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Behavioral Intervention

Cognitive Remediation for Cognitive Impairment (CRFMHC Trial)

N/A
Recruiting
Led By Patrizia Pezzoli, PhD
Research Sponsored by The Royal Ottawa Mental Health Centre
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
i1. Age 18 - 55; i2. Ability to read and speak in fluent English; i3. Current status as inpatient on the Forensic Treatment Unit.
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 1 week prior and 1 week after training, as well as at a 12-week follow-up.
Awards & highlights

CRFMHC Trial Summary

This trial tests if exercises & coaching can help forensic patients with cognitive deficits, to improve cognitive, functional & clinical outcomes.

Who is the study for?
This trial is for forensic inpatients aged 18-55 who can read and speak fluent English. It's designed to help those with cognitive challenges due to conditions like traumatic brain injury, domestic violence, substance use disorders, or mental health issues such as anxiety, schizophrenia, ADHD, depression.Check my eligibility
What is being tested?
The study tests cognitive remediation—a therapy involving cognitive exercises and coaching—against an active control to see if it improves thinking skills, daily functioning, and clinical outcomes for patients with executive function deficits.See study design
What are the potential side effects?
Cognitive remediation typically doesn't have physical side effects but may cause temporary frustration or fatigue due to the challenging nature of the exercises. Emotional discomfort could also arise from addressing sensitive personal issues during coaching.

CRFMHC Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

CRFMHC Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 1 week prior and 1 week after training, as well as at a 12-week follow-up.
This trial's timeline: 3 weeks for screening, Varies for treatment, and within 1 week prior and 1 week after training, as well as at a 12-week follow-up. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Executive Function
Secondary outcome measures
Functional Capacity
Mental Health Symptoms
Oppositional Behavior

Side effects data

From 2013 Phase 3 trial • 120 Patients • NCT01173874
9%
Exacerbation
2%
abnormal ECG
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cognitive Activity Control Group
Cognitive Remediation

CRFMHC Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Cognitive RemediationExperimental Treatment1 Intervention
Participants in the cognitive remediation condition will complete computerised exercises followed by bridging discussions delivered using tele-heath. More details regarding treatment and control conditions will be provided following study completion to ensure participant blinding.
Group II: Active controlActive Control1 Intervention
Participants in the active control condition will also complete computerised exercises followed by bridging discussions delivered using tele-heath. More details regarding treatment and control conditions will be provided following study completion to ensure participant blinding.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cognitive Remediation
2010
Completed Phase 3
~1790

Find a Location

Who is running the clinical trial?

The Royal Ottawa Mental Health CentreLead Sponsor
18 Previous Clinical Trials
2,066 Total Patients Enrolled
7 Trials studying Schizophrenia
362 Patients Enrolled for Schizophrenia
Patrizia Pezzoli, PhDPrincipal InvestigatorThe Royal's Institute of Mental Health Research

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What site did they apply to?
The Royal's Institute of Mental Health Research
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Cognitive Remediation in Forensic Mental Health Care
2020. "Cognitive Remediation in Forensic Mental Health Care". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04610697.
All > Domestic Violence > Mental Health
~4 spots leftby Feb 2025
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