Virtual Reality Cognitive Behavioral Therapy for Emotion Regulation

Overseen By Karyne Anselmo, M.Sc.

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Douglas Mental Health University Institute

Must not be taking: Psychoactive medications

Disqualifiers: Psychosis, Schizophrenia, Substance abuse, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 10

Duration: 10 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to help people manage their emotions using virtual reality (VR) and therapy. Participants will either receive VR-assisted cognitive-behavioral therapy (VR-CBT, a type of talk therapy) with a therapist or use a VR program at home for relaxation. The goal is to determine which method better improves emotion regulation and overall well-being. The trial seeks Inuit living in Montreal who are comfortable using VR headsets and do not have heart issues or epilepsy. As an unphased trial, this study offers a unique opportunity to explore innovative emotional management techniques using cutting-edge VR technology.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. However, you must not have had any changes in psychoactive medications during the 4 weeks before joining the study.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Virtual Reality Cognitive Behavioral Therapy (VR-CBT) is generally easy for people to handle. Studies indicate that VR-CBT helps individuals manage their emotions more effectively. Participants in these studies did not report any serious side effects, suggesting the treatment is safe.

Although the studies do not provide detailed safety data, no major negative effects have been reported. This suggests that most people can use VR-CBT without experiencing harmful effects. However, those considering joining a study should discuss any concerns with the study team or their doctor. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Virtual Reality Cognitive Behavioral Therapy (VR-CBT) for emotion regulation because it offers a unique way to engage in therapy through immersive technology. Unlike traditional cognitive behavioral therapy, VR-CBT uses a virtual environment to help participants practice emotion regulation in a controlled, interactive setting. This new delivery method could make therapy more engaging and accessible, potentially enhancing the effectiveness of treatment. Additionally, the VR-CBT sessions are guided by a trained psychotherapist, which combines the benefits of expert guidance with cutting-edge technology. This innovation could provide a more personalized and dynamic experience compared to standard therapy options.

What evidence suggests that this trial's treatments could be effective for improving emotion regulation?

Research has shown that virtual reality-assisted cognitive behavioral therapy (VR-CBT), which participants in this trial may receive, can help people manage their emotions better. One study combined VR-CBT with traditional therapy and virtual reality experiences, enabling people to practice coping strategies in lifelike settings. Other studies have also found that VR-CBT can reduce anxiety and improve emotional control. The evidence suggests that VR-CBT is a promising tool for helping people regulate their emotions more effectively. Meanwhile, another group in this trial will use a commercial VR application for guided self-management, allowing participants to manage their emotions at their own pace. ^{1 2 5 6 7}

Who Is on the Research Team?

Outi Linnaranta, MD, PhD

Principal Investigator

Douglas Mental Health University Institute

Are You a Good Fit for This Trial?

This trial is for Inuit individuals living in Montreal, aged 14-60, who are mentally stable and have no history of psychosis or substance abuse. Participants must be comfortable with VR technology, not at risk of suicide or homicide, and able to communicate in English or French.

Inclusion Criteria

I have never had epilepsy.

No history of psychosis or schizophrenia

Tolerance of VR headset

Exclusion Criteria

Current substance abuse, as measured by two screens (AUDIT-C, DAST-10)

Does not identify as Inuk

I am either younger than 14 or older than 60.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a ten-week manualized virtual reality (VR) assisted cognitive-behavioral psychotherapy (VR-CBT) at the clinic or use a VR self-management program, Calm Place, for guided relaxation at home.

10 weeks

10 sessions (in-person for VR-CBT group), self-paced at home for Calm Place group

Follow-up

Participants are monitored for safety and effectiveness after treatment, including psychophysiological reactivity testing and self-reports of emotion regulation and well-being.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Self-management
• VR-CBT

Trial Overview The study compares two groups: one receives a ten-week virtual reality-assisted cognitive-behavioral therapy (VR-CBT) for emotion regulation at a clinic; the other uses a VR self-management relaxation program at home. Outcomes will be measured through self-reports and physiological responses before and after treatment.

How Is the Trial Designed?

Group I: VR-CBT Experimental Treatment 1 Intervention

A trained psychotherapist provides CBT-VR for up to 10 sessions over 10 weeks.

Group II: Self-management Active Control 1 Intervention

Participants use a commercial VR application at home for guided self-management at their own pace over 10 weeks.

VR-CBT is already approved in Canada for the following indications:

Approved in Canada as VR-CBT for:

• Emotion regulation improvement
• Psychological well-being enhancement

Who Is Running the Clinical Trial?

