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| Name | Class |
|---|---|
| Indiana University | OTHER |
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This research studies the effects of Cognitive Behavior Therapy and Cognitive Remediation on work for persons with schizophrenia. Cognitive Behavior Therapy is a form of counseling that helps people to improve their mental health by changing the way they think about themselves and others. Cognitive Remediation is an exercise to improve the thinking process. The purpose of this study is to determine the extent to which Cognitive Remediation combined with Cognitive Behavior Therapy helps people who are working.
Objectives: The proposed grant seeks to compare the effects of a manualized form of Cognitive Behavior Therapy (CBT) combined with Cognitive Remediation (CR) with CBT alone and Support Services (SS) alone on vocational outcomes for persons with schizophrenia spectrum disorders. Key hypotheses are: I) Participants receiving CBT +CR will work more weeks and hours than participants receiving CBT alone or SS alone; II) Participants receiving CBT + CR condition will show better work performance than the CBT alone and SS alone conditions; III) Participants receiving CBT + CR will experience greater improvements in symptoms, dysfunctional beliefs and quality of life than the CBT alone or SS alone conditions Research Plan: One hundred twenty participants with Structured Clinical Interview for DSM-IV (SCID) confirmed diagnoses of schizophrenia or schizoaffective disorder will be recruited from the Roudebush VA Medical Center , surrounding mental health centers and the Marion VA Medical Center. Participants with these diagnoses will be eligible if they are sufficiently stable to sustain participant in rehabilitation, as defined by no hospitalizations, medication or housing changes in the last 30 days. Participants will be offered a 6 month paid job placement and randomly assigned to receive either CBT + CR, CBT only or SS only.
Methodology: Following informed consent, a baseline assessment will include an inventory of work, residential, substance abuse, legal, quality of life, psychiatric and service utilization history. Participants will be offered a 26-week job placement at the VA Medical center or within the community and randomly assigned to receive 6 months of either CBT +CR, CBT only or SS. Jobs will include entry-level positions supervised by regular job site supervisors. Participants in the SS condition will attend a weekly individual and support group offering unstructured support regarding work related problems they identify. Participants in the CBT group will attend weekly group and individual sessions employing a manualized CBT intervention to identify and correct dysfunctional cognitions related to work. Participants in the CBT + CR condition will attend meetings as indicated for CBT along with performing cognitive exercises on the computer, progressing at their own pace. Hours of work will be recorded weekly. Work performance will be measured biweekly. Symptoms and cognitions will be assessed every 2 months. Primary forms of data analyses will be multivariate repeated measure analyses of variance in which CBT +CR, CBT only and SS groups will be compared on vocational, symptom, and self-esteem variables.
Results: The investigators have recently demonstrated in separate randomized controlled trials that CBT and CR can be fully implemented in a VA setting and that each leads to better work outcomes in schizophrenia. Means and standard deviations of key outcomes have been determined and are used in the power analysis for this study.
Significance: The proposed research aims provide a scientifically sound exploration of the therapeutic value of productive activity in the rehabilitation of persons with schizophrenia and to determine the extent to which manualized CBT procedures when combined with CR may contribute to the success of this process. Results may provide exportable guidelines for augmenting work services with an appropriate psychological treatment. This information may lead to more effective rehabilitation programs as well as increases in productivity, functional independence and an enhanced quality of life for persons with schizophrenia. The study also fulfills the rehabilitation goal of maximum inclusion by providing CBT and CR services that may make it possible for some patients to function at work that otherwise could not.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Active Comparator | Support group |
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| Arm 2 | Experimental | Cognitive Behavior Therapy |
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| Arm 3 | Experimental | Cognitive Behavior Therapy and Cognitive Remediation |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Support Group | Behavioral | General support and problem solving for work activity |
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| Measure | Description | Time Frame |
|---|---|---|
| Work Quality | Average work performance scored on the Work Behavior Inventory (WBI) by total average of the 5 subscales. Scores range from 1-5. Higher scores represent better work performance. | 6 months |
| Work Quantity | Average number of hours worked per week. Higher numbers represent more hours worked, ranging from 0-40. | 6 months |
| Symptoms | Symptoms (positive, negative, cognitive, hostility, and depression subscales) are rated on Positive and Negative Syndrome Scale (PANSS). These are averages of each subscale: positive (range 6-42), negative (range 8-56), cognitive (range 7-49), hostility (range 4-28), depression (range 4-28). Higher scores indicate more extreme /worse symptoms. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul Lysaker, PhD | Richard L. Roudebush VA Medical Center, Indianapolis, IN | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Richard L. Roudebush VA Medical Center, Indianapolis, IN | Indianapolis | Indiana | 46202-2884 | United States |
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12 subjects consented, but failed to complete intake procedures for randomization. This is why the final results total enrollment number differs from the protocol enrollment number.
