Cognitive Health Interventions for Schizophrenia

(iCogCA Trial)

Recruiting at 5 trial locations

Overseen By Karyne Anselmo

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Douglas Mental Health University Institute

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

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

Compensation: Varies

Number of Visits: 12

Duration: 8-12 weeks

390 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to improve cognitive health for individuals with schizophrenia by testing two virtual treatments: Action-Based Cognitive Remediation (a type of cognitive training) and MetaCognitive Training. These interventions enhance thinking skills and address reasoning biases that can lead to delusions. The trial also evaluates the effectiveness of delivering these treatments online and training mental health professionals to use them. Participants should have a diagnosis of psychosis, be stable, and able to use online platforms in a private space. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance cognitive health treatments for schizophrenia.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that cognitive remediation (CR) is generally safe for people with schizophrenia. One study found that participants attended CR sessions as planned without major issues, suggesting CR doesn't cause significant side effects.

Studies have also shown that metacognitive training (MCT) is safe. While MCT might not greatly improve certain brain functions, it does not cause harm. Participants in MCT reported positive experiences without major problems.

Both treatments—CR and MCT—aim to improve thinking skills and are offered through online sessions. Research supports that they are safe options for addressing cognitive challenges in schizophrenia. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for schizophrenia because they focus on improving cognitive health, an area often overlooked by standard therapies. Unlike traditional treatments that primarily address symptoms through medication, Cognitive Remediation (CR) and MetaCognitive Training (MCT) target the cognitive deficits and thinking patterns contributing to schizophrenia. CR uses brain training exercises to enhance cognitive functions like memory and attention, while MCT helps participants recognize and adjust cognitive biases that fuel delusions. These innovative approaches aim to not only alleviate symptoms but also improve everyday functioning, offering a more comprehensive treatment strategy.

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

Research shows that MetaCognitive Training (MCT), a treatment in this trial, can reduce symptoms like false beliefs and thinking mistakes in people with schizophrenia. It leads to fewer hallucinations and negative symptoms, increasing patients' awareness of their thought patterns. Studies have shown promising results for this method.

Cognitive remediation, another treatment option in this trial, has improved various mental skills in people with schizophrenia. This includes faster thinking, better focus, improved memory, and enhanced daily functioning. Research demonstrates that cognitive remediation significantly improves both mental abilities and real-life outcomes. These findings suggest that both methods could improve mental health in schizophrenia. ^{6 7 8 9 10}

Who Is on the Research Team?

Martin Lepage, PhD

Principal Investigator

Douglas Mental Health University Institute

Are You a Good Fit for This Trial?

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Cognitive remediation
• MetaCognitive Training

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.

How Is the Trial Designed?

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 United States, European Union, Canada for the following indications:

Approved in United States as Cognitive Remediation for:

• Schizophrenia
• Cognitive Impairment

Approved in European Union as Cognitive Remediation Therapy for:

• Schizophrenia
• Psychotic Disorders
• Cognitive Impairment

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+

McGill University

Collaborator

Trials

421

Recruited

1,017,000+

Published Research Related to This Trial

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]

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]

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]

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]

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 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]

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

While MCT also aimed to improve cognitive biases and cognitive insight, the study did not find significant differences in these areas when compared to the control group, suggesting that MCT's primary benefit lies in symptom reduction rather than cognitive enhancement.

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.[2021]

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]

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]

A meta-analysis of over a decade of cognitive remediation research has identified key factors for effective cognitive training in schizophrenia, such as computerized practice, high dosing schedules, and individualized learning trials.

A preliminary randomized controlled trial showed that cognitive training based on these principles led to significant improvements in working memory and global cognition in patients with schizophrenia, along with evidence of cortical plasticity in the brain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive training in schizophrenia: a neuroscience-based approach. Genevsky, A., Garrett, CT., Alexander, PP., et al.[2021]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33772310/

A Meta-analysis of Cognitive Remediation for Schizophrenia The meta-analysis (4594 participants) revealed that CR produced significant small-to-moderate size improvements in all domains of cognition studied.

2. jamanetwork.com jamanetwork.com/journals/jamapsychiatry/fullarticle/2778914

Effectiveness, Core Elements, and Moderators of ... In this systematic review and meta-analysis, cognitive remediation was confirmed as effective on both cognitive and functional outcomes and potentially useful ...

3. psychiatryonline.org psychiatryonline.org/doi/full/10.1176/appi.ajp.20230396

Durability of Effects of Cognitive Remediation on ... Cognitive remediation provides substantial improvements in cognitive performance and real-world functioning for people living with schizophrenia.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3877646/

Cognitive Remediation in Schizophrenia: Current Status ... The results indicate that prodromal patients can improve their long-term verbal memory, attention, and concentration after cognitive training. Another study ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0165178123004456

Moderators of functional improvement after integrative ... Cognitive remediation is an effective intervention for improving functional outcome in schizophrenia. However, the factors that moderate this improvement ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8870375/

Advances in Cognitive Remediation Training ... Our review of the effectiveness of CRT for the treatment of cognitive symptoms of schizophrenia confirms results reported in three previous meta-analyses [1,6, ...

7. psychiatryonline.org psychiatryonline.org/doi/10.1176/appi.focus.20200035

Cognitive Remediation for Schizophrenia | Focus ... outcomes among people with schizophrenia (1). ... cognitive rehabilitation in older versus younger persons with severe mental illness.

8. sciencedirect.com sciencedirect.com/science/article/pii/S2215001323000082

Feasibility of six-month outpatient cognitive remediation in ... Our findings support the feasibility of six-month outpatient CRT in schizophrenia in terms of adherence to scheduled sessions and safety.

9. frontiersin.org frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2024.1509539/full

Cognitive rehabilitation in schizophrenia research This study provides a comprehensive review of research achievements in cognitive rehabilitation for schizophrenia spanning from 2004 to 2024.

10. nature.com nature.com/articles/s41537-017-0021-9

The effect of cognitive remediation in individuals at ultra ... ... psychosis report mixed results, with some finding ... Cognitive rehabilitation for schizophrenia: problems, prospects, and strategies.