Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202202808457152 Date of Approval: 10/02/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Teaching Adolescents Awareness of and Empathy toward Depression Using Virtual Reality Games
Official scientific title Teaching Adolescents Awareness of and Empathy toward Depression Using Virtual Reality Games
Brief summary describing the background and objectives of the trial This project will develop, validate and test the feasibility and effectiveness of a virtual reality (VR) game in i) increasing awareness and understanding of the symptoms, predisposing factors, etiology and coping strategies of depression; ii) reducing stigma about depression and iii) increasing empathy towards those with depression, focusing on adolescents in Nigeria.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Mental and Behavioural Disorders
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 01/11/2022
Actual trial start date
Anticipated date of last follow up 30/03/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Teaching Adolescents Awareness of and Empathy toward Depression Using Virtual Reality Games Single game play of a two part VR game 15-30 minutes once There will be two parts to the VR game. One part is targeted to achieving the cognitive outcomes of improved awareness and understanding of depression markers, reduced stigma and increased empathy. The other part would target the cognitive outcome of learning about coping strategies. Both parts would however form a single VR experience. Two techniques would be used to induce perspective-taking in the player. One will be an “observation” experience. Here, the player uses the VR head mounted display (HMD) to watch the 3-D story about depression, as a passive, immersive experience, with little or no interactivity. The second will be an “embody” experience. This is more interactive, as the player has a first-person agency where they are able to see themselves with a virtual “body” and “hands”, and are able to interact with and change the course of the VR experience. We will test whether the “observe” and the “embody” experience are both able to induce perspective-taking, and to what extent.4 20
Control Group Teaching Adolescents Awareness of and Empathy toward Depression Using Virtual Reality Games No VR Game Play The control group will not do any VR Game Play. They will however be assessed on the outcome variables of awareness and knowledge of depression, empathy and stigma. No VR Game Play 20 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All the adolescents in the "VR Game Play" condition who have no health conditions precluding them from a Virtual Reality experience will be included. Those with health conditions precluding them from a Virtual Reality (VR) experience will be excluded. Examples are those who suffer from motion sickness, or those who do not wish to participate. Adolescent: 13 Year-18 Year 13 Year(s) 18 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 01/08/2022 Lagos Business School Research Ethics Board
Ethics Committee Address
Street address City Postal code Country
Km. 22 Lekki-Epe Expressway Lagos 101241 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Increased awareness and knowledge about Depression Pre and post intervention - VR Game Play
Primary Outcome Reduced stigma about depression Pre and post intervention - VR Game Play
Primary Outcome Increased empathy towards those with depression Pre and post intervention - VR Game Play
Secondary Outcome Decreased depressive symptoms Pre and post intervention - VR Game Play
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Lagos Business School Pan Atlantic University Km. 22 Lekki-Epe Expressway Lagos 101241 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor National Institute of Mental Health Office of Science Policy, Planning, and Communications 6001 Executive Boulevard Room 6200, MSC 9663 Bethesda 20892-966 United States of America Funding Agency
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Eugene Ohu eohu@lbs.edu.ng 2348183955888 Lagos Business School, Km. 22, Lekki-Epe Expressway
City Postal code Country Position/Affiliation
Lagos Nigeria Senior Lecturer
Role Name Email Phone Street address
Public Enquiries Eugene Ohu eohu@lbs.edu.ng 2348083955888 Lagos Business School, Km. 22 Lekki-Epe Expressway
City Postal code Country Position/Affiliation
Lagos Nigeria Senior Lecturer
Role Name Email Phone Street address
Scientific Enquiries Eugene Ohu eohu@lbs.edu.ng 2348083955888 Lagos Business School, Km. 22 Lekki-Epe Expressway
City Postal code Country Position/Affiliation
Lagos Nigeria Senior Lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes We are committed to a policy of sharing the data from the Teaching Adolescents Awareness of and Empathy toward Depression Using Virtual Reality Games project with the scientific community through the Lagos Business School Virtual Human Computer Interaction (VHCI) Lab website. We will maintain a cloud based inventory with a list of measures administered, the source of the data (target participants, psychiatrists, psychologists, parents and teachers), and the years in which the measures were administered. The names of the measures will contain links to images of the measures (except in the case of copyrighted measures) so that interested researchers will be able to understand what project data are available. Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol IPD documents will be available for sharing from 30 December 2024 for at least 2 years. The data will be released, for research purposes only, through a restricted-access policy. The sensitive nature of some of our data (e.g., depression screening result) requires systematic safeguarding of the privacy and anonymity of respondents, through a contractual agreement with investigators and institutions requesting the data. Eligible researchers must provide the VHCI Lab with a research proposal and a data security plan for the use of requested data sets; both components of the application must be reviewed and approved by the VHCI Lab review committee as well as the IRB at the receiving institution. All data will be anonymized prior to release. We will make Teaching Adolescents Awareness of and Empathy toward Depression Using Virtual Reality Games data available for release through this restricted-access mechanism three years after the collection of the data. The VHCI Lab website will also provide instructions for applying for a restricted-access data release.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information