Computerized Cognitive Training for Psychosis

(Rem-STEP Trial)

Overseen By Kaylee Enevold, MA

Age: 18 - 65

Sex: Any

Trial Phase: Phase < 1

Sponsor: University of Minnesota

Disqualifiers: Severe substance use, Neurological disorder, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two types of computerized brain training to help individuals with psychosis better process information about their surroundings. One group will engage in exercises to enhance their ability to see and understand visual information, while the other will focus on controlling and stabilizing visual information. These exercises are part of the BrainHQ Computerized Cognitive Training, specifically the Visual Cognitive Control Training Paradigm and the Visual Perception Training Paradigm. Ideal candidates are young adults aged 18-30 with diagnoses such as schizophrenia or bipolar disorder with psychotic features, who have not been hospitalized for psychiatric reasons in the past month. Participants must speak and understand English fluently, have access to a computer, and reside in the United States. As an Early Phase 1 trial, this research aims to understand how the treatment works in people, offering participants a chance to contribute to groundbreaking research.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. It is best to discuss this with the study team or your healthcare provider.

What prior data suggests that this computerized cognitive training is safe for individuals with psychosis?

A previous study found computerized brain training to be an effective and safe method for people with schizophrenia, reducing impulsive aggression and indicating good tolerance. Another study showed similar training improved thinking skills in people with mild cognitive impairment (MCI) and healthy individuals, suggesting its effectiveness across different groups without harm.

Research has shown that technology-based training like BrainHQ effectively improves thinking skills. Large studies have used this training safely. Evidence also indicates that using devices like tablets for this training is practical and does not cause serious side effects.

Since this trial is in an early phase, researchers are closely monitoring safety. Early phases focus on ensuring the treatment's safety for participants. These findings suggest the treatments are generally safe and well-tolerated, but safety will be carefully observed in this trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments because they offer a novel approach to managing psychosis by directly targeting cognitive processes. Unlike traditional treatments for psychosis that often rely on medications to manage symptoms, these therapies use BrainHQ's computerized cognitive training paradigms to enhance specific brain functions. The Visual Perception Training focuses on improving how the brain processes visual information at the perceptual level, while the Visual Cognitive Control Training aims to stabilize how the brain represents visual information. This innovative, non-pharmacological method could complement existing treatments and potentially improve cognitive functions in those with psychosis.

What evidence suggests that this trial's treatments could be effective for psychosis?

Research has shown that BrainHQ's Visual Perception Training, one of the treatment arms in this trial, can improve thinking skills for people with psychosis. In previous studies, participants experienced better emotional understanding and social interactions. These exercises help the brain process information more efficiently, which is crucial for those with schizophrenia.

Similarly, BrainHQ's Visual Cognitive Control Training, another treatment arm in this trial, has shown positive results. Studies found that it improves thinking and memory. This training may help the brain manage visual information better, benefiting people with psychosis. Evidence supports both methods as offering new ways to address thinking challenges in schizophrenia. ^{6 7 8 9 10}

Who Is on the Research Team?

Caroline Demro, PhD

Principal Investigator

University of Minnesota Department of Psychiatry and Behavioral Sciences

Are You a Good Fit for This Trial?

This trial is for individuals aged 18-45 with conditions like schizophrenia or mood disorders with psychotic features, fluent in English, and have been stable outside a hospital for at least a month. They must not have severe substance use recently, significant cognitive training experience within the last six months, or other neurological disorders (except autism).

Exclusion Criteria

History of severe substance use in the past 3 months (determined by the MINI 7.0 diagnostic criteria)

I can make my own decisions about joining a study.

Significant cognitive training experience within the last 6 months, as determined by the PI

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Cognitive Training

Participants undergo either visual perception training or visual cognitive control training to improve state representation processes

4 weeks

All training and assessments can be completed remotely

Follow-up

Participants are monitored for changes in cognitive performance and symptoms post-intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• BrainHQ Computerized Cognitive Training - Visual Cognitive Control Training Paradigm
• BrainHQ Computerized Cognitive Training - Visual Perception Training Paradigm

Trial Overview The study tests two types of computerized cognitive training designed to improve information processing about surroundings in young adults with psychosis compared to those without psychiatric diagnoses.

How Is the Trial Designed?

Group I: Visual Perception Training Experimental Treatment 1 Intervention

Contains targeted visual perception exercises from BrainHQ's suite of cognitive exercises. This training paradigm is designed to improve state estimation processes at the perceptual input level.

