Brain Training for Schizophrenia

Not currently recruiting at 9 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Columbia University

Disqualifiers: Intellectual disability, Auditory disorder, Neurological conditions, Substance dependence, others

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

Compensation: Varies

Number of Visits: 33

Duration: 15 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to help people with schizophrenia improve their thinking and daily functioning. It compares two brain training programs: one focuses on early hearing skills, and the other targets overall thinking skills. The trial includes individuals with schizophrenia or schizoaffective disorder who are stable on their current medication and speak English. Participants will be grouped based on hearing test results and will try one of the two programs, called Brain Basics or Brain Training. The goal is to determine if these programs can improve memory and everyday skills. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance cognitive therapies for schizophrenia.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you must be psychiatrically stable, meaning no changes in your psychotropic medication in the last 21 days.

What prior data suggests that this cognitive remediation approach is safe for individuals with schizophrenia?

In a previous study, cognitive training proved to be safe and well-tolerated by people with schizophrenia. Research shows that programs like Brain Basics and Brain Training can enhance thinking skills without causing major side effects.

Cognitive training, used in both Brain Basics and Brain Training, has undergone testing in many studies. A review of 11 studies with 615 participants with early schizophrenia found this training to be generally safe, with no reports of serious side effects.

Game-based digital programs, like Brain Training, also appear safe. Studies suggest they are not only effective but also safe for people with schizophrenia.

Overall, these treatments aim to improve thinking skills, and existing research supports their safety in humans. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for schizophrenia because they offer a fresh approach to cognitive remediation. Brain Basics is unique as it focuses specifically on early auditory processing, which could enhance cognitive functions by targeting the brain's initial responses to sound. On the other hand, Brain Training covers a broader range of cognitive abilities, aiming to improve overall cognitive performance. These methods stand out since traditional treatments for schizophrenia, like antipsychotic medications, mainly address symptoms rather than improving cognitive deficits. By enhancing cognitive skills, these interventions could provide a significant boost to daily functioning and quality of life for individuals with schizophrenia.

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

Research has shown that cognitive remediation (CR) helps people with schizophrenia improve skills such as attention, memory, and learning. Studies indicate that patients participating in CR experience significant improvements in these areas compared to those receiving standard treatment. In this trial, participants will be assigned to one of two cognitive remediation interventions. The Brain Basics method, targeting early sound processing, aims to enhance these benefits further. Meanwhile, the Brain Training method has boosted thinking skills and everyday functioning. Both approaches seek to improve cognitive abilities and daily task management, offering promising options for better outcomes in schizophrenia. ^{2 3 6 7 8}

Who Is on the Research Team?

Alice Medalia, Ph.D.

Principal Investigator

Columbia University

Are You a Good Fit for This Trial?

This trial is for English-speaking individuals with a primary diagnosis of schizophrenia or schizoaffective disorder who are psychiatrically stable. They should not have had changes in medication or hospitalization in the last 21 days, and no cognitive remediation in the past 24 months, substance dependence within six months, auditory disorders, significant visual impairment, neurological conditions affecting cognition, or an IQ below 70.

Inclusion Criteria

My mental health has been stable for the last 3 weeks.

English-speaking

I have been diagnosed with schizophrenia or schizoaffective disorder.

Exclusion Criteria

I have a hearing or vision problem, or a neurological condition affecting my brain.

You have received cognitive remediation treatment within the last 2 years.

You have been dependent on a substance in the last six months and have not fully recovered.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants undergo baseline assessments including early auditory processing, cognitive ability, and functioning

1 week

1 visit (in-person)

Treatment

Cognitive Remediation (CR) sessions conducted twice a week for 15 weeks

15 weeks

30 visits (in-person)

Post-Treatment Assessment

Participants repeat behavioral assessments and EEG paradigms to explore mechanisms of change

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Brain Basics
• Brain Training

Trial Overview The study tests if Cognitive Remediation (CR) tailored to early auditory processing abilities can improve cognitive and functional outcomes for those with schizophrenia. Participants will be randomly assigned to either an enhanced CR program called Brain Basics or a standard CR method known as Brain Training. The effectiveness will be measured through verbal learning and functional capacity.

How Is the Trial Designed?

Group I: Brain Basics Experimental Treatment 1 Intervention

Brain Basics is a cognitive remediation intervention that emphasizes training in early auditory processing.

Group II: Brain Training Active Control 1 Intervention

Brain Training is a cognitive remediation intervention that targets a range of cognitive abilities

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials

1,529

Recruited

2,832,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Published Research Related to This Trial

In a study involving 87 participants with schizophrenia, those who underwent targeted auditory training showed significant improvements in cognitive functions such as global cognition, speed of processing, verbal learning, and verbal memory compared to a control group, after 50 hours of training over 10 weeks.

The training also led to a significant increase in serum brain-derived neurotrophic factor (BDNF) levels, which normalized by the end of the training, suggesting that BDNF may be a useful biomarker for the cognitive benefits of this intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuroscience-informed Auditory Training in Schizophrenia: A Final Report of the Effects on Cognition and Serum Brain-Derived Neurotrophic Factor. Fisher, M., Mellon, SH., Wolkowitz, O., et al.[2020]

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]

A meta-analysis of over a decade of cognitive remediation research has identified key factors for effective cognitive training in schizophrenia, such as computerized practice, high dosing schedules, and individualized learning trials.

A preliminary randomized controlled trial showed that cognitive training based on these principles led to significant improvements in working memory and global cognition in patients with schizophrenia, along with evidence of cortical plasticity in the brain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive training in schizophrenia: a neuroscience-based approach. Genevsky, A., Garrett, CT., Alexander, PP., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3877646/

Cognitive Remediation in Schizophrenia: Current Status ... Patients undergoing NEAR improved significantly more than treatment-as-usual (TAU) patients in attention, working memory, and immediate learning and memory.

2. nature.com nature.com/articles/s41537-017-0021-9

The effect of cognitive remediation in individuals at ultra ... There is abundant evidence for the effectiveness of cognitive remediation in patients with schizophrenia. The most recent meta-analysis on ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11744976/

Cognitive remediation for schizophrenia: current status ... Cognitive remediation (CR) is an increasingly studied behavioral intervention for improving illness-linked cognitive deficits in schizophrenia.

4. journals.lww.com journals.lww.com/jops/fulltext/2025/01000/effectiveness_of_cognitive_remediation.13.aspx

Effectiveness of Cognitive Remediation Interventions for... ... CR has demonstrated efficacy in enhancing cognitive abilities among individuals with schizophrenia and has the potential to enhance functional outcomes and ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2352154615000662

Cognitive remediation in schizophrenia — now it is really ... CR has been shown to improve frontal activity [12], prevent grey matter decay [13], improve brain network efficiency [14] and task-related blood ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8870375/

Advances in Cognitive Remediation Training ... Cognitive remediation training (CRT) is an evidence-based treatment that has been shown to produce improvements in cognition in individuals with schizophrenia [ ...

7. frontiersin.org frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2024.1509539/full

Cognitive rehabilitation in schizophrenia research This study provides a comprehensive review of research achievements in cognitive rehabilitation for schizophrenia spanning from 2004 to 2024.

8. everydayhealth.com everydayhealth.com/schizophrenia/cognitive-remediation-therapy-for-schizophrenia/guide/

What Is Cognitive Remediation Therapy for Schizophrenia? A systematic review and meta-analysis of 11 studies that included 615 participants with early schizophrenia found that cognitive remediation therapy had ...