SchizophreniaiCogCANCT05661448
Promoting Cognitive Health in Schizophrenia
A study testing Cognitive remediation and MetaCognitive Training in people with Schizophrenia and Cognition, run by Douglas Mental Health University Institute at 5 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia, Cognition
- What is being tested?
- Cognitive remediation and MetaCognitive Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 5 sitesCanada
- Study dates
- 15 Apr 2023to 31 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Intellectual disability;
- Hospitalization at the time of recruitment;
- Inability to speak or read English or French;
- High suicide risk as per evaluation.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Canada5 sites
Kingston Health Sciences Centre, Queen's University
Kingston, Ontario
Douglas Mental Health University Institute
Montreal, Quebec, H4H 1R3
Institute of Mental Health Research, University of Ottawa
Ottawa, Ontario
Ontario Shoares Centre for Mental Health Sciences, University of Toronto
Toronto, Ontario
Faculty of Medicine, University of British Columbia
Vancouver, British Columbia
About this study
Official title: Promoting Cognitive Health in Schizophrenia: A National Collaborative Effort to Implement Online Psychological Interventions
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.
Read the detailed 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:
- 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.
- Conditions
- Schizophrenia, Cognition
- Being tested
- Cognitive remediation, MetaCognitive Training
- Keywords
- intervention, cognitive remediation, metacognition, psychosis
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive remediationBehavioural
Also called Action-Based Cognitive Remediation
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.
MetaCognitive TrainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: MetaCognitive Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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
Through a semi-structured interview, the positive and negative symptomatology of schizophrenia is explored. In this reduced scale, the following symptoms are assessed: delusions, conceptual disorganization, hallucinations, flattened affect, passive social withdrawal, and poverty of speech.
Measured: Baseline to post (10 weeks)
Change from Baseline Brief Negative Symptom Scale (BNSS) score at the end of the intervention
The Brief Negative Symptom Scale (BNSS) is a 13-item instrument measuring blunted affect, alogia, asociality, anhedonia, and avolition. All the items in the BNSS are rated on a 7-point (0-6) scale, with anchor points generally ranging from the symptom's being absent (0) to severe (6).
Measured: Baseline to post (10 weeks)
Change from Baseline Psychotic Symptom Rating Scales (PSYRATS) score at the end of the intervention
The PSYRATS is comprised of 17 items inquiring about the specific dimensions of hallucinations and delusions, with each item being rated from 0 (absent) to 4 (severe).
Measured: Baseline to post (10 weeks)
Change from Baseline Emotional, and Social Loneliness Scale (OES) score at the end of the intervention
It is a self-scale assessing the 3-item emotional loneliness and the 3-item social loneliness, two dimensions of the overarching loneliness concept.
Measured: Baseline to post (10 weeks)
Change from Baseline Self-Esteem Rating Scale - Short Form (SERS-SF) score at the end of the intervention
The SERS consists of 20 items rated on a 7-point Likert scale, 10 scored positively and 10 negatively.
Measured: Baseline to post (10 weeks)
Change from Baseline Warwick-Edinburgh Mental Well-being Scale (WEMWBS) score at the end of the intervention
The scale consists of 14 items covering both hedonic and eudaimonic aspects of mental health including positive affect (feelings of optimism, cheerfulness, relaxation), satisfying interpersonal relationships and positive functioning (energy, clear thinking, self acceptance, personal development, competence and autonomy).
Measured: Baseline to post (10 weeks)
Change from Baseline Questionnaire about the Process of Recovery (QRP) score at the end of the intervention
The QPR is a 22 item self- report measure measuring the process of recovery from a psychotic disorder. The items are rated on a five-point Likert scale ranging from "strongly disagree" to "strongly agree".
Measured: Baseline to post (10 weeks)
Change from Baseline Personal and Social Performance scale (PSP) score at the end of the intervention
The PSP scale assesses functioning across four dimensions (socially useful activities, personal and social relationships, self-care, disturbing and aggressive behaviours) with a maximum score of 100.
Measured: Baseline to post (10 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2022
- Study start15 Apr 2023
- Primary completion31 Jul 2026
- Study completion31 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- Douglas Mental Health University Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), McGill University
- Responsible party
- Principal investigator, Martin Lepage, Douglas Mental Health University Institute
- Investigators
- Martin Lepage, Principal investigator, Douglas Mental Health University Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05661448
- Sponsor's protocol ID
- iCogCA
- Acronym
- iCogCA
- Status last verified
- Aug 2026
- First submitted
- 1 Nov 2022
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27100095Moritz 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.
