Education, Medical, UndergraduateECT-SIMNCT07350278
Comparing Virtual Reality Simulation to High Fidelity Simulation as an Educational Modality for Electroconvulsive Therapy Training: A Non-Inferiority Study
A study testing Virtual Reality electroconvulsive therapy simulator and Mannequin Simulator in people with Education, Medical, Undergraduate and Electroconvulsive Therapy, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial summary
The goal of this prospective, open-label non-inferiority randomized controlled trial is to investigate if Virtual Reality (VR) based simulation are an effective training tool for novice medical trainees. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Education, Medical, Undergraduate, Electroconvulsive Therapy, Virtual Reality Simulation
- What is being tested?
- Virtual Reality electroconvulsive therapy simulator and Mannequin Simulator
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteCanada
- Study dates
- 18 Jan 2026to 1 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Is a medical student at the University of Toronto
- Has not received formal ECT training before
Who cannot join
- Visual or hearing impairment that does not allow the participant to use VR.
- History of significant motion sickness.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
Fahad Alam, MD
Peter Giacobbe, MD
About this study
The goal of this prospective, open-label non-inferiority randomized controlled trial is to investigate if Virtual Reality (VR) based simulation are an effective training tool for novice medical trainees. The main questions it aims to answer are:
- Is the VR-based electroconvulsive therapy (ECT) training program non-inferior to traditional, mannequin-based ECT training programs in fostering ECT skill acquisition?
- What are the changes in confidence in administering ECT, as well as number of training repetitions completed in the VR and mannequin training groups?
- What is the ease of use of the VR-based ECT training program? Researchers will compare the VR-based ECT training program to a mannequin-based ECT training program to see if the VR-based ECT training program is comparable to traditional methods at training for ECT.
Read more
Participants will:
- Complete an ECT skills assessment at the beginning and end of the study session.
- Watch a 30-minute didactic ECT lecture video.
- Be randomized to either the VR ECT simulation group or the mannequin ECT simulation group and be given 30 minutes to practice ECT administration with their assigned education tool.
Read the detailed description
Electroconvulsive therapy (ECT) is one of the most validated treatments for major depressive disorder (MDD), particularly treatment-resistant MDD where patients do not respond to at least two full courses of antidepressant medications and one full course of cognitive behavioral therapy. Despite its proven efficacy and safety, ECT is still heavily underutilized compared to other treatments. One of the causes for ECT underutilization is a stagnation in the growth in numbers of ECT-competent practitioners over the past 30 years. This issue stems from a lack of formal, standardized, and effective ECT training for medical trainees.
Virtual reality (VR) technology has been emerging as a promising medium for medical training due to its ability to create highly immersive and interactive simulations. Compared to traditional simulation mediums such as high-fidelity mannequins, VR is advantageous in that the cost of repeated use is low, usage of VR is not limited to a specialized facility, and VR training programs can be easily disseminated. VR-based simulations for medical training has already been developed for disciplines such as anesthesiology, where VR-based simulation tools are used to aid the learning of techniques such as bronchoscopy. However, there currently lacks a validated VR training tool for ECT.
Here the investigators propose to study a VR-based ECT training simulation, and see if it is non-inferior to a mannequin-based ECT training simulation. The mannequin-based simulation represents experiential learning, which is one of the ways ECT is currently taught.
Medical students who have not received any ECT training (N = 78) will begin the study by completing an ECT skills assessment test, where they must go through an ECT scenario on a mannequin. Afterwards, participants will watch a 30-minute didactic ECT lecture video. Participants will then be randomized to either the intervention group (VR simulation training group, N = 39) or the active control (mannequin simulation training group, N = 39). Participants will be instructed on how to use their assigned education modality, then given around 30 minutes to practice with their education modality. After the training sessions, participants will complete the ECT skills assessment test again.
The ECT skills assessment tests will be recorded, and two blinded raters will rate the ECT competency of the participant based on an ECT competency scale. Participants will also be asked how confident they are at administering ECT before and after the training sessions, as well as how many training repetitions they completed during their session.
- Being tested
- Virtual Reality electroconvulsive therapy simulator, Mannequin Simulator
- Keywords
- virtual reality, mannequin, education, electroconvulsive therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality electroconvulsive therapy simulatorOther
A virtual reality (VR)-based simulator for electroconvulsive therapy (ECT) practice. Users will go through tutorials on how to use the VR equipment and be guided through an ECT tutorial, then they can practice ECT with no guidance at 3 distinct difficulty levels. Level 1 of the simulator will contain ECT scenarios with very few patient conditions that need additional consideration. Level 2 will contain more patient conditions that need additional consideration, as well as a chance for adverse events to occur during treatment. Level 3 will contain many patient conditions that require the user to consider when deciding how to provide ECT, as well as a high chance of adverse events occurring. Users will be shown how well they did after completing a run of a scenario.
