Promoting Cognitive Health in Schizophrenia

NCT05661448 | Recruiting

• 1 other identifier: iCogCA
• Study Type: interventional
• Target: 390
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Schizophrenia; Cognition

Keywords

intervention; cognitive remediation; metacognition; psychosis

Outcome Measures

Primary Outcomes (7)

• Change from Baseline Brief version of the Cambridge Neuropsychological Testing Automated Battery (CANTAB) score at the end of the intervention

  This brief version of the computerized battery assessing neurocognition provides z-scores (with zero indicating the mean of a group of values) for each MATRICS cognitive subdomain.

  Baseline to post (10 weeks)

• Change from Baseline Wechsler Memory Scale - Logical Memory (LM) subscale score at the end of the intervention

  In the LM I (maximum score=50), the two narrative stories (story A and story B) are verbally given and the examinee is required to immediately recall the stories as much as he/she can. In the LM II (maximum score=50), free recall of two stories is elicited after a 20 to 30-minute delay. Each correct detail was awarded with one score point. The 30 recognition questions (either yes or no) about the two stories are given subsequently to assess the recognition ability (maximum score=30).

  Baseline to post (10 weeks)

• Change from Baseline Brief Subjective Scale to Investigate Cognition in Schizophrenia (SSTICS-B) score at the end of the intervention

  The SSTICS-B is a 14-item measure focusing on difficulties associated with core cognitive domains including memory, attention, executive functions and praxia. Each item is rated on a five-point Likert scale ranging from "never" to "very often" with higher scores suggesting more cognitive problems.

  Baseline to post (10 weeks)

• Change from Baseline Cognitive Motivation Scale (CMS) score at the end of the intervention

  Multidimensional scale for cognitive motivation assessing approach and withdrawal from cognitively challenging activities.

  Baseline to post (10 weeks)

• Change from Baseline Davos Assessment of Cognitive Biases Scale (DACOBS) score at the end of the intervention

  This questionnaire assesses cognitive biases through 42 items rated on a Likert scale from 1 (strongly disagree) to 7 (strongly agree).

  Baseline to post (10 weeks)

• Change from Baseline Beads task score at the end of the intervention

  In the beads task, participants see two jars full of beads of two colors. The beads in the jar have equal, but opposite ratios. One jar is chosen at random and kept secret from participants. As beads are drawn one at a time from the "secret" jar, participants must decide from which jar the beads are being drawn, or request to see more beads before deciding. In this task, the number of beads drawn before the participant makes a decision determines their tendency of "jumping to conclusion". Deciding with minimal "evidence" (less beads, or after the first bead is drawn) would indicate a higher tendency to jump to conclusions.

  Baseline to post (10 weeks)

• Change from Baseline bias against disconfirmatory evidence (BADE) image task score at the end of the intervention

  In this task, participants see partial line drawings of common objects, food or animals and are asked to whether they believe the full drawing corresponds to a word displayed below the image. The presence of a BADE bias in this task is represented by failing to modify an initial, erroneous hypothesis, once disconfirmatory evidence is provided.

  Baseline to post (10 weeks)

Secondary Outcomes (8)

• Change from Baseline Short version of the Positive And Negative Syndrome Scale (PANSS-6) score at the end of the intervention

  Baseline to post (10 weeks)

• Change from Baseline Brief Negative Symptom Scale (BNSS) score at the end of the intervention

  Baseline to post (10 weeks)

• Change from Baseline Psychotic Symptom Rating Scales (PSYRATS) score at the end of the intervention

  Baseline to post (10 weeks)

• Change from Baseline Emotional, and Social Loneliness Scale (OES) score at the end of the intervention

  Baseline to post (10 weeks)

• Change from Baseline Self-Esteem Rating Scale - Short Form (SERS-SF) score at the end of the intervention

  Baseline to post (10 weeks)

Other Outcomes (5)

• Change from Baseline Basic Psychological Need Satisfaction and Frustration Scale (BPNSNF) score at the end of the intervention

  Baseline to post (10 weeks)

• Change from Baseline Autonomous-Controlled Motivation for Intervention Questionnaire (ACMIQ) score at the end of the intervention

  Baseline to post (10 weeks)

• Change from Baseline Health Care Climate Questionnaire (HCCQ) score at the end of the intervention

  Baseline to post (10 weeks)

Study Arms (2)

Cognitive remediation

EXPERIMENTAL

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.

