- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00073333
Assessment and Treatment of Social Skills Deficits in Individuals With Social Phobia
Social Phobia: Assessment and Treatment of Social Skills
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Pennsylvania
-
Hershey, Pennsylvania, United States, 17033
- Penn State Milton S. Hershey Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: 3
Placebo
|
Placebo
|
|
Active Comparator: 1
Social skills training and exposure
|
Social skills training once per week
|
|
Active Comparator: 2
Exposure treatment
|
Exposure once per week
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Social Phobia Remission
Time Frame: Measured at Month 12
|
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
|
6 month follow up
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Score on the SPAI
Time Frame: Measured at Month 12
|
Measured at Month 12
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R01MH062547 (U.S. NIH Grant/Contract)
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