Mannequin SimulatorOther
A mannequin that users can use to practice electroconvulsive therapy (ECT) administration on. Users will be provided a mannequin and ECT equipment, as well as a scenario check-list to go through.
| Study group | Role | What they receive |
|---|---|---|
| VR Simulator Group | Experimental | Participants randomized to this group will practice electroconvulsive therapy (ECT) administration using a virtual reality (VR) ECT simulator. Receives: Other: Virtual Reality electroconvulsive therapy simulator |
| Mannequin Simulator Group | Active comparator | Participants randomized to this group will practice electroconvulsive therapy (ECT) administration using a mannequin ECT simulator. Receives: Other: Mannequin Simulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electroconvulsive Therapy Objective Structured Assessment of Technical Skills (ECT-OSATS)
A comprehensive ECT proficiency assessment tool including a technical skills checklist and a global performance rating scale. The technical skills checklist includes specific tasks during ECT administration that need to be completed to ensure a successful ECT delivery. Scores for each task can range from 1 - "Not Done" to 3 - "Done Correctly". Higher scores indicate better performance. The global performance rating scale includes items such as "Efficiency", "Knowledge", "Communication", and "Overall Impression of Performance" of the participant's ECT administration session as a whole. Scores can range from 1 - 5, with higher scores indicating a more positive outcome. The rating scale culminates with a "Global Impression of Pass or Fail", with options of "Fail" - the participant cannot perform ECT independently, or "Pass" - the participant can perform ECT independently. The ECT-OSATS was adapted from Rabheru et al. (2013).
Measured: Before and after the study educational intervention administration (day 1)
Secondary outcomes (2)
VR System Usability Scale (SUS)
A questionnaire asking about the user's experience in their use of virtual reality technology. It is a 8-item questionnaire rated on a 5-point Likert scale with options of "Strongly Agree", "Somewhat Agree", "Neutral", "Somewhat Disagree", and "Strongly Disagree". Each choice is also associated with a numbered score, from "Strongly Agree" at 1 to "Strongly Disagree" at 5. Depending on the question, higher scores could indicate a more positive or a more negative outcome. E.g., for the question "I thought the VR system was easy to use", a higher score would indicate a more negative outcome. Conversely, for the question "I found the VR system unnecessarily complex", a higher score would indicate a more positive outcome. Scores will be adjusted depending on if the question rates higher scores as a positive or negative outcome. Adjusted scores will be summed, then multiplied by 2.5 and divided by 80 to yield a final system usability score out of 100. Adapted from Brooke, John (1995).
Measured: After the study educational intervention administration (day 1)
Rate of Learning Questionnaire
A 3-item questionnaire examining the participant's confidence in performing ECT at baseline and at end of study, as well as the number of practice repetitions the participant completed during the education intervention session. Confidence in performing ECT is assessed on a 3-point scale ranging from "Not At All" to "Very confident", with "Very Confident" being a more positive outcome. Practice repetitions are defined as the number of times the participant completed ECT training scenarios during their education intervention session.
Measured: Before and after the study educational intervention administration (day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start18 Jan 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Education, Medical, UndergraduateStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective randomized controlled non-inferiority study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Fahad Alam, Sunnybrook Health Sciences Centre
- Investigators
- Fahad Dr. Alam, MD, FRCPC, Principal investigator, Sunnybrook Research InstitutePeter Giacobbe, MD, MSc, Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07350278
- Sponsor's protocol ID
- 6838
- Acronym
- ECT-SIM
- Status last verified
- Aug 2026
- First submitted
- 12 Dec 2025
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified participant-level data will be made available upon reasonable request to study PI following publication of full trial results.
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Virtual Reality Simulation to High Fidelity Simulation as an Educational Modality for Electroconvulsive Therapy Training: A Non-Inferiority Study
- ClinicalTrials.gov ID
- NCT07350278
- Acronym / sponsor ID
- ECT-SIM / 6838
- Keywords
- virtual reality, mannequin, education, electroconvulsive therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- 18 Jan 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 20 Jan 2026 (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.
The goal of this prospective, open-label non-inferiority randomized controlled trial is to investigate if Virtual Reality (VR) based simulation are an effective training tool for novice medical trainees. The main questions it aims to answer are:
- Is the VR-based electroconvulsive therapy (ECT) training program non-inferior to traditional, mannequin-based ECT training programs in fostering ECT skill acquisition?
- What are the changes in confidence in administering ECT, as well as number of training repetitions completed in the VR and mannequin training groups?
- What is the ease of use of the VR-based ECT training program? Researchers will compare the VR-based ECT training program to a mannequin-based ECT training program to see if the VR-based ECT training program is comparable to traditional methods at training for ECT.
Participants will:
- Complete an ECT skills assessment at the beginning and end of the study session.
- Watch a 30-minute didactic ECT lecture video.
- Be randomized to either the VR ECT simulation group or the mannequin ECT simulation group and be given 30 minutes to practice ECT administration with their assigned education tool.
Detailed description
Electroconvulsive therapy (ECT) is one of the most validated treatments for major depressive disorder (MDD), particularly treatment-resistant MDD where patients do not respond to at least two full courses of antidepressant medications and one full course of cognitive behavioral therapy. Despite its proven efficacy and safety, ECT is still heavily underutilized compared to other treatments. One of the causes for ECT underutilization is a stagnation in the growth in numbers of ECT-competent practitioners over the past 30 years. This issue stems from a lack of formal, standardized, and effective ECT training for medical trainees.
