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1/2 A Multi-site Systems Intervention for Unemployed Persons With Social Anxiety

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ClinicalTrials.gov Identifier: NCT02633267
Recruitment Status : Recruiting
First Posted : December 17, 2015
Last Update Posted : June 20, 2019
Sponsor:
Collaborators:
University of California, Los Angeles
National Institutes of Health (NIH)
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Joseph Himle, University of Michigan

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Social Anxiety Behavioral: Vocational Services as usual plus Cognitive Behavioral Therapy (CBT) Behavioral: Usual Vocational Services Not Applicable

Detailed Description:

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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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 1/2 A Multi-site Systems Intervention for Unemployed Persons With Social Anxiety
Study Start Date : January 2016
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: 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.
Behavioral: 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

Behavioral: Usual Vocational Services
Vocational services delivered by vocational professionals at vocational service center (e.g., resume assistance, job leads)

Active Comparator: Usual Vocational Services
This is the care as usual intervention - Vocational services as usually delivered to service seeking clients
Behavioral: Usual Vocational Services
Vocational services delivered by vocational professionals at vocational service center (e.g., resume assistance, job leads)




Primary Outcome Measures :
  1. Liebowitz Social Anxiety Scale [ Time Frame: Change from baseline to post-treatment (4 weeks after baseline), and 3, 6 and 12 month follow-up ]
    measure of social anxiety


Secondary Outcome Measures :
  1. Patient Health Questionnaire [ Time Frame: Change from baseline to post-treatment (4 weeks after baseline), and 3, 6 and 12 month follow-up ]
    Rating scale for depression

  2. Hours worked per week [ Time Frame: Change from baseline to post-treatment (4 weeks after baseline), and 3, 6 and 12 month follow-up ]
    how many hours per week worked during follow up period



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants will be:
  • JVS service-seeking adults who are unemployed
  • Screen positive for social anxiety, and
  • Meet diagnostic criteria for social anxiety.
  • Potential Participant taking psychotropic medications will be offered participation without restriction.

Exclusion Criteria:

  • Presence of any of the following:
  • Substance dependence; current opiates or freebase cocaine; schizophrenia, other psychotic symptoms and/or manic symptoms that would interfere with study participation
  • Current anorexia nervosa
  • Prior course of cognitive behavioral therapy for social anxiety (at least 8 sessions)
  • Prominent suicidal/homicidal ideation with imminent risk
  • Persons meeting diagnostic criteria for substance abuse if they are unable to attend sessions while not under the influence, except for those abusing opiates or freebase cocaine who will be excluded
  • Persons who score below 6th grade reading level
  • Non-English speaking participants

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02633267


Contacts
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Contact: Katie M Check, M.S.W 7349368646 kmcheck@umich.edu
Contact: Scott Stanfill 7347632389 scottsta@umich.edu

Locations
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United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Joseph A Himle, Ph.D.    734-615-0611    himlej@umich.edu   
Sponsors and Collaborators
University of Michigan
University of California, Los Angeles
National Institutes of Health (NIH)
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Joseph A Himle, Ph.D. University of Michigan

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Responsible Party: Joseph Himle, Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT02633267     History of Changes
Other Study ID Numbers: 1R01MH102263-01A1 ( U.S. NIH Grant/Contract )
1R01MH102263-01A1 ( U.S. NIH Grant/Contract )
First Posted: December 17, 2015    Key Record Dates
Last Update Posted: June 20, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Joseph Himle, University of Michigan:
social anxiety
unemployment
cognitive behavioral therapy
group therapy
work
vocation

Additional relevant MeSH terms:
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Anxiety Disorders
Mental Disorders