Virtual Reality Compared to Screen Based Engagement on Mood

Virtual Reality Clinical Trial

Official title:

Investigating the Impacts of Virtual Reality and Mood

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05249582
• Other study ID #: 2021-075
• Status: Completed
• Phase: N/A
• Start date: January 29, 2022
• Est. completion date: September 1, 2022

Study information

• Verified date: September 2022
• Source: Palo Alto University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 1, 2022
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Virtual Reality

Intervention

Other:
• Virtual Reality
Virtual reality wireless headset
• Television Condition
Individuals will mimic hand movements of a pre-recorded video of an individual playing the virtual reality climbing game

Locations

Country	Name	City	State
United States	Palo Alto University	Los Altos	California

Sponsors (1)

Lead Sponsor	Collaborator
Palo Alto University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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 mood after 3 minutes of mood induction
Other	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
Other	Media Feedback Questions	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. Participants will also be asked a qualitative question "If you would like to answer, how would you improve the experience of the activity you just performed?".	Approximately 30 minutes after start of study
Other	Net Promoter Score	Participants will answer one 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?".	Approximately 30 minutes after start of study
Primary	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
Primary	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	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
Secondary	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
Secondary	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