Virtual Reality Cognitive Remediation for Psychosis

Overseen By Synthia Guimond, PhD

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: The Royal Ottawa Mental Health Centre

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

No Placebo Group

Trial Summary

What is the purpose of this trial?

Individuals living with a psychotic disorder often experience changes to their thinking and social skills that can lead to challenges with work, school, relationships and living independently. One intervention to target these areas is cognitive remediation therapy, which can be delivered in virtual reality to help apply the skills and strategies learned to day-to-day life. Over the past few years, our team has co-developed a cognitive remediation program in virtual reality with healthcare professionals and people with lived experiences of psychosis. The current trial tests the feasibility and efficacy of this cognitive remediation program in virtual reality at improving thinking skills, social skills, and daily life functioning.

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 data supports the effectiveness of the Virtual Reality Cognitive Remediation treatment for psychosis?

Research shows that virtual reality (VR) therapy can help reduce avoidance and distress in people with psychosis, particularly those with severe symptoms. VR-based interventions have also been found to improve cognitive impairments and social skills in patients with psychosis. ^{1 2 3 4 5}

Is Virtual Reality Cognitive Remediation safe for humans?

The research does not provide specific safety data for Virtual Reality Cognitive Remediation, but it is generally considered acceptable and potentially effective for adults with psychosis. ^{4 6 7 8 9}

How is the Virtual Reality Cognitive Remediation Program treatment different from other treatments for psychosis?

The Virtual Reality Cognitive Remediation Program is unique because it uses fully immersive virtual reality tools to enhance cognitive function in people with psychosis, offering an engaging and interactive experience that traditional therapies may not provide. This approach aims to improve cognitive and functional abilities by simulating real-life scenarios, which can be more effective in helping patients apply cognitive skills to daily life. ^{4 7 9 10 11}

Research Team

Synthia Guimond, PhD

Principal Investigator

Royal Ottawa Mental Health Centre

Eligibility Criteria

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

I am between 20 and 55 years old.

Ability to read and speak English

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

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

I have a condition that affects my thinking or memory.

Trial Timeline

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

Treatment Details

Interventions

• Active Control (Behavioral Intervention)
• Virtual Reality Cognitive Remediation Program (Behavioral Intervention)

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. England 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. [2022]

2. Canada pubmed.ncbi.nlm.nih.gov

A Safe Place to Learn: Peer Research Qualitative Investigation of gameChange Virtual Reality Therapy. [2023]

3. Switzerland 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. [2020]

4. Switzerland 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. [2023]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Application of Immersive Virtual Reality for Assessment and Intervention in Psychosis: A Systematic Review. [2023]

6. Australia pubmed.ncbi.nlm.nih.gov

Views of young people with psychosis on using virtual reality assisted therapy. A qualitative study. [2023]

7. Netherlands pubmed.ncbi.nlm.nih.gov

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

8. Netherlands pubmed.ncbi.nlm.nih.gov

Computerized or manual? Long term effects of cognitive remediation on schizophrenia. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Evaluation of a new online cognitive remediation therapy (CIRCuiTSTM ) training for mental health professionals. [2023]

10. New Zealand 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. [2022]

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

Evaluation of a computer-assisted cognitive remediation program for young people with psychosis: A pilot study. [2022]