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| ID | Title | Description |
|---|---|---|
| FG000 | Support Group | Support Group: General support and problem solving for work activity |
| FG001 | Cognitive Behavior Therapy | Cognitive Behavior Therapy: Individual and group therapy focused on identifying and correcting maladaptive beliefs about work |
| FG002 | Cognitive Behavior Therapy and Cognitive Remediation | Support Group: General support and problem solving for work activity Cognitive Behavior Therapy: Individual and group therapy focused on identifying and correcting maladaptive beliefs about work Cognitive Remediation: Computerized training to enhance cognitive functioning. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Support Group | Support group Support Group: General support and problem solving for work activity |
| BG001 | Cognitive Behavior Therapy | Cognitive Behavior Therapy Support Group: General support and problem solving for work activity Cognitive Behavior Therapy: Individual and group therapy focused on identifying and correcting maladaptive beliefs about work |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Work Quality | Average work performance scored on the Work Behavior Inventory (WBI) by total average of the 5 subscales. Scores range from 1-5. Higher scores represent better work performance. | Posted | Mean | Standard Deviation | scores on a scale | 6 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 | Support Group | Support group Support Group: General support and problem solving for work activity |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| psychiatric hospitalization | Psychiatric disorders | suicide ideation |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Paul Lysaker | Richard L. Roudebush VA Medical Center | 317-988-2546 | paul.lysaker@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 |
|---|---|
| D012657 | Self-Help Groups |
| D015928 | Cognitive Behavioral Therapy |
| D000072466 | Cognitive Remediation |
| ID | Term |
|---|---|
| D009938 | Organizations |
| D004472 | Health Care Economics and Organizations |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
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| Cognitive Behavior Therapy | Behavioral | Individual and group therapy focused on identifying and correcting maladaptive beliefs about work |
|
| Cognitive Remediation | Behavioral | Computerized training to enhance cognitive functioning. |
|
| BG002 | Cognitive Behavior Therapy and Cognitive Remediation | Cognitive Behavior Therapy and Cognitive Remediation Support Group: General support and problem solving for work activity Cognitive Behavior Therapy: Individual and group therapy focused on identifying and correcting maladaptive beliefs about work Cognitive Remediation: Computerized training to enhance cognitive functioning. |
| BG003 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| OG002 |
| Cognitive Behavior Therapy and Cognitive Remediation |
Cognitive Behavior Therapy and Cognitive Remediation Support Group: General support and problem solving for work activity Cognitive Behavior Therapy: Individual and group therapy focused on identifying and correcting maladaptive beliefs about work Cognitive Remediation: Computerized training to enhance cognitive functioning. |
|
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| Primary | Work Quantity | Average number of hours worked per week. Higher numbers represent more hours worked, ranging from 0-40. | Posted | Mean | Standard Deviation | hours worked per week | 6 months |
|
|
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| Primary | Symptoms | Symptoms (positive, negative, cognitive, hostility, and depression subscales) are rated on Positive and Negative Syndrome Scale (PANSS). These are averages of each subscale: positive (range 6-42), negative (range 8-56), cognitive (range 7-49), hostility (range 4-28), depression (range 4-28). Higher scores indicate more extreme /worse symptoms. | Posted | Mean | Standard Deviation | scores on a scale | 6 months |
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|
| 1 |
| 25 |
| 0 |
| 25 |
| EG001 | Cognitive Behavior Therapy | Cognitive Behavior Therapy Support Group: General support and problem solving for work activity Cognitive Behavior Therapy: Individual and group therapy focused on identifying and correcting maladaptive beliefs about work | 0 | 25 | 0 | 25 |
| EG002 | Cognitive Behavior Therapy and Cognitive Remediation | Cognitive Behavior Therapy and Cognitive Remediation Support Group: General support and problem solving for work activity Cognitive Behavior Therapy: Individual and group therapy focused on identifying and correcting maladaptive beliefs about work Cognitive Remediation: Computerized training to enhance cognitive functioning. | 1 | 25 | 0 | 25 |
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| D004191 |
| Behavioral Disciplines and Activities |
|
| average cognitive symptoms |
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| average hostility symptoms |
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| average depression symptoms |
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