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Behavioral Intervention
Cognitive Health Interventions for Schizophrenia (iCogCA Trial)
N/A
Recruiting
Led By Martin Lepage
Research Sponsored by Douglas Mental Health University Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to post (10 weeks)
Awards & highlights
iCogCA Trial Summary
This trial aims to improve cognitive health in people with schizophrenia through virtual interventions and training for mental health practitioners. Patients will be assessed before/after treatment. #mentalhealth #schizophrenia
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Since the interventions involve cognitive exercises and training without medication, side effects may include potential discomfort from discussing personal experiences or fatigue from engaging in the activities.
iCogCA Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to post (10 weeks)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to post (10 weeks)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change from Baseline Beads task score at the end of the intervention
Change from Baseline Brief Subjective Scale to Investigate Cognition in Schizophrenia (SSTICS-B) score at the end of the intervention
Change from Baseline Brief version of the Cambridge Neuropsychological Testing Automated Battery (CANTAB) score at the end of the intervention
+4 moreSecondary outcome measures
Change from Baseline Brief Negative Symptom Scale (BNSS) score at the end of the intervention
Change from Baseline Emotional, and Social Loneliness Scale (OES) score at the end of the intervention
Change from Baseline Personal and Social Performance scale (PSP) score at the end of the intervention
+5 moreOther outcome measures
Change from Baseline Autonomous-Controlled Motivation for Intervention Questionnaire (ACMIQ) score at the end of the intervention
Change from Baseline Basic Psychological Need Satisfaction and Frustration Scale (BPNSNF) score at the end of the intervention
Change from Baseline Health Care Climate Questionnaire (HCCQ) score at the end of the intervention
+2 moreiCogCA Trial Design
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cognitive remediation
2014
N/A
~700
Find a Location
Who is running the clinical trial?
Douglas Mental Health University InstituteLead Sponsor
29 Previous Clinical Trials
2,336 Total Patients Enrolled
3 Trials studying Schizophrenia
209 Patients Enrolled for Schizophrenia
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,344 Previous Clinical Trials
26,453,027 Total Patients Enrolled
13 Trials studying Schizophrenia
727,182 Patients Enrolled for Schizophrenia
McGill UniversityOTHER
394 Previous Clinical Trials
997,991 Total Patients Enrolled
2 Trials studying Schizophrenia
75 Patients Enrolled for Schizophrenia
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot speak or read English or French.I can use online platforms and join groups as my doctor agrees.I have been diagnosed with a psychosis-related disorder.I have a private space where I can be alone for the group sessions.
Research Study Groups:
This trial has the following groups:- Group 1: MetaCognitive Training
- Group 2: Cognitive remediation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any open opportunities to join this research project?
"According to the clinicaltrials.gov registry, this medical trial is presently not enrolling any new candidates. The study was originally posted on February 1st 2023 and last updated 19th of December 2022, however there are 368 other studies actively recruiting patients at this time."
Answered by AI
How many different centers are responsible for administering this clinical trial?
"This trial has 5 locations including Kingston Health Sciences Centre, Queen's University in Kingston, Institute of Mental health Research from the University of Ottawa in Ottawa, and Ontario Shoares Centre for Mental Health Science at the University of Toronto in Toronto. There are also other sites available."
Answered by AI
What results are researchers expecting to uncover from this investigation?
"This clinical trial will observe patients over a 10-week period in order to measure changes in Wechsler Memory Scale - Logical Memory (LM) subscale score post-intervention. Secondary outcomes include assessing shifts in BNSS, OES, and PSYRATS scores; the former two being self-assessments of emotional/social loneliness while the latter measures hallucinations & delusions on a scale from 0 (absent) to 4 (severe)."
Answered by AI
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