Social Anxiety DisorderPhase 2/3NCT01654510
A Systems Level Intervention for Unemployed Persons With Social Anxiety Disorder
A Phase 2/3 study testing Cognitive Behavioral Therapy Group and Vocational Services as Usual in people with Social Anxiety Disorder, run by University of Michigan.
Trial summary
The goal of the proposed research is to design and develop a culturally appropriate, vocationally focused, sustainable, cognitive-behavioral intervention for unemployed, economically disadvantaged, urban-dwelling persons whose job attainment efforts have been undermined by the presence of social anxiety disorder. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Social Anxiety Disorder
- What is being tested?
- Cognitive Behavioral Therapy Group and Vocational Services as Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- No sites listed yet
- Study dates
- Apr 2008to Mar 2012
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
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
- JVS service-seeking adults
- Unemployed
- Score at least four on the MINI-SPIN
- Meet structured interview criteria for Social Anxiety Disorder and other study related inclusion criteria described below.
Who cannot join
- Substance use dependence within the past 1 month
- Current use of opiates or freebase cocaine
- Chronic neurological disorder; mental retardation
- Current bipolar I disorder
- Medical conditions contraindicating study treatment
- Prominent suicidal/homicidal ideation with imminent risk
About this study
Official title: A Systems Level Intervention for Unemployed Persons With Social Anxiety
The goal of the proposed research is to design and develop a culturally appropriate, vocationally focused, sustainable, cognitive-behavioral intervention for unemployed, economically disadvantaged, urban-dwelling persons whose job attainment efforts have been undermined by the presence of social anxiety disorder.
Read the detailed description
The goal of the proposed research is to gather information from Jewish Vocational Service consumers and employees about the association between social anxiety disorder and unemployment. A recent nationally representative epidemiological study places the lifetime prevalence of DSM-IV SocAD at 12.1% (Kessler et al., 2005). Social anxiety disorder is associated with notable impairments in social functioning (Kessler, 2003; Stein and Kean, 2000). A large majority of people with social anxiety disorder report significant impairment in occupational functioning (Stein, et al., 2000; Turner et al., 1986). Specific impairments include turning down job offers and promotions (Stein, Torgrud, \& Walker, 2000), reduced productivity and job performance (Wittchen, et al., 2000), lowered educational attainment \& early school dropout (Stein \& Kean, 2000), increased unemployment (Heimberg et al.,1990a), financial dependence (Scheier et al, 1992), and reduced income (Magee et al., 1996). Social anxiety disorder likely interferes with job attainment due to job interview avoidance, excessive anxious arousal during job interviews, and limited social networks to provide job leads. Our longitudinal study of mothers receiving welfare found that the diagnosis of social anxiety disorder was the strongest psychiatric predictor of reliance on welfare for support over time. We have also completed a study that identifies social anxiety disorder as the only psychiatric disorder that significantly interferes with attaining work among individuals who participated in an internationally tested, best-practice, vocational services intervention program. We have begun to screen individuals for the presence of social anxiety at Jewish Vocational Service in Detroit, Michigan, where the primary clientele are economically disadvantaged, African Americans who are seeking work. Our screening efforts confirm the association between suspected social anxiety disorder and unemployment in this population. This project will build upon these findings and will interview JVS consumers and employees to gain more insight and knowledge into the relationship between social anxiety disorder and unemployment. It will also inform future research on the design and development of a culturally appropriate, vocationally focused, sustainable, cognitive-behavioral intervention for unemployed, economically disadvantaged, urban-dwelling persons whose job attainment efforts have been undermined by the presence of social anxiety disorder.
- Conditions
- Social Anxiety Disorder
- Being tested
- Cognitive Behavioral Therapy Group, Vocational Services as Usual
- Medical subject headings
- Phobia, Social
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral Therapy GroupBehavioural
This is a cognitive behavioral therapy group designed for homeless, unemployed people utelizing vocational rehabilitation services. The group is administered on a bi-weekly basis for four weeks, totalling eight sessions.
Vocational Services as UsualOther
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Behavioral Therapy Group | Experimental | Not described Receives: Behavioral: Cognitive Behavioral Therapy Group |
| Vocational Services as Usual Control | Active comparator | Vocational services typically present in a comprehensive vocational service center. Receives: Other: Vocational Services as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Liebowitz Social Anxiety Scale
The primary symptom measure for assessing treatment outcome will be the Liebowitz Social Anxiety Scale (LSAS: Liebowitz, 1987). It assesses fear and avoidance of several social interaction and performance situations.
Measured: April 2008 - March 2012 (4 years)
Secondary outcomes (1)
Employment Status
Reported number of paid work hours per week and the reported number of weeks working at least 35 hours per week (full-time) during the follow-up period.
Measured: April 2008 - March 2012 (4 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2012 (estimated)
- Study startApr 2008
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Social Anxiety DisorderStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joseph Himle, University of Michigan
- Investigators
- Joseph Himle, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01654510
- Sponsor's protocol ID
- HUM00017734
- Status last verified
- Jul 2012
- First submitted
- 10 May 2012
- Last updated
- 31 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Himle JA, Bybee D, Steinberger E, Laviolette WT, Weaver A, Vlnka S, Golenberg Z, Levine DS, Heimberg RG, O'Donnell LA. Work-related CBT versus vocational services as usual for unemployed persons with social anxiety disorder: A randomized controlled pilot trial. Behav Res Ther. 2014 Dec;63:169-76. doi: 10.1016/j.brat.2014.10.005. Epub 2014 Oct 30.
