1/2 A Multi-site Systems Intervention for Unemployed Persons With Social Anxiety
1 other identifier
interventional
250
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2016
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 29, 2015
CompletedFirst Posted
Study publicly available on registry
December 17, 2015
CompletedStudy Start
First participant enrolled
January 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2021
CompletedResults Posted
Study results publicly available
June 23, 2022
CompletedSeptember 21, 2022
September 1, 2022
5.3 years
October 29, 2015
April 20, 2022
September 8, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Patient Health Questionnaire
Mean scores across all timepoints(baseline, post treatment, 3 month, 6 month and 12 month follow up).
Hours Worked Per Week
Mean scores across all timepoints(3 month, 6 month and 12 month follow up), to show change across time.
Study Arms (2)
Usual Vocational Services + CBT
EXPERIMENTALThis is the experimental intervention - Usual vocational services at a vocational services center plus additional cognitive behavioral therapy at vocational service center.
Usual Vocational Services
ACTIVE COMPARATORThis is the care as usual intervention - Vocational services as usually delivered to service seeking clients
Interventions
Teaches thought restructuring and exposure therapy to socially anxious job seekers delivered by vocational service professionals
Vocational services delivered by vocational professionals at vocational service center (e.g., resume assistance, job leads)
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Michiganlead
- University of California, Los Angelescollaborator
- National Institutes of Health (NIH)collaborator
- National Institute of Mental Health (NIMH)collaborator
Study Sites (1)
University of Michigan
Ann Arbor, Michigan, 48109, United States
Related Publications (1)
Metts AV, LeBeau RT, Craske MG, Himle JA. Perceived interpersonal competence as a predictor of clinical outcomes in a randomized controlled trial for social anxiety and employment. Cogn Behav Ther. 2023 Mar;52(2):146-162. doi: 10.1080/16506073.2022.2137578. Epub 2022 Nov 21.
PMID: 36409226DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Joseph Himle
- Organization
- University of Michigan
Study Officials
- PRINCIPAL INVESTIGATOR
Joseph A Himle, Ph.D.
University of Michigan
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
October 29, 2015
First Posted
December 17, 2015
Study Start
January 1, 2016
Primary Completion
May 1, 2021
Study Completion
May 1, 2021
Last Updated
September 21, 2022
Results First Posted
June 23, 2022
Record last verified: 2022-09