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

NCT05041660 | Completed

• 1 other identifier: 1906007227
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Binge Eating; Inhibition (Psychology)

Keywords

Inhibitory control; Virtual reality; Binge eating; Continuous glucose monitoring

Outcome Measures

Primary Outcomes (5)

• 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)

• 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)

• 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).

• 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).

• 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).

Study Arms (4)

VR ICT

EXPERIMENTAL

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

Other: Virtual-reality-based training; Other: Inhibitory Control Training

VR Sham ICT

SHAM COMPARATOR

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.

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

Non-VR ICT

ACTIVE COMPARATOR

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

Other: Inhibitory Control Training; Other: Computerized training

Non-VR Sham ICT

SHAM COMPARATOR

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.

Other: Sham Inhibitory Control Training; Other: Computerized training

Interventions

Virtual-reality-based training OTHER

Uses virtual reality for the inhibitory control training, rather than a relatively simplistic computerized training.

Also known as: VR

VR ICT; VR Sham ICT

Inhibitory Control Training OTHER

Uses an active inhibitory control training which includes a "stop" signal.

Also known as: ICT

Non-VR ICT; VR ICT

Sham Inhibitory Control Training OTHER

Uses an inhibitory control training which does not include a "stop" signal.

Non-VR Sham ICT; VR Sham ICT

Computerized training OTHER

Uses a relatively simplistic computerized training.

Non-VR ICT; Non-VR Sham ICT

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Drexel University: lead
• Drexel Coulter Translational Research Partnership Program: collaborator

Study Sites (1)

Drexel Universitty

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Bulimia; Inhibition, Psychological

Condition Hierarchy (Ancestors)

Hyperphagia; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Stephanie Manasse, Ph.D.

  Drexel University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants and investigators will not be aware who is receiving the sham ICT and who is receiving the real ICT.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study is a 2x2 factorial design with the factors being VR (VR/non-VR) and ICT (ICT/Sham).

Study Record Dates

• First Submitted: October 22, 2019
• First Posted: September 13, 2021
• Study Start: October 14, 2019
• Primary Completion: August 5, 2020
• Study Completion: August 5, 2020
• Last Updated: September 13, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)