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Treating the Fear of Gaining Weight in Anorexia Nervosa

NCT ID: NCT04028635

Last Updated: 2020-11-17

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

TERMINATED

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-25

Study Completion Date

2020-07-30

Brief Summary

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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

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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.

Conditions

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Anorexia Nervosa

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Cognitive-behavioral therapy plus VR-based body exposure

Intervention Type BEHAVIORAL

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

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.

Group Type ACTIVE_COMPARATOR

Cognitive behavioral therapy

Intervention Type BEHAVIORAL

Usual CBT

Interventions

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Cognitive-behavioral therapy plus VR-based body exposure

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

Intervention Type BEHAVIORAL

Cognitive behavioral therapy

Usual CBT

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Sant Joan de Deu

OTHER

Sponsor Role collaborator

Hospital Clinic of Barcelona

OTHER

Sponsor Role collaborator

Hospital San Carlos, Madrid

OTHER

Sponsor Role collaborator

Hospital Universitari de Bellvitge

OTHER

Sponsor Role collaborator

Istituto Auxologico Italiano

OTHER

Sponsor Role collaborator

University of Barcelona

OTHER

Sponsor Role lead

Responsible Party

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Jose Gutierrez Maldonado

Full Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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José Gutiérrez-Maldonado, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

University of Barcelona

Locations

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Universitat de Barcelona

Barcelona, , Spain

Site Status

Countries

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Spain

Other Identifiers

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PSI2015-70389-R

Identifier Type: -

Identifier Source: org_study_id