Cognitive Impairment, Schizophrenia
Conditions
Keywords
Cognitive Impairment, Rehabilitation
Brief summary
The study will investigate the viability of two cognitive rehabilitation strategies to improve functional outcomes for people with schizophrenia. Many people with schizophrenia experience impairments in cognitive function which limit their abilities. These impairments have been shown to precede the onset of illness and represent a vulnerability factor which is exacerbated by emerging psychotic symptoms. These impairments affect a range of functional domains including symptom severity, work function, symptom management, treatment, and overall quality of life. Recognizing the link between cognitive impairment and function, a few clinicals and researchers have attempted to remediate cognitive impairments by providing cognitive retraining programs similar to those used in traumatic brain injured patients or adaptive skills training. Cognitive retraining involves repetitive exercises to increase elemental cognitive functions including memory, attention, psychomotor speed, planning, and cognitive flexibility. Adaptive skill training involves didactic group exercises in social skills, activities of daily living, and symptom management. Each approach has demonstrated some rehabilitation benefits. This study will investigate the effectiveness of a combination of these two approaches on outcomes in schizophrenia.
Detailed description
Objective: Many people with schizophrenia experience impairments in cognitive function which limit their abilities. These impairments affect a range of functional domains including symptom severity, work function, symptom management, treatment, and overall quality of life. Recognizing the link between cognitive impairment and function, a few clinicians and researchers have attempted to remediate cognitive impairments by providing cognitive retraining programs similar to those used in traumatic brain injured patients or adaptive skills training. Cognitive retraining involves repetitive exercises to increase elemental cognitive functions including memory, attention, psychomotor speed, planning, and cognitive flexibility. Adaptive skill training involves didactic group exercises in social skills, activities of daily living, and symptom management. This study investigates the effectiveness of a combination of these two approaches on outcomes in schizophrenia. This will be a three group randomized clinical trial investigating the effects of cognitive rehabilitation on outcomes ranging from proximal (training tasks performance and neuropsychological test performance), to more distal outcomes (treatment group performance and quality of life ratings). We believe that the cognitive augmentation will have significant impact on training task and neuro-psychological test performance and attenuated, but significant effect on performance in the treatment groups. Finally, we hypothesize that the combination of adaptive training and cognitive rehabilitation will have measurable impact on the most distal outcomes such as daily living skills and quality of life. Method: One hundred (100) individuals will be invited to participate in a 30-week program. After informed consent is obtained and diagnosis established, participants will receive an extensive assessment of neuropsychological, psychological and psychosocial functioning. Participants will be randomly assigned to one of three conditions using a stratified procedure based on cognitive test performance (this will ensure that there are similar numbers of severely and less severely impaired participants in each condition). The three conditions will be: (1) a usual care control group which is the Life Skills Development Group (LSDG), (2) Individualized computer based cognitive rehabilitation (ICBCR) augmenting the LSDG; and (3) Cognitive Remediation Therapy (CRT) with LSDG. Participants will be compared on: (1) LSDG performance, (2) neuropsychological test performance and (3) psychosocial functioning. Attendance in groups and remediation sessions will be compensated at a rate of $5 per session. The key questions t be answered are which Cognitive Rehabilitation strategy is more effective at improving cognitive function? Does Cognitive Rehabilitation produce better performance in the Life Skills Development Group (LSDG)? Does Life Skills Development Group augmented by Cognitive Rehabilitation produce better psychosocial outcomes than the standard care control group?
Interventions
BEHAVIORALCognitive Rehabilitation Therapy (CRT) + Skill Training (SDG)
CRT is a one on one cognitive skills training and Skill training is a group intervention to develop concrete skills of daily living.
BEHAVIORALIndividual Computer Based Cognitive Rehabilitation (ICBCR) and Skills Training (SDG)
ICBCR is a computerized cognitive skills training program and Skill training is a group intervention to develop concrete skills of daily living.
