Using Virtual Reality and Sensor Technology to Enhance Outcomes From Treatment for Binge Eating

Binge Eating Clinical Trial

Official title:

Using Virtual Reality and Sensor Technology to Enhance Outcomes From Treatment for Binge Eating

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05041660
• Other study ID #: 1906007227
• Status: Completed
• Phase: N/A
• Start date: October 14, 2019
• Est. completion date: August 5, 2020

Study information

• Verified date: September 2021
• Source: Drexel University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study evaluates whether virtual-reality-based inhibitory control trainings are more effective than computerized trainings in reducing binge eating symptomatology. These trainings are used to improve people's ability to resist their impulses towards highly palatable foods (such as chips or cookies). These trainings also offer promise as a companion to Cognitive Behavioral Therapy, an often used and relatively effective therapeutic methodology.

Description:

Low levels of inhibitory control (i.e., the ability to withhold a quick, automatic response) is strongly linked with binge eating pathology. One of the most widely used and effective treatments for binge eating leaves 40-60% of patients partially or fully symptomatic at post-treatment. Researchers have begun to investigate the efficacy of computerized inhibitory control trainings (ICTs), which are tasks in which participants are asked repeatedly withhold a keypress responses to food stimuli. The intention of these trainings is to improve inhibitory control and to, in turn, reduce dysregulated eating behavior. Results for the efficacy of ICTs are promising, yet mixed. ICTs that are gamified (i.e., turned into a video game) using virtual reality technology have high potential to address the barriers which may be limiting the efficacy of previous ICTs. The current study aims to finalize development and test the feasibility, acceptability and preliminary efficacy of the first-ever virtual reality ICT (VR-ICT) for individuals with binge eating pathology. Thus, the study's aims are as follows: Primary aim 1: Enhance features of a previously developed, VR-based ICT for binge eating. Primary aim 2: Examine the feasibility and acceptability of the VR ICT training program. Primary aim 3: Examine the efficacy of VR-ICT versus a non-VR ICT and ICT vs. sham training, for reductions in binge eating from pre to post-treatment and at follow-up. Based on previous research and data from a pilot study, the investigators hypothesize a) that the VR ICT training program will be feasible and acceptable and b) that the VR-ICT and ICT will produce superior reductions in binge eating from pre- to post-treatment and at follow-up, as compared, respectively, with the non-VR ICT and the sham ICT.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: August 5, 2020
• Est. primary completion date: August 5, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Speak, write, and understand English
• Age 18-65 years
• Experience objectively or subjectively large binge eating episodes once per week or more for the past three months
• Objectively large binge episodes are defined by the Eating Disorder Examination (EDE; a measure employed in this study) as consisting of at least two full meals of two courses at each (i.e., four courses total) or of at least three main courses
• Participants, also as per the EDE, must also experience a loss of control over their eating for the given episode to qualify as an objective binge
• Subjective binges are those which do not meet the food quantity criteria but during which participants experience a loss of control and feel they have eaten too much
• If applicable, have stable psychiatric medication for the past three months.

Exclusion Criteria:

• Acute suicide risk
• Are planning on receiving psychological treatment for binge eating during the course of their participation in the study
• Are planning to participate in a structured weight loss treatment program (e.g., WeightWatchers, behavioral weight loss treatment) during the course of their participation in the study
• Are currently receiving weight loss treatment
• Have a BMI below 17.5
• Co-morbid clinically significant psychological disorder that would require attention beyond the study treatment (i.e., bipolar I disorder, substance dependence, and/or psychotic conditions)
• Diagnosis of intellectual disability or autism spectrum disorder
• History of neurological condition or traumatic brain injury
• Current pregnancy or intention to become pregnant during the course of their participation
• History of bariatric surgery
• Are currently using a stimulant medication (e.g., Ritalin, Adderall)
• No internet connection at home

Related Conditions & MeSH terms

• Binge Eating
• Binge-Eating Disorder
• Bulimia
• Inhibition (Psychology)

Intervention

Other:
• Virtual-reality-based training
Uses virtual reality for the inhibitory control training, rather than a relatively simplistic computerized training.
• Inhibitory Control Training
Uses an active inhibitory control training which includes a "stop" signal.
• Sham Inhibitory Control Training
Uses an inhibitory control training which does not include a "stop" signal.
• Computerized training
Uses a relatively simplistic computerized training.

Locations

Country	Name	City	State
United States	Drexel Universitty	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Drexel University	Drexel Coulter Translational Research Partnership Program

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Protocol recruitment	This outcome will be assessed according to whether the investigators can recruit at least 40 participants. This forms the first half of the assessment of the protocol's feasibility.	The investigators will assess adherence at follow-up assessments (18 weeks after baseline assessment)
Primary	Protocol retention	This outcome will be assessed according to whether > 75% of participants completed all assessments. This forms the second half of the assessment of the protocol's feasibility.	The investigators will assess adherence at follow-up assessments (18 weeks after baseline assessment)
Primary	Protocol adherence	This outcome will be assessed according to whether participants completed = 75% of all daily training sessions. This forms the first half of the assessment of the protocol's acceptability.	The investigators will assess adherence at follow-up assessments (18 weeks after baseline assessment).
Primary	Protocol satisfaction	This outcome will be assessed according to whether the average participant rating is >= 4 on all questions on the Technology Reactions and Acceptance and Technology Expectancy Questionnaires. This forms the second half of the assessment of the protocol's acceptability.	The investigators will assess satisfaction at follow-up assessments (18 weeks after baseline assessment).
Primary	Impact of VR + ICT vs. VR + Sham on binge eating frequency	This outcome will be assessed according to whether participation in the VR + ICT condition produces a larger change in binge eating episodes than does participation in the VR + Sham condition, as measured using the binge module of the Eating Disorder Examination version 17.	The investigators will assess efficacy at post-treatment (6 weeks after baseline) and at follow-up (18 weeks after baseline).