1/2 A Multi-site Systems Intervention for Unemployed Persons With Social Anxiety

Social Anxiety Clinical Trial

Official title:

1/2 A Multi-site Systems Intervention for Unemployed Persons With Social Anxiety

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02633267
• Other study ID #: 1R01MH102263-01A1
• Secondary ID: 1R01MH102263-01A
• Status: Completed
• Phase: N/A
• Start date: January 2016
• Est. completion date: May 2021

Study information

• Verified date: September 2022
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: May 2021
• Est. primary completion date: May 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Social Anxiety

Intervention

Behavioral:
• Vocational Services as usual plus Cognitive Behavioral Therapy (CBT)
Teaches thought restructuring and exposure therapy to socially anxious job seekers delivered by vocational service professionals
• Usual Vocational Services
Vocational services delivered by vocational professionals at vocational service center (e.g., resume assistance, job leads)

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (4)

Lead Sponsor	Collaborator
University of Michigan	National Institute of Mental Health (NIMH), National Institutes of Health (NIH), University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Liebowitz Social Anxiety Scale	Measure of social anxiety and avoidance. This first set of questions asks how anxious or fearful an individual feels in the situation. Ratings range from 0-3(0=none, 1=mild, 2=moderate, 3=severe). The second set of questions asks how often an individual would avoid the situation. Ratings range from 0-3(0=never, 1=occasionally, 2=often, 3=usually). Sums of each subscale(fear/anxiety and avoidance) are added together to create the total score. The severity scale for this measure is 0-54=subclinical, 55-64=moderate, 65-79=marked, 80-94=severe, 95-144(maximum score)=very severe.	Mean scores across all timepoints: baseline, post treatment, 3 month, 6 month and 12 month follow up.
Secondary	Patient Health Questionnaire	Rating scale for depression. Participants are asked how often they have been bothered by specific symptoms within the last two weeks. They are asked about 8 different symptoms on a rating scale from 0-3(0=not at all, 1=several days, 2=more than half the days, 3=nearly everyday). Participants are asked how difficult problems made for them "do work, take care of things at home, and get along with others." This item is rated from 0-3(0=not difficult at all, 1=somewhat difficult, 2=very difficult, 3=extremely difficult). The final score is the total of all eight responses. Ranges include 0-4= minimal depression, 5-9=mild depression, 10-14 moderate depression, 15-19 moderately severe depression, 20-24*=severe depression.; Note: The study switched from using the PHQ-9 to the PHQ-8 midway throughout.	Mean scores across all timepoints(baseline, post treatment, 3 month, 6 month and 12 month follow up).
Secondary	Hours Worked Per Week	How many hours per week worked during follow up period. Participants were asked to report weekly work hours starting at 3 month follow up.	Mean scores across all timepoints(3 month, 6 month and 12 month follow up), to show change across time.