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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

No Placebo-Only Group

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.

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.

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.

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)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to post (10 weeks) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 more

Secondary study objectives

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 more

Other study objectives

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 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

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