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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01MH102263-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of California, Los Angeles | OTHER |
| National Institutes of Health (NIH) | NIH |
| National Institute of Mental Health (NIMH) | NIH |
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Social anxiety disorder is a highly prevalent condition that interferes with employment. Prior research indicates that social anxiety disorder interferes with work attainment. This project involves a two-site randomized trial of a community-based cognitive-behavioral intervention to reduce social anxiety and improve employment outcomes among unemployed persons with social anxiety disorder.
The goal of the proposed research is to conduct a multi-site trial of a cognitive-behavioral intervention for enhancing employment success among unemployed persons whose job attainment efforts have been undermined by social anxiety disorder. Social anxiety disorder is a very common and impairing condition, with negative impacts on occupational functioning. Work-related impairments include turning down job offers and promotions, reduced productivity and job performance, lowered educational attainment, increased unemployment, financial dependence, and reduced income. The investigators have shown that social anxiety disorder was the strongest psychiatric predictor of sustained reliance on welfare for support. In response to these documented employment-related impairments, the investigators produced an eight-session work-related group cognitive behavioral therapy (WCBT) that, when coupled with standard vocational rehabilitation services, significantly improved social anxiety, depression, job search behaviors and job search self-confidence compared to a control group of socially anxious jobs seekers who received only vocational services as usual (VAU).
Participants in this pilot R34 study were all homeless, primarily African American, urban-based job-seekers with high levels of psychiatric comorbidity and limited education and employment histories. WCBT is designed in a context and style that overcomes accessibility and stigma-related obstacles with special focus on employment-related targets. The current collaborative RO1 will involve two academic, investigative teams and the staff of two community-based employment service agencies to further evaluate WCBT compared to VAU.
This two-region study will address whether WCBT enhances job placement and retention assessed over a one-year interval. In addition, this trial will test the implementation of WCBT in a new vocational service agency that was not involved in the development of WCBT, and whether the effects of WCBT generalize to a new population of urban-based, racially diverse job-seekers with educational and educational histories that differ from the original WCBT study site. The investigators will also investigate the system effects of WCBT in the new site that will be informative for broad implementation of WCBT nationwide. Finally, as an innovative extension from the R34, this project will incorporate implementation tools of technology-assisted provider training and delivery of WCBT.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Vocational Services + CBT | Experimental | This is the experimental intervention - Usual vocational services at a vocational services center plus additional cognitive behavioral therapy at vocational service center. |
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| Usual Vocational Services | Active Comparator | This is the care as usual intervention - Vocational services as usually delivered to service seeking clients |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vocational Services as usual plus Cognitive Behavioral Therapy (CBT) | Behavioral | Teaches thought restructuring and exposure therapy to socially anxious job seekers delivered by vocational service professionals |
| Measure | Description | Time Frame |
|---|---|---|
| Liebowitz Social Anxiety Scale | Measure of social anxiety and avoidance. This first set of questions asks how anxious or fearful an individual feels in the situation. Ratings range from 0-3(0=none, 1=mild, 2=moderate, 3=severe). The second set of questions asks how often an individual would avoid the situation. Ratings range from 0-3(0=never, 1=occasionally, 2=often, 3=usually). Sums of each subscale(fear/anxiety and avoidance) are added together to create the total score. The severity scale for this measure is 0-54=subclinical, 55-64=moderate, 65-79=marked, 80-94=severe, 95-144(maximum score)=very severe. | Mean scores across all timepoints: baseline, post treatment, 3 month, 6 month and 12 month follow up. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Health Questionnaire | Rating scale for depression. Participants are asked how often they have been bothered by specific symptoms within the last two weeks. They are asked about 8 different symptoms on a rating scale from 0-3(0=not at all, 1=several days, 2=more than half the days, 3=nearly everyday). Participants are asked how difficult problems made for them "do work, take care of things at home, and get along with others." This item is rated from 0-3(0=not difficult at all, 1=somewhat difficult, 2=very difficult, 3=extremely difficult). The final score is the total of all eight responses. Ranges include 0-4= minimal depression, 5-9=mild depression, 10-14 moderate depression, 15-19 moderately severe depression, 20-24*=severe depression. Note: The study switched from using the PHQ-9 to the PHQ-8 midway throughout. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joseph A Himle, Ph.D. | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36409226 | Derived | Metts AV, LeBeau RT, Craske MG, Himle JA. Perceived interpersonal competence as a predictor of clinical outcomes in a randomized controlled trial for social anxiety and employment. Cogn Behav Ther. 2023 Mar;52(2):146-162. doi: 10.1080/16506073.2022.2137578. Epub 2022 Nov 21. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Usual Vocational Services + CBT | This is the experimental intervention - Usual vocational services at a vocational services center plus additional cognitive behavioral therapy at vocational service center. Vocational Services as usual plus Cognitive Behavioral Therapy (CBT): Teaches thought restructuring and exposure therapy to socially anxious job seekers delivered by vocational service professionals Usual Vocational Services: Vocational services delivered by vocational professionals at vocational service center (e.g., resume assistance, job leads) |
