Virtual Reality Cognitive Remediation for Psychosis

Recruiting in Palo Alto (17 mi)

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.

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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.

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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.

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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

Participant Groups

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.

Group I: Cognitive Remediation Experimental Treatment 1 Intervention

Group II: Active Control Active Control 1 Intervention

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Royal Ottawa Mental Health Centre Ottawa, Canada

Who Is Running the Clinical Trial?

The Royal Ottawa Mental Health Centre Lead Sponsor

Fonds de la Recherche en Santé du Québec Collaborator

The Royal's Institute of Mental Health Research Collaborator

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] Automated delivery of psychological therapy using immersive technologies such as virtual reality (VR) might greatly increase the availability of effective help for patients. We aimed to evaluate the efficacy of an automated VR cognitive therapy (gameChange) to treat avoidance and distress in patients with psychosis, and to analyse how and in whom it might work.

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

A Safe Place to Learn: Peer Research Qualitative Investigation of gameChange Virtual Reality Therapy. [2023] Automated virtual reality (VR) therapy has the potential to substantially increase access to evidence-based psychological treatments. The results of a multicenter randomized controlled trial showed that gameChange VR cognitive therapy reduces the agoraphobic avoidance of people diagnosed with psychosis, especially for those with severe avoidance.

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] This perspective paper faces the future of alternative treatments that take advantage of a social and cognitive approach with regards to pharmacological therapy of auditory verbal hallucinations (AVH) in patients with schizophrenia. AVH are the perception of voices in the absence of auditory stimulation and represents a severe mental health symptom. Virtual/augmented reality (VR/AR) and brain computer interfaces (BCI) are technologies that are growing more and more in different medical and psychological applications. Our position is that their combined use in computer-based therapies offers still unforeseen possibilities for the treatment of physical and mental disabilities. This is why, the paper expects that researchers and clinicians undergo a pathway toward human-avatar symbiosis for AVH by taking full advantage of new technologies. This outlook supposes to address challenging issues in the understanding of non-pharmacological treatment of schizophrenia-related disorders and the exploitation of VR/AR and BCI to achieve a real human-avatar symbiosis.

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] Cognitive Remediation (CR) programs are effective for the treatment of mental diseases; in recent years, Virtual Reality (VR) rehabilitation tools are increasingly used. This study aimed to systematically review and meta-analyze the published randomized controlled trials that used fully immersive VR tools for CR programs in psychiatric rehabilitation. We also wanted to map currently published CR/VR interventions, their methods components, and their evidence base, including the framework of the development intervention of CR in fully immersive VR.

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

Application of Immersive Virtual Reality for Assessment and Intervention in Psychosis: A Systematic Review. [2023] Virtual reality (VR) has emerged as a safe and non-invasive technology for the assessment of psychotic symptoms, social and cognitive impairments, and psychosocial intervention in improving outcomes in psychosis. This study systematically reviewed the current state of evidence in applying semi- and fully immersive VR for assessing and treating patients with psychosis. A systematic review was conducted adhering to the PRISMA statement and was conducted in Embase, PsycINFO, and PubMed databases for articles published between January 2013 and April 2022, which identified 28 eligible studies, including 12 for assessment and 16 for intervention. In the assessment studies, not all VR tasks could distinguish the differences between patients and healthy controls regarding their physiological responses, paranoid ideation, and certain aspects of cognitive functioning such as memory bias on the object tasks. Comparatively, VR-based interventions are more promising, especially for improving cognitive impairments, social skills, agoraphobic avoidance, negative and positive affective states, auditory verbal hallucination, paranoid ideation and persecutory delusions, and other psychiatric symptoms in patients. We conclude that more rigorous studies are needed to confirm treatment effectiveness and to understand the underlying mechanism of VR-based intervention for psychotic disorders. Future studies should also improve the reliability and validity of VR-based assessments for psychotic disorders.

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

Views of young people with psychosis on using virtual reality assisted therapy. A qualitative study. [2023] Service disengagement is a challenge in young individuals struggling with psychosis. Combining cognitive behavioural therapy for psychosis (CBTp) with virtual reality (VR) has proven acceptable and potentially effective for symptoms and social functioning in adults with psychosis. However, studies focusing on young adolescents are lacking. The aim of the present study was to investigate the acceptability of VR-assisted CBTp among adolescents with psychosis.

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] Cognitive Remediation (CR) is an evidence based treatment targeting cognitive and functional difficulties in people with psychosis. Despite the large number of effectiveness studies, only limited evidence exists for the active ingredients of this therapy. This study begins to fill this gap by exploring the relationship between CR ingredients, including alliance with a therapist, and therapy outcomes.

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

Computerized or manual? Long term effects of cognitive remediation on schizophrenia. [2022] Cognitive remediation therapy (CRT) and Computerized CRT (CCRT) improve cognition and functioning, but there is no direct evidence of whether there is an advantage of using a computer. This study fills this gap and extends research evidence to the long-term effect of these two treatments in a large sample of Chinese inpatients with a diagnosis of schizophrenia.

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

Evaluation of a new online cognitive remediation therapy (CIRCuiTSTM ) training for mental health professionals. [2023] Cognitive remediation (CR) improves cognition and aids recovery in people with psychosis. An active therapist provides increased benefit, but CR training for therapists is not routinely available, so CR has limited scalability. This study describes the development and evaluation of the first online CR therapist training programme.

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] The Computerized Interactive Remediation of Cognition - Training for Schizophrenia (CIRCuiTS) is a form of cognitive remediation therapy developed to target neurocognitive and metacognitive deficits of people with schizophrenia, which have a detrimental impact on real-life functioning. The English version of CIRCuiTS demonstrated good acceptability and feasibility. A recent randomized controlled trial provided evidence that the program improves memory and functioning, and that the impact on functional outcome is mediated by metacognition. The next steps in the development of CIRCuiTS include both: 1) the translation and adaptation of the program in different cultural settings; and 2) the demonstration of feasibility, acceptability and effectiveness of a standardized method to administer CIRCuiTS remotely.

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] People with psychosis have a range of neuropsychological impairments that impact their functional abilities and rehabilitation outcomes. We designed a Computer-Assisted Cognitive Remediation (CACR) program to help young people with psychosis to restore their cognitive function. The program combines the drill-and-practice approach and the strategic approach to remediation, with sixteen sessions of computerized cognitive training, two sessions of psychoeducation, and four session of coaching on applying cognitive skills to daily life.