Treating the Fear of Gaining Weight in Anorexia Nervosa

Anorexia Nervosa Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04028635
• Other study ID #: PSI2015-70389-R
• Status: Terminated
• Phase: N/A
• Start date: February 25, 2019
• Est. completion date: July 30, 2020

Study information

• Verified date: November 2020
• Source: University of Barcelona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 35
• Est. completion date: July 30, 2020
• Est. primary completion date: April 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anorexia
• Anorexia Nervosa

Intervention

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.
• Cognitive behavioral therapy
Usual CBT

Locations

Country	Name	City	State
Spain	Universitat de Barcelona	Barcelona

Sponsors (6)

Lead Sponsor	Collaborator
University of Barcelona	Hospital Clinic of Barcelona, Hospital San Carlos, Madrid, Hospital Sant Joan de Deu, Hospital Universitari de Bellvitge, Istituto Auxologico Italiano

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Body-related anxiety	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
Other	Fear of gaining weight	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
Other	Body ownership illusion	Visual analogue scale from 0 to 100, with higher scores indicating higher body ownership illusion	Baseline (prior to beginning the body exposure session)
Primary	Change in Body Mass Index	Evaluation of change in Body Mass Index	from pre-assessment to post-assessment after 6 weeks
Primary	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	from pre-assessment to post-assessment after 6 weeks
Primary	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	from pre-assessment to post-assessment after 6 weeks
Primary	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	from pre-assessment to post-assessment after 6 weeks
Primary	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	from pre-assessment to post-assessment after 6 weeks
Primary	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	from pre-assessment to post-assessment after 6 weeks
Primary	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	from pre-assessment to post-assessment after 6 weeks
Primary	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	from pre-assessment to post-assessment after 6 weeks
Primary	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	from pre-assessment to post-assessment after 6 weeks
Secondary	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	from pre-assessment to post-assessment after 6 weeks
Secondary	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	from pre-assessment to post-assessment after 6 weeks