Clinical trial NCT05249582: Virtual Reality Compared to Screen Based Engagement on Mood
Official title: The Effect of a Virtual Reality Exergame on Mood
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Virtual Reality
Keywords: virtual reality
mood
technology
Lead sponsor: Palo Alto University
Sponsor class: OTHER
First posted: 2022-02-21
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Positive Affect and Negative Affect From Baseline to After a 2 Minute Mood Induction
timeFrame: Baseline to after 2 minutes of mood induction
measure: Change in Positive Affect and Negative Affect From Mood Induction to After Condition Completion
timeFrame: Mood induction to after an average of 15 minutes of virtual reality or control condition
Secondary outcomes:
measure: Temple Presence Inventory Score Total
timeFrame: One measure after approximately 30 minutes after start of study
measure: Patient Health Questionnaire Depression Scale Total
timeFrame: Approximately 5 minutes after start of the study
measure: Affinity for Technology Interaction Scale Total Score
timeFrame: Once approximately 30 minutes after start of study
Other outcomes:
measure: Change in Mood Rating Scale From Baseline to After 2 Minute Mood Induction
timeFrame: Baseline to 2 minute mood induction.
measure: Change in Mood Rating Scale
timeFrame: Change in affect after average of 15 minutes of virtual reality or control condition
measure: Media Feedback Questions Scores
timeFrame: Approximately 30 minutes after start of study
measure: Net Promoter Score
timeFrame: Approximately 30 minutes after start of study
Locations:
city: Los Altos
country: United States
facility: Palo Alto University
state: California
Study officials:
affiliation: Palo Alto University
name: Eduardo Bunge, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Palo Alto University
name: Erick Kim, M.S.
role: PRINCIPAL_INVESTIGATOR
References: