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

Drexel University

Status: Completed

Conditions: Inhibition (Psychology); Binge Eating

Treatments: Other: Sham Inhibitory Control Training; Other: Virtual-reality-based training; Other: Computerized training; Other: Inhibitory Control Training

Study type: Interventional

Funder types: Other

Identifiers

NCT05041660

1906007227

Details and patient eligibility

About

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.

Full 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.

Enrollment: 41 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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41 participants in 4 patient groups

VR ICT

Experimental group

Description:

Virtual-reality-based inhibitory control training done daily at home for 6 weeks.

Treatment:

Other: Inhibitory Control Training

Other: Virtual-reality-based training

VR Sham ICT

Sham Comparator group

Description:

Virtual-reality-based sham inhibitory control training (i.e., one that does not include a "stop" signal and that thus does not truly train inhibitory control) done daily at home for 6 weeks.

Treatment:

Other: Virtual-reality-based training

Other: Sham Inhibitory Control Training

Non-VR ICT

Active Comparator group

Description:

Computerized inhibitory control training done daily at home for 6 weeks.

Treatment:

Other: Inhibitory Control Training

Other: Computerized training

Non-VR Sham ICT

Sham Comparator group

Description:

Computerized sham inhibitory control training (i.e., one that does not include a "stop" signal and that thus does not truly train inhibitory control) done daily at home for 6 weeks.

Treatment:

Other: Computerized training

Other: Sham Inhibitory Control Training