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

Primary Purpose

Social Anxiety

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Vocational Services as usual plus Cognitive Behavioral Therapy (CBT)
Usual Vocational Services
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Social Anxiety focused on measuring social anxiety, unemployment, cognitive behavioral therapy, group therapy, work, vocation

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Michigan

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Usual Vocational Services + CBT

Usual Vocational Services

Arm Description

This is the experimental intervention - Usual vocational services at a vocational services center plus additional cognitive behavioral therapy at vocational service center.

This is the care as usual intervention - Vocational services as usually delivered to service seeking clients

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
October 29, 2015
Last Updated
September 8, 2022
Sponsor
University of Michigan
Collaborators
University of California, Los Angeles, National Institutes of Health (NIH), National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT02633267
Brief Title
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

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
January 2016 (undefined)
Primary Completion Date
May 2021 (Actual)
Study Completion Date
May 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
University of California, Los Angeles, National Institutes of Health (NIH), National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Social Anxiety
Keywords
social anxiety, unemployment, cognitive behavioral therapy, group therapy, work, vocation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
250 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual Vocational Services + CBT
Arm Type
Experimental
Arm Description
This is the experimental intervention - Usual vocational services at a vocational services center plus additional cognitive behavioral therapy at vocational service center.
Arm Title
Usual Vocational Services
Arm Type
Active Comparator
Arm Description
This is the care as usual intervention - Vocational services as usually delivered to service seeking clients
Intervention Type
Behavioral
Intervention Name(s)
Vocational Services as usual plus Cognitive Behavioral Therapy (CBT)
Intervention Description
Teaches thought restructuring and exposure therapy to socially anxious job seekers delivered by vocational service professionals
Intervention Type
Behavioral
Intervention Name(s)
Usual Vocational Services
Intervention Description
Vocational services delivered by vocational professionals at vocational service center (e.g., resume assistance, job leads)
Primary Outcome Measure Information:
Title
Liebowitz Social Anxiety Scale
Description
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.
Time Frame
Mean scores across all timepoints: baseline, post treatment, 3 month, 6 month and 12 month follow up.
Secondary Outcome Measure Information:
Title
Patient Health Questionnaire
Description
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.
Time Frame
Mean scores across all timepoints(baseline, post treatment, 3 month, 6 month and 12 month follow up).
Title
Hours Worked Per Week
Description
How many hours per week worked during follow up period. Participants were asked to report weekly work hours starting at 3 month follow up.
Time Frame
Mean scores across all timepoints(3 month, 6 month and 12 month follow up), to show change across time.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph A Himle, Ph.D.
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States

12. IPD Sharing Statement

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

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