200 Participants Needed

Computerized Cognitive Training for Psychosis

(STEP (P4) Trial)

LH
AM
Overseen ByAngus MacDonald III, Ph.D.
Age: < 65
Sex: Any
Trial Phase: Academic
Sponsor: University of Minnesota
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

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

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team to understand any specific requirements.

What data supports the effectiveness of the treatment Computerized Cognitive Training for Psychosis?

Research shows that Computerized Cognitive Training (CCT) can improve cognitive performance in people with schizophrenia and healthy older adults. Additionally, Compensatory Cognitive Training (CCT) has shown promise in improving neurocognitive performance and functional capacity in individuals at high risk for psychosis.12345

Is computerized cognitive training safe for humans?

Computerized cognitive training (CCT) is considered safe and has been used in various clinical populations, including those with depression and schizophrenia, without significant safety concerns.12567

How is Computerized Cognitive Training different from other treatments for psychosis?

Computerized Cognitive Training (CCT) is unique because it uses computer-based exercises to specifically target and improve cognitive functions, such as memory and attention, which are often impaired in psychosis. Unlike traditional therapies, CCT is interactive and can be personalized to the individual's needs, potentially leading to improvements in cognitive performance and daily functioning.12578

What is the purpose of this trial?

The purpose of this study is to examine state representation in individuals aged 15-45 who have been diagnosed with a psychotic illness, as well as young adults who do not have a psychiatric diagnosis. State Representation is our ability to process information about our surroundings. The investigators will complete a clinical trial examining two paradigms of cognitive training.

Research Team

SV

Sophia Vinogradov, M.D.

Principal Investigator

University of Minnesota

AM

Angus MacDonald III, Ph.D.

Principal Investigator

University of Minnesota

Eligibility Criteria

This trial is for individuals aged 15-40 with a recent diagnosis of psychosis or related conditions, who speak English and have an IQ above 70. They must be clinically stable, not pregnant, non-dependent on substances, and without major medical or neurological issues.

Inclusion Criteria

I was diagnosed with a psychosis-related disorder and am between 36-45 years old with symptoms starting in the last 5 years.
Estimated IQ at or above 70, as estimated by the cognitive assessments
I have been stable and out of the hospital for at least one month.
See 1 more

Exclusion Criteria

Unable or unwilling to provide informed consent
I do not have, nor does my immediate family have, a history of psychotic, bipolar, or autism spectrum disorders.
I have a significant neurological condition.
See 10 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Cognitive Training

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

3-6 weeks
Multiple sessions (in-person or virtual)

Post-Intervention Follow-up

Participants undergo post-intervention assessments including interviews, questionnaires, neurocognitive assessments, and imaging appointments

Immediately after intervention
2 visits (in-person)

Long-term Follow-up

Participants are monitored for changes in cognitive performance and symptoms 5 months after intervention

5 months
1 visit (in-person)

Treatment Details

Interventions

  • Computerized Cognitive Training
Trial Overview The study is testing two types of computerized cognitive training designed to improve information processing in young adults with psychotic illnesses compared to those without psychiatric diagnoses.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Visual Cognitive Control TrainingExperimental Treatment1 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.
Group II: Perceptual Discrimination TrainingExperimental Treatment1 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.

Find a Clinic Near You

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+

Findings from Research

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

References

Controversies in Computerized Cognitive Training. [2022]
Who will benefit from computerized cognitive remediation therapy? Evidence from a multisite randomized controlled study in schizophrenia. [2021]
Compensatory Cognitive Training for Latino Youth at Clinical High Risk for Psychosis: Study Protocol for a Randomized Controlled Trial. [2020]
Computerized or manual? Long term effects of cognitive remediation on schizophrenia. [2022]
A Randomized Control Trial of Cognitive Compensatory Training (CCT) and Computerized Interactive Remediation of Cognition-Training for Schizophrenia (CIRCuiTS). [2023]
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 [2021]
Computerized cognitive training in people with depression: a protocol for a systematic review and meta-analysis. [2022]
Engagement with the auditory processing system during targeted auditory cognitive training mediates changes in cognitive outcomes in individuals with schizophrenia. [2019]
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