Social AnxietyNCT02633267
1/2 A Multi-site Systems Intervention for Unemployed Persons With Social Anxiety
A study testing Vocational Services as usual plus Cognitive Behavioral Therapy (CBT) and Usual Vocational Services in people with Social Anxiety, run by University of Michigan at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Social Anxiety
- What is being tested?
- Vocational Services as usual plus Cognitive Behavioral Therapy (CBT) and Usual Vocational Services
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to May 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Social Anxiety
- Being tested
- Vocational Services as usual plus Cognitive Behavioral Therapy (CBT), Usual Vocational Services
- Keywords
- social anxiety, unemployment, cognitive behavioral therapy, group therapy, work, vocation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vocational Services as usual plus Cognitive Behavioral Therapy (CBT)Behavioural
Teaches thought restructuring and exposure therapy to socially anxious job seekers delivered by vocational service professionals
Usual Vocational ServicesBehavioural
Vocational services delivered by vocational professionals at vocational service center (e.g., resume assistance, job leads)
| Study group | Role | What they receive |
|---|---|---|
| Usual Vocational Services + CBT | Experimental | This is the experimental intervention - Usual vocational services at a vocational services center plus additional cognitive behavioral therapy at vocational service center. Receives: Behavioral: Vocational Services as usual plus Cognitive Behavioral Therapy (CBT); Behavioral: Usual Vocational Services |
| Usual Vocational Services | Active comparator | This is the care as usual intervention - Vocational services as usually delivered to service seeking clients Receives: Behavioral: Usual Vocational Services |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Mean scores across all timepoints: baseline, post treatment, 3 month, 6 month and 12 month follow up.
Secondary outcomes (2)
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.
Measured: Mean scores across all timepoints(baseline, post treatment, 3 month, 6 month and 12 month follow up).
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.
Measured: Mean scores across all timepoints(3 month, 6 month and 12 month follow up), to show change across time.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2015 (estimated)
- Study startJan 2016
- Primary completionMay 2021
- Study completionMay 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Social AnxietyStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Los Angeles, National Institutes of Health (NIH), National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Joseph Himle, University of Michigan
- Investigators
- Joseph A Himle, Ph.D., Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02633267
- Sponsor's protocol ID
- 1R01MH102263-01A1
- Other IDs
- 1R01MH102263-01A1
- Status last verified
- Sep 2022
- First submitted
- 29 Oct 2015
- Last updated
- 21 Sep 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 36409226
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 1/2 A Multi-site Systems Intervention for Unemployed Persons With Social Anxiety
- ClinicalTrials.gov ID
- NCT02633267
- Acronym / sponsor ID
- 1R01MH102263-01A1
- Conditions
- Social Anxiety
- Keywords
- social anxiety, unemployment, cognitive behavioral therapy, group therapy, work, vocation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- University of California, Los Angeles, National Institutes of Health (NIH), National Institute of Mental Health (NIMH)
- Study start
- Jan 2016
- Primary completion
- May 2021 (actual)
- Study completion
- May 2021 (actual)
- First posted
- 17 Dec 2015 (estimated)
- Results
- Posted 23 Jun 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Vocational Services + CBT | Experimental | Behavioral: Vocational Services as usual plus Cognitive Behavioral Therapy (CBT), Behavioral: Usual Vocational ServicesThis 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 comparator | Behavioral: Usual Vocational ServicesThis is the care as usual intervention - Vocational services as usually delivered to service seeking clients |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Behavioural | Usual Vocational Services + CBT |
| Usual Vocational ServicesVocational services delivered by vocational professionals at vocational service center (e.g., resume assistance, job leads) | Behavioural | Usual Vocational Services, Usual Vocational Services + CBT |
Primary outcome
Liebowitz Social Anxiety Scale
Time frame: Mean scores across all timepoints: baseline, post treatment, 3 month, 6 month and 12 month follow up.
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.
2 secondary outcomes
Patient Health Questionnaire
Time frame: Mean scores across all timepoints(baseline, post treatment, 3 month, 6 month and 12 month follow up).
Hours Worked Per Week
Time frame: Mean scores across all timepoints(3 month, 6 month and 12 month follow up), to show change across time.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36409226Metts 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph A Himle, Ph.D. principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vocational Services as usual plus Cognitive Behavioral Therapy (CBT) and Usual Vocational Services in people with Social Anxiety, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Jun 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Liebowitz Social Anxiety Scale (time frame: Mean scores across all timepoints: baseline, post treatment, 3 month, 6 month and 12 month follow up.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02633267, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2022.