CRFMHC: Cognitive Remediation in Forensic Mental Health Care

Sponsor

The Royal Ottawa Mental Health Centre (Other)

Overall Status

Recruiting

CT.gov ID

NCT04610697

Collaborator

(none)

Enrollment

Location

Arms

29.6

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Psychotic Disorders ADHD TBI (Traumatic Brain Injury) Aggression Substance Use Disorders Violence Cognitive Dysfunction Anxiety Depression Schizophrenia Offenders Antisocial	Behavioral: Cognitive Remediation Behavioral: Active Control	N/A

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

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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.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 (Participant, Investigator, Outcomes Assessor)

Masking Description:

Participants and personnel conducting the assessments will be unaware of group assignment.

Primary Purpose:

Treatment

Official Title:

Cognitive Remediation in Forensic Mental Health Care

Actual Study Start Date :

Feb 10, 2020

Anticipated Primary Completion Date :

Jul 10, 2022

Anticipated Study Completion Date :

Jul 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	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. Other Names: Neuropsychological Rehabilitation Cognitive Enhancement Cognitive Rehabilitation
Active Comparator: 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.	Behavioral: Active Control Active control condition for cognitive remediation, matched in terms of session modality, number, duration, frequency, and format.

Arm

Intervention/Treatment

Experimental: 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.

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.

Other Names:

Neuropsychological Rehabilitation

Cognitive Enhancement

Cognitive Rehabilitation

Active Comparator: 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.

Behavioral: Active Control

Active control condition for cognitive remediation, matched in terms of session modality, number, duration, frequency, and format.

Outcome Measures

Primary Outcome Measures

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

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.
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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.