Virtual RealityNCT05249582
Virtual Reality Compared to Screen Based Engagement on Mood
A study testing Virtual Reality and Television Condition in people with Virtual Reality, run by Palo Alto University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Virtual Reality
- What is being tested?
- Virtual Reality and Television Condition
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jan 2022to 1 Sep 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Virtual Reality
- Being tested
- Virtual Reality, Television Condition
- Keywords
- virtual reality, mood, technology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual RealityOther
Virtual reality wireless headset
Television ConditionOther
Individuals will mimic hand movements of a pre-recorded video of an individual playing the virtual reality climbing game
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality Condition | Experimental | Participants will be using a virtual reality headset to engage with a mountain climbing game. Receives: Other: Virtual Reality |
| Control Condition | Active comparator | Participants will be mimicking hand movements displayed on a television screen. Receives: Other: Television Condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Positive Affect and Negative Affect From Baseline to After a 2 Minute Mood Induction
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.
Measured: Baseline to after 2 minutes of mood induction
Change in Positive Affect and Negative Affect From Mood Induction to After Condition Completion
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.
Measured: Mood induction to after an average of 15 minutes of virtual reality or control condition
Secondary outcomes (3)
Temple Presence Inventory Score Total
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.
Measured: One measure after approximately 30 minutes after start of study
Patient Health Questionnaire Depression Scale Total
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.
Measured: Approximately 5 minutes after start of the study
Affinity for Technology Interaction Scale Total Score
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.
Measured: Once approximately 30 minutes after start of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2022
- Study start29 Jan 2022
- Primary completion1 Sep 2022
- Study completion1 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Virtual RealityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Palo Alto University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erick Kim, Palo Alto University
- Investigators
- Eduardo Bunge, Ph.D., Principal investigator, Palo Alto UniversityErick Kim, M.S., Principal investigator, Palo Alto University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05249582
- Sponsor's protocol ID
- 2021-075
- Status last verified
- Sep 2024
- First submitted
- 1 Feb 2022
- Last updated
- 19 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Virtual Reality Exergame on Mood
- ClinicalTrials.gov ID
- NCT05249582
- Acronym / sponsor ID
- 2021-075
- Conditions
- Virtual Reality
- Keywords
- virtual reality, mood, technology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Palo Alto UniversityUniversity, hospital or other
- Study start
- 29 Jan 2022 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 21 Feb 2022 (actual)
- Results
- Posted 19 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Condition | Experimental | Other: Virtual RealityParticipants will be using a virtual reality headset to engage with a mountain climbing game. |
| Control Condition | Active comparator | Other: Television ConditionParticipants will be mimicking hand movements displayed on a television screen. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual RealityVirtual reality wireless headset | Other | Virtual Reality Condition |
| Television ConditionIndividuals will mimic hand movements of a pre-recorded video of an individual playing the virtual reality climbing game | Other | Control Condition |
Primary outcome
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
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.
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
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.
3 secondary outcomes
Temple Presence Inventory Score Total
Time frame: One measure after approximately 30 minutes after start of study
Patient Health Questionnaire Depression Scale Total
Time frame: Approximately 5 minutes after start of the study
Affinity for Technology Interaction Scale Total Score
Time frame: Once approximately 30 minutes after start of study
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eduardo Bunge, Ph.D. principal investigator
Palo Alto University
Erick Kim, M.S. principal investigator
Palo Alto University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality and Television Condition in people with Virtual Reality, run by Palo Alto University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.