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Cognitive Remediation

Brain Training for Schizophrenia

N/A
Waitlist Available
Led By Alice Medalia, Ph.D.
Research Sponsored by Columbia University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
A primary DSM-5 diagnosis of schizophrenia or schizoaffective disorder
Be older than 18 years old
Must not have
Documented auditory disorder or known visual impairment; presence of neurological conditions that are impacting brain and cognitive functioning
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 15 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial will enroll 200 participants with schizophrenia who will be randomized to receive either an EAP-enhanced CR approach or a routine CR approach. The trial will use a repeated-measures design to assess outcomes after treatment and after a follow-up period. The primary outcome measure will be verbal learning, with functional capacity as the secondary outcome measure. EEG is exploratory and will examine neurophysiologic markers of need for and response to EAP training.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since this trial involves non-pharmacological interventions like brain training exercises rather than medications, typical drug side effects are not expected. However, participants may experience fatigue or frustration during cognitive tasks.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with schizophrenia or schizoaffective disorder.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have a hearing or vision problem, or a neurological condition affecting my brain.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~15 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 15 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Verbal Learning
Secondary study objectives
Change in Functional Capacity

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

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

Find a Location

Who is running the clinical trial?

Columbia UniversityLead Sponsor
1,486 Previous Clinical Trials
2,662,980 Total Patients Enrolled
24 Trials studying Schizophrenia
3,126 Patients Enrolled for Schizophrenia
National Institute of Mental Health (NIMH)NIH
2,918 Previous Clinical Trials
2,739,765 Total Patients Enrolled
254 Trials studying Schizophrenia
89,831 Patients Enrolled for Schizophrenia
Alice Medalia, Ph.D.Principal InvestigatorColumbia University

Media Library

Schizophrenia Research Study Groups: Brain Basics, Brain Training
Brain Basics (Cognitive Remediation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04554121 — N/A
~16 spots leftby Apr 2025
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