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

Completed · Not applicable

Conditions studied: Schizophrenia, Schizoaffective Disorder

In brief

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.

Key facts

Study ID

NCT04554121

Run by

Columbia University

People needed

194

Starts

2020-12-14

Expected to finish

2025-12-08

Last updated by the study team

2026-03-06

Who can join

Age: 18 and older, up to 68. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Indications of Intellectual Disability as documented in medical history or measured by < 70 premorbid Full Scale IQ
• Documented auditory disorder or known visual impairment; presence of neurological conditions that are impacting brain and cognitive functioning
• Unremitted substance dependence within the past six months
• Participation in cognitive remediation in the 24 months prior

Where it is running

• Laurel House — Stamford, Connecticut, United States
• Williamsburg Clinic — Brooklyn, New York, United States
• Institute for Community Living — Brooklyn, New York, United States
• Heights Hill Clinic — Brooklyn, New York, United States
• Mapleton Mental Health Services — Brooklyn, New York, United States
• The Bridge, Inc. — New York, New York, United States
• Manhattan Psychiatric Center 125th Street Clinic — New York, New York, United States
• Rockland Psychiatric Center — Orangeburg, New York, United States
• Pibly Residential Programs Inc. — The Bronx, New York, United States

Full record on ClinicalTrials.gov

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