Douglas Mental Health University Institute

Lead Sponsor

Trials

31

Recruited

2,800+

McGill University

Collaborator

Trials

421

Recruited

1,017,000+

MedTeq

Industry Sponsor

Trials

8

Recruited

520+

Douglas Foundation

Collaborator

Trials

1

Recruited

40+

Natural Sciences and Engineering Research Council, Canada

Collaborator

Trials

63

Recruited

3,000+

Published Research Related to This Trial

Virtual reality interventions have shown large treatment effects and are considered effective for various anxiety disorders and post-traumatic stress disorder, particularly when used in cognitive behavioral therapy.

There is significant variability in the implementation of these interventions, including cost and technology used, which may affect their translation from research to clinical practice; future studies should focus on improving methodology and exploring their use for other emotional disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Decade in Review: A Systematic Review of Virtual Reality Interventions for Emotional Disorders. Rowland, DP., Casey, LM., Ganapathy, A., et al.[2023]

Virtual Reality (VR) interventions have been shown to significantly reduce symptoms of various anxiety disorders in adults, making them a promising alternative to traditional exposure therapy.

These VR treatments are generally well-accepted by clients and have minimal side effects, although caution is advised for Combat-Related PTSD in Vietnam veterans, indicating the need for further research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual reality interventions for the treatment of anxiety disorders: A scoping review. Andersen, NJ., Schwartzman, D., Martinez, C., et al.[2023]

Cardiac radioablation (cRA) was used as a last-resort treatment for two patients with terminal heart failure on LVAD therapy who had persistent ventricular tachycardia (VT), but both patients continued to experience VT after the procedure, highlighting the challenges of this approach.

While cRA did not result in immediate side effects, the long-term outcomes were poor, with one patient experiencing fatal complications shortly after treatment, suggesting that more effective post-procedural strategies are needed for managing VT in these high-risk patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiac radioablation of incessant ventricular tachycardia in patients with terminal heart failure under permanent left ventricular assist device therapy-description of two cases. Mehrhof, F., Bergengruen, P., Gerds-Li, JH., et al.[2023]

In a prospective trial involving 19 patients with treatment-refractory ventricular tachycardia (VT) or PVC-related cardiomyopathy, noninvasive cardiac radioablation significantly reduced the median number of VT episodes from 119 to just 3, demonstrating high efficacy in managing arrhythmias.

The procedure had a modest safety profile, with only 10.5% of patients experiencing serious treatment-related adverse events, and it led to a significant decrease in the use of antiarrhythmic medications from 59% to 12%, along with improvements in quality of life for many patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase I/II Trial of Electrophysiology-Guided Noninvasive Cardiac Radioablation for Ventricular Tachycardia. Robinson, CG., Samson, PP., Moore, KMS., et al.[2020]

Virtual Reality exposure therapy (VRET) has been proven effective in reducing fear and anxiety through decades of research and over 20 randomized controlled trials, but access has been limited due to the high cost of equipment.

Recent advancements in consumer VR technology, like Oculus Rift and Samsung Gear, now allow for broader implementation of VRET in clinical settings and self-help applications, making it more accessible for both providers and patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Creating state of the art, next-generation Virtual Reality exposure therapies for anxiety disorders using consumer hardware platforms: design considerations and future directions. Lindner, P., Miloff, A., Hamilton, W., et al.[2018]

The Emo-regulator, a training system combining virtual reality and EEG-based neurofeedback, effectively improved emotion regulation in subjects over a two-week period, as evidenced by enhanced ability to down-regulate negative emotions.

Participants reported above-average usability of the Emo-regulator, indicating that it not only helps in emotional management but is also user-friendly, promoting the use of cognitive reappraisal techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Emo-regulator: An emotion-regulation training system fusing virtual reality and EEG-based neurofeedback. Yu, M., Bai, Y., Li, Y.[2023]

A proof-of-concept randomized controlled trial (RCT) involving 40 Inuit participants will assess the feasibility and effectiveness of a culturally adapted virtual reality-assisted cognitive behavioral therapy (VR-CBT) designed to improve emotion regulation over a 10-week period.

The study aims to compare this culturally tailored VR-CBT with a commercially available VR relaxation program, focusing on self-rated mental well-being and psychophysiological measures, addressing the need for culturally sensitive mental health resources in Indigenous communities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Virtual Reality-Assisted Cognitive Behavioral Therapy for and With Inuit in Québec: Protocol for a Proof-of-Concept Randomized Controlled Trial. Seon, Q., Mady, N., Yang, M., et al.[2023]

A systematic review of 11 studies involving adults and older adults indicates that virtual reality (VR) technologies can effectively enhance emotion regulation and promote wellbeing.

