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A Systems Level Intervention for Unemployed Persons With Social Anxiety Disorder

Primary Purpose

Social Anxiety Disorder

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Cognitive Behavioral Therapy Group
Vocational Services as Usual
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Social Anxiety Disorder

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • JVS service-seeking adults
  • Unemployed
  • Score at least four on the MINI-SPIN
  • Meet structured interview criteria for Social Anxiety Disorder and other study related inclusion criteria described below.

Exclusion Criteria:

  • Substance use dependence within the past 1 month
  • Current use of opiates or freebase cocaine
  • Chronic neurological disorder; mental retardation
  • Current bipolar I disorder
  • Medical conditions contraindicating study treatment
  • Prominent suicidal/homicidal ideation with imminent risk

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Cognitive Behavioral Therapy Group

    Vocational Services as Usual Control

    Arm Description

    Vocational services typically present in a comprehensive vocational service center.

    Outcomes

    Primary Outcome Measures

    Liebowitz Social Anxiety Scale
    The primary symptom measure for assessing treatment outcome will be the Liebowitz Social Anxiety Scale (LSAS: Liebowitz, 1987). It assesses fear and avoidance of several social interaction and performance situations.

    Secondary Outcome Measures

    Employment Status
    Reported number of paid work hours per week and the reported number of weeks working at least 35 hours per week (full-time) during the follow-up period.

    Full Information

    First Posted
    May 10, 2012
    Last Updated
    July 30, 2012
    Sponsor
    University of Michigan
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01654510
    Brief Title
    A Systems Level Intervention for Unemployed Persons With Social Anxiety Disorder
    Official Title
    A Systems Level Intervention for Unemployed Persons With Social Anxiety
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2008 (undefined)
    Primary Completion Date
    March 2012 (Actual)
    Study Completion Date
    March 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Michigan

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The goal of the proposed research is to design and develop a culturally appropriate, vocationally focused, sustainable, cognitive-behavioral intervention for unemployed, economically disadvantaged, urban-dwelling persons whose job attainment efforts have been undermined by the presence of social anxiety disorder.
    Detailed Description
    The goal of the proposed research is to gather information from Jewish Vocational Service consumers and employees about the association between social anxiety disorder and unemployment. A recent nationally representative epidemiological study places the lifetime prevalence of DSM-IV SocAD at 12.1% (Kessler et al., 2005). Social anxiety disorder is associated with notable impairments in social functioning (Kessler, 2003; Stein and Kean, 2000). A large majority of people with social anxiety disorder report significant impairment in occupational functioning (Stein, et al., 2000; Turner et al., 1986). Specific impairments include turning down job offers and promotions (Stein, Torgrud, & Walker, 2000), reduced productivity and job performance (Wittchen, et al., 2000), lowered educational attainment & early school dropout (Stein & Kean, 2000), increased unemployment (Heimberg et al.,1990a), financial dependence (Scheier et al, 1992), and reduced income (Magee et al., 1996). Social anxiety disorder likely interferes with job attainment due to job interview avoidance, excessive anxious arousal during job interviews, and limited social networks to provide job leads. Our longitudinal study of mothers receiving welfare found that the diagnosis of social anxiety disorder was the strongest psychiatric predictor of reliance on welfare for support over time. We have also completed a study that identifies social anxiety disorder as the only psychiatric disorder that significantly interferes with attaining work among individuals who participated in an internationally tested, best-practice, vocational services intervention program. We have begun to screen individuals for the presence of social anxiety at Jewish Vocational Service in Detroit, Michigan, where the primary clientele are economically disadvantaged, African Americans who are seeking work. Our screening efforts confirm the association between suspected social anxiety disorder and unemployment in this population. This project will build upon these findings and will interview JVS consumers and employees to gain more insight and knowledge into the relationship between social anxiety disorder and unemployment. It will also inform future research on the design and development of a culturally appropriate, vocationally focused, sustainable, cognitive-behavioral intervention for unemployed, economically disadvantaged, urban-dwelling persons whose job attainment efforts have been undermined by the presence of social anxiety disorder.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Social Anxiety Disorder

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    165 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Cognitive Behavioral Therapy Group
    Arm Type
    Experimental
    Arm Title
    Vocational Services as Usual Control
    Arm Type
    Active Comparator
    Arm Description
    Vocational services typically present in a comprehensive vocational service center.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Cognitive Behavioral Therapy Group
    Intervention Description
    This is a cognitive behavioral therapy group designed for homeless, unemployed people utelizing vocational rehabilitation services. The group is administered on a bi-weekly basis for four weeks, totalling eight sessions.
    Intervention Type
    Other
    Intervention Name(s)
    Vocational Services as Usual
    Primary Outcome Measure Information:
    Title
    Liebowitz Social Anxiety Scale
    Description
    The primary symptom measure for assessing treatment outcome will be the Liebowitz Social Anxiety Scale (LSAS: Liebowitz, 1987). It assesses fear and avoidance of several social interaction and performance situations.
    Time Frame
    April 2008 - March 2012 (4 years)
    Secondary Outcome Measure Information:
    Title
    Employment Status
    Description
    Reported number of paid work hours per week and the reported number of weeks working at least 35 hours per week (full-time) during the follow-up period.
    Time Frame
    April 2008 - March 2012 (4 years)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: JVS service-seeking adults Unemployed Score at least four on the MINI-SPIN Meet structured interview criteria for Social Anxiety Disorder and other study related inclusion criteria described below. Exclusion Criteria: Substance use dependence within the past 1 month Current use of opiates or freebase cocaine Chronic neurological disorder; mental retardation Current bipolar I disorder Medical conditions contraindicating study treatment Prominent suicidal/homicidal ideation with imminent risk
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Joseph Himle, PhD
    Organizational Affiliation
    University of Michigan
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    25461793
    Citation
    Himle JA, Bybee D, Steinberger E, Laviolette WT, Weaver A, Vlnka S, Golenberg Z, Levine DS, Heimberg RG, O'Donnell LA. Work-related CBT versus vocational services as usual for unemployed persons with social anxiety disorder: A randomized controlled pilot trial. Behav Res Ther. 2014 Dec;63:169-76. doi: 10.1016/j.brat.2014.10.005. Epub 2014 Oct 30.
    Results Reference
    derived

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    A Systems Level Intervention for Unemployed Persons With Social Anxiety Disorder

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