Schizoaffective Disorder, Schizophrenia
Conditions
Keywords
Schizophrenia, Cognitive Behavioral Therapy, Cognition, Vocational Rehabilitation, Supported Employment, Schizoaffective Disorder
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALintegrated Cognitive Behavioral Therapy
Novel CBT paradigm for schizophrenia/schizoaffective disorder
OTHERUsual 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)
BEHAVIORALComputerized cognitive remediation (CCR)
Part of the iCBT paradigm, a four month block of bi-weekly computerized cognitive remediation using BrainHQ program.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of DSM-IV schizophrenia or schizoaffective disorder (SCID) * Severe/extreme functional disability \[World Health Organization Disability Assessment Scale (WHODAS) score \> 50\] * Clinical stability (as per primary mental health provider) * Receiving treatment at the Veterans Administration * Minimal engagement in psychiatric rehabilitation services (just psychiatrist and therapist/case management in the last 6 months) * Eligible for and willing to be enrolled in Supported Employment program * Age 18 to 65 * Proficient in English * Able to give informed consent
Exclusion criteria
* Neurologic disease or damage that would make the diagnosis of schizophrenia questionable * Current opioid or stimulant dependence (SCID) * Not appropriate due to safety concerns (based on risk assessment)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Workforce Participation Measure - Total Number of Jobs Attained | Baseline to post-treatment (18-months) | 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) |
| Overall Job Attainment Proportion | Study start through 18 months of the active portion of the study. | This is the proportion of participants, by group, that attained at least one job during the active portion of the study. |
| Job Participant Composite-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. | This is a composite of hours work per week X number of weeks worked, in each assessment period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Work Behavior Inventory | Baseline, mid-treatment (6-months), end of treatment (12-months), and post-treatment (18-months) | 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. |
| Specific Levels of Functioning (SLOF) | Baseline, mid-treatment (6-months), end of treatment (12-months), and post-treatment (18-months) | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 37 |
| 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) | 30 |
| Total | 67 |
Baseline characteristics
| Characteristic | Treatment As Usual | Integrated CBT With Computerized Cognitive Remediation | Total |
|---|---|---|---|
| Age, Continuous | 51.3 years STANDARD_DEVIATION 12.2 | 46.4 years STANDARD_DEVIATION 11.9 | 48.6 years STANDARD_DEVIATION 12.2 |
| Brief Negative Symptom Scale | 28.7 units on a scale STANDARD_DEVIATION 10.6 | 28.5 units on a scale STANDARD_DEVIATION 12.2 | 28.6 units on a scale STANDARD_DEVIATION 11.4 |
| Marital status Cohabitating | 1 Participants | 1 Participants | 2 Participants |
| Marital status Currently married | 3 Participants | 4 Participants | 7 Participants |
| Marital status Divorced | 8 Participants | 10 Participants | 18 Participants |
| Marital status Never married | 15 Participants | 18 Participants | 33 Participants |
| Marital status Separated | 2 Participants | 4 Participants | 6 Participants |
| Marital status Widowed | 1 Participants | 0 Participants | 1 Participants |
| Primary Diagnosis Schizoaffective disorder | 8 Participants | 6 Participants | 14 Participants |
| Primary Diagnosis Schizophrenia | 22 Participants | 31 Participants | 53 Participants |
| Race/Ethnicity, Customized Hispanic or Non-Hispanic ethnicity Hispanic | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Hispanic or Non-Hispanic ethnicity NonHispanic | 29 Participants | 37 Participants | 66 Participants |
| Race/Ethnicity, Customized Race Black of African American | 26 Participants | 25 Participants | 51 Participants |
| Race/Ethnicity, Customized Race Caucasian | 3 Participants | 9 Participants | 12 Participants |
| Race/Ethnicity, Customized Race More than one race | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Race Native American, Alaskan native | 0 Participants | 2 Participants | 2 Participants |
| Region of Enrollment United States | 30 Participants | 37 Participants | 67 Participants |
| Scale for the Assessment of Positive Symptoms | 30.5 units on a scale STANDARD_DEVIATION 14.3 | 27.6 units on a scale STANDARD_DEVIATION 20.1 | 28.9 units on a scale STANDARD_DEVIATION 17.7 |
| Sex: Female, Male Female | 5 Participants | 5 Participants | 10 Participants |
| Sex: Female, Male Male | 25 Participants | 32 Participants | 57 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 37 | 0 / 30 |
| other Total, other adverse events | 0 / 37 | 0 / 30 |
| serious Total, serious adverse events | 12 / 37 | 9 / 30 |
Outcome results
Primary
