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

Trial Summary

What is the purpose of this trial?

The study design is a two-arm randomized controlled pilot trial. The investigators will recruit Inuit in Montreal and randomly assign them to two treatment groups (n=20 each). The active psychotherapy group will receive a ten-week manualized virtual reality (VR) assisted cognitive-behavioral psychotherapy (VR-CBT) at the clinic and guided by a psychotherapist. The VR-CBT will aim at improving emotion regulation. The comparison group will use a VR self-management program, Calm Place, for guided relaxation during ten weeks at home. To evaluate outcome in both groups, the researchers will measure self-reports of emotion regulation, affect, distress and well-being, as well as a psychophysiological reactivity paradigm pre-post treatment.

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.

What data supports the idea that Virtual Reality Cognitive Behavioral Therapy for Emotion Regulation is an effective treatment?

The available research shows that Virtual Reality Cognitive Behavioral Therapy (VR-CBT) is effective in helping people manage their emotions. For example, a study involving Inuit communities used VR-CBT to improve emotion regulation by creating culturally adapted virtual environments. Another review found that virtual reality interventions, including VR-CBT, are effective for treating anxiety and post-traumatic stress disorders, with large positive effects reported. These studies suggest that VR-CBT can be a powerful tool for emotional well-being, offering an engaging and interactive way to practice emotion regulation skills. ^{1 2 3 4 5}

What safety data exists for Virtual Reality Cognitive Behavioral Therapy for Emotion Regulation?

The provided research does not contain any safety data related to Virtual Reality Cognitive Behavioral Therapy (VR-CBT) or its variants such as Self-management, Calm Place, Guided Relaxation Program, VR-Assisted CBT. The studies focus on cardiac radioablation and radiotherapy for ventricular tachycardia and breast cancer, which are unrelated to VR-CBT. ^{6 7 8 9 10}

Is VR-CBT a promising treatment for emotion regulation?

Yes, VR-CBT is a promising treatment for emotion regulation. It uses virtual reality to create immersive environments that help people practice controlling their emotions. Studies show that it can improve emotional control and overall well-being, making it a valuable tool for therapy. ^{1 3 4 11 12}

Research Team

Outi Linnaranta, MD, PhD

Principal Investigator

Douglas Mental Health University Institute

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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 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]

References

1. Canada 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. [2023]

2. Spain pubmed.ncbi.nlm.nih.gov

A Decade in Review: A Systematic Review of Virtual Reality Interventions for Emotional Disorders. [2023]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Virtual reality interventions for the treatment of anxiety disorders: A scoping review. [2023]

4. England 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. [2018]

5. Israel pubmed.ncbi.nlm.nih.gov

Virtual reality exposure versus cognitive restructuring for treatment of public speaking anxiety: a pilot study. [2018]

6. Germany pubmed.ncbi.nlm.nih.gov

Stereotactic body radiotherapy for ventricular tachycardia (cardiac radiosurgery) : First-in-patient treatment in Germany. [2020]

7. Germany 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. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Phase I/II Trial of Electrophysiology-Guided Noninvasive Cardiac Radioablation for Ventricular Tachycardia. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

Computational ECG mapping and respiratory gating to optimize stereotactic ablative radiotherapy workflow for refractory ventricular tachycardia. [2022]

10. Germany 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. [2023]

11. United States pubmed.ncbi.nlm.nih.gov

Emo-regulator: An emotion-regulation training system fusing virtual reality and EEG-based neurofeedback. [2023]

12. Switzerland 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. [2020]