Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • ADHD
  • Aggression
  • Cognitive Dysfunction
  • Depression, Anxiety
  • Psychotic Disorders
  • Substance Use Disorders
  • TBI (Traumatic Brain Injury)
  • Violence
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention 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: Triple (Participant, Investigator, Outcomes Assessor)Masking Description: Participants and personnel conducting the assessments will be unaware of group assignment.Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 55 years
Gender
Both males and females

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 inc...

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 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 further examine the effect of cognitive remediation (vs. active control) on other variables that are critical for forensic rehabilitation, namely aggression, therapeutic noncompliance, daily functioning, and mental health (Aim 2). Lastly, we 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.

Tracking Information

NCT #
NCT04610697
Collaborators
Not Provided
Investigators
Principal Investigator: Patrizia Pezzoli, PhD The Royal's Institute of Mental Health Research