Job Participant Composite-hours Worked
This is a composite of hours work per week X number of weeks worked, in each assessment period.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| iCBT Group | Job Participant Composite-hours Worked | Baseline to intervention start point | 96.5 Hours worked | Standard Deviation 361.1 |
| iCBT Group | Job Participant Composite-hours Worked | Intervention start to 6 mos. | 109.3 Hours worked | Standard Deviation 228.8 |
| iCBT Group | Job Participant Composite-hours Worked | 6-12 mos. | 110.8 Hours worked | Standard Deviation 221.6 |
| iCBT Group | Job Participant Composite-hours Worked | 12-18 mos. | 123.5 Hours worked | Standard Deviation 245.8 |
| TAU Group | Job Participant Composite-hours Worked | 12-18 mos. | 133.4 Hours worked | Standard Deviation 304.3 |
| TAU Group | Job Participant Composite-hours Worked | Baseline to intervention start point | 25.3 Hours worked | Standard Deviation 83.6 |
| TAU Group | Job Participant Composite-hours Worked | 6-12 mos. | 77.3 Hours worked | Standard Deviation 169.3 |
| TAU Group | Job Participant Composite-hours Worked | Intervention start to 6 mos. | 27.0 Hours worked | Standard Deviation 118.5 |
Comparison: Compare the groups on proportions in employment at the 6 month assessment points.p-value: <0.3395% CI: [-2.67, 0.89]Mixed Models Analysis
Comparison: Compare the groups on proportions in employment at the 12 month assessment points.p-value: <0.5495% CI: [-1.14, 2.19]Mixed Models Analysis
Comparison: Compare the groups on proportions in employment at the 18 month assessment point.p-value: <0.7195% CI: [-1.32, 1.73]Mixed Models Analysis
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.
Time frame: Study start through 18 months of the active portion of the study.
Population: Participants with diagnoses of schizophrenia or schizoaffective disorder seeking employment
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| iCBT Group | Overall Job Attainment Proportion | No job attainment | 16 Participants |
| iCBT Group | Overall Job Attainment Proportion | At least one job attained | 21 Participants |
| TAU Group | Overall Job Attainment Proportion | No job attainment | 20 Participants |
| TAU Group | Overall Job Attainment Proportion | At least one job attained | 10 Participants |
Comparison: We conducted a 2 X 2 chi-square analysis of differences in proportion.p-value: <0.05Fisher Exact
Comparison: Chis Sq: group (iCBT/TAU) X Job attained (Yes/No)p-value: <0.0695% CI: [0.97, 7.13]Chi-squared
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)
Time frame: Baseline to post-treatment (18-months)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| iCBT Group | Workforce Participation Measure - Total Number of Jobs Attained | Baseline | 0 Number of jobs attained | Standard Deviation 0 |
| iCBT Group | Workforce Participation Measure - Total Number of Jobs Attained | 18 month follow-up (study end) | 0.95 Number of jobs attained | Standard Deviation 1.2 |
| TAU Group | Workforce Participation Measure - Total Number of Jobs Attained | Baseline | 0 Number of jobs attained | Standard Deviation 0 |
| TAU Group | Workforce Participation Measure - Total Number of Jobs Attained | 18 month follow-up (study end) | 0.43 Number of jobs attained | Standard Deviation 0.68 |
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.
Time frame: Baseline, mid-treatment (6-months), end of treatment (12-months), and post-treatment (18-months)
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| iCBT Group | Specific Levels of Functioning (SLOF) | 6 months | 125.3 score on a scale | Standard Deviation 18.1 |
| iCBT Group | Specific Levels of Functioning (SLOF) | Baseline | 128.0 score on a scale | Standard Deviation 12.87 |
| iCBT Group | Specific Levels of Functioning (SLOF) | 18 months | 127.9 score on a scale | Standard Deviation 13.3 |
| iCBT Group | Specific Levels of Functioning (SLOF) | 12 months | 127.8 score on a scale | Standard Deviation 13.1 |
| TAU Group | Specific Levels of Functioning (SLOF) | 18 months | 121.1 score on a scale | Standard Deviation 18.7 |
| TAU Group | Specific Levels of Functioning (SLOF) | Baseline | 123.0 score on a scale | Standard Deviation 19.33 |
| TAU Group | Specific Levels of Functioning (SLOF) | 12 months | 127.2 score on a scale | Standard Deviation 16.3 |
| TAU Group | Specific Levels of Functioning (SLOF) | 6 months | 127.8 score on a scale | Standard Deviation 10.9 |
p-value: <0.19Fisher Exact
p-value: <0.99Fisher Exact
p-value: <0.94Fisher Exact
p-value: <0.14Fisher Exact
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.
Time frame: Baseline, mid-treatment (6-months), end of treatment (12-months), and post-treatment (18-months)
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| iCBT Group | Work Behavior Inventory | Baseline | 5.0 units on a scale | Standard Deviation 0 |
| iCBT Group | Work Behavior Inventory | 6 months | 4.0 units on a scale | Standard Deviation 0 |