Cognitive Remediation for Cognitive Impairment
(CRFMHC Trial)
Recruiting in Palo Alto (17 mi)
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: The Royal Ottawa Mental Health Centre
No Placebo Group
Approved in 2 Jurisdictions
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.
12345What 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.
36789Is 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.
157810Eligibility 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.
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: Cognitive RemediationExperimental Treatment1 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 controlActive Control1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
The Royal's Institute of Mental Health ResearchOttawa, Canada
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Who Is Running the Clinical Trial?
The Royal Ottawa Mental Health CentreLead Sponsor
References
A Randomized Controlled Trial of Executive Functioning Training Compared With Perceptual Training for Schizophrenia Spectrum Disorders: Effects on Neurophysiology, Neurocognition, and Functioning. [2019]Cognitive remediation is an efficacious treatment for schizophrenia. However, different theoretical approaches have developed without any studies to directly compare them. This is the first study to compare the two dominant approaches to cognitive remediation (training of executive skills and training of perceptual skills) and employed the broadest assessment battery in the literature to date.
Clinical impact of RehaCom software for cognitive rehabilitation of patients with acquired brain injury. [2022]We describe the clinical impact of the RehaCom computerized cognitive training program instituted in the International Neurological Restoration Center for rehabilitation of brain injury patients. Fifty patients admitted from 2008 through 2010 were trained over 60 sessions. Attention and memory functions were assessed with a pre- and post-treatment design, using the Mini-Mental State Examination, Wechsler Memory Scale and Trail Making Test (Parts A and B). Negative effects were assessed, including mental fatigue, headache and eye irritation. The program's clinical usefulness was confirmed, with 100% of patients showing improved performance in trained functions.
Implementing Cognitive Remediation Programs in France: The "Secret Sauce". [2018]Cognitive remediation (CR) is a psychosocial therapy that seeks to restore patients' cognitive abilities by providing strategies to improve functioning in cognitive domains and helping them transfer acquired capabilities to everyday life. Since 2008, CR programs have been introduced in several regional health ministry areas in France. This column describes that implementation initiative, which includes creation of a network of the most active CR programs to conduct multicenter trials; establishment of a university degree in CR, awarded after completion of a one-year clinical training program; and implementation activities of regional health agencies. The authors describe three core elements of a "secret sauce"-a common language, timing, and leadership-that has helped ensure the success of the implementation efforts and that may be useful in other countries.
Thinking about the future cognitive remediation therapy--what works and could we do better? [2022]This article reviews progress in the development of effective cognitive remediation therapy (CRT) and its translational process. There is now enough evidence that cognitive difficulties experienced by people with schizophrenia can change and that the agenda for the next generation of studies is to increase these effects systematically through cognitive remediation. We examine the necessary steps and challenges of moving CRT to treatment dissemination. Theories which have been designed to explain the effects of cognitive remediation, are important but we conclude that they are not essential for dissemination which could progress in an empirical fashion. One apparent barrier is that cognitive remediation therapies look different on the surface. However, they still tend to use many of the same training procedures. The only important marker for outcome identified in the current studies seems to be the training emphasis. Some therapies concentrate on massed practice of cognitive functions, whereas others also use direct training of strategies. These may produce differing effects as noted in the most recent meta-analyses. We recommend attention to several critical issues in the next generation of empirical studies. These include developing more complex models of the therapy effects that take into account participant characteristics, specific and broad cognitive outcomes, the study design, as well as the specific and nonspecific effects of treatment, which have rarely been investigated in this empirical programme.
The Application of Cognitive Remediation Therapy in The Treatment of Mental Disorders. [2020]Cognitive impairment is common in patients with mental disorders. At present, one of the only effective ways to improve cognitive impairment is cognitive remediation therapy. This article reviews the application of cognitive remediation therapy in the treatment of mental disorders.
Individual cognitive remediation therapy benefits for patients with anorexia nervosa and high autistic features. [2022]Cognitive remediation therapy (CRT) is an increasingly implemented intervention in psychiatric conditions. The majority of randomized treatment trials in psychiatry reports cognitive improvements resulting in better functional outcomes in CRT groups. This brief report from the national inpatient treatment programme for eating disorders demonstrates cognitive performance task-based improvements in patients with high and low autistic characteristics. This preliminary study shows feasibility and benefits of individual CRT in patients who have autism spectrum disorder features.
Cognitive remediation therapy in autism spectrum disorder: Tunisian experience. [2020]Cognitive dysfunctions associated with Autism spectrum disorder (ASD) are nowadays highlighted. These cognitive impairments include mainly executive dysfunctioning and are linked with academic difficulties, thus representing one of the treatment targets. Cognitive remediation therapy (CRT) is a new promising program aiming to remediate cognitive impairments by targeting executive functions. It attempts to teach information processing strategies through guided mental exercises.
Action-based cognitive remediation for individuals with serious mental illnesses: Effects of real-world simulations and goal setting on functional and vocational outcomes. [2019]Cognitive remediation programs often have larger effects on cognition compared with everyday outcomes. We compared changes across cognitive, functional competence, and vocational domains in 2 cognitive remediation programs.
Cognitive deficits in children with autism spectrum disorders: Toward an integrative approach combining social and non-social cognition. [2022]Autism spectrum disorder (ASD) is associated with neurocognitive impairment, including executive dysfunctioning and social cognition (SC) deficits. Cognitive remediation (CR) is a behavioral training-based intervention aiming to improve cognitive processes. Its first use in psychiatry interested patients with schizophrenia, in whom promising results have been shown. Integrated CR programs targeting both social and non-social cognition have demonstrated to be effective in improving both cognitive domains and functional outcomes. CR studies in children and adolescents with ASD are still new, those regarding CR approaches combining social and executive functioning remediation are scares. One study examining the efficacy of cognitive enhancement therapy (CET) for improving cognitive abilities in ADS adults, showed significant differential increases in neurocognitive function and large social-cognitive improvements. Therefore, taking into account the overlap between ASD and schizophrenia, and considering the close link between executive functions (EF) and SC, we suggest that integrative approach in ASD could result in better outcomes. The present perspective aimed to highlight cognitive remediation (CR) programs contributions in ASD (especially in children and adolescents), and to discuss the value of combining social and non-social programs.
[Tunisia: nursing practice of cognitive remediation in child psychiatry]. [2019]Cognitive remediation is today afforded a significant place in the treatment of neurodevelopmental disorders. A hospital team, comprising in particular a nurse offering consultations in a child psychiatry unit in a public hospital in Tunis, shares its experience with regard to this technique which aims to restore impaired cognitive functions in order to improve the efficiency and quality of life of young patients.