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VR-assisted Curriculum on Depression for Stigma Reduction

Primary Purpose

Control, Behavior

Status
Unknown status
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Virtual Reality
Brochure
Standard Video Control
Sponsored by
Yale-NUS College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Control focused on measuring virtual reality, stigma reduction, depression, mental health campaigns, user experience, enjoyment, presence

Eligibility Criteria

18 Years - 26 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Yale-NUS CollegeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Active Comparator

Experimental

Arm Label

Virtual Reality [A]

Brochure Waitlist Control [A]

Standard Video Control [B]

Virtual Reality [B]

Arm Description

Participants watch a 4-minute virtual reality video, on top of reading a brochure, then answer post-intervention questionnaires.

Participants read an informational brochure about depression, then answer post-intervention questionnaires. After that, they will be given a chance to watch the VR video at the end of their participation session.

Participants watch a 4-minute standard video. After which, using a video, a discussion of the video will be facilitated for participants to contextualise and understand the video better. Then, participants answer post-intervention questionnaires.

Participants answer pre-questionnaires, then watch a 4-minute virtual reality video. After which, using a video, a discussion of the video will be facilitated for participants to contextualise and understand the video better. Then, participants answer post-intervention questionnaires.

Outcomes

Primary Outcome Measures

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.
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.
Knowledge about depression
A Depression Literacy measure will be used to assess participants' understanding and knowledge of depression.
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".
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".

Secondary Outcome Measures

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".
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.
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.

Full Information

First Posted
April 10, 2019
Last Updated
April 15, 2019
Sponsor
Yale-NUS College
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1. Study Identification

Unique Protocol Identification Number
NCT03912597
Brief Title
VR-assisted Curriculum on Depression for Stigma Reduction
Official Title
Reducing Stigma Against Depression: Designing and Implementing a VR-assisted Curriculum to Reduce Students' Perceptions of Patients With Depression
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
September 19, 2018 (Actual)
Primary Completion Date
April 20, 2019 (Anticipated)
Study Completion Date
April 20, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale-NUS College

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Control, Behavior
Keywords
virtual reality, stigma reduction, depression, mental health campaigns, user experience, enjoyment, presence

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Virtual Reality [A]
Arm Type
Experimental
Arm Description
Participants watch a 4-minute virtual reality video, on top of reading a brochure, then answer post-intervention questionnaires.
Arm Title
Brochure Waitlist Control [A]
Arm Type
Active Comparator
Arm Description
Participants read an informational brochure about depression, then answer post-intervention questionnaires. After that, they will be given a chance to watch the VR video at the end of their participation session.
Arm Title
Standard Video Control [B]
Arm Type
Active Comparator
Arm Description
Participants watch a 4-minute standard video. After which, using a video, a discussion of the video will be facilitated for participants to contextualise and understand the video better. Then, participants answer post-intervention questionnaires.
Arm Title
Virtual Reality [B]
Arm Type
Experimental
Arm Description
Participants answer pre-questionnaires, then watch a 4-minute virtual reality video. After which, using a video, a discussion of the video will be facilitated for participants to contextualise and understand the video better. Then, participants answer post-intervention questionnaires.
Intervention Type
Device
Intervention Name(s)
Virtual Reality
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Brochure
Intervention Description
Participants read an informational brochure about depression depicting standard information about depression, including symptoms and information on how to support someone with depression.
Intervention Type
Device
Intervention Name(s)
Standard Video Control
Intervention Description
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.
Primary Outcome Measure Information:
Title
Stigmatising beliefs towards depression
Description
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.
Time Frame
2 minutes
Title
Stigmatising attitudes towards depression
Description
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.
Time Frame
5 minutes
Title
Knowledge about depression
Description
A Depression Literacy measure will be used to assess participants' understanding and knowledge of depression.
Time Frame
2 minutes
Title
Video Enjoyment
Description
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".
Time Frame
1 minute
Title
Video Presence
Description
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".
Time Frame
1 minute
Secondary Outcome Measure Information:
Title
Affect (PANAS)
Description
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".
Time Frame
3 minutes
Title
Heart rate live tracking
Description
Changes in heart rate, assessed live during the video viewing duration, will be measured as a physiological measure of user experience.
Time Frame
4 minutes
Title
Qualitative feedback about VR video
Description
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.
Time Frame
10 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
26 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jean Liu, PhD
Phone
66013694
Email
jeanliu@yale-nus.edu.sg
Facility Information:
Facility Name
Yale-NUS College
City
Singapore
ZIP/Postal Code
138527
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean Liu, PhD
Email
jeanliu@yale-nus.edu.sg

12. IPD Sharing Statement

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VR-assisted Curriculum on Depression for Stigma Reduction

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