Treating the Fear of Gaining Weight in Anorexia Nervosa

NCT04028635 | Terminated

• 1 other identifier: PSI2015-70389-R
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Anorexia Nervosa

Outcome Measures

Primary Outcomes (9)

• Change in Body Mass Index

  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

  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

  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

  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

  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

  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

  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)

  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)

  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 Outcomes (2)

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

  from pre-assessment to post-assessment after 6 weeks

• Change in number of fixations of the gaze towards weight-related body parts

  from pre-assessment to post-assessment after 6 weeks

Other Outcomes (3)

• 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

  Up to 40 minutes. Baseline (prior to beginning the body exposure session) and at the end of the body exposure session

• Body ownership illusion

  Baseline (prior to beginning the body exposure session)

Study Arms (2)

Cognitive-behavioral therapy plus VR-based body exposure

EXPERIMENTAL

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

Cognitive behavioral therapy

ACTIVE COMPARATOR

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

Interventions

Cognitive-behavioral therapy plus VR-based body exposure BEHAVIORAL

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

Cognitive-behavioral therapy plus VR-based body exposure

Cognitive behavioral therapy BEHAVIORAL

Usual CBT

Cognitive behavioral therapy

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Barcelona: lead
• Hospital Sant Joan de Deu: collaborator
• Hospital Clinic of Barcelona: collaborator
• Hospital San Carlos, Madrid: collaborator
• Hospital Universitari de Bellvitge: collaborator
• Istituto Auxologico Italiano: collaborator

Study Sites (1)

Universitat de Barcelona

Barcelona, 08035, Spain

Location

MeSH Terms

Conditions

Anorexia Nervosa

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• José Gutiérrez-Maldonado, Prof. Dr.

  University of Barcelona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Study Record Dates

• First Submitted: July 16, 2019
• First Posted: July 22, 2019
• Study Start: February 25, 2019
• Primary Completion: April 30, 2020
• Study Completion: July 30, 2020
• Last Updated: November 17, 2020

Record last verified: 2020-11

Locations

ES (1)