Behavioral: Cognitive remediation

MetaCognitive Training

EXPERIMENTAL

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.

Behavioral: MetaCognitive Training

Interventions

Cognitive remediation BEHAVIORAL

The goal of this program is to improve performance on cognitive domains known to hinder functioning. It aims to promote positive attitudes towards learning and facilitate the development of independent learning skills to foster competence and confidence. Another aim is to increase patients' awareness of their cognitive strengths and weaknesses and their own problem solving strategies.

Also known as: Action-Based Cognitive Remediation

Cognitive remediation

MetaCognitive Training BEHAVIORAL

The metacognitive training (MCT) program is based on the theoretical foundations of cognitive models of schizophrenia but employs a slightly different focus in its therapeutic approach targeting the specific cognitive biases underlying delusions. The modules aim to raise awareness of these biases and prompts participants to critically reflect on and update their problem-solving repertoire.

MetaCognitive Training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Douglas Mental Health University Institute: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• McGill University: collaborator

Study Sites (5)

Faculty of Medicine, University of British Columbia

Vancouver, British Columbia, Canada

NOT YET RECRUITING

Kingston Health Sciences Centre, Queen's University

Kingston, Ontario, Canada

RECRUITING

Institute of Mental Health Research, University of Ottawa

Ottawa, Ontario, Canada

RECRUITING

Ontario Shoares Centre for Mental Health Sciences, University of Toronto

Toronto, Ontario, Canada

RECRUITING

Douglas Mental Health University Institute

Montreal, Quebec, H4H 1R3, Canada

RECRUITING

Related Publications (4)

• Bowie CR, Grossman M, Gupta M, Holshausen K, Best MW. Action-based cognitive remediation for individuals with serious mental illnesses: Effects of real-world simulations and goal setting on functional and vocational outcomes. Psychiatr Rehabil J. 2017 Mar;40(1):53-60. doi: 10.1037/prj0000189. Epub 2016 Apr 21.

  PMID: 27100095 BACKGROUND

• Moritz S, Woodward TS. Metacognitive training in schizophrenia: from basic research to knowledge translation and intervention. Curr Opin Psychiatry. 2007 Nov;20(6):619-25. doi: 10.1097/YCO.0b013e3282f0b8ed.

  PMID: 17921766 BACKGROUND

• Mendelson D, Thibaudeau E, Sauve G, Lavigne KM, Bowie CR, Menon M, Woodward TS, Lepage M, Raucher-Chene D. Remote group therapies for cognitive health in schizophrenia-spectrum disorders: Feasible, acceptable, engaging. Schizophr Res Cogn. 2021 Dec 6;28:100230. doi: 10.1016/j.scog.2021.100230. eCollection 2022 Jun.

  PMID: 35242604 BACKGROUND

• Au-Yeung C, Thai H, Best M, Bowie CR, Guimond S, Lavigne KM, Menon M, Moritz S, Piat M, Sauve G, Sousa AE, Thibaudeau E, Woodward TS, Lepage M, Raucher-Chene D. iCogCA to Promote Cognitive Health Through Digital Group Interventions for Individuals Living With a Schizophrenia Spectrum Disorder: Protocol for a Nonrandomized Concurrent Controlled Trial. JMIR Res Protoc. 2025 Apr 15;14:e63269. doi: 10.2196/63269.

  PMID: 40233365 DERIVED

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Interventions

Cognitive Remediation

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Martin Lepage

  Douglas Mental Health University Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karyne Anselmo

CONTACT

(514) 761-6131; karyne.anselmo@douglas.mcgill.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: James McGill Professor

Model Details: A non-randomized concurrent control design (NRCC) is proposed and will allow for a comparison between the two interventions using one (e.g., CR) as the active control for the other (e.g., MCT) and vice-versa, on intervention-specific primary outcomes.

Study Record Dates

• First Submitted: November 1, 2022
• First Posted: December 22, 2022
• Study Start: April 15, 2023
• Primary Completion (Estimated): August 31, 2029
• Study Completion (Estimated): August 31, 2029
• Last Updated: February 12, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (5)