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Schizophrenia/Schizoaffective Disorder is associated with serious problems with cognitive skills, social skills, and functional skills (like employment). There is a new form of cognitive behavioral therapy called integrated cognitive behavioral therapy (iCBT) that specifically addresses the cognitive, social, and functional deficits of schizophrenia/schizoaffective disorder. This study compared iCBT to the usual care (UC) that Veteran's receive. The investigators compared iCBT to UC in subjects with schizophrenia/schizoaffective disorder who are enrolled in a Supported Employment (SE) program, and evaluate whether iCBT is more helpful in improving job attainment, and other areas of functioning, both right after treatment, and 6 months after the end of treatment.
The objective of the current study was to evaluate whether integrated cognitive behavior therapy (iCBT) can improve engagement and success in an existing Supported Employment (SE) program among the most functionally disabled patients with schizophrenia/schizoaffective disorder. The iCBT condition also included computerized cognitive remediation. The primary specific aim was to determine whether iCBT will significantly improve work outcomes at post-treatment to a greater extent than Usual Care (UC) in low functioning patients with schizophrenia/schizoaffective disorder who join the SE program. The secondary aims were to evaluate the whether iCBT will significantly improve work outcomes at 6 month follow-up relative to UC, and whether iCBT will improve functional outcomes post-treatment and at follow-up relative to UC in subjects who join the SE program.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| integrated CBT with computerized cognitive remediation | Experimental | integrated CBT with computerized cognitive remediation |
|
| Treatment As Usual | Other | Treatment As Usual |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| integrated Cognitive Behavioral Therapy | Behavioral | Novel CBT paradigm for schizophrenia/schizoaffective disorder |
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| Measure | Description | Time Frame |
|---|---|---|
| Workforce Participation Measure - Total Number of Jobs Attained | Measure completed by the support employment specialist that evaluates participation in the workforce: Total number of jobs attained per group across the full length of the study (Baseline to 18 month follow-up, study end) | Baseline to post-treatment (18-months) |
| Overall Job Attainment Proportion | This is the proportion of participants, by group, that attained at least one job during the active portion of the study. | Study start through 18 months of the active portion of the study. |
| Job Participant Composite-hours Worked | This is a composite of hours work per week X number of weeks worked, in each assessment period. | Baseline to study intervention start point (ranging from 1-10 months), then at 6 months after intervention start, 12 months after intervention start, and then 18 months after intervention start. |
| Measure | Description | Time Frame |
|---|---|---|
| Work Behavior Inventory | Measure completed by the supported employment specialist that evaluates work quality in an employment setting, based on the job supervisor's report, using the overall impression rating, ranging from 1 (consistently needing improvement) to 5 (consistently superior performance). Only the job supervisor's was used, rather than other options possible with the measure. | Baseline, mid-treatment (6-months), end of treatment (12-months), and post-treatment (18-months) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven L. Sayers, PhD | Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA | Philadelphia | Pennsylvania | 19104 | United States |
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Eighty-seven Veterans completed baseline assessment and met study criteria. Twenty Veterans subsequently withdrew or were administratively withdrawn for clinical reasons from further participation, prior to randomization. Six more Veterans in the first cohort who were to be randomized to the TAU group were assigned to the iCBT group to obtain sufficient participants for an initial therapy group (i.e., ten to twelve). This violated random assignment, thus were administratively withdrawn.
Veterans receiving treatment for schizophrenia or schizoaffective disorder at the Corporal Michael Crescenz VA Medical Center in the Mental Health Clinic were offered the opportunity to participate in a research project meant to test whether a CBT group treatment that included cognitive remediation enhanced the employment outcomes of a standard Supported Employment program. Recruitment began 6/2015 and enrollment ended 7/2019.
