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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04554121
Recruitment Status : Not yet recruiting
First Posted : September 18, 2020
Last Update Posted : September 21, 2020
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Alice A. Medalia, PhD, Columbia University

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.


Condition or disease Intervention/treatment Phase
Schizophrenia Schizoaffective Disorder Behavioral: Brain Basics Behavioral: Brain Training Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Personalizing Cognitive Remediation for Schizophrenia by Targeting Impairments in Early Auditory Processing
Estimated Study Start Date : December 10, 2020
Estimated Primary Completion Date : April 1, 2024
Estimated Study Completion Date : May 1, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Experimental: Brain Basics
Brain Basics is a cognitive remediation intervention that emphasizes training in early auditory processing.
Behavioral: Brain Basics

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.


Active Comparator: Brain Training
Brain Training is a cognitive remediation intervention that targets a range of cognitive abilities
Behavioral: Brain Training
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Change in Functional Capacity [ Time Frame: 15 weeks ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 68 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04554121


Contacts
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Contact: Alice Medalia, Ph.D. 646-774-8482 am2938@cumc.columbia.edu
Contact: Alice Saperstein, Ph.D. 646-774-8464 Alice.Saperstein@nyspi.columbia.edu

Locations
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United States, Connecticut
Laurel House
Stamford, Connecticut, United States, 06902
Contact: Eileen McAndrews, LCSW         
United States, New York
Pibly Residential Programs Inc.
Bronx, New York, United States, 10461
Contact: Kim Baltich, MSW         
Williamsburg Clinic
Brooklyn, New York, United States, 11206
Contact: Cordelle Yorke, Ph.D.         
Heights Hill Clinic
Brooklyn, New York, United States, 11217
Contact: Susanne Shulman, MD         
Mapleton Mental Health Services
Brooklyn, New York, United States, 11230
Contact: Bella Proskurov, Ph.D.         
The Bridge, Inc.
New York, New York, United States, 10025
Contact: Ariel Taitz-Paine         
Manhattan Psychiatric Center 125th Street Clinic
New York, New York, United States, 10027
Contact: Blair Schwartz, PsyD         
Rockland Psychiatric Center
Orangeburg, New York, United States, 10962
Contact: Priscilla Villavicencio, PsyD         
Sponsors and Collaborators
Columbia University
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Alice Medalia, Ph.D. Columbia University
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Responsible Party: Alice A. Medalia, PhD, Professor, Columbia University
ClinicalTrials.gov Identifier: NCT04554121    
Other Study ID Numbers: 7982
1R01MH123561-01 ( U.S. NIH Grant/Contract )
First Posted: September 18, 2020    Key Record Dates
Last Update Posted: September 21, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alice A. Medalia, PhD, Columbia University:
Cognitive Remediation
Additional relevant MeSH terms:
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Schizophrenia
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders