Recruiting

Cognitive Remediation

Sponsor:

The Royal Ottawa Mental Health Centre

Code:

NCT04610697

Conditions

Psychotic Disorders

ADHD

TBI (Traumatic Brain Injury)

Aggression

Substance Use Disorders

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Not accepted

Interventions

Cognitive Remediation

Active Control

Study Details

Brief summary:

Forensic patients often display cognitive deficits, particularly in the domain of executive functions, that represent a challenge to forensic rehabilitation.

One empirically-validated method to train executive functions is cognitive remediation, which consists of cognitive exercises combined with coaching.

This trial investigates whether cognitive remediation can improve cognitive, functional, and clinical outcomes in forensic inpatients.

Conditions

Psychotic Disorders

ADHD

TBI (Traumatic Brain Injury)

Aggression

Substance Use Disorders

Study ID

NCT04610697

Start date

Feb 10, 2020

Status verified date

Apr, 2025

Completion date

Feb 10, 2026

Anticipated

Primary completion date

Feb 10, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Not accepted

Inclusion Criteria:

i1. Age 18 - 55; i2. Ability to read and speak in fluent English; i3. Current status as inpatient on the Forensic Treatment Unit.

Exclusion Criteria:

e1. Intellectual disability; e2. TBI with loss of consciousness followed by known severe neurological sequelae requiring hospitalisation and rehabilitation.

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cognitive Remediation

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.

active comparator: Active control

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.

Interventions

Cognitive Remediation

Cognitive Remediation consists of exercises, preferably supported by coaching, aimed at engaging cognitive skills and, as a result, at improving cognition as well as functional and clinical outcomes.

Active Control

Active control condition for cognitive remediation, matched in terms of session modality, number, duration, frequency, and format.

Primary outcome measure

  • Executive Function [ Time Frame: within 1 week prior and 1 week after training, as well as at a 12-week follow-up. ]

Central Contacts and Locations

Central contacts

Patrizia Pezzoli, PhD

613-722-6521p.pezzoli@ucl.ac.uk

Locations

The Royal's Institute of Mental Health Research

Recruiting

Ottawa, Ontario, Canada, K1Z 7K4

Contacts

Tammy Beaudoin

(613) 722-6521Tammy.Beaudoin@theroyal.ca

Principal Investigator:

Patrizia Pezzoli, PhD

More Information

Sponsor

The Royal Ottawa Mental Health Centre

Last update posted

Dec 12, 2025

Last verified

Apr, 2025

Keywords

  • Cognitive Remediation
  • Cognitive Training
  • Cognitive Enhancement
  • Cognitive Rehabilitation
  • Neuropsychological Rehabilitation
  • Executive Function
  • Forensic Mental Health
  • Forensic Psychology
  • Forensic Neuropsychology
  • Forensic Neuroscience
  • Forensic Rehabilitation
  • Cognition
  • Executive Functioning

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The Royal Ottawa Mental Health Centre on 2025-12-12.