Brain Training for Schizophrenia

Recruiting in Palo Alto (17 mi)

+8 other locations

Overseen ByAlice Medalia, Ph.D.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Columbia University

No Placebo Group

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.

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.

+1 more

Participant Groups

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.

2Treatment groups

Experimental Treatment

Active Control

Group I: Brain BasicsExperimental Treatment1 Intervention

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

Group II: Brain TrainingActive Control1 Intervention

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