Cognitive Health Interventions for Schizophrenia

(iCogCA Trial)

Recruiting in Palo Alto (17 mi)

+4 other locations

Overseen by Martin Lepage, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Douglas Mental Health University Institute

Disqualifiers: Intellectual disability, Hospitalization, High suicide risk, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to effectively implement virtually-delivered interventions in mental health institutions nationwide to improve the cognitive health of individuals living with schizophrenia. The main objectives are: * To determine the clinical effectiveness of two virtual cognitive health interventions (i.e., Action-Based Cognitive Remediation or MetaCognitive Training). * To evaluate our implementation strategy involving the virtual delivery of cognitive health interventions combined with a digital learning platform to train mental health practitioners. Participants will be assessed for the severity of symptoms, cognitive performance, and overall functioning before and after receiving the intervention. Qualitative interviews will also be conducted with participants and therapists to evaluate the implementation strategies.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Cognitive remediation, Cognitive Remediation Therapy, Cognitive Training, Cognitive Rehabilitation, MetaCognitive Training, MetaCognitive Training, MCT for schizophrenia?

Research shows that cognitive remediation and metacognitive training can help improve thinking skills and social functioning in people with schizophrenia. These treatments have been found to reduce cognitive deficits and improve real-world outcomes, making them promising strategies for early intervention in schizophrenia. ^{1 2 3 4 5}

Is metacognitive training (MCT) safe for people with schizophrenia?

The studies on metacognitive training (MCT) for schizophrenia do not report any safety concerns, suggesting it is generally safe for use in humans. ^{3 4 6 7 8}

How is the treatment Cognitive Health Interventions for Schizophrenia different from other treatments for this condition?

Cognitive Health Interventions for Schizophrenia, including Cognitive Remediation and MetaCognitive Training, are unique because they focus on improving cognitive and social functioning through psychological therapy rather than medication. These treatments use computer-based exercises and group training to enhance thinking skills and correct cognitive biases, aiming to improve daily living and reduce symptoms like delusions. ^{2 3 9 10 11}

Research Team

Martin Lepage, PhD

Principal Investigator

Douglas Mental Health University Institute

Eligibility Criteria

This trial is for individuals with schizophrenia or related disorders who are stable and can use online platforms. They must have a private space for sessions, an emergency contact, and be able to communicate in English or French. Those with intellectual disabilities, high suicide risk, or current hospitalization cannot join.

Inclusion Criteria

Participants must be able to nominate an emergency contact and to agree to allow researchers to contact their clinician and/or emergency services in the event of an emergency during study procedures

I can use online platforms and join groups as my doctor agrees.

Follow-up and treatment by a clinician at one of the services mentioned above

Exclusion Criteria

Hospitalization at the time of recruitment

I cannot speak or read English or French.

Intellectual disability

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive virtual cognitive health interventions (Action-Based Cognitive Remediation or MetaCognitive Training) over a period of 8-12 weeks

8-12 weeks

12 sessions (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments of symptomatology, cognitive performance, and overall functioning

4 weeks

Treatment Details

Interventions

• Cognitive remediation (Behavioral Intervention)
• MetaCognitive Training (Behavioral Intervention)

Trial Overview The study tests two virtual cognitive health interventions: Action-Based Cognitive Remediation and MetaCognitive Training. It aims to see if these can improve cognition in schizophrenia when delivered online alongside training mental health practitioners using digital platforms.

Participant Groups

Group I: MetaCognitive Training Experimental Treatment 1 Intervention

MCT, developed by Drs. Moritz (co-applicant) and Woodward (PI), is based in the theoretical foundations of CBT, but targets the biases underlying symptoms rather than symptoms directly. MCT includes eight modules targeting common cognitive errors and reasoning biases in schizophrenia that have, through decades of research, been shown to contribute to delusions (e.g., jumping to conclusions). MCT will be offered to groups of up to 8 participants over 12 sessions of 45-60 min each (two per week) through Zoom Health. Session aims include raising participants' awareness of distortions and prompting them to critically reflect on, expand upon, and change their current repertoire of problem-solving strategies.

Group II: Cognitive remediation Experimental Treatment 1 Intervention

CR was developed by Dr. Bowie (PI). Approximately 60% of CR sessions are spent on cognitive training activities, 20% on developing, monitoring, and flexibly adjusting problem-solving strategies, and 20% on transfer activities. Transfer includes discussing and role-playing how cognitive skills and strategies are applied in everyday life and teaches potential compensatory strategies for overcoming cognitive challenges. Targeted cognitive domains are processing speed, attention, memory, and executive functions, which are all commonly impaired in psychosis. The manual includes 1.5-hour sessions and uses Brain Training Pro and will be offered over an 8-week period. Zoom Health will be used for group transfer activities.

Cognitive remediation is already approved in Canada for the following indications:

Approved in Canada as Cognitive Training for:

• Schizophrenia
• Cognitive Impairment

Who Is Running the Clinical Trial?

Douglas Mental Health University Institute

Lead Sponsor

Trials

31

Recruited

2,800+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

Dr. Paul C. Hébert

Canadian Institutes of Health Research (CIHR)

Chief Executive Officer

MD, University of Ottawa

Dr. Paul C. Hébert

Canadian Institutes of Health Research (CIHR)

Chief Medical Officer

MD, University of Ottawa

McGill University

Collaborator

Trials

421

Recruited

1,017,000+

Philippe Drouet

McGill University

Chief Executive Officer since 2021

Master of Science and Bachelor in Chemical Engineering from McGill University

Marianne Mancini

McGill University

Chief Medical Officer

BS in Nutritional Sciences from McGill University

Findings from Research

Cognitive remediation strategies for schizophrenia have shown improvements in working memory, emotion perception, and executive function, indicating that targeted cognitive exercises can effectively engage underfunctioning brain systems.

