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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the idea that Cognitive Remediation for Cognitive Impairment is an effective treatment?

The available research shows that Cognitive Remediation is effective for improving cognitive functions in people with schizophrenia and brain injuries. For example, a study on schizophrenia found that cognitive remediation helps improve thinking skills. Another study using the RehaCom program for brain injury patients showed that all participants improved in attention and memory after the treatment. This suggests that Cognitive Remediation can be a helpful treatment for cognitive impairments. ^{1 2 3 4 5}

What safety data exists for cognitive remediation therapy?

The provided research abstracts do not specifically mention safety data for cognitive remediation therapy. They focus on the effectiveness and implementation of cognitive remediation in various conditions, such as serious mental illnesses, anorexia nervosa, and autism spectrum disorder. While these studies highlight cognitive improvements and functional outcomes, they do not provide explicit safety data or discuss adverse effects related to the therapy. ^{3 6 7 8 9}

Is Cognitive Remediation a promising treatment for cognitive impairment?

Yes, Cognitive Remediation is a promising treatment for cognitive impairment. It helps improve thinking skills by using mental exercises and strategies, and has shown positive effects in conditions like schizophrenia, autism, and other mental disorders. ^{1 5 7 8 10}

Research Team

Patrizia Pezzoli, PhD

Principal Investigator

The Royal's Institute of Mental Health Research

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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 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 (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]

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]

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]

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]

References

1. United States 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. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Clinical impact of RehaCom software for cognitive rehabilitation of patients with acquired brain injury. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Implementing Cognitive Remediation Programs in France: The "Secret Sauce". [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Thinking about the future cognitive remediation therapy--what works and could we do better? [2022]

5. China pubmed.ncbi.nlm.nih.gov

The Application of Cognitive Remediation Therapy in The Treatment of Mental Disorders. [2020]

6. England pubmed.ncbi.nlm.nih.gov

Individual cognitive remediation therapy benefits for patients with anorexia nervosa and high autistic features. [2022]

7. Tunisia pubmed.ncbi.nlm.nih.gov

Cognitive remediation therapy in autism spectrum disorder: Tunisian experience. [2020]

8. United States 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. [2019]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Cognitive deficits in children with autism spectrum disorders: Toward an integrative approach combining social and non-social cognition. [2022]

10. France pubmed.ncbi.nlm.nih.gov

[Tunisia: nursing practice of cognitive remediation in child psychiatry]. [2019]