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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
165

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Cognitive Behavioral Therapy Group
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.
ACTIVE_COMPARATOR: Vocational Services as Usual Control
Vocational services typically present in a comprehensive vocational service center.
Other: Vocational Services as Usual

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Michigan

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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.

General Publications

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2008

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2012

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 10, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 30, 2012

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 31, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 31, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 30, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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