BEHAVIORALSkills Group (SDG)
Skill training is a group intervention to develop concrete skills of daily living. This is augmented with the opportunity to receive up to 5 hours of individual staff contact.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of schizophrenia or schizoaffective disorder. Between the ages of 18-65. Stable medication regime (no changes in last 30 days)Minimum of 30 days since last hospitalization. No hx of TBI
Exclusion criteria
* Current Substance abuse, no comorbid neurological disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wisconsin Card Sort Percent Perseverative Errors (Standard Score) | 16 weeks after intake | This is a measure of cognitive flexibility and the ability to shift set in the face of a changing reinforcement. The measure reflects density of perseverative errors in relation to the overall test performance. It is computed by calculating the ration of perseverative errors to trials administered and multiplied by 100. Then the percentage score is translate using the available Standard Score Tables provided in the manual and converted to a standard score with a mean of 100, a maximum of 145 and a minimum of 55, with higher Standard Scores indicating better performance. |
| Bell Lysaker Emotion Recognition Test | 16 weeks from intake | 21 Item audio-visual task that measures the ability to recognize affective states in others. Affective states presented include: Happiness, Sadness, Surprise, Disgust, Fear, Anger and No Emotion. The instrument is scored for total correct responses with scores ranging from 0 to 21 with higher scores indicate better overall performance. |
| Continuous Performance Task X/A Version | 16 weeks after intake assessment | CPT relative X/A Percentage. This is a task-oriented computerized assessment of attention-related problems. This variable measures the relative sustained attention, and vigilance over the time of the task. Raw performance is standardize using available age and education norms yielding a Standardized Score with a mean of 100. Maximum Standard score is 145 and the minimum is 55 with higher scores reflect better performance. |
| Hopkins Verbal Learning Test- Total Recall Variable | 16 weeks post intake assessment | This is measure of verbal learning and memory for immediate recall. Respondents are read a list of 12 items and asked to repeat once the last item is given. The list if given 3 times. Each time all items are recorded giving a total score ranging from 0 to 36. The score is converted to T-scores (mean of 50 and sd of 10) using the norms in the manual. The data reported are that in T-Scores with higher scores indicating better functioning. |
| Independent Living Skills Survey | 16 weeks after intake | Independent Living Skills Survey is a 103 items that assess 12 areas of skills; personal hygiene (6 items), appearance and care of clothing (12 items), care of personal possessions and living space (9 items), food preparation (9 items), care of one's own health and safety (10 items), money management (10 items), transportation (7 items), leisure and recreational activities (13 items), job seeking (6 items), job maintenance (3 items), eating behaviors (9 items), and social interactions (9 items). The items describe relatively specific skills such as washes hair twice a week, and informants indicate how frequently an individual has performed each skill within the past month. The responses are yes (1 point) no (0 points). Scores reports are the average #of yes items/number of total items. Higher scores indicating better functioning. |
Countries
United States
Participant flow
Recruitment details
Veterans with schizophrenia or schizoaffective disorder who met the following inclusion were recruited between 2004 and 2008.
Participants by arm
| Arm | Count |
|---|---|
| CRT +Skills Group Participants receive upto 5 hours of CRT and weekly skills training group for 15 weeks | 25 |
| ICBCR + Skills Group Participants receive upto 5 hours of ICBCR and weekly skills training group for 15 weeks | 24 |
| Skills Group Only Participants receive upto 5 hours of generic staff contact and weekly skills training group for 15 weeks | 10 |
| Total | 59 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 6 | 8 | 3 |
Baseline characteristics
| Characteristic | CRT +Skills Group | ICBCR + Skills Group | Skills Group Only | Total |
|---|---|---|---|---|
| Age, Continuous | 49.4 years STANDARD_DEVIATION 6.7 | 47.6 years STANDARD_DEVIATION 8.1 | 48.1 years STANDARD_DEVIATION 6.9 | 47.8 years STANDARD_DEVIATION 7.2 |
| Region of Enrollment United States | 25 participants | 24 participants | 10 participants | 59 participants |
| Sex: Female, Male Female | 4 Participants | 4 Participants | 1 Participants | 9 Participants |
| Sex: Female, Male Male | 21 Participants | 20 Participants | 9 Participants | 50 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 6 / 25 | 7 / 24 | 3 / 10 |
| serious Total, serious adverse events | 2 / 25 | 1 / 24 | 1 / 10 |
Outcome results
Primary
Bell Lysaker Emotion Recognition Test
21 Item audio-visual task that measures the ability to recognize affective states in others. Affective states presented include: Happiness, Sadness, Surprise, Disgust, Fear, Anger and No Emotion. The instrument is scored for total correct responses with scores ranging from 0 to 21 with higher scores indicate better overall performance.
