Assessment and Treatment of Social Skills Deficits in Individuals With Social Phobia
Primary Purpose
Social Phobia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Social Skills Training
Exposure Treatment
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Social Phobia focused on measuring Phobic Disorders
Eligibility Criteria
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
Sites / Locations
- Penn State Milton S. Hershey Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
1
2
3
Arm Description
Social skills training and exposure
Exposure treatment
Placebo
Outcomes
Primary Outcome Measures
Social Phobia Remission
Social Phobia Remission Rate at 6 Month Follow-up
Lack of SocialPhobia Diagnosis at 6 month follow-up
Secondary Outcome Measures
Score on the SPAI
Full Information
NCT ID
NCT00073333
First Posted
November 19, 2003
Last Updated
July 1, 2013
Sponsor
Milton S. Hershey Medical Center
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT00073333
Brief Title
Assessment and Treatment of Social Skills Deficits in Individuals With Social Phobia
Official Title
Social Phobia: Assessment and Treatment of Social Skills
Study Type
Interventional
2. Study Status
Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
December 2002 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
March 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Milton S. Hershey Medical Center
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Social Phobia
Keywords
Phobic Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
379 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Social skills training and exposure
Arm Title
2
Arm Type
Active Comparator
Arm Description
Exposure treatment
Arm Title
3
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Behavioral
Intervention Name(s)
Social Skills Training
Intervention Description
Social skills training once per week
Intervention Type
Behavioral
Intervention Name(s)
Exposure Treatment
Intervention Description
Exposure once per week
Intervention Type
Behavioral
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Social Phobia Remission
Time Frame
Measured at Month 12
Title
Social Phobia Remission Rate at 6 Month Follow-up
Description
Lack of SocialPhobia Diagnosis at 6 month follow-up
Time Frame
6 month follow up
Secondary Outcome Measure Information:
Title
Score on the SPAI
Time Frame
Measured at Month 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Penn State Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Assessment and Treatment of Social Skills Deficits in Individuals With Social Phobia
We'll reach out to this number within 24 hrs