PubMed 25461793
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Systems Level Intervention for Unemployed Persons With Social Anxiety
- ClinicalTrials.gov ID
- NCT01654510
- Acronym / sponsor ID
- HUM00017734
- Conditions
- Social Anxiety Disorder
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 31 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of the proposed research is to design and develop a culturally appropriate, vocationally focused, sustainable, cognitive-behavioral intervention for unemployed, economically disadvantaged, urban-dwelling persons whose job attainment efforts have been undermined by the presence of social anxiety disorder.
Detailed description
The goal of the proposed research is to gather information from Jewish Vocational Service consumers and employees about the association between social anxiety disorder and unemployment. A recent nationally representative epidemiological study places the lifetime prevalence of DSM-IV SocAD at 12.1% (Kessler et al., 2005). Social anxiety disorder is associated with notable impairments in social functioning (Kessler, 2003; Stein and Kean, 2000). A large majority of people with social anxiety disorder report significant impairment in occupational functioning (Stein, et al., 2000; Turner et al., 1986). Specific impairments include turning down job offers and promotions (Stein, Torgrud, \& Walker, 2000), reduced productivity and job performance (Wittchen, et al., 2000), lowered educational attainment \& early school dropout (Stein \& Kean, 2000), increased unemployment (Heimberg et al.,1990a), financial dependence (Scheier et al, 1992), and reduced income (Magee et al., 1996). Social anxiety disorder likely interferes with job attainment due to job interview avoidance, excessive anxious arousal during job interviews, and limited social networks to provide job leads. Our longitudinal study of mothers receiving welfare found that the diagnosis of social anxiety disorder was the strongest psychiatric predictor of reliance on welfare for support over time. We have also completed a study that identifies social anxiety disorder as the only psychiatric disorder that significantly interferes with attaining work among individuals who participated in an internationally tested, best-practice, vocational services intervention program. We have begun to screen individuals for the presence of social anxiety at Jewish Vocational Service in Detroit, Michigan, where the primary clientele are economically disadvantaged, African Americans who are seeking work. Our screening efforts confirm the association between suspected social anxiety disorder and unemployment in this population. This project will build upon these findings and will interview JVS consumers and employees to gain more insight and knowledge into the relationship between social anxiety disorder and unemployment. It will also inform future research on the design and development of a culturally appropriate, vocationally focused, sustainable, cognitive-behavioral intervention for unemployed, economically disadvantaged, urban-dwelling persons whose job attainment efforts have been undermined by the presence of social anxiety disorder.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive Behavioral Therapy Group | Experimental | Behavioral: Cognitive Behavioral Therapy Group |
| Vocational Services as Usual Control | Active comparator | Other: Vocational Services as UsualVocational services typically present in a comprehensive vocational service center. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- JVS service-seeking adults
- Unemployed
- Score at least four on the MINI-SPIN
- Meet structured interview criteria for Social Anxiety Disorder and other study related inclusion criteria described below.
Key exclusion criteria (6 listed)
- Substance use dependence within the past 1 month
- Current use of opiates or freebase cocaine
- Chronic neurological disorder; mental retardation
- Current bipolar I disorder
- Medical conditions contraindicating study treatment
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 |
|---|---|---|
| Cognitive Behavioral Therapy GroupThis is a cognitive behavioral therapy group designed for homeless, unemployed people utelizing vocational rehabilitation services. The group is administered on a bi-weekly basis for four weeks, totalling eight sessions. | Behavioural | Cognitive Behavioral Therapy Group |
| Vocational Services as Usual | Other | Vocational Services as Usual Control |
Primary outcome
Liebowitz Social Anxiety Scale
Time frame: April 2008 - March 2012 (4 years)
The primary symptom measure for assessing treatment outcome will be the Liebowitz Social Anxiety Scale (LSAS: Liebowitz, 1987). It assesses fear and avoidance of several social interaction and performance situations.
1 secondary outcome
Employment Status
Time frame: April 2008 - March 2012 (4 years)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2012.
- Derived from this study: PubMed 25461793Himle JA, Bybee D, Steinberger E, Laviolette WT, Weaver A, Vlnka S, Golenberg Z, Levine DS, Heimberg RG, O'Donnell LA. Work-related CBT versus vocational services as usual for unemployed persons with social anxiety disorder: A randomized controlled pilot trial. Behav Res Ther. 2014 Dec;63:169-76. doi: 10.1016/j.brat.2014.10.005. Epub 2014 Oct 30.
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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 Himle, PhD principal investigator
University of Michigan
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Cognitive Behavioral Therapy Group and Vocational Services as Usual in people with Social Anxiety Disorder, run by University of Michigan.
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 4 inclusion and 6 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 31 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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: April 2008 - March 2012 (4 years)). 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 NCT01654510, 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 31 Jul 2012.