- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05249582
Virtual Reality Compared to Screen Based Engagement on Mood
The Effect of a Virtual Reality Exergame on Mood
Depression has a lifetime prevalence rate of 20.6% and has one of the highest prevalence rates of mental health disorders. Major depressive disorder can lead to higher costs of living for individuals as well as a larger economic decrease associated with inability to work. Current treatment targets one of the two core symptoms of depression of decreased mood or loss of interest in activities. However, current treatment models are not enough because there are more individuals who require treatment than treatment opportunities which creates inequities of care.
Digital interventions provide a unique opportunity to increase widespread accessibility of treatment at reduced and scalable costs. Virtual reality is a newer type of digital intervention that consists of providing experiences for individuals that are different from the physical environment they are currently in. Through audio and visual displays, virtual reality creates a sense of presence, or the experience of immersion, with an environment. Virtual reality has been used in a variety of clinical psychology areas such as training, assessment, and treatment of mental health disorders and other medical conditions. Despite research finding efficacy for virtual reality with anxiety and PTSD, few studies have examined the impact of virtual reality on depressive disorders and low mood. Of studies that have looked at mood changes, most studies measured indirect measures of mood such as energy levels which leads to a gap of research on the efficacy of virtual reality with low mood.
The present study aims to examine if virtual reality exergames improve participant's mood and affect. Additionally, the study will determine if there are different effects of presence, depressive symptoms, and technology familiarity on mood. Furthermore, the study will examine helpfulness and satisfaction to examine usability of virtual reality as a medium for clinical intervention.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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California
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Los Altos, California, United States, 94022
- Palo Alto University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Any individuals who are a general adult population (18-64), be able to read English, and United States Residents. Individuals must be able to read English as all surveys are provided in English.
Exclusion Criteria:
- Individuals who are not part of the general adult population
- Individuals who can not read English
- Individuals who are not United States residents
- Individuals who endorse a history of motion sickness, nausea, migraines, headaches, balance issues, dizziness, epilepsy, neurological conditions where visual stimuli may trigger seizures or other issues, pregnancy, recent concussions, recent illness, recent contagious condition, or other conditions where dizziness, nausea, or headaches are present
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Virtual Reality Condition
Participants will be using a virtual reality headset to engage with a mountain climbing game.
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Virtual reality wireless headset
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Active Comparator: Control Condition
Participants will be mimicking hand movements displayed on a television screen.
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Individuals will mimic hand movements of a pre-recorded video of an individual playing the virtual reality climbing game
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Positive Affect and Negative Affect From Baseline to After a 2 Minute Mood Induction
Time Frame: Baseline to after 2 minutes of mood induction
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There are twenty total items of the Positive and Negative Affect Schedule.
The Positive and Negative Affect Schedule has two subscales, negative affect and positive affect, that consist of 10 items each on a 5-point likert scale from 1 (very slightly or not at all) to 5 (extremely).
The PANAS has different time instructions based on when the researcher would like to measure affect and the moment instruction was used.
The minimum value for each subscale is 1 and the maximum for each subscale is 5.
Each subscale is calculated from an average of 10 items that compose of the subscale.
Higher scores indicate more endorsement of positive affect or negative affect depending on the subscale endorsed.
Individuals were provided the Positive and Negative Affect Schedule at baseline and after completion 2 minute of mood induction.
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Baseline to after 2 minutes of mood induction
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Change in Positive Affect and Negative Affect From Mood Induction to After Condition Completion
Time Frame: Mood induction to after an average of 15 minutes of virtual reality or control condition
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There are twenty total items of the Positive and Negative Affect Schedule.
The Positive and Negative Affect Schedule has two subscales, negative affect and positive affect, that consist of 10 items each on a 5-point likert scale from 1 (very slightly or not at all) to 5 (extremely).
The PANAS has different time instructions based on when the researcher would like to measure affect and the moment instruction was used.
The minimum total value for both positive and negative affect subscales is 10 and the maximum total value for each subscale is 50.
Higher scores indicate more endorsement of positive affect or negative affect depending on the subscale endorsed.
Participants were measured after mood induction and after completion of the virtual reality or control condition.
