Virtual Reality Compared to Screen Based Engagement on Mood

Study Overview
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Brief Summary
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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. Lastly, findings of this study could inform the development and efficacy of virtual reality interventions that can be used to provide more access to treatment for individuals and improve outcomes to reduce the burdens associated with depression.

Detailed Description
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Once participants consent, they will complete the three demographic questions and their familiarity with virtual reality. Participants will also complete the Patient Health Questionnaire-8(PHQ-8), Affinity for Technology Interaction scale (ATI), Positive and Negative Affect Schedule (PANAS), and the mood sliding scale. Participants will then be informed that they are going to watch a short clip and press play to watch a 2-minute video of Lion King. After the sad mood induction, participants will complete the PANAS and a mood slider scale. Participants will then be randomly assigned to the virtual reality or control condition. In the virtual reality condition, participants will be asked to complete the first course a virtual reality game called The Climb. In the control condition, participants will be told that they will be watching a video of a virtual environment climbing game and then be asked to copy all hand movements as accurately as they can. After completing either the virtual reality or control condition, individuals will then complete the PANAS, mood scale, temple presence inventory, three feedback questions, net promoter question, and an open-ended question on improving the activity they just completed. Participants will then be debriefed about the study and compensated for their time.

Official Title
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Investigating the Impacts of Virtual Reality and Mood

Conditions
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Virtual Reality

Intervention / Treatment
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* Other: Virtual Reality
* Other: Television Condition


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual Reality Condition<br>Participants will be using a virtual reality headset to engage with a mountain climbing game. | Other: Virtual Reality<br>* Virtual reality wireless headset<br>|
| Active Comparator: Control Condition<br>Participants will be mimicking hand movements displayed on a television screen. | Other: Television Condition<br>* Individuals will mimic hand movements of a pre-recorded video of an individual playing the virtual reality climbing game<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Positive and Negative Affect Schedule | There are twenty total items of the PANAS. The PANAS has two subscales 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. | Change in affect after 3 minutes of mood induction | 
| Change in Positive and Negative Affect Schedule | There are twenty total items of the PANAS. The PANAS has two subscales 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. | Change in affect after average of 15 minutes of virtual reality or control condition | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Temple Presence Inventory | Only spatial presence and presence as engagement will be utilized in the study to determine presence as no social interaction will be utilized in the study. Each item is rated on a 7-point scale from 1 (not at all) to 7 (very much). | Approximately 30 minutes after start of study | 
| Patient Health Questionnaire depression scale (PHQ-8) | The PHQ-8 is an 8 item scale. Each item is rated on a 4-point scale from 0 (not at all) to 3 (nearly every day). | Approximately 5 minutes after start of the study | 
| Affinity for Technology Interaction Scale (ATI) | Each item is rated on a 6-point Likert scale from 1 (completely disagree) to 6 (completely agree). | Approximately 30 minutes after start of study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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virtual reality, mood, technology