Virtual Reality Cognitive Remediation for Psychosis

Overseen By Synthia Guimond, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: The Royal Ottawa Mental Health Centre

Disqualifiers: Neurological disorders, Intellectual disability, Vision conditions, Seizures, others

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

Compensation: Varies

Number of Visits: 16

Duration: 6 weeks

52 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a virtual reality program designed to help people with psychosis improve their thinking and social skills. The program uses virtual reality to make it easier for participants to practice and apply these skills in everyday life. The trial includes two groups: one experiences the Virtual Reality Cognitive Remediation Program, while the other receives a different active treatment, called the Active Control, for comparison. It suits those diagnosed with a psychotic disorder who have stable symptoms and have not recently changed medications. As an unphased trial, this study offers a unique opportunity to contribute to innovative research and potentially benefit from cutting-edge virtual reality therapy.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you must not have changed your medication dosage, started a new medication, or stopped a medication in the month before joining the trial.

What prior data suggests that this virtual reality cognitive remediation program is safe for individuals with psychosis?

Research has shown that virtual reality for cognitive therapy is safe for people with psychotic disorders. Studies have found that this therapy is generally well-tolerated, with most people not experiencing serious side effects. For example, one study found that participants using virtual reality to enhance their thinking and social skills did not report major problems. Instead, they noticed improvements in their cognitive abilities and daily life.

Overall, the evidence suggests that virtual reality cognitive therapy safely aids in improving thinking and social skills in those with psychotic disorders. For those considering joining a clinical trial for this treatment, the safety data is reassuring. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Virtual Reality Cognitive Remediation Program for psychosis because it offers a unique approach compared to standard treatments like medication and traditional therapy. Unlike typical methods that mainly focus on managing symptoms, this program uses virtual reality technology to actively engage patients in cognitive exercises. This interactive method aims to improve cognitive functions such as memory and attention, which are often impaired in psychosis, potentially leading to better overall outcomes for patients. By providing an immersive and engaging experience, it might enhance patient motivation and adherence to therapy, offering a promising complement to existing treatment options.

What evidence suggests that this trial's treatments could be effective for psychosis?

Research shows that virtual reality can enhance thinking and social skills in people with psychotic disorders. In this trial, participants in the Virtual Reality Cognitive Remediation Program arm will engage in cognitive exercises using virtual reality. Studies have found that these exercises lead to better thinking skills and social interactions. One study found that virtual reality led to greater improvements in overall thinking skills compared to traditional methods. The immersive experience of virtual reality helps people apply these skills more effectively in real-life situations. This approach shows promise for improving daily life for those living with psychosis. Meanwhile, participants in the Active Control arm will receive a different program for comparison. ^{1 4 5 6 7}

Who Is on the Research Team?

Synthia Guimond, PhD

Principal Investigator

Royal Ottawa Mental Health Centre

Are You a Good Fit for This Trial?

This trial is for people aged 20-55 with a psychosis-spectrum disorder like schizophrenia, who speak English and have had stable medication doses for the past month. It's not suitable for those with cognitive impairments from other conditions, no smartphone, seizure history, severe eye/ear/balance issues, significant brain injury, intellectual disability or recent substance abuse.

Inclusion Criteria

Clinically stable with a total Positive And Negative Severity Symptoms score between 30 - 95

I have been diagnosed with a psychosis-spectrum disorder.

I am between 20 and 55 years old.

Exclusion Criteria

I have a history of seizures or epilepsy.

Vision conditions that cannot be corrected with contact lenses or glasses that can fit in the virtual reality goggles

Intellectual disability or a score below 70 on the Wechsler Abbreviated Scale of Intelligence

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

2 visits (in-person)

Treatment

Participants undergo a six-week cognitive remediation program using virtual reality, with exercises and discussions.

6 weeks

12 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments at 1-week and 3-months post-intervention.

3 months

2 visits (in-person)

Long-term Follow-up

Participants complete additional assessments at 6-months post-intervention to evaluate long-term effects.

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Active Control
• Virtual Reality Cognitive Remediation Program

Trial Overview The study tests a virtual reality program designed to improve thinking and social skills in individuals with psychotic disorders. Participants will use VR as part of cognitive remediation therapy to see if it helps them better manage daily activities and relationships.

