Cognitive Remediation in Forensic Mental Health Care

NCT04610697 | Recruiting

• 1 other identifier: TheRoyal
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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; Violence; Cognitive Dysfunction; Anxiety; Depression; Schizophrenia; Offenders; Antisocial

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

Outcome Measures

Primary Outcomes (1)

• Executive Function

  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 Outcomes (3)

• Oppositional Behavior

  within 12 weeks before and 12 weeks after training.

• Functional Capacity

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

• Mental Health Symptoms

  within 1 week before and 1 week after training, as well as at a 12-week follow-up.

Study Arms (2)

Cognitive Remediation

EXPERIMENTAL

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

Active control

ACTIVE COMPARATOR

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

Interventions

Cognitive Remediation BEHAVIORAL

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.

Also known as: Neuropsychological Rehabilitation, Cognitive Enhancement, Cognitive Rehabilitation

Cognitive Remediation

Active Control BEHAVIORAL

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

Active control

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• The Royal Ottawa Mental Health Centre: lead

Study Sites (1)

The Royal's Institute of Mental Health Research

Ottawa, Ontario, K1Z 7K4, Canada

RECRUITING

MeSH Terms

Conditions

Psychotic Disorders; Attention Deficit Disorder with Hyperactivity; Brain Injuries, Traumatic; Aggression; Substance-Related Disorders; Cognitive Dysfunction; Anxiety Disorders; Depression; Schizophrenia; Antisocial Personality Disorder

Interventions

Cognitive Remediation; Cognitive Training

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior; Social Behavior; Chemically-Induced Disorders; Cognition Disorders; Neurocognitive Disorders; Personality Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Neurological Rehabilitation; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Patrizia Pezzoli, PhD

  UCL and The Royal's Institute of Mental Health Research

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrizia Pezzoli, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants and personnel conducting the assessments will be unaware of group assignment. At the halfway mark of recruitment, we will perform preliminary analyses including intention-to-treat liner mixed models. Study staff performing the assessment visits and participants will remain blinded to the study conditions.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Double blind randomised controlled trial with active control condition. Given the clinically heterogeneous recruitment pool, pseudo-randomization will be employed to match groups on the main diagnosis.

Study Record Dates

• First Submitted: October 26, 2020
• First Posted: October 30, 2020
• Study Start: February 10, 2020
• Primary Completion: February 10, 2026
• Study Completion: February 10, 2026
• Last Updated: December 12, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: The data will be made available upon manuscript preparation (estimated fall 2021).
• Access Criteria: Access information will be provided.

Locations

CA (1)