Cognitive Health Interventions for Schizophrenia
(iCogCA Trial)
Recruiting in Palo Alto (17 mi)
+4 other locations
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.12345
Is metacognitive training (MCT) safe for people with schizophrenia?
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.2391011
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
See 2 more
Exclusion Criteria
Hospitalization at the time of recruitment
I cannot speak or read English or French.
Intellectual disability
See 1 more
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 OverviewThe 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
2Treatment groups
Experimental Treatment
Group I: MetaCognitive TrainingExperimental Treatment1 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 remediationExperimental Treatment1 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, Australia 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
🇦🇺 Approved in Australia as Cognitive Rehabilitation for:
- Schizophrenia
- Psychotic Disorders
- Cognitive Impairment
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Douglas Mental Health University InstituteMontréal, Canada
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Who Is Running the Clinical Trial?
Douglas Mental Health University InstituteLead Sponsor
Canadian Institutes of Health Research (CIHR)Collaborator
McGill UniversityCollaborator
References
Neurocognitive rehabilitation for schizophrenia. [2019]A critical review of randomized, controlled trials of extended programs of neurocognitive rehabilitation for the cognitive deficits characteristic of schizophrenia conducted between the years 2000 to 2002 was completed. Over the past several years, two models of cognitive rehabilitation have emerged. In one model, labeled "cognitive remediation," cognitive deficits are treated directly through repeated practice and acquisition of compensatory strategies on cognitive exercises designed to engage underfunctioning brain systems. In a second model, labeled "cognitive adaptation," neurocognitive deficits are addressed through modification of the patients' environment to allow patients to bypass their deficits. Results revealed that a range of cognitive remediation strategies varying widely along dimensions of duration, intensity, method, target of behavioral intervention, and clinical status of participants produced improvements on measures of working memory, emotion perception, and executive function distinct from those trained during remediation. No effects were evident in secondary verbal or nonverbal memory. Results of two pilot studies using functional magnetic resonance imaging to assess changes in task-evoked brain activation have revealed that these interventions may produce changes in several functionally relevant neural systems in a subset of patients. Results from studies of standardized cognitive adaptation interventions have indicated that these treatments can produce improvements in symptoms, psychosocial status, and relapse rates. A variety of approaches for future research are also discussed.
Cognitive remediation in schizophrenia: current status and future perspectives. [2021]Objectives. This study is aimed to review the current scientific literature on cognitive remediation in schizophrenia. In particular, the main structured protocols of cognitive remediation developed for schizophrenia are presented and the main results reported in recent meta-analyses are summarized. Possible benefits of cognitive remediation in the early course of schizophrenia and in subjects at risk for psychosis are also discussed. Methods. Electronic search of the relevant studies which appeared in the PubMed database until April 2013 has been performed and all the meta-analyses and review articles on cognitive remediation in schizophrenia have been also taken into account. Results. Numerous intervention programs have been designed, applied, and evaluated, with the objective of improving cognition and social functioning in schizophrenia. Several quantitative reviews have established that cognitive remediation is effective in reducing cognitive deficits and in improving functional outcome of the disorder. Furthermore, the studies available support the usefulness of cognitive remediation when applied in the early course of schizophrenia and even in subjects at risk of the disease. Conclusions. Cognitive remediation is a promising approach to improve real-world functioning in schizophrenia and should be considered a key strategy for early intervention in the psychoses.
Efficacy of Metacognitive Training in a Chilean Sample of People with Schizophrenia. [2021]Moritz et al.'s metacognitive training (MCT), a new development of cognitive therapy, is a manualized group training program, designed to correct cognitive biases involved in the formation and maintenance of psychotic symptoms, especially delusions. We report on the efficacy of MCT in a Chilean sample of people with schizophrenia.
Efficacy of Metacognitive Training in a Chilean Sample of People with Schizophrenia. [2022]Moritz et al.'s metacognitive training (MCT), a new development of cognitive therapy, is a manualised group training programme, designed to correct cognitive biases involved in the formation and maintenance of psychotic symptoms, especially delusions. We report on the efficacy of MCT in a Chilean sample of people with schizophrenia.
Cognitive remediation: a promising tool for the treatment of schizophrenia. [2018]Cognitive remediation is a type of treatment added recently to the range of tools available to therapists. It includes a number of miscellaneous methods that aim to correct some of the cognitive impairments observed in schizophrenia. These cover the fields of target attention, memory and executive deficits, as well as impaired social cognition. Cognitive remediation acts as a complement to medication and psychological therapies, which constitute the core methods of treatment for schizophrenia. The present paper reviews the state of the art in cognitive remediation. The principle underlying this innovative therapeutic approach is the enhancement of the cognitive resources of patients with schizophrenia in order to improve their cognitive functions, social skills and in some cases alleviate some of the symptoms of the disease. Several programs developed within the past two decades (e.g., IPT, CRT, NEAR, CET, NET, CRT and CAT) are becoming more widely used. Their efficacy on neurocognition and on functional outcome has been demonstrated, with inconstant continuation of benefit after completion of treatment. The sustainability of the cognitive and functional improvements following completion of these programs has to be further studied. Other programs aimed at acting upon altered social cognition (one of the critical facets of schizophrenia) are still in the experimental stages, but the results obtained so far are encouraging. A preliminary study has also demonstrated the effectiveness of board games in improving cognitive functioning, which seems to be a highly promising therapeutic avenue owing to its ease of use.
