Virtual Reality Compared to Screen Based Engagement on Mood

NCT05249582 | Completed Results

• 1 other identifier: 2021-075
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Virtual Reality

Keywords

virtual reality; mood; technology

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (3)

• Temple Presence Inventory Score Total

  One measure after approximately 30 minutes after start of study

• Patient Health Questionnaire Depression Scale Total

  Approximately 5 minutes after start of the study

• Affinity for Technology Interaction Scale Total Score

  Once approximately 30 minutes after start of study

Other Outcomes (4)

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

  Baseline to 2 minute mood induction.

• Change in Mood Rating Scale

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

• Media Feedback Questions Scores

  Approximately 30 minutes after start of study

Study Arms (2)

Virtual Reality Condition

EXPERIMENTAL

Participants will be using a virtual reality headset to engage with a mountain climbing game.

Other: Virtual Reality

Control Condition

ACTIVE COMPARATOR

Participants will be mimicking hand movements displayed on a television screen.

Other: Television Condition

Interventions

Virtual Reality OTHER

Virtual reality wireless headset

Virtual Reality Condition

Television Condition OTHER

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

Control Condition

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Palo Alto University: lead

Study Sites (1)

Palo Alto University

Los Altos, California, 94022, United States

Location

Results Point of Contact

• Title: Erick Kim
• Organization: Palo Alto University

ekim@paloaltou.edu

(510) 457-1584

Study Officials

• Eduardo Bunge, Ph.D.

  Palo Alto University

  PRINCIPAL INVESTIGATOR

• Erick Kim, M.S.

  Palo Alto University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D. Doctoral Candidate in Clinical Psychology

Study Record Dates

• First Submitted: February 1, 2022
• First Posted: February 21, 2022
• Study Start: January 29, 2022
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: September 19, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)