ControlNCT03912597
VR-assisted Curriculum on Depression for Stigma Reduction
A study testing Virtual Reality and Brochure in people with Control and Behavior, run by Yale-NUS College at 1 site in Singapore.
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. Read more about this study
- Who is it for?
- Ages 18 to 26 yearsHealthy volunteers can take part
- What is being tested?
- Virtual Reality and Brochure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteSingapore
- Study dates
- 19 Sep 2018to 20 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 26 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Tertiary students from NUS and Yale-NUS only
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
Yale-NUS College
Singapore, 138527
Jean Liu, PhD, jeanliu@yale-nus.edu.sg
About this study
Official title: Reducing Stigma Against Depression: Designing and Implementing a VR-assisted Curriculum to Reduce Students' Perceptions of Patients With Depression
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.
Read the 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.
- Being tested
- Virtual Reality, Brochure, Standard Video Control
- Keywords
- virtual reality, stigma reduction, depression, mental health campaigns, user experience, enjoyment, presence
- Medical subject headings
- Behavior, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual RealityDevice
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.
BrochureDevice
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 ControlDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality [A] | Experimental | Participants watch a 4-minute virtual reality video, on top of reading a brochure, then answer post-intervention questionnaires. Receives: Device: Virtual Reality; Device: Brochure |
| Brochure Waitlist Control [A] | Active comparator | 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. Receives: Device: Brochure |
| Standard Video Control [B] | Active comparator | 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. Receives: Device: Brochure; Device: Standard Video Control |
| Virtual Reality [B] | Experimental | 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. Receives: Device: Virtual Reality; Device: Brochure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 minutes
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.
Measured: 5 minutes
Knowledge about depression
A Depression Literacy measure will be used to assess participants' understanding and knowledge of depression.
Measured: 2 minutes
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".
Measured: 1 minute
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".
Measured: 1 minute
Secondary outcomes (3)
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".
Measured: 3 minutes
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.
Measured: 4 minutes
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.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2019
- Study start19 Sep 2018
- Primary completion20 Apr 2019 (estimated)
- Study completion20 Apr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ControlStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale-NUS College
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03912597
- Sponsor's protocol ID
- S-18-208
- Status last verified
- Apr 2019
- First submitted
- 10 Apr 2019
- Last updated
- 17 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Stigma Against Depression: Designing and Implementing a VR-assisted Curriculum to Reduce Students' Perceptions of Patients With Depression
- ClinicalTrials.gov ID
- NCT03912597
- Acronym / sponsor ID
- S-18-208
- Keywords
- virtual reality, stigma reduction, depression, mental health campaigns, user experience, enjoyment, presence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Yale-NUS CollegeUniversity, hospital or other
- Study start
- 19 Sep 2018 (actual)
- Primary completion
- 20 Apr 2019 (estimated)
- Study completion
- 20 Apr 2019 (estimated)
- First posted
- 11 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality [A] | Experimental | Device: Virtual Reality, Device: BrochureParticipants watch a 4-minute virtual reality video, on top of reading a brochure, then answer post-intervention questionnaires. |
| Brochure Waitlist Control [A] | Active comparator | Device: BrochureParticipants 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. |
| Standard Video Control [B] | Active comparator | Device: Brochure, Device: Standard Video ControlParticipants 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. |
| Virtual Reality [B] | Experimental | Device: Virtual Reality, Device: BrochureParticipants 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. |
Who may qualify
- Ages
- 18 to 26 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Tertiary students from NUS and Yale-NUS only
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual RealityThe 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. | Device | Virtual Reality [A], Virtual Reality [B] |
| BrochureParticipants read an informational brochure about depression depicting standard information about depression, including symptoms and information on how to support someone with depression. | Device | Brochure Waitlist Control [A], Standard Video Control [B], Virtual Reality [A], Virtual Reality [B] |
| Standard Video ControlThe 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. | Device | Standard Video Control [B] |
Primary outcome
Stigmatising beliefs towards depression
Time frame: 2 minutes
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
Time frame: 5 minutes
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
Time frame: 2 minutes
A Depression Literacy measure will be used to assess participants' understanding and knowledge of depression.
Video Enjoyment
Time frame: 1 minute
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
Time frame: 1 minute
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".
3 secondary outcomes
Affect (PANAS)
Time frame: 3 minutes
Heart rate live tracking
Time frame: 4 minutes
Qualitative feedback about VR video
Time frame: 10 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality and Brochure in people with Control and Behavior, run by Yale-NUS College at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jean Liu, PhD (66013694, jeanliu@yale-nus.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stigmatising beliefs towards depression (time frame: 2 minutes). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2019.