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Completed Not applicable Interventional

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

ClinicalTrials.gov ID: NCT04554121

Public ClinicalTrials.gov record NCT04554121. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 5, 2026, 2:12 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT04554121
Recruitment status
Completed
Study type
Interventional
Phase
Not applicable
Lead sponsor
Columbia University
Other
Enrollment
194 participants

Conditions and interventions

Interventions

Behavioral

Eligibility (public fields only)

Age range
18 Years to 68 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Dec 13, 2020
Primary completion
Oct 23, 2025
Completion
Dec 7, 2025
Last update posted
Mar 5, 2026

2020 – 2025

United States locations

U.S. sites
9
U.S. states
2
U.S. cities
5
Facility City State ZIP Site status
Laurel House Stamford Connecticut 06902
Williamsburg Clinic Brooklyn New York 11206
Institute for Community Living Brooklyn New York 11207
Heights Hill Clinic Brooklyn New York 11217
Mapleton Mental Health Services Brooklyn New York 11230
The Bridge, Inc. New York New York 10025
Manhattan Psychiatric Center 125th Street Clinic New York New York 10027
Rockland Psychiatric Center Orangeburg New York 10962
Pibly Residential Programs Inc. The Bronx New York 10461

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04554121, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Mar 5, 2026 · Synced Sep 5, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT04554121 live on ClinicalTrials.gov.

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