390 Participants Needed

Cognitive Health Interventions for Schizophrenia

(iCogCA Trial)

Recruiting at 4 trial locations
KA
Overseen ByKaryne Anselmo
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Douglas Mental Health University Institute
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

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.

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.12345

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.36789

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.2371011

Who Is on the Research Team?

Martin Lepage - The Douglas Research Centre

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
See 2 more

Exclusion Criteria

Hospitalization at the time of recruitment
I cannot speak or read English or French.
Intellectual disability
See 1 more

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?
2Treatment groups
Experimental Treatment
Group I: MetaCognitive TrainingExperimental Treatment1 Intervention
Group II: Cognitive remediationExperimental Treatment1 Intervention

Cognitive remediation is already approved in United States, European Union, Canada for the following indications:

🇺🇸
Approved in United States as Cognitive Remediation for:
🇪🇺
Approved in European Union as Cognitive Remediation Therapy for:
🇨🇦
Approved in Canada as Cognitive Training for:

Find a Clinic Near You

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 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.
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.
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 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.
Efficacy of Metacognitive Training in a Chilean Sample of People with Schizophrenia.Acuña, V., Otto, A., Cavieres, A., et al.[2021]

Citations

Neurocognitive rehabilitation for schizophrenia. [2019]
Cognitive remediation in schizophrenia: current status and future perspectives. [2021]
Efficacy of Metacognitive Training in a Chilean Sample of People with Schizophrenia. [2021]
Efficacy of Metacognitive Training in a Chilean Sample of People with Schizophrenia. [2022]
Cognitive remediation: a promising tool for the treatment of schizophrenia. [2018]
Further evidence for the efficacy of a metacognitive group training in schizophrenia. [2022]
A Randomized Control Trial of Cognitive Compensatory Training (CCT) and Computerized Interactive Remediation of Cognition-Training for Schizophrenia (CIRCuiTS). [2023]
Efficacy of Metacognitive Training for Patients With Schizophrenia in Psychiatric Emergency Wards: A Pilot Randomized Controlled Trial. [2022]
A new generation computerised metacognitive cognitive remediation programme for schizophrenia (CIRCuiTS): a randomised controlled trial. [2022]
Cognitive training in schizophrenia: a neuroscience-based approach. [2021]
A review of cognitive remediation approaches for schizophrenia: from top-down to bottom-up, brain training to psychotherapy. [2019]
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