Cognitive Remediation for Cognitive Impairment

(CRFMHC Trial)

Overseen By Synthia Guimond, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: The Royal Ottawa Mental Health Centre

Disqualifiers: Intellectual disability, TBI, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 12

Duration: 6 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether cognitive remediation, involving mental exercises and coaching, can enhance thinking and problem-solving skills in forensic inpatients. Forensic patients often face cognitive challenges, which hinder their ability to benefit from rehabilitation programs. Participants will engage in either cognitive remediation or a similar set of exercises for comparison, known as the Active Control Program. Inpatients in a forensic treatment unit who can read and speak English may be suitable candidates for the trial. As an unphased trial, this study provides a unique opportunity to advance understanding of cognitive improvement strategies in forensic settings.

Do I need to stop taking my current medications to join the trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What prior data suggests that cognitive remediation is safe for forensic inpatients?

Research has shown that cognitive remediation is generally safe. Various studies have found this treatment reduces thinking problems and improves mental skills. For instance, one study found that an 8-week cognitive remediation program lessened negative symptoms and boosted thinking abilities. Another study showed that this therapy improved skills like planning and problem-solving in children and teens with autism.

These studies have reported no major negative effects, suggesting that cognitive remediation is well-tolerated. This treatment uses computer exercises and coaching, which are non-invasive activities, indicating a likely low risk of harmful effects. However, as with any treatment, experiences can vary, so discussing any concerns with the trial team or a healthcare provider is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about cognitive remediation for cognitive impairment because it offers a fresh approach by combining computerized exercises with telehealth-based discussions. Unlike traditional treatments, which often focus on medication or in-person therapy sessions, this method leverages technology to enhance cognitive abilities from the comfort of home. This innovative delivery method not only increases accessibility but also allows for personalized, flexible treatment that can adapt to each participant's needs.

What evidence suggests that cognitive remediation is effective for cognitive impairment?

Research has shown that cognitive remediation, a treatment in this trial, can greatly enhance thinking skills and daily functioning. Studies have found that these programs improve memory, essential mental skills for managing time and tasks, and the speed of information processing. Other research has linked cognitive remediation to improvements in daily activities and benefits in treating substance use disorders. Thus, strong evidence suggests that cognitive remediation could enhance thinking and daily abilities for trial participants. Participants in the active control arm will also engage in computerized exercises and discussions, with specific details provided after the study to maintain blinding. ^{6 7 8 9 10}

Who Is on the Research Team?

Patrizia Pezzoli, PhD

Principal Investigator

The Royal's Institute of Mental Health Research

Are You a Good Fit for This Trial?

This trial is for forensic inpatients aged 18-55 who can read and speak fluent English. It's designed to help those with cognitive challenges due to conditions like traumatic brain injury, domestic violence, substance use disorders, or mental health issues such as anxiety, schizophrenia, ADHD, depression.

Inclusion Criteria

I am between 18 and 55 years old, speak English fluently, and am currently an inpatient in a Forensic Treatment Unit.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive 12 hours of computerised cognitive remediation over 6 weeks using tele-health

6 weeks

Tele-health sessions

Follow-up

Participants are monitored for cognitive, functional, and clinical outcomes 12 weeks after treatment

12 weeks

Assessments at 12-week follow-up

What Are the Treatments Tested in This Trial?

Interventions

• Active Control
• Cognitive Remediation

Trial Overview The study tests cognitive remediation—a therapy involving cognitive exercises and coaching—against an active control to see if it improves thinking skills, daily functioning, and clinical outcomes for patients with executive function deficits.

How Is the Trial Designed?

Group I: Cognitive Remediation Experimental Treatment 1 Intervention

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.

Group II: Active control Active Control 1 Intervention

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 is already approved in European Union, United States for the following indications:

Approved in European Union as Cognitive Remediation for:

• Schizophrenia
• Forensic psychiatric rehabilitation

Approved in United States as Cognitive Remediation for:

• Schizophrenia
• Forensic psychiatric rehabilitation

Who Is Running the Clinical Trial?

The Royal Ottawa Mental Health Centre

Lead Sponsor

Trials

24

Recruited

2,300+

Published Research Related to This Trial

Cognitive remediation is increasingly recognized as an important treatment for neurodevelopmental disorders, focusing on restoring cognitive functions in young patients.

A hospital team in Tunis, including a nurse in a child psychiatry unit, has successfully implemented this technique to enhance the quality of life and efficiency of their patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Tunisia: nursing practice of cognitive remediation in child psychiatry]. Chaari, E., Hamza, M., Charfi, F., et al.[2019]

Cognitive remediation therapy (CRT) has shown promise in improving cognitive difficulties in individuals with schizophrenia, indicating that these cognitive challenges can be effectively addressed through targeted interventions.

The success of CRT may depend on the training emphasis, with some therapies focusing on massed practice while others incorporate strategy training, suggesting that the approach taken can lead to different outcomes in cognitive improvement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Thinking about the future cognitive remediation therapy--what works and could we do better? Wykes, T., Spaulding, WD.[2022]

Perceptual training showed immediate improvements in EEG mismatch negativity, indicating enhanced neurophysiological response, but these effects did not last at the 12-week follow-up.

Executive training led to significant long-term improvements in neurocognition and community functioning, suggesting that targeting higher-order cognitive skills can yield benefits that emerge after the treatment period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomized Controlled Trial of Executive Functioning Training Compared With Perceptual Training for Schizophrenia Spectrum Disorders: Effects on Neurophysiology, Neurocognition, and Functioning. Best, MW., Milanovic, M., Iftene, F., et al.[2019]

Cognitive Remediation Therapy (CRT) significantly improved executive functions and school performance in children and adolescents with Autism Spectrum Disorder (ASD), with 16 out of 25 participants completing an average of 22 sessions.