A change in score was calculated by subtracting the total value of the negative subscale before and after the time point and subtracting the total value of the positive subscale before and after the time point.
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Mood induction to after an average of 15 minutes of virtual reality or control condition
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Temple Presence Inventory Score Total
Time Frame: One measure after approximately 30 minutes after start of study
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The Temple Presence Inventory measures the amount of presence across different technologies such as virtual reality.
The Temple Presence Inventory has eight subscales that measure the following dimensions: spatial presence, social presence with actor in medium, passive social presence, active social presence, presence as engagement, presence as social richness, presence as social realism, and presence as perceptual realism.
Only spatial presence and presence as engagement was utilized in the study to determine presence as no social interaction was utilized in the study.
Each item is rated on a 7-point scale from 1 (not at all) to 7 (very much) with higher mean subscale scores reflecting higher association with the specific presence factor.
The minimum value for each subscale was 1 and the maximum value was 7.
Each participant was only measured once approximately 30 minutes after the start of study after they completed rather the virtual reality condition or control condition.
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One measure after approximately 30 minutes after start of study
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Patient Health Questionnaire Depression Scale Total
Time Frame: Approximately 5 minutes after start of the study
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The Patient Health Questionnaire-8 is an 8-item self-report measure used to screen for major depressive episodes and the severity of depressive symptoms.
Each item is rated on a 4-point scale from 0 (not at all) to 3 (nearly every day) with higher mean scores reflecting more depressive symptoms.
Individuals were measured once at the beginning of the study.
The minimum value for the PHQ-8 was 0 and maximum was 24.
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Approximately 5 minutes after start of the study
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Affinity for Technology Interaction Scale Total Score
Time Frame: Once approximately 30 minutes after start of study
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The Affinity for Technology Interaction Scale is a 9-item measure used to assess an individual's level of engagement with technology.
Each item is rated on a 6-point Likert scale from 1 (completely disagree) to 6 (completely agree).
Items 3, 6, and 8 are reverse coded and a mean score is calculated with higher scores reflecting an individual having more independence and utilization of technology.
Each participant completed the measure once after completion of the virtual reality condition or control condition.
The minimum score was 1 and maximum was 6.
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Once approximately 30 minutes after start of study
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Mood Rating Scale
Time Frame: Change in affect after average of 15 minutes of virtual reality or control condition
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Participant subjective mood rating will be measured with a 10-point Likert visual analogue scale from not smiling to smiling.
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Change in affect after average of 15 minutes of virtual reality or control condition
|
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Change in Mood Rating Scale From Baseline to After 2 Minute Mood Induction
Time Frame: Baseline to 2 minute mood induction.
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Participant subjective mood rating was measured with a 10-point Likert visual analogue scale from not smiling (1) to smiling (10).
Higher scores indicate more positive mood and lower scores indicate more negative mood.
Minimum score was 1 and maximum was 10.
A change in score was calculated by comparing the baseline score to after the 2 minute mood induction.
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Baseline to 2 minute mood induction.
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Media Feedback Questions Scores
Time Frame: Approximately 30 minutes after start of study
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Participants will be asked three questions on a 7-point Likert scale from 1 (not at all) to 7 (very much) about the difficulty, enjoyment, and helpfulness of the virtual reality or control condition technology.
Higher scores indicate more endorsement of difficulty, enjoyment, or helpfulness.
Minimum score was 1 and maximum score was 7. Individuals were given the measure once at the end of the study and reported score was utilized with no additional calculations.
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Approximately 30 minutes after start of study
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Net Promoter Score
Time Frame: Approximately 30 minutes after start of study
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The Net Promoter Score is a single question used to examine an individual's satisfaction with the company or service.
Participants answered the question on an 11-point scale from 0 (not likely at all) to 10 (extremely likely), "how likely would you recommend the activity you did to a friend or colleague?".
Participants completed the measure at the end of the study with a minimum score of 0 and maximum score of 10.
Higher scores represent more endorsement and satisfaction with their experience.
Individuals score was reported with no additional calculations.
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Approximately 30 minutes after start of study
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Eduardo Bunge, Ph.D., Palo Alto University
- Principal Investigator: Erick Kim, M.S., Palo Alto University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2021-075
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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