| FG001 | Usual Vocational Services | This is the care as usual intervention - Vocational services as usually delivered to service seeking clients Usual Vocational Services: Vocational services delivered by vocational professionals at vocational service center (e.g., resume assistance, job leads) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Usual Vocational Services + CBT | This is the experimental intervention - Usual vocational services at a vocational services center plus additional cognitive behavioral therapy at vocational service center. Vocational Services as usual plus Cognitive Behavioral Therapy (CBT): Teaches thought restructuring and exposure therapy to socially anxious job seekers delivered by vocational service professionals Usual Vocational Services: Vocational services delivered by vocational professionals at vocational service center (e.g., resume assistance, job leads) |
| 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 | Liebowitz Social Anxiety Scale | Measure of social anxiety and avoidance. This first set of questions asks how anxious or fearful an individual feels in the situation. Ratings range from 0-3(0=none, 1=mild, 2=moderate, 3=severe). The second set of questions asks how often an individual would avoid the situation. Ratings range from 0-3(0=never, 1=occasionally, 2=often, 3=usually). Sums of each subscale(fear/anxiety and avoidance) are added together to create the total score. The severity scale for this measure is 0-54=subclinical, 55-64=moderate, 65-79=marked, 80-94=severe, 95-144(maximum score)=very severe. | Posted | Mean | Standard Deviation | score on a scale | Mean scores across all timepoints: baseline, post treatment, 3 month, 6 month and 12 month follow up. |
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Adverse events were monitored from consent to to the final interview for each participant. The time frame was approximately 12-16 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 | Usual Vocational Services + CBT | This is the experimental intervention - Usual vocational services at a vocational services center plus additional cognitive behavioral therapy at vocational service center. Vocational Services as usual plus Cognitive Behavioral Therapy (CBT): Teaches thought restructuring and exposure therapy to socially anxious job seekers delivered by vocational service professionals Usual Vocational Services: Vocational services delivered by vocational professionals at vocational service center (e.g., resume assistance, job leads) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Joseph Himle | University of Michigan | (734) 615-0611 | himlej@umich.edu |
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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 | Dec 12, 2018 | May 24, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| Usual Vocational Services | Behavioral | Vocational services delivered by vocational professionals at vocational service center (e.g., resume assistance, job leads) |
|
| Mean scores across all timepoints(baseline, post treatment, 3 month, 6 month and 12 month follow up). |
| Hours Worked Per Week | How many hours per week worked during follow up period. Participants were asked to report weekly work hours starting at 3 month follow up. | Mean scores across all timepoints(3 month, 6 month and 12 month follow up), to show change across time. |
| BG001 | Usual Vocational Services | This is the care as usual intervention - Vocational services as usually delivered to service seeking clients Usual Vocational Services: Vocational services delivered by vocational professionals at vocational service center (e.g., resume assistance, job leads) |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG001 | Usual Vocational Services | This is the care as usual intervention - Vocational services as usually delivered to service seeking clients Usual Vocational Services: Vocational services delivered by vocational professionals at vocational service center (e.g., resume assistance, job leads) |
|
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| Secondary | Patient Health Questionnaire | Rating scale for depression. Participants are asked how often they have been bothered by specific symptoms within the last two weeks. They are asked about 8 different symptoms on a rating scale from 0-3(0=not at all, 1=several days, 2=more than half the days, 3=nearly everyday). Participants are asked how difficult problems made for them "do work, take care of things at home, and get along with others." This item is rated from 0-3(0=not difficult at all, 1=somewhat difficult, 2=very difficult, 3=extremely difficult). The final score is the total of all eight responses. Ranges include 0-4= minimal depression, 5-9=mild depression, 10-14 moderate depression, 15-19 moderately severe depression, 20-24*=severe depression. Note: The study switched from using the PHQ-9 to the PHQ-8 midway throughout. | Posted | Mean | Standard Deviation | score on a scale | Mean scores across all timepoints(baseline, post treatment, 3 month, 6 month and 12 month follow up). |
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| Secondary | Hours Worked Per Week | How many hours per week worked during follow up period. Participants were asked to report weekly work hours starting at 3 month follow up. | Posted | Mean | Standard Deviation | hours per week | Mean scores across all timepoints(3 month, 6 month and 12 month follow up), to show change across time. |
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| 0 |
| 120 |
| 0 |
| 120 |
| 0 |
| 120 |
| EG001 | Usual Vocational Services | This is the care as usual intervention - Vocational services as usually delivered to service seeking clients Usual Vocational Services: Vocational services delivered by vocational professionals at vocational service center (e.g., resume assistance, job leads) | 0 | 130 | 0 | 130 | 0 | 130 |
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| 3 month follow up |
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| 6 month follow up |
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| 12 month follow up |
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| 12 month follow up |
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