Cognitive Remediation in Forensic Mental Health Care (CRFMHC)

December 4, 2025 updated by: The Royal Ottawa Mental Health Centre

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Forensic patients often display deficits in executive functions, namely difficulties in planning, strategic thinking, problem-solving, and inhibiting inappropriate behavior. Such deficits are transdiagnostic and often underlie behavioral incidents, undermine reintegration into the community, and increase recidivism risk. Despite this, forensic programs usually do not include executive function training.

One approach to train executive functions is cognitive remediation, which consists of behavioral exercises engaging cognitive skills, supported by coaching. In various mental health conditions, cognitive remediation has been repeatedly associated with improvements in cognitive, functional, and clinical outcomes, with small-to-moderate effect sizes. Thus, it should be clarified whether this approach can lead to similar improvements in forensic populations.

In the present trial, we will investigate whether 12 hours over 6 weeks of computerised cognitive remediation administered using tele-health can improve executive functions relative to an active control condition in a sample of 30 forensic inpatients (Aim 1). We will further examine the effect of cognitive remediation (vs. active control) on other variables that are critical for forensic rehabilitation, namely oppositional behaviour, functional capacity, and mental health symptoms (Aim 2). Lastly, we will explore whether any effects persist 12 weeks following cognitive remediation (Aim 3).

Cognitive remediation is an evidence-based inexpensive training method that could be integrated into forensic healthcare practice. In the long term, the expected cognitive, functional, and clinical improvements associated with cognitive remediation have the potential to result in shorter hospitalisations and reduced recidivism rates.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1Z 7K4
        • Recruiting
        • The Royal's Institute of Mental Health Research
        • Contact:
        • Principal Investigator:
          • Patrizia Pezzoli, PhD
        • Principal Investigator:
          • Michael Seto, PhD
        • Principal Investigator:
          • Synthia Guimond, PhD
        • Principal Investigator:
          • Sanjiv Gulati, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Behavioral: 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.
Other Names:
  • Neuropsychological Rehabilitation
  • Cognitive Enhancement
  • Cognitive Rehabilitation
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.
Behavioral: Active Control
Active control condition for cognitive remediation, matched in terms of session modality, number, duration, frequency, and format.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Executive Function
Time Frame: within 1 week prior and 1 week after training, as well as at a 12-week follow-up.
We will measure executive functions using tests from the Cambridge Neuropsychological Test Automated Battery (CANTAB; Sandberg, 2011).
within 1 week prior and 1 week after training, as well as at a 12-week follow-up.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oppositional Behavior
Time Frame: within 12 weeks before and 12 weeks after training.
We will measure oppositional behavior using case-manager reports over the 12 weeks preceding and following the study. We will code frequency and severity of behavioral incidents (e.g., verbal and physical aggression) and compliance with rehabilitative interventions.
within 12 weeks before and 12 weeks after training.
Functional Capacity
Time Frame: within 1 week prior and 1 week after training, as well as at a 12-week follow-up.
We will measure perceived functioning in daily life using the Generalized Self-Efficacy Scale (GSES; Schwarzer & Jerusalem, 1995), scored on a scale of 10 to 40, with higher values indicating higher perceived general self-efficacy.
within 1 week prior and 1 week after training, as well as at a 12-week follow-up.
Mental Health Symptoms
Time Frame: within 1 week before and 1 week after training, as well as at a 12-week follow-up.
We will measure mental health symptoms using the Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM; Evans et al., 2000), scored on a scale of 0 to 136, with greater scores indicating greater psychological distress.
within 1 week before and 1 week after training, as well as at a 12-week follow-up.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Royal Ottawa Mental Health Centre

Investigators

  • Principal Investigator: Patrizia Pezzoli, PhD, UCL and The Royal's Institute of Mental Health Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 10, 2020

Primary Completion (Estimated)

February 10, 2026

Study Completion (Estimated)

February 10, 2026

Study Registration Dates

First Submitted

October 26, 2020

First Submitted That Met QC Criteria

October 26, 2020

First Posted (Actual)

October 30, 2020

Study Record Updates

Last Update Posted (Estimated)

December 12, 2025

Last Update Submitted That Met QC Criteria

December 4, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TheRoyal

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Anonymized datasets will be made available in appropriate online repositories to assist transparency and reproducibility.

IPD Sharing Time Frame

The data will be made available upon manuscript preparation (estimated fall 2021).

IPD Sharing Access Criteria

Access information will be provided.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Aggression

Clinical Trials on Cognitive Remediation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Turkmenistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe