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| ID | Type | Description | Link |
|---|---|---|---|
| JMF0001 | Other Identifier | VACHS |
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The purpose of this study is to determine which variables predict improvement on a cognitive training task battery, used for patients with schizophrenia, and to determine the proportion of patients whose performance returns to normal following cognitive training
It has been suggested that level of cognitive function is a "rate-limiter" for the efficacy of other psychosocial treatments in schizophrenia. Cognitive remediation, which entails training and practice of successively more difficult cognitive exercises, has shown efficacy in improving cognitive function. However, the rate of improvement has not been uniform among patients receiving this intervention. Given the time- and cost-intensiveness of cognitive remediation, it is important to examine variables that will predict response to this treatment, as well as to examine the clinical significance of any improvement.
The current proposal has two aims: 1) to determine which neuropsychological, demographic, and illness variables predict response to cognitive remediation training; and 2) to determine the proportion of patients whose performance returns to normal following cognitive remediation training. For the first part of the proposed study, 50 outpatients diagnosed with schizophrenia spectrum disorders will be invited to participate in an 8-week trial of cognitive remediation training. Detailed neuropsychological, demographic, symptom and illness course variables will be collected prior to training, at the conclusion of training, and 4 months from study intake. In order to answer the second question, additional data on the computerized task performance for healthy controls will be collected, and compared to patient data, in order to determine what constitutes normal-range performance
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cognitive remediation | Experimental | cognitive remediation |
|
| treatment as usual | No Intervention | treatment as usual |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cognitive remediation | Behavioral | individual cognitive training |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cognitive Performance | Change in verbal memory scores from baseline to end of active phase (2 months), measured as trials 1-5 total score on the California Verbal Learning Test -II (range 0-80, higher scores represent better performance). | baseline and 2 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joanna Fiszdon, PhD | VA Connecticut Health Care System (West Haven) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Connecticut Health Care System (West Haven) | West Haven | Connecticut | 06516 | United States |
103 participants were enrolled. Of those, 75 were found eligible, completed baseline assessments and were then randomized to either Arm 1 (n=50) or Arm 2 (n=25). The remaining 28 participants were either discontinued from the study by the PI or chose to withdraw prior to randomization.
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1 | cognitive remediation cognitive remediation: individual cognitive training |
| FG001 | Arm 2 | treatment as usual |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
individuals randomized to Arm 1 or Arm 2
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm 1 | cognitive remediation cognitive remediation: individual cognitive training |
| BG001 | Arm 2 | treatment as usual |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Cognitive Performance | Change in verbal memory scores from baseline to end of active phase (2 months), measured as trials 1-5 total score on the California Verbal Learning Test -II (range 0-80, higher scores represent better performance). | individuals who were randomized and completed 2 month assessments | Mean | Standard Error | units on a scale | baseline and 2 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm 1 | cognitive remediation cognitive remediation: individual cognitive training |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| shortness of breath | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | participant reported to ER complaining of shortness of breath; determined not to be study related |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| worsening of psychiatric symptoms | Psychiatric disorders | Non-systematic Assessment | determined not to be study related |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Joanna Fiszdon | VA Connecticut Healthcare System | 203-932-5711 | 2231 | joanna.fiszdon@va.gov |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000072466 | Cognitive Remediation |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 3 |
| 50 |
| 4 |
| 50 |
| EG001 | Arm 2 | treatment as usual | 2 | 25 | 5 | 50 |
|
| pulled chest muscle | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | presented to ER with chest pain diagnosed as pulled chest muscle; determined not to be study related |
|
| worsening of psychiatric symptoms | Psychiatric disorders | Non-systematic Assessment | all determined not to be study related |
|
| substance abuse | Psychiatric disorders | Non-systematic Assessment | determined not to be study related |
|
| renal failure | Renal and urinary disorders | Non-systematic Assessment | determined not to be study related |
|
|
| substance use | Psychiatric disorders | Non-systematic Assessment | determined not to be study related |
|
| dizziness | General disorders | Non-systematic Assessment | determined not to be study related |
|
| toe pain | Injury, poisoning and procedural complications | Non-systematic Assessment | determined not to be study related |
|
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