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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03912597
Other study ID # S-18-208
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 19, 2018
Est. completion date April 20, 2019

Study information

Verified date April 2019
Source Yale-NUS College
Contact Jean Liu, PhD
Phone 66013694
Email jeanliu@yale-nus.edu.sg
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Two randomised controlled trials will be conducted to evaluate a virtual reality (VR) simulation designed to reduce stigma against depression. Qualitative interviews will also be carried out to evaluate the VR simulation.


Description:

The investigators examine the impact of a VR-assisted curriculum on stigma reduction towards individuals with depression. This is done through the development and evaluation of a VR-assisted curriculum that promotes stigma reduction towards depression among tertiary-aged students. Collection of data will provide insights about the effectiveness of VR's immersive quality in enhancing stigma reduction skills through measures of attitudes, beliefs and knowledge about depression. In the first study, VR is compared with traditional pamphlets in an information sharing booth about depression. In the second study, participants attend a 30-min session where they undergo an educational curriculum with either a VR or standard video as adjunctive tools.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date April 20, 2019
Est. primary completion date April 20, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 26 Years
Eligibility Inclusion Criteria:

- Tertiary students from NUS and Yale-NUS only

Exclusion Criteria:

- History of medical or psychiatric disorder; History of motion sickness, dizziness or epilepsy; (For reliability and safety of heart-rate monitoring) Tattoos near the wrist and/or nickel or acrylate allergies

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Virtual Reality
The 4-minute virtual reality video depicts a day in a life of a student with depression. The one-take video, filmed with a 360° camera, is designed to provide users with an immersive experience that simulates what it feels like to have depression. The user interface consisted of a Google Cardboard VR headset attached to a smartphone.
Brochure
Participants read an informational brochure about depression depicting standard information about depression, including symptoms and information on how to support someone with depression.
Standard Video Control
The 4-minute standard video depicts a similar storyline as was shown in the VR video. The standard video is filmed from a third-party perspective with multiple takes edited into a final video, following the standard filming style of these videos. The standard video will be viewed from a laptop with headphones attached.

Locations

Country Name City State
Singapore Yale-NUS College Singapore

Sponsors (1)

Lead Sponsor Collaborator
Yale-NUS College

Country where clinical trial is conducted

Singapore, 

Outcome

Type Measure Description Time frame Safety issue
Primary Stigmatising beliefs towards depression The extent of agreement with negative beliefs and stereotypes about depression will be adapted from the 10-item agreement sub-scale of the Self-Stigma of Mental Illness Scale. 2 minutes
Primary Stigmatising attitudes towards depression Stigmatising attitudes refer to the opinions that one has towards persons with depression, and how they would interact with these group of people. This will be measured using an adapted version of the Attribution Questionnaire-27. 5 minutes
Primary Knowledge about depression A Depression Literacy measure will be used to assess participants' understanding and knowledge of depression. 2 minutes
Primary Video Enjoyment In the VR condition, enjoyment of the VR simulation will be assessed through five items on a video enjoyment questionnaire created by the researchers, that includes items such as "I found the video interesting" and "The video made me more interested in the topic" on a visual analog scale. The scale was anchored between 0 indicating "Strongly Disagree" to 10 indicating "Strongly Agree". 1 minute
Primary Video Presence Presence felt in the VR simulation will be assessed through four items on a video presence questionnaire, that includes items such as "How aware were you of events happening in your actual surroundings outside of the video?" and "How strong was your sense of 'being there' in the video environment?" on a visual analog scale. The questions were adapted from the original Presence Questionnaire by Witmer and Singer (1998) that outlined four sub-factors of control, sensory, distraction and realism; items in our questionnaire were carefully selected to represent all of the factors. The scale ranged from 0 indicating "Not At All" to 10 indicating "Very Much So". 1 minute
Secondary Affect (PANAS) Participants' mood will be assessed using the Positive and Negative Affect Scale (PANAS) as a secondary measure of user experience with the respective videos. The PANAS consists of two 10-item subscales assessing positive and negative affect, and is rated on a 5-point scale ranging from 1 representing "Very Slightly or Not at All" to 5 representing "Extremely". 3 minutes
Secondary Heart rate live tracking Changes in heart rate, assessed live during the video viewing duration, will be measured as a physiological measure of user experience. 4 minutes
Secondary Qualitative feedback about VR video Participants will be invited to give feedback on their VR experience. Questions in the qualitative interview will address (1) their thoughts on mental health awareness amongst the public, (2) their experience watching the VR simulation and (3) reasons for stopping, or not, at similar mental health booths with VR simulations in the future. 10 minutes
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