Personalized and Scalable Cognitive Remediation Approaches
2 other identifiers
interventional
122
1 country
5
Brief Summary
The purpose of this study is to develop and pilot test personalized and scalable approaches to Cognitive Remediation (CR) for schizophrenia and schizoaffective disorder. The intent is to more clearly define the therapeutic targets important to the facilitation of cognitive and functional improvement so that clinicians know how to customize cognitive interventions and deliver treatment in a more effective, efficient and personally relevant manner.
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 Sep 2013
Longer than P75 for not_applicable schizophrenia
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2013
CompletedFirst Submitted
Initial submission to the registry
September 13, 2013
CompletedFirst Posted
Study publicly available on registry
September 18, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 2, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
March 20, 2019
CompletedSeptember 16, 2020
September 1, 2020
4.1 years
September 13, 2013
September 11, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Feasibility
Feasibility of conducting a larger trial will be measured by recruitment, feasibility of enrollment, stratification, blinding and assessment, acceptability of randomization, retention of subjects
Two years
Secondary Outcomes (2)
Change in neurocognition from baseline to treatment end-point
10 weeks
Change in neurocognition from baseline to 3-month follow-up
5.5 to 6 months
Other Outcomes (8)
Tone Matching Ability - Treatment end-point
10 weeks
UCSD Performance-Based Skills Assessment (UPSA)-Brief - treatment end-point
10 weeks
Structured Clinical Interview for the Positive and Negative Syndrome Scale (SCI-PANSS) - Treatment end-point
10 weeks
- +5 more other outcomes
Study Arms (4)
Brain Basics for Impaired Tone Matchers
ACTIVE COMPARATORCognitive remediation includes sensory processing training
Brain Basics for Intact Tone Matchers
ACTIVE COMPARATORCognitive remediation includes sensory processing training
Brain Training for Impaired Tone Matcher
ACTIVE COMPARATORCognitive remediation does not include sensory processing training
Brain Training for Intact Tone Matchers
ACTIVE COMPARATORCognitive remediation does not include sensory processing training
Interventions
Cognitive remediation sessions include working on computer based cognitive exercises and participating in a verbal discussion.
Eligibility Criteria
You may qualify if:
- Diagnostic and Statistical Manual-IV (DSM-IV) diagnosis of schizophrenia or schizoaffective disorder
- Age 18 to 65
- English speaking
- Psychiatrically stable, verified by current living/treatment status
You may not qualify if:
- Indication of mental retardation, determined by estimated IQ of less than 70
- Hearing or visual impairment that precludes completing assessments
- Neurologic illness that may affect brain physiology (e.g. Parkinson's, seizure disorder, epilepsy)
- Current substance dependence symptoms in the past 6 weeks
- Participation in cognitive remediation in the 12 months prior to study entry.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Williamsburg Clinic
Brooklyn, New York, 11206, United States
Institute for Community Living
Brooklyn, New York, 11207, United States
Nyspi/ Cumc
New York, New York, 10032, United States
The Bridge Inc
New York, New York, 10040, United States
FEGS Bronx Mental Health Clinic
The Bronx, New York, 10467, United States
Related Publications (1)
Medalia A, Saperstein AM, Qian M, Javitt DC. Impact of baseline early auditory processing on response to cognitive remediation for schizophrenia. Schizophr Res. 2019 Jun;208:397-405. doi: 10.1016/j.schres.2019.01.012. Epub 2019 Jan 18.
PMID: 30665714RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alice Medalia, PhD
NYSPI
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
- Clinical Psychiatrist
Study Record Dates
First Submitted
September 13, 2013
First Posted
September 18, 2013
Study Start
September 1, 2013
Primary Completion
October 2, 2017
Study Completion
March 20, 2019
Last Updated
September 16, 2020
Record last verified: 2020-09