Virtual Reality Based Cue-exposure Treatment for Bulimia Nervosa

NCT02237300 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2017-02-09

No results posted yet for this study

Summary

Introduction: The purpose of this research is to develop a new component for cognitive-behavioral treatment (CBT), empirically validated, for binge eating behavior in patients with bulimia nervosa (BN) and binge eating disorder (BED), by means of cue-exposure therapy (CET) with virtual reality. While CBT is an effective treatment for these eating disorders, an important percentage of patients do not improve despite treatment. It is necessary to explore how to enhance the effectivity of usual treatments with the incorporation of new technologies and procedures. The innovation of this investigation is based on the use of VR for cue-exposure therapy, which has been found effective with patients resistant to conventional treatments (CBT and pharmacological intervention), and seeks to enhance this efficacy by increasing possibilities of generalization and providing more useful tools to clinicians, diminishing the logistic complications of the exposure to real cues (food).

Participants: 60 patients with a diagnosis of BN or BED according the DSM-5 who had been proposed for participation in the study by their referral mental health's professional after conducting unsuccessfully a first level treatment (CBT structured intervention) at the clinical sites involved will participate in the study.

Procedure: Participants with active episodes of binge eating (and purging, in the case of BN) during the last 2 weeks of the structured intervention of CBT will be provided with detailed information about the study. All patients who agree to participate in the study and who sign the informed consent form will be randomly assigned to one of the two second-level treatment conditions: virtual reality based cue-exposure therapy (VR-CET) or additional cognitive-behavioral treatment (A-CBT). Both second-level treatment conditions consist of six 60-minute sessions that are held two times per week over a period of three weeks.

In an interview setting, all of the participants will be administered several questionnaires (BN, DT and BD subscales of EDI-3, FCQ-T/S, and STAI-Y) and participants assigned to the VR-CET will also be exposed to various types of virtual foods in different virtual environments (kitchen, dining-room, bedroom, and café) where they will be asked about their food cravings and anxiety experienced in each situation to develop a proper exposure hierarchy according to the specific characteristics and needs of each patient.

Conditions

  • Bulimia Nervosa
  • Binge-Eating Disorder
  • Binge Eating

Interventions

BEHAVIORAL

VR based cue-exposure therapy

Comparison of VR based cue-exposure therapy sessions and additional Cognitive-behavioral treatment sessions

BEHAVIORAL

Additional Cognitive-behavioral treatment

Comparison of VR based cue-exposure therapy sessions and additional Cognitive-behavioral treatment sessions

Sponsors & Collaborators

  • Hospital Universitari de Bellvitge

    collaborator OTHER
  • Consorci Sanitari de l'Anoia

    collaborator OTHER
  • Centro ABB

    collaborator UNKNOWN
  • Hospital Universitari Joan XXIII de Tarragona.

    collaborator OTHER
  • Istituto Auxologico Italiano

    collaborator OTHER
  • University of Barcelona

    lead OTHER

Principal Investigators

  • José Gutiérrez-Maldonado, PhD · University of Barcelona

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-02-28
Primary Completion
2015-09-30
Completion
2016-03-31

Countries

  • Italy
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02237300 on ClinicalTrials.gov