Virtual Reality Based Cue-exposure Treatment for Bulimia Nervosa

NCT02237300 | Completed DMC

• 1 other identifier: PSI2011-28801
• Study Type: interventional
• Target: 60
• Locations: 2 countries
• Sites: 2

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.

Conditions

Bulimia Nervosa; Binge-Eating Disorder; Binge Eating

Keywords

Bulimia nervosa; Binge eating disorder; Food craving; Anxiety; Bingeing; Cue Exposure Therapy; Virtual Reality

Outcome Measures

Primary Outcomes (3)

• 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

  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

• 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

  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

  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

• 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

  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 Outcomes (1)

• Change from baseline in anxiety on the State-Trait Anxiety Inventory at the end of the treatment and at six month follow-up

  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 Outcomes (2)

• Anxiety and food craving experienced during exposure to food-related VR environments on a visual analog scale from 0 to 100 (at pre-test)

  Pre-test prior to initiating the booster sessions (one session)

• Intrasession anxiety and food craving assessed using a visual analog scale from 0 to 100

  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

Study Arms (2)

VR based cue-exposure therapy

EXPERIMENTAL

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

Additional Cognitive-behavioral treatment

ACTIVE COMPARATOR

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

Interventions

VR based cue-exposure therapy BEHAVIORAL

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

VR based cue-exposure therapy

Additional Cognitive-behavioral treatment BEHAVIORAL

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

Additional Cognitive-behavioral treatment

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Barcelona: lead
• Hospital Universitari de Bellvitge: collaborator
• Consorci Sanitari de l'Anoia: collaborator
• Centro ABB: collaborator
• Hospital Universitari Joan XXIII de Tarragona.: collaborator
• Istituto Auxologico Italiano: collaborator

Study Sites (2)

Università Cattolica del Sacro Cuore

Milan, Milan, Italy

Location

Universitat de Barcelona

Barcelona, Barcelona, 08035, Spain

Location

Related Publications (4)

• Martinez-Mallen E, Castro-Fornieles J, Lazaro L, Moreno E, Morer A, Font E, Julien J, Vila M, Toro J. Cue exposure in the treatment of resistant adolescent bulimia nervosa. Int J Eat Disord. 2007 Nov;40(7):596-601. doi: 10.1002/eat.20423.

  PMID: 17607695 BACKGROUND

• Toro J, Cervera M, Feliu MH, Garriga N, Jou M, Martinez E, Toro E. Cue exposure in the treatment of resistant bulimia nervosa. Int J Eat Disord. 2003 Sep;34(2):227-34. doi: 10.1002/eat.10186.

  PMID: 12898559 BACKGROUND

• Fairburn, Christopher G; Wilson, G Terence. Binge eating: Nature, assessment, and treatment. New York: Guilford Press, 1993. NLM ID: 9216440 [Book]

  BACKGROUND

• Ferrer-Garcia M, Pla-Sanjuanelo J, Dakanalis A, Vilalta-Abella F, Riva G, Fernandez-Aranda F, Forcano L, Riesco N, Sanchez I, Clerici M, Ribas-Sabate J, Andreu-Gracia A, Escandon-Nagel N, Gomez-Tricio O, Tena V, Gutierrez-Maldonado J. A Randomized Trial of Virtual Reality-Based Cue Exposure Second-Level Therapy and Cognitive Behavior Second-Level Therapy for Bulimia Nervosa and Binge-Eating Disorder: Outcome at Six-Month Followup. Cyberpsychol Behav Soc Netw. 2019 Jan;22(1):60-68. doi: 10.1089/cyber.2017.0675. Epub 2018 Jul 30.

  PMID: 30059240 DERIVED

MeSH Terms

Conditions

Bulimia Nervosa; Binge-Eating Disorder; Bulimia; Anxiety Disorders

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders; Hyperphagia; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• José Gutiérrez-Maldonado, PhD

  University of Barcelona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Study Record Dates

• First Submitted: September 4, 2014
• First Posted: September 11, 2014
• Study Start: February 1, 2015
• Primary Completion: September 1, 2015
• Study Completion: March 1, 2016
• Last Updated: February 9, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1); IT (1)