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Cognitive Remediation in Forensic Mental Health Care (CRFMHC)

Primary Purpose

Psychotic Disorders, ADHD, TBI (Traumatic Brain Injury)

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Cognitive Remediation
Active Control
Sponsored by
The Royal Ottawa Mental Health Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psychotic Disorders focused on measuring 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

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept 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.

Sites / Locations

  • The Royal's Institute of Mental Health ResearchRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cognitive Remediation

Active control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Executive Function
We will measure executive functions using tests from the Cambridge Neuropsychological Test Automated Battery (CANTAB; Sandberg, 2011).

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
October 26, 2020
Last Updated
June 7, 2022
Sponsor
The Royal Ottawa Mental Health Centre
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1. Study Identification

Unique Protocol Identification Number
NCT04610697
Brief Title
Cognitive Remediation in Forensic Mental Health Care
Acronym
CRFMHC
Official Title
Cognitive Remediation in Forensic Mental Health Care
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 10, 2020 (Actual)
Primary Completion Date
July 10, 2022 (Anticipated)
Study Completion Date
July 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Royal Ottawa Mental Health Centre

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Participants and personnel conducting the assessments will be unaware of group assignment.
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cognitive Remediation
Arm Type
Experimental
Arm Description
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.
Arm Title
Active control
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Remediation
Other Intervention Name(s)
Neuropsychological Rehabilitation, Cognitive Enhancement, Cognitive Rehabilitation
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Active Control
Intervention Description
Active control condition for cognitive remediation, matched in terms of session modality, number, duration, frequency, and format.
Primary Outcome Measure Information:
Title
Executive Function
Description
We will measure executive functions using tests from the Cambridge Neuropsychological Test Automated Battery (CANTAB; Sandberg, 2011).
Time Frame
within 1 week prior and 1 week after training, as well as at a 12-week follow-up.
Secondary Outcome Measure Information:
Title
Oppositional Behavior
Description
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.
Time Frame
within 12 weeks before and 12 weeks after training.
Title
Functional Capacity
Description
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.
Time Frame
within 1 week prior and 1 week after training, as well as at a 12-week follow-up.
Title
Mental Health Symptoms
Description
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.
Time Frame
within 1 week before and 1 week after training, as well as at a 12-week follow-up.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patrizia Pezzoli, PhD
Phone
613-722-6521
Ext
6539
Email
patrizia.pezzoli@theroyal.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrizia Pezzoli, PhD
Organizational Affiliation
The Royal's Institute of Mental Health Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Royal's Institute of Mental Health Research
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Z 7K4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tammy Beaudoin
Phone
(613) 722-6521
Ext
6214
Email
Tammy.Beaudoin@theroyal.ca
First Name & Middle Initial & Last Name & Degree
Patrizia Pezzoli, PhD
First Name & Middle Initial & Last Name & Degree
Michael Seto, PhD
First Name & Middle Initial & Last Name & Degree
Synthia Guimond, PhD
First Name & Middle Initial & Last Name & Degree
Sanjiv Gulati, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Anonymized datasets will be made available in appropriate online repositories to assist transparency and reproducibility.
IPD Sharing Time Frame
The data will be made available upon manuscript preparation (estimated fall 2021).
IPD Sharing Access Criteria
Access information will be provided.
IPD Sharing URL
https://osf.io/94ukh/

Learn more about this trial

Cognitive Remediation in Forensic Mental Health Care

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