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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00073333
Other study ID # R01MH062547
Secondary ID R01MH062547
Status Completed
Phase N/A
First received November 19, 2003
Last updated July 1, 2013
Start date December 2002
Est. completion date March 2008

Study information

Verified date July 2013
Source Milton S. Hershey Medical Center
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

This study will determine whether people with social phobia are deficient in certain social skills.


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.


Recruitment information / eligibility

Status Completed
Enrollment 379
Est. completion date March 2008
Est. primary completion date March 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
Social Skills Training
Social skills training once per week
Exposure Treatment
Exposure once per week
Placebo
Placebo

Locations

Country Name City State
United States Penn State Milton S. Hershey Medical Center Hershey Pennsylvania

Sponsors (2)

Lead Sponsor Collaborator
Milton S. Hershey Medical Center National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Social Phobia Remission Measured at Month 12 No
Primary Social Phobia Remission Rate at 6 Month Follow-up Lack of SocialPhobia Diagnosis at 6 month follow-up 6 month follow up No
Secondary Score on the SPAI Measured at Month 12 No
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