Clinical trial NCT02633267: 1/2 A Multi-site Systems Intervention for Unemployed Persons With Social Anxiety
Official title: 1/2 A Multi-site Systems Intervention for Unemployed Persons With Social Anxiety
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Social Anxiety
Keywords: social anxiety
unemployment
cognitive behavioral therapy
group therapy
work
vocation
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: University of California, Los Angeles
name: National Institutes of Health (NIH)
name: National Institute of Mental Health (NIMH)
First posted: 2015-12-17
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Social anxiety disorder is a highly prevalent condition that interferes with employment. Prior research indicates that social anxiety disorder interferes with work attainment. This project involves a two-site randomized trial of a community-based cognitive-behavioral intervention to reduce social anxiety and improve employment outcomes among unemployed persons with social anxiety disorder.

Detailed description: The goal of the proposed research is to conduct a multi-site trial of a cognitive-behavioral intervention for enhancing employment success among unemployed persons whose job attainment efforts have been undermined by social anxiety disorder. Social anxiety disorder is a very common and impairing condition, with negative impacts on occupational functioning. Work-related impairments include turning down job offers and promotions, reduced productivity and job performance, lowered educational attainment, increased unemployment, financial dependence, and reduced income. The investigators have shown that social anxiety disorder was the strongest psychiatric predictor of sustained reliance on welfare for support. In response to these documented employment-related impairments, the investigators produced an eight-session work-related group cognitive behavioral therapy (WCBT) that, when coupled with standard vocational rehabilitation services, significantly improved social anxiety, depression, job search behaviors and job search self-confidence compared to a control group of socially anxious jobs seekers who received only vocational services as usual (VAU).

Participants in this pilot R34 study were all homeless, primarily African American, urban-based job-seekers with high levels of psychiatric comorbidity and limited education and employment histories. WCBT is designed in a context and style that overcomes accessibility and stigma-related obstacles with special focus on employment-related targets. The current collaborative RO1 will involve two academic, investigative teams and the staff of two community-based employment service agencies to further evaluate WCBT compared to VAU.

This two-region study will address whether WCBT enhances job placement and retention assessed over a one-year interval. In addition, this trial will test the implementation of WCBT in a new vocational service agency that was not involved in the development of WCBT, and whether the effects of WCBT generalize to a new population of urban-based, racially diverse job-seekers with educational and educational histories that differ from the original WCBT study site. The investigators will also investigate the system effects of WCBT in the new site that will be informative for broad implementation of WCBT nationwide. Finally, as an innovative extension from the R34, this project will incorporate implementation tools of technology-assisted provider training and delivery of WCBT.

Eligibility criteria: Inclusion Criteria:

* Participants will be:
* JVS service-seeking adults who are unemployed
* Screen positive for social anxiety, and
* Meet diagnostic criteria for social anxiety.
* Potential Participant taking psychotropic medications will be offered participation without restriction.

Exclusion Criteria:

* Presence of any of the following:
* Substance dependence; current opiates or freebase cocaine; schizophrenia, other psychotic symptoms and/or manic symptoms that would interfere with study participation
* Current anorexia nervosa
* Prior course of cognitive behavioral therapy for social anxiety (at least 8 sessions)
* Prominent suicidal/homicidal ideation with imminent risk
* Persons meeting diagnostic criteria for substance abuse if they are unable to attend sessions while not under the influence, except for those abusing opiates or freebase cocaine who will be excluded
* Persons who score below 6th grade reading level
* Non-English speaking participants

Primary outcomes:
measure: Liebowitz Social Anxiety Scale
timeFrame: Mean scores across all timepoints: baseline, post treatment, 3 month, 6 month and 12 month follow up.
Secondary outcomes:
measure: Patient Health Questionnaire
timeFrame: Mean scores across all timepoints(baseline, post treatment, 3 month, 6 month and 12 month follow up).
measure: Hours Worked Per Week
timeFrame: Mean scores across all timepoints(3 month, 6 month and 12 month follow up), to show change across time.
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Joseph A Himle, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: