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Virtual Reality Compared to Screen Based Engagement on Mood

The Effect of a Virtual Reality Exergame on Mood

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05249582
Enrollment
64
Registered
2022-02-21
Start date
2022-01-29
Completion date
2022-09-01
Last updated
2024-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Virtual Reality

Keywords

virtual reality, mood, technology

Brief 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. 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.

Interventions

OTHERVirtual Reality

Virtual reality wireless headset

OTHERTelevision Condition

Individuals will mimic hand movements of a pre-recorded video of an individual playing the virtual reality climbing game

Sponsors

Palo Alto University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Positive Affect and Negative Affect From Baseline to After a 2 Minute Mood InductionBaseline to after 2 minutes of mood inductionThere 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 CompletionMood induction to after an average of 15 minutes of virtual reality or control conditionThere 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.

Secondary

MeasureTime frameDescription
Affinity for Technology Interaction Scale Total ScoreOnce approximately 30 minutes after start of studyThe 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.
Temple Presence Inventory Score TotalOne measure after approximately 30 minutes after start of studyThe 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.
Patient Health Questionnaire Depression Scale TotalApproximately 5 minutes after start of the studyThe 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.

Other

MeasureTime frameDescription
Net Promoter ScoreApproximately 30 minutes after start of studyThe 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.
Change in Mood Rating Scale From Baseline to After 2 Minute Mood InductionBaseline to 2 minute mood induction.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.
Change in Mood Rating ScaleChange in affect after average of 15 minutes of virtual reality or control conditionParticipant subjective mood rating will be measured with a 10-point Likert visual analogue scale from not smiling to smiling.
Media Feedback Questions ScoresApproximately 30 minutes after start of studyParticipants 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
Virtual Reality Condition
Participants will be using a virtual reality headset to engage with a mountain climbing game. Virtual Reality: Virtual reality wireless headset
30
Control Condition
Participants will be mimicking hand movements displayed on a television screen. Television Condition: Individuals will mimic hand movements of a pre-recorded video of an individual playing the virtual reality climbing game
30
Total60

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyDeclined to use virtual reality headset10
Overall StudyInternet connectivity prevented completion of the condition01
Overall StudyTechnical Problems with virtual reality prevented completion20

Baseline characteristics

CharacteristicVirtual Reality ConditionControl ConditionTotal
Age, Continuous37.17 Years
STANDARD_DEVIATION 13.42
34.87 Years
STANDARD_DEVIATION 14.52
36.02 Years
STANDARD_DEVIATION 13.92
Mood Sliding Scale7.71 units on scale
STANDARD_DEVIATION 1.54
7.6 units on scale
STANDARD_DEVIATION 1.92
7.65 units on scale
STANDARD_DEVIATION 1.37
Positive and Negative Affect Schedule
Negative Affect subscale
14.07 units on scale
STANDARD_DEVIATION 5.71
12.8 units on scale
STANDARD_DEVIATION 3.84
13.43 units on scale
STANDARD_DEVIATION 4.87
Positive and Negative Affect Schedule
Positive Affect subscale
33.83 units on scale
STANDARD_DEVIATION 8.55
30.07 units on scale
STANDARD_DEVIATION 8.41
31.95 units on scale
STANDARD_DEVIATION 8.62
Race/Ethnicity, Customized
American Indian or Alaskan Native
0 Participants0 Participants0 Participants
Race/Ethnicity, Customized
Asian
5 Participants8 Participants13 Participants
Race/Ethnicity, Customized
Black or African American
4 Participants1 Participants5 Participants
Race/Ethnicity, Customized
Hispanic or Latino
4 Participants7 Participants11 Participants
Race/Ethnicity, Customized
Middle Eastern or North African
1 Participants0 Participants1 Participants
Race/Ethnicity, Customized
Multiple
4 Participants0 Participants4 Participants
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
1 Participants1 Participants2 Participants
Race/Ethnicity, Customized
No Answer
1 Participants0 Participants1 Participants
Race/Ethnicity, Customized
Some Other
1 Participants1 Participants2 Participants
Race/Ethnicity, Customized
White
9 Participants12 Participants21 Participants
Region of Enrollment
United States
30 participants30 participants60 participants
Sex/Gender, Customized
Female
15 Participants14 Participants29 Participants
Sex/Gender, Customized
Male
13 Participants16 Participants29 Participants
Sex/Gender, Customized
Not Specified
2 Participants0 Participants2 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 330 / 31
other
Total, other adverse events
0 / 330 / 31
serious
Total, serious adverse events
0 / 330 / 31

Outcome results

Primary

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.

Time frame: Baseline to after 2 minutes of mood induction

Population: Participants in the study

ArmMeasureGroupValue (MEAN)Dispersion
Virtual Reality ConditionChange in Positive Affect and Negative Affect From Baseline to After a 2 Minute Mood InductionPositive Affect Change from Baseline to 2 minute mood induction3.7 units on a scaleStandard Deviation 7.22
Virtual Reality ConditionChange in Positive Affect and Negative Affect From Baseline to After a 2 Minute Mood InductionNegative Affect Change from Baseline to 2 minute mood induction1.97 units on a scaleStandard Deviation 3.24
Control ConditionChange in Positive Affect and Negative Affect From Baseline to After a 2 Minute Mood InductionPositive Affect Change from Baseline to 2 minute mood induction4.63 units on a scaleStandard Deviation 6
Control ConditionChange in Positive Affect and Negative Affect From Baseline to After a 2 Minute Mood InductionNegative Affect Change from Baseline to 2 minute mood induction1.56 units on a scaleStandard Deviation 5.59
Primary

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.

