Schizophrenia Clinical Trial
Official title:
Personalized and Scalable Cognitive Remediation Approaches
Verified date | September 2020 |
Source | New York State Psychiatric Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 122 |
Est. completion date | March 20, 2019 |
Est. primary completion date | October 2, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: 1. Diagnostic and Statistical Manual-IV (DSM-IV) diagnosis of schizophrenia or schizoaffective disorder 2. Age 18 to 65 3. English speaking 4. Psychiatrically stable, verified by current living/treatment status Exclusion Criteria: 1. Indication of mental retardation, determined by estimated IQ of less than 70 2. Hearing or visual impairment that precludes completing assessments 3. Neurologic illness that may affect brain physiology (e.g. Parkinson's, seizure disorder, epilepsy) 4. Current substance dependence symptoms in the past 6 weeks 5. Participation in cognitive remediation in the 12 months prior to study entry. |
Country | Name | City | State |
---|---|---|---|
United States | FEGS Bronx Mental Health Clinic | Bronx | New York |
United States | Institute for Community Living | Brooklyn | New York |
United States | Williamsburg Clinic | Brooklyn | New York |
United States | Nyspi/ Cumc | New York | New York |
United States | The Bridge Inc | New York | New York |
Lead Sponsor | Collaborator |
---|---|
New York State Psychiatric Institute | National Institute of Mental Health (NIMH) |
United States,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Tone Matching Ability - Treatment end-point | Tone matching (percent correct) will be assessed at baseline and at treatment end-point, using pairs of 100-ms tones in series, with 500-ms inter-tone interval. | 10 weeks | |
Other | UCSD Performance-Based Skills Assessment (UPSA)-Brief - treatment end-point | The UPSA - Brief is a proxy measure of daily functioning skills. Change from baseline to treatment end-point will be assessed. | 10 weeks | |
Other | Structured Clinical Interview for the Positive and Negative Syndrome Scale (SCI-PANSS) - Treatment end-point | The SCI-PANSS is a semi-structured interview containing 30 items that assess symptoms of psychotic disorders including positive, negative and general psychopathology. Change from baseline to treatment end-point will be assessed. | 10 weeks | |
Other | Intrinsic Motivation Inventory for Schizophrenia Research (IMI-SR) | Intrinsic Motivation Inventory for Schizophrenia Research (IMI-SR), a 21 item 7-point Likert type scale designed to assess a participant's subjective experience of an activity, specifically in an experimental setting (e.g. "I enjoyed doing this activity very much"). The IMI-SR will be administered at the first and last treatment sessions. | 10 weeks | |
Other | Perceived Competency Scale (PCS) | The PCS consists of 4 items on a 7-point Likert-type scale that assess feelings of competency when performing computer-based learning activities, with higher scores indicating greater perceived competency. The PCS will be administered at the first and last treatment sessions. | 10 weeks | |
Other | Tone Matching ability - 3-month follow up | Tone Matching (percent correct) will be assessed at baseline and 3-month follow-up, using pairs of 100-ms tones in series, with 500-ms inter-tone interval. | 5.5 to 6 months | |
Other | UCSD Performance-Based Skills Assessment (UPSA)-Brief - 3-month follow-up | The UPSA-Brief is a proxy measure for daily functioning skills. Change from baseline to 3-month follow-up will be assessed. | 5.5 to 6 months | |
Other | Structured Clinical Interview for the Positive and Negative Syndrome Scale (SCI-PANSS) - 3-month follow-up | The SCI-PANSS is a semi-structured interview containing 30 items that assess symptoms of psychotic disorders including positive, negative and general psychopathology. Change from baseline to 3-month follow-up will be assessed. | 5.5 to 6 months | |
Primary | 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 | Change in neurocognition from baseline to treatment end-point | Change in neurocognition will be measured with the MATRICS Consensus Cognitive Battery, including measures of: a) working memory; b) attention/vigilance; c) verbal learning; d) visual learning; e) processing speed; f) reasoning and problem solving. | 10 weeks | |
Secondary | Change in neurocognition from baseline to 3-month follow-up | Change in neurocognition will be measured with the MATRICS Consensus Cognitive Battery (see above). | 5.5 to 6 months |
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