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| ID | Title | Description |
|---|---|---|
| FG000 | Integrated CBT With Computerized Cognitive Remediation | Integrated CBT with computerized cognitive remediation (iCBT) Integrated Cognitive Behavioral Therapy: Novel CBT group treatment for schizophrenia/schizoaffective disorder Computerized cognitive remediation (CCR): Part of the iCBT paradigm, a four month block of bi-weekly computerized cognitive remediation using BrainHQ program. Participants were also enrolled in a Supported Employment program to support job attainment and continuation, and any other treatments that were available to Veterans at the VA Medical Center. |
| FG001 | Treatment As Usual | Treatment As Usual (TAU) The usual care that Veterans receive - not limited in scope (i.e., subjects may participate in any/all available treatments, outside the study condition). Participants were also enrolled in a Supported Employment program to support job attainment and continuation. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline Assessment |
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| 6 Month Assessment |
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| 12 Month Assessment |
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| 18 Month Assessment |
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Participants were Veterans with schizophrenia or schizoaffective disorder receiving clinical services in Behavioral Health of a large VA Medical Center. Participants indicated they were interested in receiving supportive employment services for assistance in job seeking and support in maintaining employment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Integrated CBT With Computerized Cognitive Remediation | integrated CBT with computerized cognitive remediation integrated Cognitive Behavioral Therapy: Novel CBT paradigm for schizophrenia/schizoaffective disorder Computerized cognitive remediation (CCR): Part of the iCBT paradigm, a four month block of bi-weekly computerized cognitive remediation using BrainHQ program. |
| 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, Continuous | Mean |
| 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 | Workforce Participation Measure - Total Number of Jobs Attained | Measure completed by the support employment specialist that evaluates participation in the workforce: Total number of jobs attained per group across the full length of the study (Baseline to 18 month follow-up, study end) | Posted | Mean | Standard Deviation | Number of jobs attained | Baseline to post-treatment (18-months) |
|
Adverse events were noted from study beginning (baseline) until the study end for the last participant. Adverse events were assessed, at minimum, at each major assessment point, from Baseline to intervention start, a period of time that varied across participants from 1 to 10 months, intervention start to the 6 month assessment, 6 months to 12 months assessments, and 12 months to 18 months assessment.
Adverse events were also noted as reported by the Veteran or by clinicians in the medical record of the participants at times other than major assessments. Ongoing medical events not conceivably associated with the study's psychosocial intervention were not noted or reported by study staff, unless the event was accompanied by inpatient treatment or death. This included incarceration, which occurred in two instances for these significantly disordered participants.
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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 | iCBT Group | Integrative Cognitive Behavioral Therapy group (experimental group) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Inpatient psychiatric hospitalization | Psychiatric disorders | Non-systematic Assessment | admission to a psychiatric unit for reasons of increased psychiatric symptoms, including substance abuse |
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The population for which this study was designed were highly functionally impaired by serious psychiatric illness as an effort to improve employment outcomes in this vulnerable group. This led to significant problems with the ability for participants to respond to and complete requests for ongoing participation in study activities and assessments. The significant missing data was the result of these issues.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Steven L. Sayers, Ph.D. | Corporal Michael J Crescenz VA Medical Center | (215) 823-5196 | steven.sayers@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 14, 2017 | Oct 23, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D011618 | Psychotic Disorders |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| Usual Care | Other | The usual care that Veterans receive - not limited in scope (i.e., subjects may participate in any/all available treatments, outside the study condition) |
|
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| Computerized cognitive remediation (CCR) | Behavioral | Part of the iCBT paradigm, a four month block of bi-weekly computerized cognitive remediation using BrainHQ program. |
|
|
| Specific Levels of Functioning (SLOF) | This is measure designed to assess individual social, work, and interpersonal functioning of individuals with severe mental illness. The possible total score ranges from 30 - 150 with higher scores representing higher levels of functioning. | Baseline, mid-treatment (6-months), end of treatment (12-months), and post-treatment (18-months) |
| NOT COMPLETED |
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| NOT COMPLETED |
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| NOT COMPLETED |
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| BG001 | Treatment As Usual | Treatment As Usual Usual Care: The usual care that Veterans receive - not limited in scope (i.e., subjects may participate in any/all available treatments, outside the study condition) |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Primary Diagnosis | Count of Participants | Participants |
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| Marital status | Self-reported marital status at the time of entry into the study | Count of Participants | Participants |
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| Brief Negative Symptom Scale | The Brief Negative Symptom Scale total score has a possible range from 0 - 73, with higher scores indicating a higher level of negative symptoms associated with schizophrenia. | Mean | Standard Deviation | units on a scale |
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| Scale for the Assessment of Positive Symptoms | The Scale for the Assessment of Positive Symptoms has a possible range from 0 - 170, with higher scores indicating higher levels of positive symptoms of schizophrenia. | Mean | Standard Deviation | units on a scale |