PubMed 17921766Mendelson 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.
PubMed 35242604Au-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.
PubMed 40233365
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Cognitive Health in Schizophrenia: A National Collaborative Effort to Implement Online Psychological Interventions
- ClinicalTrials.gov ID
- NCT05661448
- Acronym / sponsor ID
- iCogCA / iCogCA
- Conditions
- Schizophrenia, Cognition
- Keywords
- intervention, cognitive remediation, metacognition, psychosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- Douglas Mental Health University InstituteUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), McGill University
- Study start
- 15 Apr 2023 (actual)
- Primary completion
- 31 Jul 2026 (actual)
- Study completion
- 31 Jul 2026 (actual)
- First posted
- 22 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Cognitive remediation | Experimental | Behavioral: Cognitive remediationCR 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. |
| MetaCognitive Training | Experimental | Behavioral: MetaCognitive TrainingMCT, 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- Intellectual disability;
- Hospitalization at the time of recruitment;
- Inability to speak or read English or French;
- High suicide risk as per evaluation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive remediationAlso: Action-Based Cognitive RemediationThe 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. | Behavioural | Cognitive remediation |
| MetaCognitive TrainingThe 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. | Behavioural | MetaCognitive Training |
Primary outcome
Change from Baseline Brief version of the Cambridge Neuropsychological Testing Automated Battery (CANTAB) score at the end of the intervention
Time frame: Baseline to post (10 weeks)
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.
Change from Baseline Wechsler Memory Scale - Logical Memory (LM) subscale score at the end of the intervention
Time frame: Baseline to post (10 weeks)
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).
Change from Baseline Brief Subjective Scale to Investigate Cognition in Schizophrenia (SSTICS-B) score at the end of the intervention
Time frame: Baseline to post (10 weeks)
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.
Change from Baseline Cognitive Motivation Scale (CMS) score at the end of the intervention
Time frame: Baseline to post (10 weeks)
Multidimensional scale for cognitive motivation assessing approach and withdrawal from cognitively challenging activities.
Change from Baseline Davos Assessment of Cognitive Biases Scale (DACOBS) score at the end of the intervention
Time frame: Baseline to post (10 weeks)
This questionnaire assesses cognitive biases through 42 items rated on a Likert scale from 1 (strongly disagree) to 7 (strongly agree).
Change from Baseline Beads task score at the end of the intervention
Time frame: Baseline to post (10 weeks)
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.
Change from Baseline bias against disconfirmatory evidence (BADE) image task score at the end of the intervention
Time frame: Baseline to post (10 weeks)
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.
8 secondary outcomes
Change from Baseline Short version of the Positive And Negative Syndrome Scale (PANSS-6) score at the end of the intervention
Time frame: Baseline to post (10 weeks)
Change from Baseline Brief Negative Symptom Scale (BNSS) score at the end of the intervention
Time frame: Baseline to post (10 weeks)
Change from Baseline Psychotic Symptom Rating Scales (PSYRATS) score at the end of the intervention
Time frame: Baseline to post (10 weeks)
Change from Baseline Emotional, and Social Loneliness Scale (OES) score at the end of the intervention
Time frame: Baseline to post (10 weeks)
Change from Baseline Self-Esteem Rating Scale - Short Form (SERS-SF) score at the end of the intervention
Time frame: Baseline to post (10 weeks)
Change from Baseline Warwick-Edinburgh Mental Well-being Scale (WEMWBS) score at the end of the intervention
Time frame: Baseline to post (10 weeks)
Change from Baseline Questionnaire about the Process of Recovery (QRP) score at the end of the intervention
Time frame: Baseline to post (10 weeks)
Change from Baseline Personal and Social Performance scale (PSP) score at the end of the intervention
Time frame: Baseline to post (10 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
- Background: PubMed 27100095Bowie 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.
- Background: PubMed 17921766Moritz 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.
- Background: PubMed 35242604Mendelson 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.
- Derived from this study: PubMed 40233365Au-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.
- Individual participant dataSharing planned: No
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Active, not recruiting
Designing and Evaluating a Classroom-Based Mental Health Programme for Adolescents.
Mental Health Promotion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Lepage principal investigator
Douglas Mental Health University Institute
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive remediation and MetaCognitive Training in people with Schizophrenia and Cognition, run by Douglas Mental Health University Institute at 5 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Brief version of the Cambridge Neuropsychological Testing Automated Battery (CANTAB) score at the end of the intervention (time frame: Baseline to post (10 weeks)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05661448, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026.