Promoting Cognitive Health in Schizophrenia (iCogCA)

Douglas Mental Health University Institute

Status: Enrolling

Conditions: Schizophrenia; Cognition

Treatments: Behavioral: MetaCognitive Training; Behavioral: Cognitive remediation

Study type: Interventional

Funder types: Other

Identifiers

NCT05661448

iCogCA

Details and patient eligibility

About

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.

Full description

In Canada, few individuals with psychotic disorders have access to online psychosocial therapies integrated with the care they receive from the public mental health care system. There is thus an urgent need for pragmatic trials, conducted in diversified settings, on the effectiveness and implementation of technology- enabled psychosocial interventions in this population. Even at the respective sites of the investigators, such interventions are predominately offered within the context of research and not as a clinical service. The investigators propose a hybrid effectiveness-implementation trial relying on digital technology to facilitate the rapid adoption of high- quality psychosocial interventions in five distinct care settings (Douglas Institute, Royal Institute of Mental Health Research, Kingston Health Science Centre, Ontario Shores Centre for Mental Health Sciences and Vancouver Coastal Health/UBC). Each site provides a unique environment to promote the uptake of interventions; all have a track-record of integrated clinical infrastructure for psychological interventions and access to large cohorts of potential participants (n>6000). These sites have all been providing psychological interventions for schizophrenia for several years and have the necessary infrastructure to provide virtual care.

Considering that both proposed cognitive health interventions are well established, the investigators are proposing a hybrid effectiveness-implementation design, Type 2 which is ideal when studying interventions that already have evidence of effectiveness in other settings or populations and that seek to determine feasibility and utility of an implementation strategy. Such designs are now commonly used to move evidence-based behavioral interventions into real care environments as they address the need to confirm clinical effectiveness while targeting the methods and procedures necessary to deliver and sustain such interventions in real-world care settings.

Objective 1: To determine the clinical effectiveness of two virtual cognitive health interventions. The investigators will use a non-randomized concurrent control design (NRCC) in which one intervention (e.g., CR) acts as the active control for the other (e.g., MCT) and vice-versa, on intervention-specific primary outcomes. The investigators hypothesize that participation in CR will specifically improve cognitive capacity (i.e., increase performance on measures of memory, executive functions, attention, etc.) whereas participation in MCT will specifically improve cognitive biases, per the objective standard measures described below. Moreover, participation in either intervention will be associated with improvement in symptomatology, reduced social isolation and greater functioning at post-intervention and maintained at 1 month follow-up. The investigators are also expecting a greater improvement in all those domains when participants are doing both interventions.

Objective 2: To evaluate the implementation strategy involving the virtual delivery of cognitive health interventions combined with a digital learning platform (E-Cog) to train mental health practitioners across multiple care settings. The investigators will assess how this strategy promotes the uptake of these cognitive health interventions across different mental health care settings. More specifically, the investigators will assess:

i) whether the E-Cog digital learning platform represents an effective educational strategy for implementation, ii) the contextual factors influencing the implementation of the two virtual interventions (i.e., potential barriers and facilitators to adoption) across sites, and iii) sustainability, the extent to which these interventions will be maintained within a service setting's ongoing operations.

Enrollment: 390 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of affective or non-affective psychosis or related disorder;
• Follow-up and treatment by a clinician at one of the services mentioned above;
• Participants symptomatically stable and capable of using the online platforms and participating in intervention groups, as judged by their primary clinicians (i.e., psychiatrist, case manager);
• Participants must have access to a private space (i.e., a room where the participant can be alone) to ensure confidentiality for the group;
• 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.

Exclusion criteria

• Intellectual disability;
• Hospitalization at the time of recruitment;
• Inability to speak or read English or French;
• High suicide risk as per evaluation.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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390 participants in 2 patient groups

Cognitive remediation

Experimental group

Description:

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.

Treatment:

Behavioral: Cognitive remediation

MetaCognitive Training

Experimental group

Description:

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.

Treatment:

Behavioral: MetaCognitive Training