Time frame: Mood induction to after an average of 15 minutes of virtual reality or control condition

ArmMeasureGroupValue (MEAN)Dispersion
Virtual Reality ConditionChange in Positive Affect and Negative Affect From Mood Induction to After Condition CompletionPositive Affect Subscale Change from Mood Induction to After Condition8.68 units on a scaleStandard Deviation 10.7
Virtual Reality ConditionChange in Positive Affect and Negative Affect From Mood Induction to After Condition CompletionNegative Affect Subscale Change from Mood Induction to After Condition Completion.21 units on a scaleStandard Deviation 5.75
Control ConditionChange in Positive Affect and Negative Affect From Mood Induction to After Condition CompletionPositive Affect Subscale Change from Mood Induction to After Condition5.5 units on a scaleStandard Deviation 7.3
Control ConditionChange in Positive Affect and Negative Affect From Mood Induction to After Condition CompletionNegative Affect Subscale Change from Mood Induction to After Condition Completion2.92 units on a scaleStandard Deviation 3.8
Secondary

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.

Time frame: Once approximately 30 minutes after start of study

ArmMeasureValue (MEAN)Dispersion
Virtual Reality ConditionAffinity for Technology Interaction Scale Total Score4 units on a scaleStandard Deviation 0.72
Control ConditionAffinity for Technology Interaction Scale Total Score3.86 units on a scaleStandard Deviation 1.09
Secondary

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.

Time frame: Approximately 5 minutes after start of the study

ArmMeasureValue (MEAN)Dispersion
Virtual Reality ConditionPatient Health Questionnaire Depression Scale Total3.21 units on a scaleStandard Deviation 3.29
Control ConditionPatient Health Questionnaire Depression Scale Total4.07 units on a scaleStandard Deviation 3.82
Secondary

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.

Time frame: One measure after approximately 30 minutes after start of study

ArmMeasureGroupValue (MEAN)Dispersion
Virtual Reality ConditionTemple Presence Inventory Score TotalSpatial Presence Subscale5.71 units on a scaleStandard Deviation 0.85
Virtual Reality ConditionTemple Presence Inventory Score TotalPresence as Engagement subscale6.25 units on a scaleStandard Deviation 0.76
Control ConditionTemple Presence Inventory Score TotalSpatial Presence Subscale3.63 units on a scaleStandard Deviation 1.64
Control ConditionTemple Presence Inventory Score TotalPresence as Engagement subscale3.89 units on a scaleStandard Deviation 1.47
Other Pre-specified

Change in Mood Rating Scale

Participant subjective mood rating will be measured with a 10-point Likert visual analogue scale from not smiling to smiling.

Time frame: Change in affect after average of 15 minutes of virtual reality or control condition

Population: Participants in study

ArmMeasureValue (MEAN)Dispersion
Virtual Reality ConditionChange in Mood Rating Scale1.76 units on a scaleStandard Deviation 1.71
Control ConditionChange in Mood Rating Scale1.3 units on a scaleStandard Deviation 1.18
Other Pre-specified

Change in Mood Rating Scale From Baseline to After 2 Minute Mood Induction

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.

Time frame: Baseline to 2 minute mood induction.

Population: Participants in study

ArmMeasureValue (MEAN)Dispersion
Virtual Reality ConditionChange in Mood Rating Scale From Baseline to After 2 Minute Mood Induction1.21 units on a scaleStandard Deviation 1.34
Control ConditionChange in Mood Rating Scale From Baseline to After 2 Minute Mood Induction1.2 units on a scaleStandard Deviation 1.06
Other Pre-specified

Media Feedback Questions Scores

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.

Time frame: Approximately 30 minutes after start of study

ArmMeasureGroupValue (MEAN)Dispersion
Virtual Reality ConditionMedia Feedback Questions ScoresDifficulty Question4.7 units on a scaleStandard Deviation 1.6
Virtual Reality ConditionMedia Feedback Questions ScoresEnjoyment Question5.97 units on a scaleStandard Deviation 1.45
Virtual Reality ConditionMedia Feedback Questions ScoresHelpfulness Question5.4 units on a scaleStandard Deviation 1.55
Control ConditionMedia Feedback Questions ScoresDifficulty Question3.31 units on a scaleStandard Deviation 1.52
Control ConditionMedia Feedback Questions ScoresEnjoyment Question3.79 units on a scaleStandard Deviation 1.7
Control ConditionMedia Feedback Questions ScoresHelpfulness Question3.6 units on a scaleStandard Deviation 1.63
Other Pre-specified

Net Promoter Score

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.

Time frame: Approximately 30 minutes after start of study

ArmMeasureValue (MEAN)Dispersion
Virtual Reality ConditionNet Promoter Score8.47 units on a scaleStandard Deviation 2.2
Control ConditionNet Promoter Score5.49 units on a scaleStandard Deviation 3.05

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026