NCT03912597

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 19, 2018

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 10, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 11, 2019

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 20, 2019

Completed
Last Updated

April 17, 2019

Status Verified

April 1, 2019

Enrollment Period

7 months

First QC Date

April 10, 2019

Last Update Submit

April 15, 2019

Conditions

Keywords

virtual realitystigma reductiondepressionmental health campaignsuser experienceenjoymentpresence

Outcome Measures

Primary Outcomes (5)

  • 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

  • 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

  • Knowledge about depression

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

    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".

    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".

    1 minute

Secondary Outcomes (3)

  • Affect (PANAS)

    3 minutes

  • Heart rate live tracking

    4 minutes

  • Qualitative feedback about VR video

    10 minutes

Study Arms (4)

Virtual Reality [A]

EXPERIMENTAL

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

Device: Virtual RealityDevice: 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.

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.

Device: BrochureDevice: 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.

Device: Virtual RealityDevice: Brochure

Interventions

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.

Virtual Reality [A]Virtual Reality [B]
BrochureDEVICE

Participants read an informational brochure about depression depicting standard information about depression, including symptoms and information on how to support someone with depression.

Brochure Waitlist Control [A]Standard Video Control [B]Virtual Reality [A]Virtual Reality [B]

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.

Standard Video Control [B]

Eligibility Criteria

Age18 Years - 26 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Tertiary students from NUS and Yale-NUS only

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale-NUS College

Singapore, 138527, Singapore

RECRUITING

MeSH Terms

Conditions

BehaviorDepression

Condition Hierarchy (Ancestors)

Behavioral Symptoms

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 10, 2019

First Posted

April 11, 2019

Study Start

September 19, 2018

Primary Completion

April 20, 2019

Study Completion

April 20, 2019

Last Updated

April 17, 2019

Record last verified: 2019-04

Locations