Group II: Visual Cognitive Control Training Experimental Treatment 1 Intervention

Contains targeted visual cognitive control exercises from BrainHQ's suite of exercises. This training paradigm is designed to enhance state representation stability of visual information.

BrainHQ Computerized Cognitive Training - Visual Cognitive Control Training Paradigm is already approved in United States, European Union for the following indications:

Approved in United States as BrainHQ for:

• Cognitive training for individuals with psychotic illnesses
• General cognitive improvement

Approved in European Union as BrainHQ for:

• Cognitive training for individuals with psychotic illnesses
• General cognitive improvement

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials

1,459

Recruited

1,623,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Published Research Related to This Trial

In a multicenter study involving 64 patients with schizophrenia, a 5-week computer-based cognitive training program (Cogpack) was found to significantly improve cognitive function and was highly accepted by the participants.

Patients reported increased self-esteem and reduced computer anxiety after the training, indicating that not only was the cognitive training effective, but it also positively impacted their overall well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Subjective experience of a computer-assisted cognitive training by patients with schizophrenia]. Bender, S., Dittmann-Balcar, A., Prehn, G., et al.[2018]

A 3-week computer-based attention training program for schizophrenic patients showed limited effectiveness, with only slight improvements in specific attention tasks like the Span of Apprehension, but no overall enhancement in attentional capacity as measured by the Continuous Performance Test (CPT).

The study suggests that instead of focusing on basic cognitive remediation, it may be more beneficial to teach behavioral strategies that help patients work around their attention deficits or to engage them in more complex cognitive skill exercises.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Effectiveness of computer-assisted attention training of schizophrenic patients]. Suslow, T., Arolt, V.[2006]

Both a computer-assisted attention training program and a cognitive group training program were effective in reducing cognitive deficits in 30 acute schizophrenics, allowing them to perform similarly to healthy individuals in reaction-time tasks.

The study suggests that targeted training can significantly improve attention and reduce distraction in individuals with schizophrenia, highlighting the potential for cognitive rehabilitation in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computer-assisted attention training in schizophrenics. A comparative study. Hermanutz, M., Gestrich, J.[2019]

In a study of 26 recent onset psychosis patients undergoing 10 hours of computerized cognitive training (CCT), changes in sensory processing were linked to cognitive improvements and reductions in psychosis-like symptoms, highlighting the potential for personalized treatment approaches.

Using multivariate pattern analysis (MVPA) on resting-state functional connectivity, researchers identified that patients with intact sensory processing at baseline showed better attention improvements, suggesting that neuroimaging can help predict individual responses to CCT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A multivariate neuromonitoring approach to neuroplasticity-based computerized cognitive training in recent onset psychosis. Haas, SS., Antonucci, LA., Wenzel, J., et al.[2021]

The trial involved 18 adolescents with ADHD over a 7-week period, comparing computerized cognitive exercises from Scientific Brain Training (SBT) to the game Tetris as an active placebo.

While no significant differences were found between the two groups, SBT showed a significant improvement in sustained attention, and Tetris improved working memory, indicating that both interventions may have beneficial effects on cognitive functions in adolescents with ADHD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A double-blind randomized pilot trial comparing computerized cognitive exercises to Tetris in adolescents with attention-deficit/hyperactivity disorder. Bikic, A., Christensen, TØ., Leckman, JF., et al.[2018]

Computerized cognitive training (CCT) using Brain HQ showed significant cognitive improvements in psychiatric rehabilitation clients, with an average increase of 4.4 points in BACS t-scores after about 17 days of training.

Higher engagement in training (measured by levels completed per day) was positively correlated with cognitive gains, suggesting that monitoring engagement can help identify patients who may need additional support to benefit from CCT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Training engagement, baseline cognitive functioning, and cognitive gains with computerized cognitive training: A cross-diagnostic study. Harvey, PD., Balzer, AM., Kotwicki, RJ.[2020]

A 26-week study involving 150 participants found that a novel computerized cognitive training program did not significantly improve cognitive or functional outcomes in individuals with schizophrenia compared to an active control group.

The lack of effectiveness may be attributed to inadequate target engagement during the training, suggesting that future studies should focus on improving participant motivation and the design of cognitive training interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a plasticity-based cognitive training program in schizophrenia: Results from the eCaesar trial. Mahncke, HW., Kim, SJ., Rose, A., et al.[2023]

The first online cognitive remediation (CR) therapist training program was developed and evaluated, showing that it is feasible and acceptable for mental health professionals, with most participants completing the training successfully.