Further evidence for the efficacy of a metacognitive group training in schizophrenia. [2022]Metacognitive training (MCT) for patients with schizophrenia is a novel psychological group treatment targeting cognitive biases putatively involved in the pathogenesis of schizophrenia (e.g. jumping to conclusions, overconfidence in errors). Its eight modules are available cost-free online in many languages. In the present study, 36 subacute or remitted patients were randomly allocated to either the MCT or a wait-list group who received treatment-as-usual (TAU). Baseline and post assessments were 8 weeks apart and were performed blind to group status. MCT showed significantly greater improvement on the following parameters relative to the TAU group: delusion distress (PSYRATS), memory and social quality of life. In the MCT group, the rate of jumping to conclusions bias was reduced after training. No differences occurred on the PANSS. The present study confirms prior reports that MCT exerts beneficial effects on some cognitive and symptomatic parameters.
A Randomized Control Trial of Cognitive Compensatory Training (CCT) and Computerized Interactive Remediation of Cognition-Training for Schizophrenia (CIRCuiTS). [2023]Various modes of delivering cognitive remediation (CR) are effective, but there have been few head-to-head trials of different approaches. This trial aimed to evaluate the relative effectiveness of two different programmes, Cognitive Compensatory Training (CCT) and Computerized Interactive Remediation of Cognition-Training for Schizophrenia (CIRCuiTs).
Efficacy of Metacognitive Training for Patients With Schizophrenia in Psychiatric Emergency Wards: A Pilot Randomized Controlled Trial. [2022]Metacognitive training (MCT) is a group program for improving cognitive bias in patients with schizophrenia. MCT has a reported positive effect on psychiatric symptoms and cognitive bias in patients with schizophrenia, but the effect of the intervention on patients with schizophrenia in the early recovery stage during hospitalization is not comprehensible. Therefore, this study aimed to investigate the efficacy of MCT in the early recovery stage of patients with schizophrenia in a Japanese emergency psychiatric ward.
A new generation computerised metacognitive cognitive remediation programme for schizophrenia (CIRCuiTS): a randomised controlled trial. [2022]Cognitive remediation (CR) is a psychological therapy, which improves cognitive and social functioning in people with schizophrenia. It is now being implemented within routine clinical services and mechanisms of change are being explored. We designed a new generation computerised CR programme, CIRCuiTS (Computerised Interactive Remediation of Cognition - a Training for Schizophrenia), to enhance strategic and metacognitive processing, with an integrated focus on the transfer of cognitive skills to daily living. This large trial tested its feasibility to be delivered in therapist-led and independent sessions, and its efficacy for improved cognitive and social functioning.
Cognitive training in schizophrenia: a neuroscience-based approach. [2021]Meta-analytic data from over a decade of research in cognitive remediation, when combined with recent findings from basic and clinical neuroscience, have resulted in a new understanding of the critical elements that can contribute to successful cognitive training approaches for schizophrenia. Some of these elements include: the use of computerized repetitive practice methods, high dosing schedules, a focus on sensory processing, and carefully constrained and individually adapted learning trials. In a preliminary randomized controlled trial of cognitive training exercises based on these principles, we demonstrated significant improvements in working memory, verbal learning and memory, and global cognition in patients with schizophrenia. These cognitive improvements were accompanied by neurobiological findings suggestive of learning-induced cortical plasticity. Future directions for research and essential remaining questions are discussed.
A review of cognitive remediation approaches for schizophrenia: from top-down to bottom-up, brain training to psychotherapy. [2019]Individuals with psychotic disorders experience profound impairment in neurocognition, which is consistently found to be the best predictor of independent community functioning. Several diverse behavioural treatments designed to enhance neurocognitive abilities have been developed, with subtle to stark differences among them. Various approaches, to varying degrees, have demonstrated success across diffuse outcomes: improved brain structure and function, performance on neuropsychological tests, and community activities associated with daily living. Areas covered: This paper reviews the different approaches to cognitive remediation and the differential effects these approaches have on neurophysiological function, neurocognitive abilities, and real-world community functioning. Cognitive remediation approaches can be broadly classified along two dimensions: 1) treatment target, and 2) treatment modality. Some approaches target more basic perceptual skills, some target higher level executive processes, while some are non-targeted and seek to improve general cognitive ability. With regard to modality, approaches might have little/no therapist involvement and rely exclusively on computerized practice or they may include intensive therapist involvment to generalize neurocognitive change to community functioning. Expert commentary: Compared to other widely implemented treatments for schizophrenia, cognitive remediation produces better effects on outcome measures. It is time for cognitive remediation to be adopted as a best practice in the treatment of schizophrenia.