- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01654510
A Systems Level Intervention for Unemployed Persons With Social Anxiety Disorder
July 30, 2012 updated by: Joseph Himle, University of Michigan
A Systems Level Intervention for Unemployed Persons With Social Anxiety
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
165
Phase
- Phase 2
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: 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.
|
|
ACTIVE_COMPARATOR: Vocational Services as Usual Control
Vocational services typically present in a comprehensive vocational service center.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Liebowitz Social Anxiety Scale
Time Frame: April 2008 - March 2012 (4 years)
|
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)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Employment Status
Time Frame: April 2008 - March 2012 (4 years)
|
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)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Joseph Himle, PhD, University of Michigan
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2008
Primary Completion (ACTUAL)
March 1, 2012
Study Completion (ACTUAL)
March 1, 2012
Study Registration Dates
First Submitted
May 10, 2012
First Submitted That Met QC Criteria
July 30, 2012
First Posted (ESTIMATE)
July 31, 2012
Study Record Updates
Last Update Posted (ESTIMATE)
July 31, 2012
Last Update Submitted That Met QC Criteria
July 30, 2012
Last Verified
July 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HUM00017734
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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