Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
30 participants
INTERVENTIONAL
2020-02-10
2026-02-10
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
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.
Study Groups
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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.
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
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.
Active Control
Active control condition for cognitive remediation, matched in terms of session modality, number, duration, frequency, and format.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
55 Years
ALL
No
Sponsors
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The Royal Ottawa Mental Health Centre
OTHER
Responsible Party
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Principal Investigators
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Patrizia Pezzoli, PhD
Role: PRINCIPAL_INVESTIGATOR
UCL and The Royal's Institute of Mental Health Research
Locations
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The Royal's Institute of Mental Health Research
Ottawa, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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TheRoyal
Identifier Type: -
Identifier Source: org_study_id
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