How Is the Trial Designed?

Group I: Cognitive Remediation Experimental Treatment 1 Intervention

Group II: Active Control Active Control 1 Intervention

Who Is Running the Clinical Trial?

The Royal Ottawa Mental Health Centre

Lead Sponsor

Trials

24

Recruited

2,300+

Fonds de la Recherche en Santé du Québec

Collaborator

Trials

84

Recruited

46,700+

The Royal's Institute of Mental Health Research

Collaborator

Trials

8

Recruited

1,300+

Published Research Related to This Trial

Participants with psychosis reported significant improvements in managing agoraphobic avoidance after using gameChange VR therapy, particularly those with severe avoidance, highlighting its efficacy as a therapeutic tool.

The immersive VR scenarios allowed users to confront their anxieties in a safe environment, enabling them to learn new coping strategies and gradually apply these skills in real-world situations, suggesting a promising mechanism for anxiety reduction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Safe Place to Learn: Peer Research Qualitative Investigation of gameChange Virtual Reality Therapy. Bond, J., Kenny, A., Pinfold, V., et al.[2023]

Cognitive Remediation (CR) therapy significantly improved non-verbal memory and functioning in 46 participants with psychosis, suggesting its efficacy in addressing cognitive difficulties associated with the condition.

The study highlights the importance of therapeutic alliance, as it was linked to improvements in functioning and cognitive outcomes, indicating that the relationship between the therapist and the patient plays a crucial role in the effectiveness of CR.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The nuts and bolts of Cognitive Remediation: Exploring how different training components relate to cognitive and functional gains. Cella, M., Wykes, T.[2022]

A study involving 16 adolescents aged 13 to 18 years with early onset psychosis found that VR-assisted cognitive behavioral therapy (CBTp) was well-accepted, with 14 out of 16 participants expressing positive expectations about using VR for therapy.

The use of VR in therapy provided a less threatening environment for adolescents to confront their fears, suggesting that VR could be a valuable tool in treating early onset psychosis and enhancing engagement in therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Views of young people with psychosis on using virtual reality assisted therapy. A qualitative study. Holgersen, G., Nordgreen, T., Ten Velden Hegelstad, W., et al.[2023]

The Italian version of the CIRCuiTS program, a cognitive remediation therapy for schizophrenia, was found to be highly acceptable and feasible for remote administration, with low dropout rates and high patient satisfaction.

Participants who completed the program showed significant improvements in cognitive functions such as learning, working memory, and executive control, as well as enhanced self-esteem and real-life functioning after 40 therapy sessions over three months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Efficacy, Feasibility And Acceptability Of A Remotely Accessible Use Of CIRCuiTS, A Computerized Cognitive Remediation Therapy Program For Schizophrenia: A Pilot Study. Palumbo, D., Mucci, A., Giordano, GM., et al.[2022]

Virtual reality (VR) has been shown to be a safe and non-invasive method for assessing psychotic symptoms and cognitive impairments, but not all VR tasks effectively differentiate between patients with psychosis and healthy controls.

VR-based interventions appear promising for treating various symptoms of psychosis, including cognitive impairments and social skills, but further rigorous studies are needed to confirm their effectiveness and understand the mechanisms involved.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Application of Immersive Virtual Reality for Assessment and Intervention in Psychosis: A Systematic Review. Chan, KC., Hui, CL., Suen, YN., et al.[2023]

The Computer-Assisted Cognitive Remediation (CACR) program significantly improved cognitive function in young people with psychosis, particularly in verbal learning and speed of processing, compared to a treatment-as-usual control group.

Participants in the CACR program also reported enhanced mental well-being and perceived occupational competence, although there were no significant changes in functional status between the two groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a computer-assisted cognitive remediation program for young people with psychosis: A pilot study. Siu, AMH., Ng, RSH., Poon, MYC., et al.[2022]

The automated VR therapy (gameChange) significantly reduced avoidance and distress in everyday situations for patients with psychosis compared to usual care alone, with notable improvements observed at 6 weeks after treatment.

