Schizophrenia
Conditions
Keywords
cognition, neuropsychology, Rehabilitation, treatment efficacy, cognitive remediation
Brief summary
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
Detailed description
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
Interventions
BEHAVIORALcognitive remediation
individual cognitive training
Sponsors
US Department of Veterans Affairs
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of schizophrenia spectrum disorder * English speakers * Clinically stable * No substance abuse in past 30 days
Exclusion criteria
* Traumatic brain injury * Neurological disease * Diagnosis of mental retardation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cognitive Performance | baseline and 2 months | 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). |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Arm 1 cognitive remediation
cognitive remediation: individual cognitive training | 50 |
| Arm 2 treatment as usual | 25 |
| Total | 75 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 13 | 7 |
Baseline characteristics
| Characteristic | Arm 1 | Arm 2 | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 50 Participants | 25 Participants | 75 Participants |
| Sex: Female, Male Female | 10 Participants | 9 Participants | 19 Participants |
| Sex: Female, Male Male | 40 Participants | 16 Participants | 56 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 4 / 50 | 5 / 50 |
| serious Total, serious adverse events | 3 / 50 | 2 / 25 |
Outcome results
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).
Time frame: baseline and 2 months
Population: individuals who were randomized and completed 2 month assessments
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1 | Cognitive Performance | 4.97 units on a scale | Standard Error 1.38 |
| Arm 2 | Cognitive Performance | -2.30 units on a scale | Standard Error 1.98 |