)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
José Gutiérrez-Maldonado, Prof. Dr.
Organizational Affiliation
University of Barcelona
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitat de Barcelona
City
Barcelona
ZIP/Postal Code
08035
Country
Spain

12. IPD Sharing Statement

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Treating the Fear of Gaining Weight in Anorexia Nervosa

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