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

Primary Purpose

Binge Eating, Inhibition (Psychology)

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Virtual-reality-based training
Inhibitory Control Training
Sham Inhibitory Control Training
Computerized training
Sponsored by
Drexel University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Binge Eating focused on measuring Inhibitory control, Virtual reality, Binge eating, Continuous glucose monitoring

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Drexel Universitty

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Sham Comparator

Active Comparator

Sham Comparator

Arm Label

VR ICT

VR Sham ICT

Non-VR ICT

Non-VR Sham ICT

Arm Description

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

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.

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

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
October 22, 2019
Last Updated
September 8, 2021
Sponsor
Drexel University
Collaborators
Drexel Coulter Translational Research Partnership Program
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1. Study Identification

Unique Protocol Identification Number
NCT05041660
Brief Title
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

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
October 14, 2019 (Actual)
Primary Completion Date
August 5, 2020 (Actual)
Study Completion Date
August 5, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Drexel University
Collaborators
Drexel Coulter Translational Research Partnership Program

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Binge Eating, Inhibition (Psychology)
Keywords
Inhibitory control, Virtual reality, Binge eating, Continuous glucose monitoring

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
The study is a 2x2 factorial design with the factors being VR (VR/non-VR) and ICT (ICT/Sham).
Masking
Participant
Masking Description
Participants and investigators will not be aware who is receiving the sham ICT and who is receiving the real ICT.
Allocation
Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
VR ICT
Arm Type
Experimental
Arm Description
Virtual-reality-based inhibitory control training done daily at home for 6 weeks.
Arm Title
VR Sham ICT
Arm Type
Sham Comparator
Arm 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.
Arm Title
Non-VR ICT
Arm Type
Active Comparator
Arm Description
Computerized inhibitory control training done daily at home for 6 weeks.
Arm Title
Non-VR Sham ICT
Arm Type
Sham Comparator
Arm 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.
Intervention Type
Other
Intervention Name(s)
Virtual-reality-based training
Other Intervention Name(s)
VR
Intervention Description
Uses virtual reality for the inhibitory control training, rather than a relatively simplistic computerized training.
Intervention Type
Other
Intervention Name(s)
Inhibitory Control Training
Other Intervention Name(s)
ICT
Intervention Description
Uses an active inhibitory control training which includes a "stop" signal.
Intervention Type
Other
Intervention Name(s)
Sham Inhibitory Control Training
Intervention Description
Uses an inhibitory control training which does not include a "stop" signal.
Intervention Type
Other
Intervention Name(s)
Computerized training
Intervention Description
Uses a relatively simplistic computerized training.
Primary Outcome Measure Information:
Title
Protocol recruitment
Description
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)
Title
Protocol retention
Description
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)
Title
Protocol adherence
Description
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 adherence at follow-up assessments (18 weeks after baseline assessment).
Title
Protocol satisfaction
Description
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 satisfaction at follow-up assessments (18 weeks after baseline assessment).
Title
Impact of VR + ICT vs. VR + Sham on binge eating frequency
Description
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.
Time Frame
The investigators will assess efficacy at post-treatment (6 weeks after baseline) and at follow-up (18 weeks after baseline).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephanie Manasse, Ph.D.
Organizational Affiliation
Drexel University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Drexel Universitty
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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