Clinical trial NCT04610697: Cognitive Remediation in Forensic Mental Health Care
Official title: Cognitive Remediation in Forensic Mental Health Care
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: The Royal Ottawa Mental Health Centre
Sponsor class: OTHER
First posted: 2020-10-30
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Executive Function
timeFrame: within 1 week prior and 1 week after training, as well as at a 12-week follow-up.
Secondary outcomes:
measure: Oppositional Behavior
timeFrame: within 12 weeks before and 12 weeks after training.
measure: Functional Capacity
timeFrame: within 1 week prior and 1 week after training, as well as at a 12-week follow-up.
measure: Mental Health Symptoms
timeFrame: within 1 week before and 1 week after training, as well as at a 12-week follow-up.
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: The Royal's Institute of Mental Health Research
state: Ontario
Study officials:
affiliation: The Royal's Institute of Mental Health Research
name: Patrizia Pezzoli, PhD
role: PRINCIPAL_INVESTIGATOR
References: