Computerized Cognitive Training for Psychosis

(STEP Trial)

Overseen By Angus MacDonald III, Ph.D.

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Minnesota

Disqualifiers: Pregnancy, Illiteracy, Neurological disorder, others

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

Compensation: Varies

Number of Visits: 4

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests how computerized cognitive training can help people with psychosis improve their ability to process information about their surroundings. Participants complete tasks on a computer while researchers monitor their brain activity. The trial includes two types of training: one focuses on recognizing visual patterns, and the other on tracking rules to make decisions. It suits individuals diagnosed with a psychotic disorder who have been stable for at least a month. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could enhance cognitive therapies for psychosis.

Will I have to stop taking my current medications?

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

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that computerized cognitive training (CCT) is generally safe. It has been successfully used with individuals who have conditions like depression and schizophrenia. This training aims to improve thinking skills and has demonstrated positive results in past studies.

For Perceptual Discrimination Training, evidence from similar methods suggests they are well-tolerated. Participants improve their attention and ability to distinguish important information with minimal side effects.

Similarly, Cognitive Control Training, which helps maintain focus and improve memory, has been used safely in various settings. This training adapts to the participant's performance, making it challenging yet manageable.

Overall, both training methods in this trial are considered safe based on past research and experiences. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the computerized cognitive training for psychosis because it offers a novel approach by directly targeting cognitive deficits, unlike traditional treatments that mainly focus on managing symptoms with medications like antipsychotics. The Perceptual Discrimination Training improves signal-to-noise resolution and attentional control through adaptive visual exercises, potentially enhancing how patients process and respond to visual stimuli. On the other hand, Cognitive Control Training focuses on maintaining cognitive context and working memory, adapting the difficulty based on the participant's performance to strengthen mental flexibility and decision-making. These targeted cognitive enhancements could lead to improved daily functioning for individuals with psychosis, addressing aspects that current treatments may not fully cover.

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

Research has shown that computer-based brain exercises can enhance thinking and memory in people with psychosis. In this trial, participants will engage in different training methods. One method, Perceptual Discrimination Training, helps individuals see and understand visual information more clearly and has been linked to moderate improvements in overall thinking skills, particularly in memory and information use. Another method, Cognitive Control Training, focuses on improving the ability to hold and use information for decision-making, aiding concentration and mental flexibility. Both training types adjust to the user's performance, ensuring the exercises remain challenging yet manageable. ^{2 3 6 7 8}

Who Is on the Research Team?

Sophia Vinogradov, M.D.

Principal Investigator

University of Minnesota

Angus MacDonald III, Ph.D.

Principal Investigator

University of Minnesota

Are You a Good Fit for This Trial?

This trial is for individuals aged 15-40 who have been diagnosed with psychotic illnesses like schizophrenia, and also for young adults without psychiatric diagnoses. Participants must speak English, have an IQ of 70 or above, and be able to give informed consent. Pregnant individuals, those with major neurological disorders or medical conditions that could interfere with the study, recent substance dependence cases, or significant head injuries are excluded.

Inclusion Criteria

I have been stable and out of the hospital for at least one month.

Estimated IQ at or above 70, as estimated by the cognitive assessments

I am 36-45 with recent onset of psychosis or have a diagnosis of a psychotic disorder.

Exclusion Criteria

Meets criteria for substance or alcohol dependence within 3 months of enrollment

Meets DSM-5 criteria for psychotic, bipolar, or autism spectrum disorder

Presence of severe alcohol or substance abuse

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete interviews, self-report questionnaires, neurocognitive assessments, and imaging with EEG-fMRI

1-2 weeks

1 visit (in-person)

Follow-up Assessment

Participants repeat the baseline assessments after 6 months to evaluate changes in clinical and experimental measures

1-2 weeks

1 visit (in-person)

Cognitive Training

Participants undergo 10 hours of computerized cognitive training over a 3-6 week period

3-6 weeks

Multiple sessions (in-person or virtual)

Post-Intervention Assessment

Participants complete post-intervention assessments similar to baseline, immediately after training

1-2 weeks

1 visit (in-person)

Long-term Follow-up

Participants are monitored for changes in symptoms and cognitive performance 12 months from enrollment

5 months

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Computerized Cognitive Training

Trial Overview The study is testing how well people can process information about their surroundings (state representation) using observational tests and computerized cognitive training. It includes both individuals with psychotic illnesses and healthy young adults to compare results.

How Is the Trial Designed?

Group I: Perceptual Discrimination Training Experimental Treatment 1 Intervention

Training will involve Gabor patch and other visual stimuli discrimination exercises that focus on improving signal-to-noise resolution and attentional control with minimal working memory/cognitive control effects. On each training trial, participants are required to distinguish a target stimulus among a set of distractor stimuli. The similarity between target and distractors increases in level of difficulty based on an adaptive perceptual processing staircase function. Consecutive correct responses lead to increased modulation of the distractors to be more similar to the target, while 1 incorrect response drops the user to an easier level. Difficulty is adapted to maintain an 80% correct response rate. Each session will consist of 4 exercises requiring \~45 minutes. with 40 trials for each exercise.

Group II: Cognitive Control Training Active Control 1 Intervention

Training will involve maintaining accurate representations of cognitive context (the "rule") in working memory during response selection. On each training trial, participants must observe stimuli, and hold the correct response context "on-line" in order to select the correct response from among the stimuli. Training is adaptive using a staircase function, such that two consecutive correct responses increases either the speed of stimuli presentation or the working memory load via an increased number of stimuli that are presented; one incorrect response reduces the cognitive load. Each session will consist of 45 exercises requiring \~45 minutes.

