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Assessment and Treatment of Social Skills Deficits in Individuals With Social Phobia

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ClinicalTrials.gov Identifier: NCT00073333
Recruitment Status : Completed
First Posted : November 21, 2003
Results First Posted : July 2, 2013
Last Update Posted : July 18, 2013
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Deborah C. Beidel, Milton S. Hershey Medical Center

Tracking Information
First Submitted Date  ICMJE November 19, 2003
First Posted Date  ICMJE November 21, 2003
Results First Submitted Date  ICMJE May 14, 2013
Results First Posted Date  ICMJE July 2, 2013
Last Update Posted Date July 18, 2013
Study Start Date  ICMJE December 2002
Actual Primary Completion Date March 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 14, 2013)
  • Social Phobia Remission [ Time Frame: Measured at Month 12 ]
  • Social Phobia Remission Rate at 6 Month Follow-up [ Time Frame: 6 month follow up ]
    Lack of SocialPhobia Diagnosis at 6 month follow-up
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00073333 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 6, 2007)
Score on the SPAI [ Time Frame: Measured at Month 12 ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Assessment and Treatment of Social Skills Deficits in Individuals With Social Phobia
Official Title  ICMJE Social Phobia: Assessment and Treatment of Social Skills
Brief Summary This study will determine whether people with social phobia are deficient in certain social skills.
Detailed Description

Social phobia is a debilitating condition that can cause severe social, emotional, educational, and occupational functioning problems. Evidence suggests that individuals with social phobia are deficient in social skills, but the exact skills deficits have not been elucidated. This study will comprise two substudies: one will examine social skills deficits in social phobics and determine how they differ from those of people without social phobia; the other will determine if skills deficits in social phobics can be improved and whether improvements will affect overall social functioning.

Participants in this study will be randomly assigned to one of three groups for 16 weeks: an exposure group, a social skills training and exposure (SET) group, or a wait-list control group. Interviews, self-reports, and simulated role plays will be used to assess the social skills of participants.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Social Phobia
Intervention  ICMJE
  • Behavioral: Social Skills Training
    Social skills training once per week
  • Behavioral: Exposure Treatment
    Exposure once per week
  • Behavioral: Placebo
    Placebo
Study Arms  ICMJE
  • Active Comparator: 1
    Social skills training and exposure
    Intervention: Behavioral: Social Skills Training
  • Active Comparator: 2
    Exposure treatment
    Intervention: Behavioral: Exposure Treatment
  • Placebo Comparator: 3
    Placebo
    Intervention: Behavioral: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 14, 2013)
379
Original Enrollment  ICMJE
 (submitted: June 23, 2005)
380
Actual Study Completion Date  ICMJE March 2008
Actual Primary Completion Date March 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis of Social Phobia

Exclusion Criteria:

  • Axis II diagnosis of schizoid or schizotypal personality disorder or paranoia
  • Axis II diagnosis of mental retardation, obsessive-compulsive disorder, and personality disorders, except for avoidant personality disorder
  • Instability on any antidepressants
  • Psychotic disorder
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00073333
Other Study ID Numbers  ICMJE R01MH062547( U.S. NIH Grant/Contract )
R01MH062547 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Deborah C. Beidel, Milton S. Hershey Medical Center
Study Sponsor  ICMJE Milton S. Hershey Medical Center
Collaborators  ICMJE National Institute of Mental Health (NIMH)
Investigators  ICMJE Not Provided
PRS Account Milton S. Hershey Medical Center
Verification Date July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP