Cognitive Remediation in Forensic Mental Health Care

Depression Clinical Trial

— CRFMHC  

Official title:

Cognitive Remediation in Forensic Mental Health Care

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04610697
• Other study ID #: TheRoyal
• Status: Recruiting
• Phase: N/A
• Start date: February 10, 2020
• Est. completion date: February 10, 2025

Study information

• Verified date: November 2023
• Source: The Royal Ottawa Mental Health Centre
• Contact: Patrizia Pezzoli, PhD
• Phone: 613-722-6521
• Email: patrizia.pezzoli[@]theroyal.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

This trial investigates whether cognitive remediation can improve cognitive, functional, and clinical outcomes in forensic inpatients.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: February 10, 2025
• Est. primary completion date: February 10, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• ADHD
• Aggression
• Antisocial
• Anxiety
• Brain Injuries
• Brain Injuries, Traumatic
• Cognitive Dysfunction
• Depression
• Offenders
• Psychotic Disorders
• Schizophrenia
• Substance Use Disorders
• Substance-Related Disorders
• TBI (Traumatic Brain Injury)
• Violence

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Canada	The Royal's Institute of Mental Health Research	Ottawa	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
The Royal Ottawa Mental Health Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	within 12 weeks before and 12 weeks after training.
Secondary	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.	within 1 week prior and 1 week after training, as well as at a 12-week follow-up.
Secondary	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.	within 1 week before and 1 week after training, as well as at a 12-week follow-up.