Time frame: 16 weeks from intake
Population: Two way ANOVA using baseline and completion of intervention data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CRT + Skills Training | Bell Lysaker Emotion Recognition Test | 14.17 total correct | Standard Deviation 0.74 |
| ICBCR and Skills Training | Bell Lysaker Emotion Recognition Test | 13.40 total correct | Standard Deviation 0.73 |
| Skills Group Control | Bell Lysaker Emotion Recognition Test | 14.50 total correct | Standard Deviation 1.15 |
p-value: 0.77ANOVA
Primary
Continuous Performance Task X/A Version
CPT relative X/A Percentage. This is a task-oriented computerized assessment of attention-related problems. This variable measures the relative sustained attention, and vigilance over the time of the task. Raw performance is standardize using available age and education norms yielding a Standardized Score with a mean of 100. Maximum Standard score is 145 and the minimum is 55 with higher scores reflect better performance.
Time frame: 16 weeks after intake assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CRT + Skills Training | Continuous Performance Task X/A Version | 91.31 units on a scale (standardized units) | Standard Deviation 3.55 |
| ICBCR and Skills Training | Continuous Performance Task X/A Version | 92.65 units on a scale (standardized units) | Standard Deviation 3.48 |
| Skills Group Control | Continuous Performance Task X/A Version | 92.17 units on a scale (standardized units) | Standard Deviation 5.5 |
Primary
Hopkins Verbal Learning Test- Total Recall Variable
This is measure of verbal learning and memory for immediate recall. Respondents are read a list of 12 items and asked to repeat once the last item is given. The list if given 3 times. Each time all items are recorded giving a total score ranging from 0 to 36. The score is converted to T-scores (mean of 50 and sd of 10) using the norms in the manual. The data reported are that in T-Scores with higher scores indicating better functioning.
Time frame: 16 weeks post intake assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CRT + Skills Training | Hopkins Verbal Learning Test- Total Recall Variable | 36.33 units on a scale (T-scores) | Standard Deviation 2.19 |
| ICBCR and Skills Training | Hopkins Verbal Learning Test- Total Recall Variable | 32.56 units on a scale (T-scores) | Standard Deviation 2.14 |
| Skills Group Control | Hopkins Verbal Learning Test- Total Recall Variable | 32.90 units on a scale (T-scores) | Standard Deviation 3.39 |
Primary
Independent Living Skills Survey
Independent Living Skills Survey is a 103 items that assess 12 areas of skills; personal hygiene (6 items), appearance and care of clothing (12 items), care of personal possessions and living space (9 items), food preparation (9 items), care of one's own health and safety (10 items), money management (10 items), transportation (7 items), leisure and recreational activities (13 items), job seeking (6 items), job maintenance (3 items), eating behaviors (9 items), and social interactions (9 items). The items describe relatively specific skills such as washes hair twice a week, and informants indicate how frequently an individual has performed each skill within the past month. The responses are yes (1 point) no (0 points). Scores reports are the average #of yes items/number of total items. Higher scores indicating better functioning.
Time frame: 16 weeks after intake
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CRT + Skills Training | Independent Living Skills Survey | .73 units on a scale | Standard Error 0.02 |
| ICBCR and Skills Training | Independent Living Skills Survey | .73 units on a scale | Standard Error 0.02 |
| Skills Group Control | Independent Living Skills Survey | .77 units on a scale | Standard Error 0.04 |
Primary
Wisconsin Card Sort Percent Perseverative Errors (Standard Score)
This is a measure of cognitive flexibility and the ability to shift set in the face of a changing reinforcement. The measure reflects density of perseverative errors in relation to the overall test performance. It is computed by calculating the ration of perseverative errors to trials administered and multiplied by 100. Then the percentage score is translate using the available Standard Score Tables provided in the manual and converted to a standard score with a mean of 100, a maximum of 145 and a minimum of 55, with higher Standard Scores indicating better performance.
Time frame: 16 weeks after intake
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CRT + Skills Training | Wisconsin Card Sort Percent Perseverative Errors (Standard Score) | 87.54 standard score units | Standard Deviation 4.04 |
| ICBCR and Skills Training | Wisconsin Card Sort Percent Perseverative Errors (Standard Score) | 87.88 standard score units | Standard Deviation 3.98 |
| Skills Group Control | Wisconsin Card Sort Percent Perseverative Errors (Standard Score) | 91.80 standard score units | Standard Deviation 6.3 |
p-value: <0.97ANOVA