An interventional study of Cognitive Remediation and Active Control in Psychotic Disorders, ADHD and TBI (Traumatic Brain Injury), sponsored by The Royal Ottawa Mental Health Centre. Recruiting at 1 site in Canada. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2025-12-12.
Sponsored by The Royal Ottawa Mental Health Centre · Not applicable, Interventional, and Treatment
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.
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.
1,587 studies on the registry are indexed under Psychotic Disorders; 281 are open to participants now.
This study's planned enrollment of 30 is below the median of 65 across 1,320 interventional studies indexed under Psychotic Disorders.
Browse Psychotic Disorders studies →The Royal Ottawa Mental Health Centre is the lead sponsor of 22 studies on the registry; 16 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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.
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
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
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
Active control condition for cognitive remediation, matched in terms of session modality, number, duration, frequency, and format.
Executive Function
We will measure executive functions using tests from the Cambridge Neuropsychological Test Automated Battery (CANTAB; Sandberg, 2011).
Time frame: within 1 week prior and 1 week after training, as well as at a 12-week follow-up.
Oppositional Behavior
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.
Time frame: within 12 weeks before and 12 weeks after training.
Functional Capacity
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.
Time frame: within 1 week prior and 1 week after training, as well as at a 12-week follow-up.
Mental Health Symptoms
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.
Time frame: within 1 week before and 1 week after training, as well as at a 12-week follow-up.
Plan to share: Yes — Anonymized datasets will be made available in appropriate online repositories to assist transparency and reproducibility.
Supporting information: Study protocol, Statistical analysis plan, Analytic code
Time frame: The data will be made available upon manuscript preparation (estimated fall 2021).
Access criteria: Access information will be provided.
Data sharing details ↗ · osf.io
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
The Royal Ottawa Mental Health Centre