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
About this trial
This is an interventional treatment trial for Social Anxiety Disorder
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
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
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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