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Virtual Reality Based Cue-exposure Treatment for Bulimia Nervosa

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02237300
Recruitment Status : Completed
First Posted : September 11, 2014
Last Update Posted : February 10, 2017
Sponsor:
Collaborators:
Hospital Universitari de Bellvitge
Consorci Sanitari de l'Anoia
Centro ABB
Hospital Universitari Joan XXIII de Tarragona.
Istituto Auxologico Italiano
Information provided by (Responsible Party):
Jose Gutierrez Maldonado, University of Barcelona

Brief 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.


Condition or disease Intervention/treatment Phase
Bulimia Nervosa Binge-Eating Disorder Binge Eating Behavioral: VR based cue-exposure therapy Behavioral: Additional Cognitive-behavioral treatment Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Tratamiento de la Bulimia Nerviosa Mediante exposición a señales Con Realidad Virtual
Actual Study Start Date : February 2015
Actual Primary Completion Date : September 2015
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: VR based cue-exposure therapy
Throughout the six sessions, participants (n=30) will be exposed to different VR environments related to binge behavior, according to a previously constructed hierarchy. During exposure, patients will face high risk situations to diminish or to extinguish the conditioned response of anxiety when exposed to food related cues. In each session, the patient will be exposed to the corresponding step of the hierarchy. During the exposure session, the patient can handle the virtual foods using the laptop's mouse but cannot eat the foods (exposure with response prevention). Exposure will end when the anxiety level decreased by 40% in relation to the level registered at the initiation of the exposure session or after 60 minutes of exposure.
Behavioral: VR based cue-exposure therapy
Comparison of VR based cue-exposure therapy sessions and additional Cognitive-behavioral treatment sessions

Active Comparator: Additional Cognitive-behavioral treatment
Participants (n=30) in this condition will receive six CBT booster sessions (two sessions per week) over the course of three weeks to improve the output of treatment. CBT sessions are based on the approach described by by Eldredge and colleagues (Eldredge et al.,1997). In this treatment program, patients are trained to self-monitor their food patterns and to identify and manage thoughts, emotions, and environmental factors related to disrupted eating behaviors.
Behavioral: Additional Cognitive-behavioral treatment
Comparison of VR based cue-exposure therapy sessions and additional Cognitive-behavioral treatment sessions




Primary Outcome Measures :
  1. Change from baseline in eating disorders symptomatology on the BN, DT and BD subscales of EDI-3 (Eating Disorders Inventory-3), at the end of the treatment and at six month follow-up [ Time Frame: Baseline (one assessment session before to the first second-level treatment session), week 3 (at the end of the last treatment session), and at the six-month follow-up ]
  2. Change from baseline in the frequency of binging and purging episodes using self-reports at the end of the treatment and at six month follow-up [ Time Frame: Baseline (daily along the two weeks before to the first second-level treatment session), daily along the two weeks after the last treatment session, and daily along the two weeks after six months follow-up ]
    Binging and purging episodes will be self-registered by the participants of the two groups during the two weeks prior to beginning the second-level treatment sessions, during the two weeks after the end of the treatment sessions, and during two weeks after six-month follow-up

  3. Change from baseline in food craving on the FCQ-T/S (Food Craving Questionnaire-Trait/State) at the end of the treatment and at six months follow-up [ Time Frame: Baseline (one assessment session before to the first second-level treatment session), week 3 (at the end of the last treatment session), and at the six-month follow-up ]

Secondary Outcome Measures :
  1. Change from baseline in anxiety on the State-Trait Anxiety Inventory at the end of the treatment and at six month follow-up [ Time Frame: Baseline (one assessment session before to the first second-level treatment session), week 3 (at the end of the last treatment session), and at the six-month follow-up ]

Other Outcome Measures:
  1. Anxiety and food craving experienced during exposure to food-related VR environments on a visual analog scale from 0 to 100 (at pre-test) [ Time Frame: Pre-test prior to initiating the booster sessions (one session) ]
    Participants assigned to the virtual reality based cue-exposure therapy condition will be exposed to 10 virtual foods in 4 different virtual environments (kitchen, dining-room, bedroom, and café) where they will be asked about their food craving and anxiety experienced in each situation to develop a proper exposure hierarchy according to the specific characteristics and needs of each patient.

  2. Intrasession anxiety and food craving assessed using a visual analog scale from 0 to 100 [ Time Frame: Up to 60 minutes. Baseline (prior to beginning the exposure task on each VR-CET session), every five minutes during the exposure task on each session, and at the end of the exposure task on each session ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of bulimia nervosa or binge eating disorder according the DSM-5
  • Written and informed consent to participate

Exclusion Criteria:

  • Other concurrent severe mental disorders (substance use disorders, bipolar disorder, psychosis)
  • Suicidal ideation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02237300


Locations
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Italy
Università Cattolica del Sacro Cuore
Milan, Italy
Spain
Universitat de Barcelona
Barcelona, Spain, 08035
Sponsors and Collaborators
University of Barcelona
Hospital Universitari de Bellvitge
Consorci Sanitari de l'Anoia
Centro ABB
Hospital Universitari Joan XXIII de Tarragona.
Istituto Auxologico Italiano
Investigators
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Principal Investigator: José Gutiérrez-Maldonado, PhD University of Barcelona
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jose Gutierrez Maldonado, Full Professor, University of Barcelona
ClinicalTrials.gov Identifier: NCT02237300    
Other Study ID Numbers: PSI2011-28801
PSI2011-28801 ( Other Grant/Funding Number: Ministerio de Ciencia e Innovación - Gobierno de España )
First Posted: September 11, 2014    Key Record Dates
Last Update Posted: February 10, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jose Gutierrez Maldonado, University of Barcelona:
Bulimia nervosa
Binge eating disorder
Food craving
Anxiety
Bingeing
Cue Exposure Therapy
Virtual Reality
Additional relevant MeSH terms:
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Bulimia
Feeding and Eating Disorders
Binge-Eating Disorder
Bulimia Nervosa
Mental Disorders
Hyperphagia
Signs and Symptoms, Digestive
Signs and Symptoms