SchizophreniaNCT04554121
Efficacy of Personalizing Cognitive Remediation for Schizophrenia by Targeting Impairments in Early Auditory Processing
A study testing Brain Basics and Brain Training in people with Schizophrenia and Schizoaffective Disorder, run by Columbia University at 9 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 68 years
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder
- What is being tested?
- Brain Basics and Brain Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 194 participants
- Where
- 9 sitesUnited States
- Study dates
- 14 Dec 2020to 8 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 68 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
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
Laurel House
Stamford, Connecticut, 06902
Pibly Residential Programs Inc.
The Bronx, New York, 10461
About this study
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.
Read the detailed description
This personalized Cognitive Remediation (CR) confirmatory efficacy trial will be conducted at behavioral health facilities offering CR, located within the New York metropolitan area. Participants for this study will include adults diagnosed with schizophrenia or schizoaffective disorder, age 18-68, who have identified cognitive health as a pertinent treatment for recovery goal attainment and are seeking CR services. Individuals referred to CR may be referred for research by their treating clinician or may be self-referred. Consented individuals will receive a numeric study ID which will be used to de-identify all data collected for research.
Time 1 (baseline) outcomes assessments conducted by the research team include early auditory processing (EAP) ability, cognitive ability, and functioning. Participants will be classified as EAP impaired (EAP-) or EAP intact (EAP+). Following completion of Time 1 assessments, assignment to treatment condition will be stratified by EAP ability and randomized to Brain Basics (BB, n=100) or Brain Training (BT, n=100). Participants will be invited to participate in a separate EEG assessment of Mismatch Negativity (MMN).
CR will be conducted by trained clinicians at each performance site. CR will entail 30, 60-minute sessions administered two times a week (approximately 15 weeks). All participants will continue to receive recovery oriented therapeutic activities. Participants will be scheduled to repeat behavioral assessments at Time 2 (post-treatment) and Time 3 (follow-up) with a research team member who is blind to treatment group. The EAP- group receiving Brain Basics will also repeat EEG paradigms at Time 2 to explore 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. Mediation analysis will examine whether gains in cognition (verbal learning) mediate the gains in EAP and functioning. This will inform our understanding of EAP as the therapeutic change mechanism for about half of CR participants and confirm that EAP training need not be given to those CR participants with baseline intact EAP.
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Being tested
- Brain Basics, Brain Training
- Keywords
- Cognitive Remediation
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain BasicsBehavioural
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.
Brain TrainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Brain Basics | Experimental | Brain Basics is a cognitive remediation intervention that emphasizes training in early auditory processing. Receives: Behavioral: Brain Basics |
| Brain Training | Active comparator | Brain Training is a cognitive remediation intervention that targets a range of cognitive abilities Receives: Behavioral: Brain Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 15 weeks
Secondary outcomes (2)
Change in Functional Capacity
Functional Capacity is assessed with the UCSD Performance Based Skills Assessment, Brief version. The secondary outcome will be change in the total score from pre to post treatment such that a higher value represents a better outcome.
Measured: 15 weeks
Change in Global Neurocognition
Global neurocognition is assessed with the MATRICS Consensus Cognitive Battery Neurocognitive Composite Domain score. The outcome will be change in this score from pre to post treatment such that a higher value represents a better outcome.
Measured: 15 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2020
- Study start14 Dec 2020
- Primary completion24 Oct 2025
- Study completion8 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 194 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Alice A. Medalia, PhD, Columbia University
- Investigators
- Alice Medalia, Ph.D., Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04554121
- Sponsor's protocol ID
- AAAU8479
- Other IDs
- 1R01MH123561-01, 7982
- Status last verified
- Mar 2026
- First submitted
- 14 Sep 2020
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Personalizing Cognitive Remediation for Schizophrenia by Targeting Impairments in Early Auditory Processing
- ClinicalTrials.gov ID
- NCT04554121
- Acronym / sponsor ID
- AAAU8479
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Keywords
- Cognitive Remediation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 194 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 14 Dec 2020 (actual)
- Primary completion
- 24 Oct 2025 (actual)
- Study completion
- 8 Dec 2025 (actual)
- First posted
- 18 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This personalized Cognitive Remediation (CR) confirmatory efficacy trial will be conducted at behavioral health facilities offering CR, located within the New York metropolitan area. Participants for this study will include adults diagnosed with schizophrenia or schizoaffective disorder, age 18-68, who have identified cognitive health as a pertinent treatment for recovery goal attainment and are seeking CR services. Individuals referred to CR may be referred for research by their treating clinician or may be self-referred. Consented individuals will receive a numeric study ID which will be used to de-identify all data collected for research.
Time 1 (baseline) outcomes assessments conducted by the research team include early auditory processing (EAP) ability, cognitive ability, and functioning. Participants will be classified as EAP impaired (EAP-) or EAP intact (EAP+). Following completion of Time 1 assessments, assignment to treatment condition will be stratified by EAP ability and randomized to Brain Basics (BB, n=100) or Brain Training (BT, n=100). Participants will be invited to participate in a separate EEG assessment of Mismatch Negativity (MMN).
CR will be conducted by trained clinicians at each performance site. CR will entail 30, 60-minute sessions administered two times a week (approximately 15 weeks). All participants will continue to receive recovery oriented therapeutic activities. Participants will be scheduled to repeat behavioral assessments at Time 2 (post-treatment) and Time 3 (follow-up) with a research team member who is blind to treatment group. The EAP- group receiving Brain Basics will also repeat EEG paradigms at Time 2 to explore 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. Mediation analysis will examine whether gains in cognition (verbal learning) mediate the gains in EAP and functioning. This will inform our understanding of EAP as the therapeutic change mechanism for about half of CR participants and confirm that EAP training need not be given to those CR participants with baseline intact EAP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brain Basics | Experimental | Behavioral: Brain BasicsBrain Basics is a cognitive remediation intervention that emphasizes training in early auditory processing. |
| Brain Training | Active comparator | Behavioral: Brain TrainingBrain Training is a cognitive remediation intervention that targets a range of cognitive abilities |
Who may qualify
- Ages
- 18 to 68 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brain BasicsComputer-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. | Behavioural | Brain Basics |
| Brain TrainingComputer-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. | Behavioural | Brain Training |
Primary outcome
Change in Verbal Learning
Time frame: 15 weeks
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.
2 secondary outcomes
Change in Functional Capacity
Time frame: 15 weeks
Change in Global Neurocognition
Time frame: 15 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alice Medalia, Ph.D. principal investigator
Columbia University
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brain Basics and Brain Training in people with Schizophrenia and Schizoaffective Disorder, run by Columbia University at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Verbal Learning (time frame: 15 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2026.