Virtual reality (VR) technology has been emerging as a promising medium for medical training due to its ability to create highly immersive and interactive simulations. Compared to traditional simulation mediums such as high-fidelity mannequins, VR is advantageous in that the cost of repeated use is low, usage of VR is not limited to a specialized facility, and VR training programs can be easily disseminated. VR-based simulations for medical training has already been developed for disciplines such as anesthesiology, where VR-based simulation tools are used to aid the learning of techniques such as bronchoscopy. However, there currently lacks a validated VR training tool for ECT.
Here the investigators propose to study a VR-based ECT training simulation, and see if it is non-inferior to a mannequin-based ECT training simulation. The mannequin-based simulation represents experiential learning, which is one of the ways ECT is currently taught.
Medical students who have not received any ECT training (N = 78) will begin the study by completing an ECT skills assessment test, where they must go through an ECT scenario on a mannequin. Afterwards, participants will watch a 30-minute didactic ECT lecture video. Participants will then be randomized to either the intervention group (VR simulation training group, N = 39) or the active control (mannequin simulation training group, N = 39). Participants will be instructed on how to use their assigned education modality, then given around 30 minutes to practice with their education modality. After the training sessions, participants will complete the ECT skills assessment test again.
The ECT skills assessment tests will be recorded, and two blinded raters will rate the ECT competency of the participant based on an ECT competency scale. Participants will also be asked how confident they are at administering ECT before and after the training sessions, as well as how many training repetitions they completed during their session.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective randomized controlled non-inferiority study
| Arm | Type | Receives |
|---|---|---|
| VR Simulator Group | Experimental | Other: Virtual Reality electroconvulsive therapy simulatorParticipants randomized to this group will practice electroconvulsive therapy (ECT) administration using a virtual reality (VR) ECT simulator. |
| Mannequin Simulator Group | Active comparator | Other: Mannequin SimulatorParticipants randomized to this group will practice electroconvulsive therapy (ECT) administration using a mannequin ECT simulator. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Is a medical student at the University of Toronto
- Has not received formal ECT training before
Key exclusion criteria (2 listed)
- Visual or hearing impairment that does not allow the participant to use VR.
- History of significant motion sickness.
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 Reality electroconvulsive therapy simulatorA virtual reality (VR)-based simulator for electroconvulsive therapy (ECT) practice. Users will go through tutorials on how to use the VR equipment and be guided through an ECT tutorial, then they can practice ECT with no guidance at 3 distinct difficulty levels. Level 1 of the simulator will contain ECT scenarios with very few patient conditions that need additional consideration. Level 2 will contain more patient conditions that need additional consideration, as well as a chance for adverse events to occur during treatment. Level 3 will contain many patient conditions that require the user to consider when deciding how to provide ECT, as well as a high chance of adverse events occurring. Users will be shown how well they did after completing a run of a scenario. | Other | VR Simulator Group |
| Mannequin SimulatorA mannequin that users can use to practice electroconvulsive therapy (ECT) administration on. Users will be provided a mannequin and ECT equipment, as well as a scenario check-list to go through. | Other | Mannequin Simulator Group |
Primary outcome
Electroconvulsive Therapy Objective Structured Assessment of Technical Skills (ECT-OSATS)
Time frame: Before and after the study educational intervention administration (day 1)
A comprehensive ECT proficiency assessment tool including a technical skills checklist and a global performance rating scale. The technical skills checklist includes specific tasks during ECT administration that need to be completed to ensure a successful ECT delivery. Scores for each task can range from 1 - "Not Done" to 3 - "Done Correctly". Higher scores indicate better performance. The global performance rating scale includes items such as "Efficiency", "Knowledge", "Communication", and "Overall Impression of Performance" of the participant's ECT administration session as a whole. Scores can range from 1 - 5, with higher scores indicating a more positive outcome. The rating scale culminates with a "Global Impression of Pass or Fail", with options of "Fail" - the participant cannot perform ECT independently, or "Pass" - the participant can perform ECT independently. The ECT-OSATS was adapted from Rabheru et al. (2013).
2 secondary outcomes
VR System Usability Scale (SUS)
Time frame: After the study educational intervention administration (day 1)
Rate of Learning Questionnaire
Time frame: Before and after the study educational intervention administration (day 1)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Individual participant dataSharing planned: Yes. De-identified participant-level data will be made available upon reasonable request to study PI following publication of full trial results.
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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.
Fahad Dr. Alam, MD, FRCPC principal investigator
Sunnybrook Research Institute
Peter Giacobbe, MD, MSc principal investigator
Sunnybrook Health Sciences Centre
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 electroconvulsive therapy simulator and Mannequin Simulator in people with Education, Medical, Undergraduate and Electroconvulsive Therapy, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
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 2 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 10 Aug 2026. 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 Canada. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fahad Alam, MD, FRCPC (416-480-4864, Fahad.Alam@Sunnybrook.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Electroconvulsive Therapy Objective Structured Assessment of Technical Skills (ECT-OSATS) (time frame: Before and after the study educational intervention administration (day 1)). 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 10 Aug 2026.