NCT04554121

Efficacy of Personalizing Cognitive Remediation for Schizophrenia by Targeting Impairments in Early Auditory Processing

Completed NA Last updated 6 March 2026

What this trial tests

NA trial testing Brain Basics in Schizophrenia in 194 participants. Completed in 8 December 2025.

Timeline

14 December 2020

Primary endpoint
24 October 2025

8 December 2025

Quick facts

Lead sponsor	Columbia University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	194
Start date	14 December 2020
Primary completion	24 October 2025
Estimated completion	8 December 2025
Sites	9 locations across United States

Drugs / interventions tested

• Brain Basics
• Brain Training

Conditions studied

• Schizophrenia — all drugs for Schizophrenia →
• Schizoaffective Disorder — all drugs for Schizoaffective Disorder →

Sponsor

Columbia University

Who can join

Adults 18 to 68, any sex, with Schizophrenia or Schizoaffective Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Psychiatric and functional correlates of stigma associated with cognitive impairment in schizophrenia.
   Gonzales L, Saperstein AM, Qian M, Gorecki A, et al · · 2024 · cited 3× · PMID 39461092 · DOI 10.1016/j.psychres.2024.116233
2. Impact of Early Auditory Processing on Negative Symptom Response to Cognitive Remediation for Schizophrenia.
   Saperstein AM, Brennan R, Qian M, Javitt DC, et al · · 2025 · cited 1× · PMID 39982844 · DOI 10.1093/schbul/sbaf017