The review emphasizes the importance of carefully selecting both objective and subjective measures to assess the effectiveness of VR-based emotion regulation interventions in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Benefits of emotion Regulation Interventions in Virtual Reality for the Improvement of Wellbeing in Adults and Older Adults: A Systematic Review. Montana, JI., Matamala-Gomez, M., Maisto, M., et al.[2020]

Cardiac stereotactic body radiotherapy (CRS/RA) was successfully performed on a 78-year-old patient with refractory ventricular tachycardia (VT), resulting in a significant reduction in VT episodes from 5.0 to 1.6 per week and an 81.2% decrease in ICD shock interventions.

The procedure was completed without major complications, although the patient later died from unrelated causes, highlighting the need for further clinical trials to assess long-term outcomes and safety of CRS/RA in treating refractory VT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic body radiotherapy for ventricular tachycardia (cardiac radiosurgery) : First-in-patient treatment in Germany. Krug, D., Blanck, O., Demming, T., et al.[2020]

In a study of 159 breast cancer patients treated with breast-conserving therapy and 3D conformal radiotherapy, axillary clearing surgery was linked to a higher risk of arm lymphoedema and breast oedema, indicating that surgical extent can influence late radiation side effects.

Patients with larger breast sizes (≥ cup C) and those with significant breast ptosis were more likely to experience poor cosmetic outcomes and chronic breast oedema, suggesting that physical characteristics may affect treatment results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Late radiation side effects, cosmetic outcomes and pain in breast cancer patients after breast-conserving surgery and three-dimensional conformal radiotherapy : Risk-modifying factors. Hille-Betz, U., Vaske, B., Bremer, M., et al.[2022]

The use of automated 12-lead ECG mapping and respiratory-gated therapy in stereotactic ablative radiotherapy (SAbR) for refractory ventricular tachycardia (VT) improved planning precision and safety, with no gastrointestinal complications observed in patients with targets near the stomach.

In a study of 6 patients, the approach led to a significant reduction in implantable cardioverter-defibrillator shocks, decreasing from an average of 23 to 0.67 shocks per patient after treatment, indicating effective management of VT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computational ECG mapping and respiratory gating to optimize stereotactic ablative radiotherapy workflow for refractory ventricular tachycardia. Ho, G., Atwood, TF., Bruggeman, AR., et al.[2022]

Virtual Reality Exposure Therapy (VRE) and Cognitive Therapy (CT) were found to be equally effective as Cognitive-Behavior Therapy (CBT) in reducing public speaking anxiety (PSA) in a study involving subjects who received 12 therapy sessions.

While CT showed some superiority over VRE on one behavioral measure, VRE was better at reducing fear during a behavioral task, indicating that both therapies can be effective options for treating PSA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual reality exposure versus cognitive restructuring for treatment of public speaking anxiety: a pilot study. Wallach, HS., Safir, MP., Bar-Zvi, M.[2018]

Citations

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A Virtual Reality–Assisted Cognitive Behavioral Therapy ... Virtual reality–assisted cognitive behavioral therapy (VR-CBT) is an effective psychotherapy to target and strengthen emotion regulation; however, it currently ...

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Virtual reality-assisted cognitive behavioral therapy for ... This study aims to test a new approach to therapy that uses Virtual Reality (VR) alongside traditional Cognitive Behavioral Therapy (CBT). The ...

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A virtual reality-assisted cognitive behavioral therapy for and ... Virtual reality–assisted cognitive behavioral therapy (VR-CBT) is an effective psychotherapy to target and strengthen emotion regulation ...

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Effectiveness of Virtual Reality Psychotherapy and Yoga on ... The treatment will include reducing anxiety and improving emotion regulation through Cognitive-Behavioural techniques such as mindfulness, acceptance and ...

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Comparative Efficacy of Virtual Reality–Assisted Cognitive ... This trial aims to compare VR-assisted cognitive behavioral therapy (CBT) with yoga interventions to find effective treatments.

7. withpower.com withpower.com/trial/phase-emotion-regulation-2023-cd738

Virtual Reality Cognitive Behavioral Therapy for Emotion ... The available research shows that Virtual Reality Cognitive Behavioral Therapy (VR-CBT) is effective in helping people manage their emotions. For example, a ...