Drexel Universitty
Philadelphia, Pennsylvania, 19104, United States
NCT Number: NCT05041660
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.
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Notify Me18 year–65 year
All sexes
Interventional
Not applicable
Philadelphia, Pennsylvania, 19104, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Uses virtual reality for the inhibitory control training, rather than a relatively simplistic computerized training.
Other names: VR
Uses an active inhibitory control training which includes a "stop" signal.
Other names: ICT
Uses an inhibitory control training which does not include a "stop" signal.
Uses a relatively simplistic computerized training.
Time frame: The investigators will assess adherence at follow-up assessments (18 weeks after baseline assessment)
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.
Time frame: The investigators will assess adherence at follow-up assessments (18 weeks after baseline assessment)
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.
Time frame: The investigators will assess adherence at follow-up assessments (18 weeks after baseline assessment).
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.
Time frame: The investigators will assess satisfaction at follow-up assessments (18 weeks after baseline assessment).
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.
Time frame: The investigators will assess efficacy at post-treatment (6 weeks after baseline) and at follow-up (18 weeks after baseline).
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.
Drexel University
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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