After CRT, participants showed notable enhancements in intellectual abilities, working memory, and specific aspects of cognitive flexibility, indicating that CRT is a promising intervention for addressing cognitive impairments associated with ASD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive remediation therapy in autism spectrum disorder: Tunisian experience. Hajri, M., Abbes, Z., Ben Yahia, H., et al.[2020]

Cognitive remediation therapy (CRT) has shown cognitive performance improvements in patients with eating disorders, regardless of their level of autistic characteristics, indicating its broad applicability.

This preliminary study supports the feasibility and benefits of individual CRT for patients exhibiting features of autism spectrum disorder, suggesting it can enhance cognitive functioning in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Individual cognitive remediation therapy benefits for patients with anorexia nervosa and high autistic features. Dandil, Y., Smith, K., Adamson, J., et al.[2022]

Cognitive remediation therapy is currently one of the few effective treatments available for improving cognitive impairment in patients with mental disorders.

This review highlights the importance of cognitive remediation therapy as a valuable intervention for enhancing cognitive function in individuals suffering from various mental health conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Application of Cognitive Remediation Therapy in The Treatment of Mental Disorders. Fan, Q., Liao, L., Pan, G.[2020]

Cognitive remediation (CR) is an effective psychosocial therapy aimed at improving cognitive abilities in patients, with programs established in France since 2008 to enhance cognitive functioning and everyday life skills.

The successful implementation of CR programs involved creating a network for multicenter trials, establishing a university degree in CR, and focusing on key elements like a common language, timing, and leadership, which could serve as a model for other countries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementing Cognitive Remediation Programs in France: The "Secret Sauce". Amado, I., Sederer, LI.[2018]

Cognitive remediation (CR) programs, which focus on improving cognitive processes, show promise in enhancing both social cognition and executive functioning in individuals with autism spectrum disorder (ASD), particularly in children and adolescents.

Evidence from studies, including one on cognitive enhancement therapy (CET) for adults with ASD, indicates that integrated CR approaches can lead to significant improvements in neurocognitive function and social cognition, suggesting that combining these strategies may yield better outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive deficits in children with autism spectrum disorders: Toward an integrative approach combining social and non-social cognition. Hajri, M., Abbes, Z., Yahia, HB., et al.[2022]

The RehaCom computerized cognitive training program significantly improved attention and memory functions in 50 brain injury patients after 60 training sessions, with all patients showing enhanced performance in the targeted areas.

The program was well-tolerated, with no reported negative effects such as mental fatigue, headache, or eye irritation, indicating its safety for use in rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical impact of RehaCom software for cognitive rehabilitation of patients with acquired brain injury. Fernández, E., Bringas, ML., Salazar, S., et al.[2022]

The Action-Based Cognitive Remediation (ABCR) program showed significantly better retention rates (83%) and improvements in perceived competence in cognitively challenging tasks compared to the traditional cognitive remediation (tCR) program (57%).

Participants in the ABCR program also had greater functional competence and were more likely to be competitively employed (68.4% vs. 40%), indicating that this approach may lead to better real-world outcomes for individuals with serious mental illnesses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Action-based cognitive remediation for individuals with serious mental illnesses: Effects of real-world simulations and goal setting on functional and vocational outcomes. Bowie, CR., Grossman, M., Gupta, M., et al.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11349022/

Thinking About the Future of Cognitive Remediation ... Cognition improvement was positively correlated with functional outcome, as has been found in other studies, but it was not a mediator. Symptoms ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0165178125004342

Effect of Computerized Cognitive Remediation Therapy ... Meta-analyses have shown that cognitive remediation interventions can substantially improve cognitive performance and functional outcomes ( ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5378626/

Neurocognitive and substance use outcomes Cognitive Remediation Therapy (CRT) is reported to improve neurocognitive and substance use disorder (SUD) outcomes in residential treatments.

4. frontiersin.org frontiersin.org/journals/psychology/articles/10.3389/fpsyg.2021.730165/full

Cognitive Training Effectiveness on Memory, Executive ... This systematic review aims to synthesize evidence on the effectiveness of cognitive training in memory, executive functioning, and processing speed in ...

5. systematicreviewsjournal.biomedcentral.com systematicreviewsjournal.biomedcentral.com/articles/10.1186/s13643-022-02032-0

Efficacy of cognitive remediation on activities of daily living in ... Cognitive remediation is effective in improving instrumental activities of daily living performance immediately post-intervention in older adults with mild ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11780405/

Enhanced computerized cognitive remediation therapy ... In conclusion, 8-week cognitive remediation training promoted the alleviation of negative symptoms, depressive symptoms, and cognitive deficits ...

7. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT06348810

Dual-Task Training for People With Mild Cognitive ... Therefore, this study aims to analyze the effect of dual-task training in improving global cognitive function, executive function, working memory, sleep, ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S2215001324000143

Efficacy of cognitive training on cognition, symptoms and ... In this study, we examined the efficacy of CT on training task, cognitive, symptom, and functional ability measures as well as the impact of motivational ...

9. withpower.com withpower.com/trial/phase-brain-injuries-traumatic-1-2020-dd457

Cognitive Remediation for Cognitive Impairment Cognitive Remediation Therapy (CRT) significantly improved executive functions and school performance in children and adolescents with Autism Spectrum Disorder ...

10. jmir.org jmir.org/2025/1/e73140

The Effectiveness of Computerized Cognitive Training in ... We conclude that CCT can significantly enhance general cognitive function, attention, executive function, and quality of life in PSCI patients.