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NCT04554121Completed

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

Source: ClinicalTrials.gov · Last updated 6 Mar 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
194 (actual)
First submitted
14 Sept 2020
Start date
14 Dec 2020
Primary completion date
24 Oct 2025
Lead sponsor
Columbia University
NCT number
NCT04554121

What you commit to

  • Study type: Interventional
  • Participants enrolled: 194
  • From 14 Dec 2020 to the primary completion date, 24 Oct 2025
  • 9 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Participation in cognitive remediation in the 24 months prior

Other illness

  • Documented auditory disorder or known visual impairment; presence of neurological conditions that are impacting brain and cognitive functioning

Other

  • Indications of Intellectual Disability as documented in medical history or measured by \< 70 premorbid Full Scale IQ
  • Unremitted substance dependence within the past six months

Who the study is looking for

  • A primary DSM-5 diagnosis of schizophrenia or schizoaffective disorder
  • Psychiatrically stable, as defined by no changes in psychotropic medication or psychiatric hospitalization in the most recent 21 days
  • English-speaking

Age in the registry: 18 years to 68 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (9)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Williamsburg Clinic
Coordinator of this site? Confirm its status
BrooklynUnited StatesUnknown status
Mapleton Mental Health Services
Coordinator of this site? Confirm its status
BrooklynUnited StatesUnknown status
Heights Hill Clinic
Coordinator of this site? Confirm its status
BrooklynUnited StatesUnknown status
Institute for Community Living
Coordinator of this site? Confirm its status
BrooklynUnited StatesUnknown status
The Bridge, Inc.
Coordinator of this site? Confirm its status
New YorkUnited StatesUnknown status
Manhattan Psychiatric Center 125th Street Clinic
Coordinator of this site? Confirm its status
New YorkUnited StatesUnknown status
Rockland Psychiatric Center
Coordinator of this site? Confirm its status
OrangeburgUnited StatesUnknown status
Laurel House
Coordinator of this site? Confirm its status
StamfordUnited StatesUnknown status
Pibly Residential Programs Inc.
Coordinator of this site? Confirm its status
The BronxUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.