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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

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within 1 week prior and 1 week after training, as well as at a 12-week follow-up.

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

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

Primary study objectives

Executive Function

Secondary study objectives

Functional Capacity

Mental Health Symptoms

Oppositional Behavior

Side effects data

From 2013 Phase 3 trial • 120 Patients • NCT01173874

Exacerbation

abnormal ECG

100%

80%

60%

40%

20%

Study treatment Arm

Cognitive Remediation

Cognitive Activity Control Group

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

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

0 / 1Eligibility criteria met