Brain Training for Schizophrenia

Recruiting at 8 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

194 Participants Needed

Trial Summary

What is the purpose of this trial?

The primary aim of this study is to provide confirmation that Cognitive Remediation (CR) for schizophrenia, when personalized based on pre-treatment assessment of early auditory processing ability, facilitates improved cognitive and functional outcomes. Additional aims of this study address the mechanisms of treatment effect. The study uses a repeated-measures randomized trial design. Enrollment will be by invitation, open to individuals receiving services at select community behavioral health facilities where CR is offered. Clients who are eligible for the service, who agree to participate in research and who meet inclusion/exclusion criteria will be assessed on outcome measures and categorized via performance on the Tone Matching (TM) test, as EAP impaired (EAP-) or EAP intact (EAP+). Subsequently, EAP- and EAP+ subgroups will be randomized to either (1) Brain Basics (BB; n = 100), an EAP-enhanced CR approach or (2) Brain Training (BT; n = 100), a routine CR approach. Participants will be invited to participate in a second pre-treatment assessment to measure electrophysiologic responses to auditory stimuli. All participants will be scheduled to repeat outcome measure assessments after treatment and after a follow-up period. The EAP- group receiving BB will be invited to repeat electrophysiological paradigms post-treatment to investigate mechanisms of change related to the CR intervention. Verbal learning will be the primary outcome with functional capacity the secondary outcome. EEG is exploratory and will examine neurophysiologic markers of need for and response to EAP training.

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 data supports the effectiveness of the treatment Brain Basics, Brain Training for schizophrenia?

Research shows that cognitive training, similar to Brain Basics, Brain Training, can improve memory, learning, and overall thinking skills in people with schizophrenia. These improvements are linked to changes in the brain that suggest increased brain flexibility and protection. ^{1 2 3 4 5}

Is brain training for schizophrenia safe for humans?

Research on brain training for schizophrenia shows it is generally safe for humans. Studies have found positive changes in brain function and structure, with no major safety concerns reported. ^{2 3 6 7 8}

How does the Brain Training treatment for schizophrenia differ from other treatments?

Brain Training for schizophrenia is unique because it focuses on enhancing brain plasticity (the brain's ability to change and adapt) through intensive cognitive exercises, targeting specific brain areas to improve memory and learning. Unlike traditional treatments, it uses computer-assisted methods to harness neuroplasticity, potentially reversing some of the brain changes associated with schizophrenia. ^{1 2 3 4 9}

Research Team

Alice Medalia, Ph.D.

Principal Investigator

Columbia University

Eligibility Criteria

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

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

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

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

Timeline

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Cognitive training in schizophrenia: a neuroscience-based approach. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Neuroscience-informed computer-assisted cognitive training in schizophrenia. [2018]

3. Ireland pubmed.ncbi.nlm.nih.gov

Harnessing neuroplasticity. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Neural Effects of Cognitive Training in Schizophrenia: A Systematic Review and Activation Likelihood Estimation Meta-analysis. [2020]

5. Netherlands pubmed.ncbi.nlm.nih.gov

White matter microstructure predicts cognitive training-induced improvements in attention and executive functioning in schizophrenia. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Improving Cognition via Exercise (ICE): Study Protocol for a Multi-Site, Parallel-Group, Single-Blind, Randomized Clinical Trial Examining the Efficacy of Aerobic Exercise to Improve Neurocognition, Daily Functioning, and Biomarkers of Cognitive Change in Individuals with Schizophrenia. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

When top-down meets bottom-up: auditory training enhances verbal memory in schizophrenia. [2021]

8. United States 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. [2020]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Computerized cognitive training targeting brain plasticity in schizophrenia. [2013]