Virtual Reality Based Cue-exposure Treatment for Bulimia Nervosa

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02237300
• Date of registration: 04/09/2014
• Prospective Registration: Yes
• Primary sponsor: University of Barcelona
• Public title: Virtual Reality Based Cue-exposure Treatment for Bulimia Nervosa
• Scientific title: Tratamiento de la Bulimia Nerviosa Mediante exposición a señales Con Realidad Virtual
• Date of first enrolment: February 2015
• Target sample size: 60
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02237300
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Care Provider).
• Phase: N/A

Countries of recruitment

Italy, Spain

Contacts

• Name: José Gutiérrez-Maldonado, PhD
• Affiliation: University of Barcelona

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 60 Years
Gender: All

Health Condition(s) or Problem(s) studied

Binge-Eating Disorder

Bulimia Nervosa

Binge Eating

Intervention(s)

Behavioral: Additional Cognitive-behavioral treatment

Behavioral: VR based cue-exposure therapy

Primary Outcome(s)

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]

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]

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(s)

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]

Secondary ID(s)

PSI2011-28801

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Istituto Auxologico Italiano

Consorci Sanitari de l'Anoia

Hospital Universitari Joan XXIII de Tarragona.

Hospital Universitari de Bellvitge

Centro ABB