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| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Overall Job Attainment Proportion | This is the proportion of participants, by group, that attained at least one job during the active portion of the study. | Participants with diagnoses of schizophrenia or schizoaffective disorder seeking employment | Posted | Count of Participants | Participants | No | Study start through 18 months of the active portion of the study. |
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| Primary | Job Participant Composite-hours Worked | This is a composite of hours work per week X number of weeks worked, in each assessment period. | Posted | Mean | Standard Deviation | Hours worked | Baseline to study intervention start point (ranging from 1-10 months), then at 6 months after intervention start, 12 months after intervention start, and then 18 months after intervention start. |
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| Secondary | Work Behavior Inventory | Measure completed by the supported employment specialist that evaluates work quality in an employment setting, based on the job supervisor's report, using the overall impression rating, ranging from 1 (consistently needing improvement) to 5 (consistently superior performance). Only the job supervisor's was used, rather than other options possible with the measure. | Participants from both groups were very reluctant for the interventionists to obtain formal Work Behavior Inventory ratings from their employers. It was clear that insufficient data would be obtained and so efforts to complete it were abandoned. No data analysis was possible with this measure. | Posted | Mean | Standard Deviation | units on a scale | Baseline, mid-treatment (6-months), end of treatment (12-months), and post-treatment (18-months) |
|
|
|
| Secondary | Specific Levels of Functioning (SLOF) | This is measure designed to assess individual social, work, and interpersonal functioning of individuals with severe mental illness. The possible total score ranges from 30 - 150 with higher scores representing higher levels of functioning. | The number of participants available for assessment at each time point varied due to the variability in willingness on the part of the participants to complete these interviews. Thus, data available at each time point for each group varied across time. | Posted | Mean | Standard Deviation | score on a scale | Baseline, mid-treatment (6-months), end of treatment (12-months), and post-treatment (18-months) |
|
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|
|
| 2 |
| 37 |
| 12 |
| 37 |
| 0 |
| 37 |
| EG001 | TAU Group | Treatment as Usual group (control group) | 0 | 30 | 9 | 30 | 0 | 30 |
|
| Inpatient surgical hospitalization | Surgical and medical procedures | Non-systematic Assessment | Inpatient hospitalization for reasons of planned or unplanned surgical procedure |
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| Dizziness | General disorders | Non-systematic Assessment |
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| Bleeding | Gastrointestinal disorders | Non-systematic Assessment | Rectal bleeding |
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| Observation | General disorders | Non-systematic Assessment | Admitted for observation due to fluid restriction |
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| Weakness | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Weakness in legs, unknown origin |
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| Colonscopy | Gastrointestinal disorders | Non-systematic Assessment | Admitted for colonoscopy |
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| Hand injury | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Admitted for hand injury |
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| Acute coronary syndrome | Cardiac disorders | Non-systematic Assessment |
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| General Medical | Surgical and medical procedures | Non-systematic Assessment | Admitted for "general medical purposes"--no other information availably |
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| UTI/blood infection | Blood and lymphatic system disorders | Non-systematic Assessment | Blood infection that began with a urinary tract infection |
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| Chi-squared |
ChiSq = 3.6562, df = 1 |
| <.06 |
| Odds Ratio (OR) |
| 2.65 |
| 2-Sided |
| 95 |
| 0.97 |
| 7.13 |
OR, iCBT / TAU in job attainment |
| Superiority |
| 6-12 mos. |
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| 12-18 mos. |
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| Compare the groups on proportions in employment at the 12 month assessment points. | Mixed Models Analysis | F (1, 130) = 1.0, p<0.37, for the group X assessment interaction, adjusting for baseline differences in hours worked at the start of the intervention. | <.54 | Odds Ratio, log | .52 | Standard Error of the Mean | 0.85 | 2-Sided | 95 | -1.14 | 2.19 | Superiority | A mixed effects logistic regression model was conducted on a binary work variable, with a random intercept, using the baseline measure as a binary covariate. |
| Compare the groups on proportions in employment at the 18 month assessment point. | Mixed Models Analysis | F (1, 130) = 1.0, p<0.37, for the group X assessment interaction, adjusting for baseline differences in hours worked at the start of the intervention. | <0.71 | Odds Ratio, log | 0.31 | Standard Error of the Mean | 0.83 | 2-Sided | 95 | -1.32 | 1.73 | Superiority | A mixed effects logistic regression model was conducted on a binary work variable, with a random intercept, using the baseline measure as a binary covariate. |
| 6 months |
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| 12 months |
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| 18 months |
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| 6 months |
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| 12 months |
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| 18 months |
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| Fisher Exact |
df (1, 114) |
| <0.99 |
| Mean Difference (Final Values) |
| 0.03 |
| Standard Error of the Mean |
| 4.42 |
| 2-Sided |
| Superiority |
This is mixed model analysis of the group X assessment interaction. This analysis is the test of mean differences in level of functioning at the 6 month assessment. |
| Fisher Exact | df (1, 114) | <0.94 | Mean Difference (Final Values) | -0.33 | Standard Error of the Mean | 4.54 | 2-Sided | Superiority | This is mixed model analysis of the group X assessment interaction. This analysis is the test of mean differences in level of functioning at the 12 month assessment. |
| Fisher Exact | df (1, 114) | <0.14 | Mean Difference (Final Values) | -6.67 | Standard Error of the Mean | 4.52 | 2-Sided | Superiority | This is mixed model analysis of the group X assessment interaction. This analysis is the test of mean differences in level of functioning at the baseline assessment. |