Cognitive adaptation interventions have been linked to better symptoms, psychosocial status, and reduced relapse rates, suggesting that modifying the environment can help patients manage their cognitive deficits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurocognitive rehabilitation for schizophrenia. Kurtz, MM.[2019]

Cognitive remediation has been shown to effectively reduce cognitive deficits and improve functional outcomes in individuals with schizophrenia, based on a review of various intervention programs and meta-analyses.

This approach is particularly beneficial when applied early in the course of schizophrenia and even in individuals at risk for developing the disorder, highlighting its potential as a key strategy for early intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive remediation in schizophrenia: current status and future perspectives. Barlati, S., Deste, G., De Peri, L., et al.[2021]

In a study involving 50 outpatients with schizophrenia, metacognitive training (MCT) showed significant improvements in positive symptoms compared to treatment as usual (TAU).

While MCT was effective in reducing positive symptoms, it did not demonstrate superiority in improving cognitive biases or cognitive insight, indicating its targeted efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Metacognitive Training in a Chilean Sample of People with Schizophrenia. Acuña, V., Otto, A., Cavieres, A., et al.[2022]

Cognitive remediation is an emerging treatment for schizophrenia that aims to improve cognitive functions, social skills, and potentially alleviate symptoms, complementing traditional medication and therapy.

Several cognitive remediation programs have shown efficacy in enhancing neurocognition and functional outcomes, although the long-term benefits after treatment completion need further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive remediation: a promising tool for the treatment of schizophrenia. Demily, C., Franck, N.[2018]

Metacognitive training (MCT) for schizophrenia significantly improved delusion distress, memory, and social quality of life in a study of 36 patients over 8 weeks compared to those receiving treatment-as-usual.

The training also effectively reduced the cognitive bias of jumping to conclusions, suggesting that MCT can positively influence cognitive processes related to schizophrenia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Further evidence for the efficacy of a metacognitive group training in schizophrenia. Moritz, S., Kerstan, A., Veckenstedt, R., et al.[2022]

In a study involving 100 clinically stable patients with schizophrenia spectrum disorders, two cognitive remediation programs (CCT and CIRCuiTs) showed no significant differences in effectiveness based on neurocognition and functional outcomes.

Both treatment groups experienced small improvements in cognitive assessments, but the study's limited sample size may have affected its ability to detect meaningful differences, suggesting that cost-effective options could be viable for cognitive interventions in schizophrenia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomized Control Trial of Cognitive Compensatory Training (CCT) and Computerized Interactive Remediation of Cognition-Training for Schizophrenia (CIRCuiTS). Dark, FL., Gore-Jones, V., Newman, E., et al.[2023]

Metacognitive training (MCT) combined with occupational therapy significantly reduced readmission rates for patients with schizophrenia in the early recovery stage, with only 25% of the MCT group readmitted compared to 75% in the OT-only group.

The study showed significant improvements in psychiatric symptoms and cognitive insight among patients receiving MCT, indicating its potential effectiveness in enhancing recovery during hospitalization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Metacognitive Training for Patients With Schizophrenia in Psychiatric Emergency Wards: A Pilot Randomized Controlled Trial. Haga, S., Kobayashi, M., Takehara, A., et al.[2022]

The CIRCuiTS program, a new computerized cognitive remediation therapy, showed significant improvements in visual memory and community functioning in 93 individuals with schizophrenia, with 85% adherence to the program.

Improvements in executive functioning were identified as a key predictor of enhanced social functioning, suggesting that targeting executive skills could lead to better outcomes in cognitive remediation for schizophrenia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A new generation computerised metacognitive cognitive remediation programme for schizophrenia (CIRCuiTS): a randomised controlled trial. Reeder, C., Huddy, V., Cella, M., et al.[2022]

Cognitive remediation therapies have been shown to significantly improve neurocognitive abilities in individuals with psychotic disorders, which is crucial for enhancing their independent functioning in the community.

These therapies vary in their focus, targeting either basic perceptual skills or higher-level executive functions, and can be delivered through different modalities, including computer-based methods or intensive therapist involvement, making them a promising best practice for treating schizophrenia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A review of cognitive remediation approaches for schizophrenia: from top-down to bottom-up, brain training to psychotherapy. Best, MW., Bowie, CR.[2019]

References

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

Neurocognitive rehabilitation for schizophrenia. [2019]

2. Egypt pubmed.ncbi.nlm.nih.gov

Cognitive remediation in schizophrenia: current status and future perspectives. [2021]

3. Spain pubmed.ncbi.nlm.nih.gov

Efficacy of Metacognitive Training in a Chilean Sample of People with Schizophrenia. [2021]

4. Spain pubmed.ncbi.nlm.nih.gov

Efficacy of Metacognitive Training in a Chilean Sample of People with Schizophrenia. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Cognitive remediation: a promising tool for the treatment of schizophrenia. [2018]

6. England pubmed.ncbi.nlm.nih.gov

Further evidence for the efficacy of a metacognitive group training in schizophrenia. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

A Randomized Control Trial of Cognitive Compensatory Training (CCT) and Computerized Interactive Remediation of Cognition-Training for Schizophrenia (CIRCuiTS). [2023]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Efficacy of Metacognitive Training for Patients With Schizophrenia in Psychiatric Emergency Wards: A Pilot Randomized Controlled Trial. [2022]

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

A new generation computerised metacognitive cognitive remediation programme for schizophrenia (CIRCuiTS): a randomised controlled trial. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Cognitive training in schizophrenia: a neuroscience-based approach. [2021]

11. England pubmed.ncbi.nlm.nih.gov

A review of cognitive remediation approaches for schizophrenia: from top-down to bottom-up, brain training to psychotherapy. [2019]