NCT01654510

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
165

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Apr 2008

Typical duration for phase_2

Status
completed

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

Study Start

First participant enrolled

April 1, 2008

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 10, 2012

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 31, 2012

Completed
Last Updated

July 31, 2012

Status Verified

July 1, 2012

Enrollment Period

3.9 years

First QC Date

May 10, 2012

Last Update Submit

July 30, 2012

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    April 2008 - March 2012 (4 years)

Secondary Outcomes (1)

  • Employment Status

    April 2008 - March 2012 (4 years)

Study Arms (2)

Cognitive Behavioral Therapy Group

EXPERIMENTAL
Behavioral: Cognitive Behavioral Therapy Group

Vocational Services as Usual Control

ACTIVE COMPARATOR

Vocational services typically present in a comprehensive vocational service center.

Other: Vocational Services as Usual

Interventions

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.

Cognitive Behavioral Therapy Group
Vocational Services as Usual Control

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • JVS service-seeking adults
  • Unemployed
  • Score at least four on the MINI-SPIN

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Phobia, Social

Condition Hierarchy (Ancestors)

Phobic DisordersAnxiety DisordersMental Disorders

Study Officials

  • Joseph Himle, PhD

    University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 10, 2012

First Posted

July 31, 2012

Study Start

April 1, 2008

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

July 31, 2012

Record last verified: 2012-07