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 study of 131 individuals with schizophrenia undergoing 40 hours of targeted cognitive training (TCT), significant improvements in auditory processing speed (APS) were observed, particularly after the first 20 hours, indicating that TCT can enhance cognitive functions related to auditory processing.

The degree of cognitive improvement was closely linked to how quickly and effectively individuals could achieve and maintain their APS plateau, suggesting that this plateau may serve as a key measure of engagement with the treatment and its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Engagement with the auditory processing system during targeted auditory cognitive training mediates changes in cognitive outcomes in individuals with schizophrenia. Biagianti, B., Fisher, M., Neilands, TB., et al.[2019]

In a study involving 120 individuals (60 with subjective memory complaints and 60 with early-stage Alzheimer's), computerized cognitive training (CCT) significantly improved cognitive scores in Alzheimer's patients compared to a control group, indicating its potential efficacy in this population.

While CCT showed some positive effects in cognitively healthy older adults, the improvements were much smaller, suggesting that CCT may be more beneficial for individuals with cognitive impairments like Alzheimer's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of the online computerized cognitive training program BEYNEX on the cognitive tests of individuals with subjective cognitive impairment and Alzheimer’s disease on rivastigmine therapy Çinar, N., Şahiner, TAH.[2021]

In a study involving 100 clinically stable patients with schizophrenia spectrum disorders, two cognitive remediation programs (CCT and CIRCuiTs) showed no significant differences in effectiveness based on neurocognition and functional outcomes.

Both treatment groups experienced small improvements in cognitive assessments, but the study's limited sample size may have affected its ability to detect meaningful differences, suggesting that cost-effective options could be viable for cognitive interventions in schizophrenia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomized Control Trial of Cognitive Compensatory Training (CCT) and Computerized Interactive Remediation of Cognition-Training for Schizophrenia (CIRCuiTS). Dark, FL., Gore-Jones, V., Newman, E., et al.[2023]

Computerized cognitive remediation therapy (CCRT) significantly improved cognitive function in patients with schizophrenia, as evidenced by a notable increase in the MATRICS Consensus Cognitive Battery total score after 12 weeks of treatment involving 311 participants.

The effectiveness of CCRT was influenced by factors such as age and baseline cognitive levels, with younger participants showing improvements on different cognitive tests compared to older participants, suggesting the need for personalized treatment approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Who will benefit from computerized cognitive remediation therapy? Evidence from a multisite randomized controlled study in schizophrenia. Tan, S., Zhu, X., Fan, H., et al.[2021]

The ongoing pilot randomized controlled trial is evaluating the efficacy of Compensatory Cognitive Training (CCT) compared to recreational therapy (RT) in Latino youth aged 12-30 at clinical high risk for psychosis, aiming to improve neurocognitive performance and functional capacity.

This study is significant as it targets an underserved population and assesses outcomes in participants' preferred language, potentially leading to a low-risk intervention that could enhance cognitive and functional outcomes in pre-illness phases of psychosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Compensatory Cognitive Training for Latino Youth at Clinical High Risk for Psychosis: Study Protocol for a Randomized Controlled Trial. Mahmood, Z., Kelsven, S., Cadenhead, K., et al.[2020]

Cognitive remediation therapy (CRT) and computerized cognitive remediation therapy (CCRT) both significantly improved cognitive function in Chinese inpatients with schizophrenia, with effects maintained for up to 18 months after treatment.

While both therapies showed similar overall efficacy, CRT demonstrated a specific advantage in processing speed on certain cognitive tests compared to CCRT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computerized or manual? Long term effects of cognitive remediation on schizophrenia. Zhu, X., Fan, H., Zou, Y., et al.[2022]

Computerized cognitive training (CCT) has been shown to improve cognitive performance in both healthy older adults and individuals with schizophrenia, as indicated by various studies.

Functional improvements in schizophrenia are primarily observed in cognitive remediation (CR) studies rather than CCT, highlighting the need for clear definitions and measurements of cognitive and functional gains in treatment programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Controversies in Computerized Cognitive Training. Harvey, PD., McGurk, SR., Mahncke, H., et al.[2022]

This study aims to systematically review and analyze the efficacy of computerized cognitive training (CCT) in improving cognitive performance in adults with depression, focusing on randomized controlled trials.

The research will explore how CCT affects not only cognitive outcomes but also mood and daily functioning, making it the first comprehensive analysis of its kind in this specific clinical population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computerized cognitive training in people with depression: a protocol for a systematic review and meta-analysis. Lampit, A., Launder, NH., Minkov, R., et al.[2022]

Citations

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Computerized cognitive training is associated with ... Cognitive training improves cognition and functional outcomes for patients diagnosed with schizophrenia (SZ) (Fisher et al., 2009; Keshavan et al., 2014; Wykes ...

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Computerized Cognitive Training for Psychosis Computerized cognitive remediation therapy (CCRT) significantly improved cognitive function in patients with schizophrenia, as evidenced by a notable increase ...

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Computerized cognitive training in schizophrenia The past 15 years have seen explosive growth in research and clinical interest in cognitive remediation for schizophrenia. Meta-analytic work confirms that ...

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Targeted Cognitive Training in Clinical High Risk (CHR) for ... This project is a randomized-controlled trial to test the efficacy of computer-based targeted cognitive training (TCT) versus a placebo intervention of ...