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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01654510
Other study ID # HUM00017734
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received May 10, 2012
Last updated July 30, 2012
Start date April 2008
Est. completion date March 2012

Study information

Verified date July 2012
Source University of Michigan
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 165
Est. completion date March 2012
Est. primary completion date March 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 60 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Intervention

Behavioral:
Cognitive Behavioral Therapy Group
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.
Other:
Vocational Services as Usual


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Michigan

Outcome

Type Measure Description Time frame Safety issue
Primary 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. April 2008 - March 2012 (4 years) No
Secondary 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. April 2008 - March 2012 (4 years) No
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