The training significantly improved knowledge among clinicians, particularly benefiting those with less experience, indicating its potential to enhance the delivery of CR in treating psychosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a new online cognitive remediation therapy (CIRCuiTSTM ) training for mental health professionals. Taylor, R., Crowther, A., Tinch-Taylor, R., et al.[2023]

A study involving schizophrenia patients and healthy subjects found that the psychostimulant amphetamine significantly enhances auditory processing speed (APS) learning after targeted cognitive training, indicating its potential to improve cognitive therapy outcomes.

The effects of amphetamine on auditory discrimination learning were sustained for at least one week, suggesting that it could be a valuable addition to cognitive training strategies for schizophrenia patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Amphetamine Enhances Gains in Auditory Discrimination Training in Adult Schizophrenia Patients. Swerdlow, NR., Tarasenko, M., Bhakta, SG., et al.[2019]

Cognitive training for 71 first episode psychosis patients showed significant improvements in global cognition, particularly in working memory and processing speed, indicating its potential effectiveness in enhancing cognitive function.

Patients without comorbid diagnoses who participated in cognitive training had lower re-hospitalization rates compared to those in other treatment programs, suggesting that cognitive training may improve long-term outcomes in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Cognitive Training in an Intensive Outpatient First Episode Psychosis Program. Murray, A., Svendahl, K., Lee, S., et al.[2019]

Schizophrenia is now recognized as a neurodevelopmental disorder with abnormal brain activation patterns that can be identified before symptoms appear and worsen over time.

Interventions that promote brain plasticity, especially during the early stages of schizophrenia, can lead to improvements, and computerized cognitive training programs show promise in targeting cognitive impairments associated with the disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computerized cognitive training targeting brain plasticity in schizophrenia. Biagianti, B., Vinogradov, S.[2013]

Citations

1. brainhq.com brainhq.com/world-class-science/information-researchers/schizophrenia/

Schizophrenia & Related Psychoses “The Effects of Remote Cognitive Training Combined With a Mobile App Intervention on Psychosis: Double-Blind Randomized Controlled Trial.” Journal of Medical ...

2. brainhq.com brainhq.com/news/press-releases/new-study-brain-training-reduces-aggressive-behavior-in-people-with-schizophrenia/

New Study: Brain Training Reduces Aggressive Behavior ... A number of prior studies in schizophrenia found that BrainHQ exercises improved measures of cognitive function and social cognition in people ...

3. brainhq.com brainhq.com/news/press-releases/mountain-of-evidence-on-brain-training-keeps-growing/

Mountain of Evidence on Brain Training Keeps Growing Another study of patients with TBI found the BrainHQ produced moderate-to-large gains in both objective and subjective cognitive measures, as ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0165178116308058

Using visual processing training to enhance standard ... The aim of this study was to explore whether the addition of visual processing training could enhance standard cognitive remediation outcomes in a schizophrenia ...

5. brainhq.com brainhq.com/news/press-releases/recent-studies-indicate-brain-training-may-provide-new-path-to-treat-mental-illness/

Recent Studies Indicate Brain Training May Provide New ... Three recently published studies add significant new evidence that brain training exercises may provide a new path for treating schizophrenia.

6. brainhq.com brainhq.com/news/latest-news/computerized-brain-training-diminishes-aggressive-behavior/

Computerized Brain Training Diminishes Aggressive… A specific type of computerized brain training was an effective nonpharmacological treatment in decreasing impulsive aggression in patients with schizophrenia.

7. brainhq.com brainhq.com/news/latest-news/computerized-training-improved-cognitive-performance-in-those-with-mci/

Computerized training improved cognitive performance… The study examined the impact of computerized cognitive training on those with MCI and healthy controls. Those with MCI showed more rapid ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10515553/

Effects of computer-based cognitive training combined with ... Our study showed SEQ and SIMUL motor-cognitive training led to more pronounced improvements in visuospatial working memory or verbal memory compared with ...

9. cognitivetrainingdata.org cognitivetrainingdata.org/how-to-evaluate-a-brain-training-program/our-self-evaluation/

Our Self-evaluation We conducted a self-evaluation of BrainHQ, a cognitive training program developed by Posit Science, guided by the five requirements specified in the IoM report.

10. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0920996418304791

The efficacy of computerized cognitive drill and practice ... This study evaluates the available evidence for the efficacy of computerized cognitive drill and practice training for patients with schizophrenia-spectrum ...