Efficacy of Personalizing Cognitive Remediation for Schizophrenia by Targeting Impairments in Early Auditory Processing
3 other identifiers
interventional
194
1 country
9
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable schizophrenia
Started Dec 2020
Longer than P75 for not_applicable schizophrenia
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 14, 2020
CompletedFirst Posted
Study publicly available on registry
September 18, 2020
CompletedStudy Start
First participant enrolled
December 14, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 24, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 8, 2025
CompletedMarch 6, 2026
March 1, 2026
4.9 years
September 14, 2020
March 4, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Verbal Learning
Verbal Learning is assessed with the MATRICS Consensus Cognitive Battery Verbal Learning Domain score. The primary outcome will be change in this score from pre to post treatment such that a higher value represents a better outcome.
15 weeks
Secondary Outcomes (2)
Change in Functional Capacity
15 weeks
Change in Global Neurocognition
15 weeks
Study Arms (2)
Brain Basics
EXPERIMENTALBrain Basics is a cognitive remediation intervention that emphasizes training in early auditory processing.
Brain Training
ACTIVE COMPARATORBrain Training is a cognitive remediation intervention that targets a range of cognitive abilities
Interventions
Computer-based exercises targeting impairments in cognitive domains (sensory processing, processing speed, attention, working memory, memory) are paired with verbal discussions and group-based activities to strengthen metacognition and to bridge newly learned cognitive skills to everyday. life.
Computer-based exercises targeting impairments in cognitive domains (processing speed, attention, working memory, executive functions) are paired with verbal discussions and group-based activities to strengthen metacognition and to bridge newly learned cognitive skills to everyday life.
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Columbia Universitylead
- National Institute of Mental Health (NIMH)collaborator
Study Sites (9)
Laurel House
Stamford, Connecticut, 06902, United States
Williamsburg Clinic
Brooklyn, New York, 11206, United States
Institute for Community Living
Brooklyn, New York, 11207, United States
Heights Hill Clinic
Brooklyn, New York, 11217, United States
Mapleton Mental Health Services
Brooklyn, New York, 11230, United States
The Bridge, Inc.
New York, New York, 10025, United States
Manhattan Psychiatric Center 125th Street Clinic
New York, New York, 10027, United States
Rockland Psychiatric Center
Orangeburg, New York, 10962, United States
Pibly Residential Programs Inc.
The Bronx, New York, 10461, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alice Medalia, Ph.D.
Columbia University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
September 14, 2020
First Posted
September 18, 2020
Study Start
December 14, 2020
Primary Completion
October 24, 2025
Study Completion
December 8, 2025
Last Updated
March 6, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- A list of all data expected to be collected in the project will be submitted by January 2021. Subsequently, descriptive and raw data will be submitted on a semi-annual basis. Unpublished de-identified data will be submitted prior to study completion and will be shared within one year after project completion, or when the data are published, whichever is earlier.
- Access Criteria
- Data in NIH repositories may be accessed through the NIH Data Access Committee which reviews data access and submission requests.
Raw data will be made available for research to investigators working under a Federal Wide Assurance who meet security measures and data use agreement criteria associated with public repositories including the National Database for Clinical Trials related to Mental Illness (NDCT). Data will include baseline demographic data, and baseline and post raw data derived from primary and secondary outcome measures.