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NCT Number: NCT07350278

Comparing Virtual Reality Simulation to High Fidelity Simulation as an Educational Modality for Electroconvulsive Therapy Training: A Non-Inferiority 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.

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.

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Key information

Conditions

Education, Medical, Undergraduate Electroconvulsive Therapy Virtual Reality Simulation

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Is a medical student at the University of Toronto
  • Has not received formal ECT training before

Exclusion criteria

  • Visual or hearing impairment that does not allow the participant to use VR.
  • History of significant motion sickness.

Treatment and study plan

Virtual Reality electroconvulsive therapy simulator

Other

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 Simulator

Other

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.

Primary outcomes

  1. 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).

Secondary outcomes

  1. VR System Usability Scale (SUS)

    Time frame: After the study educational intervention administration (day 1)

    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).

  2. Rate of Learning Questionnaire

    Time frame: Before and after the study educational intervention administration (day 1)

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Fahad Alam, MD, FRCPC, MHSc

CONTACT

[email protected]

416-480-4864

Lilia Kaustov, PhD

CONTACT

[email protected]

416-480-6100 ext. 689607

Sponsors and collaborators

Lead sponsor

Sunnybrook Health Sciences Centre

Other

Registry information

Acronym: ECT-SIM

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Jan 20, 2026
Registry last updated
Jan 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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