Cognitive Remediation in Forensic Mental Health Care

Not Applicable

Recruiting

• Conditions: ADHD; TBI (Traumatic Brain Injury); Substance Use Disorders; Depression; Offenders; Antisocial; Psychotic Disorders; Aggression; Violence; Cognitive Dysfunction
• Interventions: Behavioral: Active Control; Behavioral: Cognitive Remediation

• Registration Number: NCT04610697
• Lead Sponsor: The Royal Ottawa Mental Health Centre

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.

Study Timeline

• Study Start: 2020-02-10
• Study First Submitted: 2020-10-26
• Study First Submitted QC: 2020-10-26
• Study First Posted: 2020-10-30
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-28
• Last Update Posted: 2023-11-29
• Primary Completion: 2025-02-10
• Study Completion: 2025-02-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active control	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.
Cognitive Remediation	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.

Primary Outcome Measures

Name	Time	Method
Executive Function	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).

Secondary Outcome Measures

Name	Time	Method
Oppositional Behavior	within 12 weeks before and 12 weeks after training.	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.
Mental Health Symptoms	within 1 week before and 1 week after training, as well as at a 12-week follow-up.	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.
Functional Capacity	within 1 week prior and 1 week after training, as well as at a 12-week follow-up.	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.

Trial Locations

Locations (1)

The Royal's Institute of Mental Health Research; 🇨🇦 Ottawa, Ontario, Canada