Clinical trial NCT05041660: Using Virtual Reality and Sensor Technology to Enhance Outcomes From Treatment for Binge Eating
Official title: Using Virtual Reality and Sensor Technology to Enhance Outcomes From Treatment for Binge Eating
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Binge Eating
Inhibition (Psychology)
Keywords: Inhibitory control
Virtual reality
Binge eating
Continuous glucose monitoring
Lead sponsor: Drexel University
Sponsor class: OTHER
Collaborators: name: Drexel Coulter Translational Research Partnership Program
First posted: 2021-09-13
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: The study is a 2x2 factorial design with the factors being VR (VR/non-VR) and ICT (ICT/Sham).
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Protocol recruitment
timeFrame: The investigators will assess adherence at follow-up assessments (18 weeks after baseline assessment)
measure: Protocol retention
timeFrame: The investigators will assess adherence at follow-up assessments (18 weeks after baseline assessment)
measure: Protocol adherence
timeFrame: The investigators will assess adherence at follow-up assessments (18 weeks after baseline assessment).
measure: Protocol satisfaction
timeFrame: The investigators will assess satisfaction at follow-up assessments (18 weeks after baseline assessment).
measure: Impact of VR + ICT vs. VR + Sham on binge eating frequency
timeFrame: The investigators will assess efficacy at post-treatment (6 weeks after baseline) and at follow-up (18 weeks after baseline).
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Drexel Universitty
state: Pennsylvania
Study officials:
affiliation: Drexel University
name: Stephanie Manasse, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: