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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Virtual Reality Condition | Experimental | Participants will be using a virtual reality headset to engage with a mountain climbing game. |
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| Control Condition | Active Comparator | Participants will be mimicking hand movements displayed on a television screen. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual Reality | Other | Virtual reality wireless headset |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Mood induction to after an average of 15 minutes of virtual reality or control condition |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eduardo Bunge, Ph.D. | Palo Alto University | Principal Investigator |
| Erick Kim, M.S. | Palo Alto University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Palo Alto University | Los Altos | California | 94022 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Virtual Reality Condition | Participants will be using a virtual reality headset to engage with a mountain climbing game. Virtual Reality: Virtual reality wireless headset |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Virtual Reality Condition | Participants will be using a virtual reality headset to engage with a mountain climbing game. Virtual Reality: Virtual reality wireless headset |
| BG001 | Control Condition |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Participants in the study | Posted | Mean | Standard Deviation | units on a scale | Baseline to after 2 minutes of mood induction |
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Each participant's adverse event data was collected 30-45 minutes after collection of baseline.
No participants reported adverse affects during each session as well as up to the 7 months of study collection date. Before the end of the study, all participants were asked after both virtual reality and control conditions if they were feeling any nausea, dizziness, or other adverse side effects. The total number of individuals at risk was 64, 33 in the virtual reality condition, and 31 in the control condition, and 0 participants endorsed any adverse symptoms.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Virtual Reality Condition | Participants will be using a virtual reality headset to engage with a mountain climbing game. Virtual Reality: Virtual reality wireless headset |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Erick Kim | Palo Alto University | (510) 457-1584 | ekim@paloaltou.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 13, 2021 | Apr 6, 2024 | Prot_SAP_000.pdf |
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| Television Condition |
| Other |
Individuals will mimic hand movements of a pre-recorded video of an individual playing the virtual reality climbing game |
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| 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. | 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. | Once approximately 30 minutes after start of study |
| Baseline to 2 minute mood induction. |
| 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. | Change in affect after average of 15 minutes of virtual reality or control condition |
| 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. | Approximately 30 minutes after start of study |
| 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. | Approximately 30 minutes after start of study |
| Declined to use virtual reality headset |
|
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
| BG002 | Total | Total of all reporting groups |
| Years |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Positive and Negative Affect Schedule | The Positive and Negative Affect Schedule (PANAS) measures mood through two dimensions: positive affect and negative affect. There are twenty total items of the PANAS and 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 "moment" instruction was used in the current study to measure current affect. Total scores were reported for each subscale with a range from 10 to 50 for positive affect and 10 to 50 for negative affect. The higher the score for the subscale, the more the individual endorses that affect. | Mean | Standard Deviation | units on scale |
|
| Mood Sliding Scale | 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. | Mean | Standard Deviation | units on scale |
|
| OG000 |
| Virtual Reality Condition |
Participants will be using a virtual reality headset to engage with a mountain climbing game. Virtual Reality: Virtual reality wireless headset |
| OG001 | 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 |
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | Mood induction to after an average of 15 minutes of virtual reality or control condition |
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|
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| 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. | Posted | Mean | Standard Deviation | units on a scale | One measure after approximately 30 minutes after start of study |
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| 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. | Posted | Mean | Standard Deviation | units on a scale | Approximately 5 minutes after start of the study |
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| 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. | Posted | Mean | Standard Deviation | units on a scale | Once approximately 30 minutes after start of study |
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| 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. | Participants in study | Posted | Mean | Standard Deviation | units on a scale | Baseline to 2 minute mood induction. |
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| 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. | Participants in study | Posted | Mean | Standard Deviation | units on a scale | Change in affect after average of 15 minutes of virtual reality or control condition |
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| 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. | Posted | Mean | Standard Deviation | units on a scale | Approximately 30 minutes after start of study |
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| 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. | Posted | Mean | Standard Deviation | units on a scale | Approximately 30 minutes after start of study |
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| 0 |
| 33 |
| 0 |
| 33 |
| 0 |
| 33 |
| EG001 | 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 | 0 | 31 | 0 | 31 | 0 | 31 |
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| Helpfulness Question |
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