Psychotic DisordersCRFMHCNCT04610697
Cognitive Remediation in Forensic Mental Health Care
A study testing Cognitive Remediation in people with Psychotic Disorders and ADHD, run by The Royal Ottawa Mental Health Centre at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Psychotic Disorders, ADHD, TBI (Traumatic Brain Injury)
- What is being tested?
- Cognitive Remediation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 10 Feb 2020to 10 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- i1. Age 18 - 55; i2. Ability to read and speak in fluent English; i3. Current status as inpatient on the Forensic Treatment Unit.
Who cannot join
- e1. Intellectual disability; e2. TBI with loss of consciousness followed by known severe neurological sequelae requiring hospitalisation and rehabilitation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
The Royal's Institute of Mental Health Research
Ottawa, Ontario, K1Z 7K4
Tammy Beaudoin, (613) 722-6521 ext. 6214, Tammy.Beaudoin@theroyal.ca
Patrizia Pezzoli, PhD
About this study
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.
Read the 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.
- Conditions
- Psychotic Disorders, ADHD, TBI (Traumatic Brain Injury), Aggression, Substance Use Disorders, Violence
- Being tested
- Cognitive Remediation, Active Control
- 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
- Medical subject headings
- Psychotic Disorders, Attention Deficit Disorder with Hyperactivity, Brain Injuries, Traumatic, Aggression, Substance-Related Disorders, Cognitive Dysfunction, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive RemediationBehavioural
Also called Neuropsychological Rehabilitation, Cognitive Enhancement, Cognitive Rehabilitation
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 ControlBehavioural
Active control condition for cognitive remediation, matched in terms of session modality, number, duration, frequency, and format.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Active Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Executive Function
We will measure executive functions using tests from the Cambridge Neuropsychological Test Automated Battery (CANTAB; Sandberg, 2011).
Measured: within 1 week prior and 1 week after training, as well as at a 12-week follow-up.
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: within 1 week before and 1 week after training, as well as at a 12-week follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2020
- Study start10 Feb 2020
- Primary completion10 Feb 2026 (estimated)
- Study completion10 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychotic DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Royal Ottawa Mental Health Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patrizia Pezzoli, PhD, Principal investigator, UCL and The Royal's Institute of Mental Health Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04610697
- Sponsor's protocol ID
- TheRoyal
- Acronym
- CRFMHC
- Status last verified
- Apr 2025
- First submitted
- 26 Oct 2020
- Last updated
- 12 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized datasets will be made available in appropriate online repositories to assist transparency and reproducibility.
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Remediation in Forensic Mental Health Care
- ClinicalTrials.gov ID
- NCT04610697
- Acronym / sponsor ID
- CRFMHC / TheRoyal
- Conditions
- Psychotic Disorders, ADHD, TBI (Traumatic Brain Injury), Aggression, Substance Use Disorders, Violence
- Keywords
- Cognitive Remediation, Cognitive Training, Cognitive Enhancement, Cognitive Rehabilitation, Neuropsychological Rehabilitation, Executive Function, Forensic Mental Health, Forensic Psychology
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- The Royal Ottawa Mental Health CentreUniversity, hospital or other
- Study start
- 10 Feb 2020 (actual)
- Primary completion
- 10 Feb 2026 (estimated)
- Study completion
- 10 Feb 2026 (estimated)
- First posted
- 30 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Cognitive Remediation | Experimental | Behavioral: Cognitive RemediationParticipants 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 control | Active comparator | Behavioral: Active ControlParticipants 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- i1. Age 18 - 55; i2. Ability to read and speak in fluent English; i3. Current status as inpatient on the Forensic Treatment Unit.
Key exclusion criteria (1 listed)
- e1. Intellectual disability; e2. TBI with loss of consciousness followed by known severe neurological sequelae requiring hospitalisation and rehabilitation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive RemediationAlso: Neuropsychological Rehabilitation, Cognitive Enhancement, Cognitive RehabilitationCognitive 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. | Behavioural | Cognitive Remediation |
| Active ControlActive control condition for cognitive remediation, matched in terms of session modality, number, duration, frequency, and format. | Behavioural | Active control |
Primary outcome
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).
3 secondary outcomes
Oppositional Behavior
Time frame: 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.
Mental Health Symptoms
Time frame: within 1 week before and 1 week after training, as well as at a 12-week follow-up.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2025.
- Individual participant dataSharing planned: Yes. Anonymized datasets will be made available in appropriate online repositories to assist transparency and reproducibility.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Patrizia Pezzoli, PhD principal investigator
UCL and The Royal's Institute of Mental Health Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Remediation in people with Psychotic Disorders and ADHD, run by The Royal Ottawa Mental Health Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Patrizia Pezzoli, PhD (613-722-6521, p.pezzoli@ucl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2025.