Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Drexel Coulter Translational Research Partnership Program | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VR ICT | Experimental | Virtual-reality-based inhibitory control training done daily at home for 6 weeks. |
|
| 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. |
|
| Non-VR ICT | Active Comparator | Computerized inhibitory control training done daily at home for 6 weeks. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual-reality-based training | Other | Uses virtual reality for the inhibitory control training, rather than a relatively simplistic computerized training. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
Not provided
Not provided
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
If applicable, have stable psychiatric medication for the past three months.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Stephanie Manasse, Ph.D. | Drexel University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Drexel Universitty | Philadelphia | Pennsylvania | 19104 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The study is a 2x2 factorial design with the factors being VR (VR/non-VR) and ICT (ICT/Sham).
Not provided
Not provided
Participants and investigators will not be aware who is receiving the sham ICT and who is receiving the real ICT.
|
| Inhibitory Control Training | Other | Uses an active inhibitory control training which includes a "stop" signal. |
|
|
| Sham Inhibitory Control Training | Other | Uses an inhibitory control training which does not include a "stop" signal. |
|
| Computerized training | Other | Uses a relatively simplistic computerized training. |
|
| ID | Term |
|---|---|
| D002032 | Bulimia |
| D007266 | Inhibition, Psychological |
| ID | Term |
|---|---|
| D006963 | Hyperphagia |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
Not provided
Not provided