The therapy was particularly effective for patients with severe agoraphobic avoidance, and it worked by reducing anxious thoughts and protective behaviors, showing promise for increasing access to psychological therapy for those struggling to leave their homes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Automated virtual reality therapy to treat agoraphobic avoidance and distress in patients with psychosis (gameChange): a multicentre, parallel-group, single-blind, randomised, controlled trial in England with mediation and moderation analyses. Freeman, D., Lambe, S., Kabir, T., et al.[2022]

The paper suggests that combining virtual/augmented reality (VR/AR) and brain-computer interfaces (BCI) could revolutionize the treatment of auditory verbal hallucinations (AVH) in schizophrenia, offering new non-pharmacological therapies.

It emphasizes the potential for creating a human-avatar symbiosis, which could enhance understanding and treatment of schizophrenia-related disorders, moving beyond traditional pharmacological approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Human-Avatar Symbiosis for the Treatment of Auditory Verbal Hallucinations in Schizophrenia through Virtual/Augmented Reality and Brain-Computer Interfaces. Fernández-Caballero, A., Navarro, E., Fernández-Sotos, P., et al.[2020]

Cognitive Remediation (CR) programs using fully immersive Virtual Reality (VR) tools show significant efficacy in improving cognitive functions in patients with mental disorders, as evidenced by a review of 11 randomized controlled trials involving various conditions like mild cognitive impairment and schizophrenia.

Despite the promising results, the lack of detailed descriptions of the VR interventions and their components limits the understanding of their effectiveness and hinders the establishment of standardized practices for implementing CR/VR in real-world settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fully Immersive Virtual Reality-Based Cognitive Remediation for Adults with Psychosocial Disabilities: A Systematic Scoping Review of Methods Intervention Gaps and Meta-Analysis of Published Effectiveness Studies. Perra, A., Riccardo, CL., De Lorenzo, V., et al.[2023]

The first online cognitive remediation (CR) therapist training program was developed and evaluated, showing that it is feasible and acceptable for mental health professionals, with most participants completing the training successfully.

The training significantly improved knowledge among clinicians, particularly benefiting those with less experience, indicating its potential to enhance the delivery of CR in treating psychosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a new online cognitive remediation therapy (CIRCuiTSTM ) training for mental health professionals. Taylor, R., Crowther, A., Tinch-Taylor, R., et al.[2023]

Cognitive remediation therapy (CRT) and computerized cognitive remediation therapy (CCRT) both significantly improved cognitive function in Chinese inpatients with schizophrenia, with effects maintained for up to 18 months after treatment.

While both therapies showed similar overall efficacy, CRT demonstrated a specific advantage in processing speed on certain cognitive tests compared to CCRT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computerized or manual? Long term effects of cognitive remediation on schizophrenia. Zhu, X., Fan, H., Zou, Y., et al.[2022]

Citations

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Cognitive Remediation for Psychosis in Virtual Reality ... Cognitive remediation improves cognition and psychosocial functioning in individuals with psychotic disorders. The use of virtual reality ...

2. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-024-07910-7

Effect of immersive virtual reality-based cognitive remediation ... We will examine the effect of a 4-week, intensive virtual reality-based cognitive remediation programme involving daily life challenges on cognition and daily ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06038955

Effect of Immersive Virtual Reality-based Cognitive ... The investigators hypothesize that VR-based cognitive remediation vs. a VR control treatment has a beneficial effect on cognition after four-weeks treatment ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S277240852500105X

Virtual reality interventions for cognitive remediation in ... Their work indicated that VR intervention resulted in significant improvement in the global cognitive skills assessed with Cognition Assessment in Virtual ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38268043/

Effect of immersive virtual reality-based cognitive ... We will examine the effect of a 4-week, intensive virtual reality-based cognitive remediation programme involving daily life challenges on cognition and daily ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12244106/

Virtual reality interventions for cognitive remediation in ... Their work indicated that VR intervention resulted in significant improvement in the global cognitive skills assessed with Cognition Assessment ...

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Effect of immersive virtual reality-based cognitive ... We will examine the effect of a 4-week, intensive virtual reality-based cognitive remediation programme involving daily life challenges on cognition and daily ...