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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Social Phobia
Interventions Behavioral: Social Skills Training
Behavioral: Exposure Treatment
Behavioral: Placebo
Enrollment 379
Recruitment Details  
Pre-assignment Details There were two studies contained in this grant. Study 1 was an assessment study and consisted of 379 participants - 200 normal controls and 179 participants with social phobia. Study 2 was a treatment study that consisted of 106 participants with social phobia. That is the study described below.
Arm/Group Title 1Social Effectiveness Therapy 2Imaginal and In Vivo Exposure 3Attention Placebo
Hide Arm/Group Description Social skills training and exposure therapy - each conducted once per week. Social Skills was conducted in groups of 4-6 participants. Exposure was individual therapy conducted weekly. Exposure treatment - imaginal and in vivo exposure conducted twice per week for entire study. Imaginal was instituted first followed by in vivo exposure in the form of programmed practice Placebo - attention placebo control condition consisting of weekly telephone contact of ten minutes during which clinical status, particularly level of depression was assessed. There was no other contact
Period Title: Overall Study
Started 46 41 19
Completed 32 27 19
Not Completed 14 14 0
Arm/Group Title 1Social Effectiveness Therapy 2Imaginal and in Vivo Exposure Attention Placebo Control Total
Hide Arm/Group Description Social skills training and exposure therapy - each conducted once per week. Exposure treatment - imaginal and in vivo exposure conducted twice per week Placebo - attention placebo control condition consisting of weekly telephone contact Total of all reporting groups
Overall Number of Baseline Participants 46 41 19 106
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 46 participants 41 participants 19 participants 106 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
45
  97.8%
41
 100.0%
19
 100.0%
105
  99.1%
>=65 years
1
   2.2%
0
   0.0%
0
   0.0%
1
   0.9%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 46 participants 41 participants 19 participants 106 participants
36.7  (14.4) 36.1  (13.8) 36.4  (14.2) 36.3  (13.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 46 participants 41 participants 19 participants 106 participants
Female
25
  54.3%
18
  43.9%
12
  63.2%
55
  51.9%
Male
21
  45.7%
23
  56.1%
7
  36.8%
51
  48.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 46 participants 41 participants 19 participants 106 participants
46 41 19 106
1.Primary Outcome
Title Social Phobia Remission
Hide Description [Not Specified]
Time Frame Measured at Month 12
Outcome Measure Data Not Reported
2.Primary Outcome
Title Social Phobia Remission Rate at 6 Month Follow-up
Hide Description Lack of SocialPhobia Diagnosis at 6 month follow-up
Time Frame 6 month follow up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Social Effectiveness Therapy Imaginal and In Vivo Exposure Attention Placebo Control
Hide Arm/Group Description:
Social skills training and exposure therapy - each conducted once per week.
Exposure treatment - imaginal and in vivo exposure conducted twice per week
Placebo - attention placebo control condition consisting of weekly telephone contact
Overall Number of Participants Analyzed 46 41 19
Measure Type: Number
Unit of Measure: participants
29 23 NA [1] 
[1]
Wait list was treated at the end of 12 weeks
3.Secondary Outcome
Title Score on the SPAI
Hide Description [Not Specified]
Time Frame Measured at Month 12
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Social Effectiveness Therapy Imaginal and In Vivo Exposure Attention Placebo Control
Hide Arm/Group Description Social skills training and exposure therapy - each conducted once per week. Exposure treatment - imaginal and in vivo exposure conducted twice per week Placebo - attention placebo control condition consisting of weekly telephone contact
All-Cause Mortality
Social Effectiveness Therapy Imaginal and In Vivo Exposure Attention Placebo Control
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Social Effectiveness Therapy Imaginal and In Vivo Exposure Attention Placebo Control
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/46 (0.00%)   0/41 (0.00%)   0/19 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Social Effectiveness Therapy Imaginal and In Vivo Exposure Attention Placebo Control
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/46 (0.00%)   0/41 (0.00%)   0/19 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Deborah C. Beidel, Ph.D.
Organization: University of Central Florida
Phone: 407-823-3254
EMail: deborah.beidel@ucf.edu
Layout table for additonal information
Responsible Party: Deborah C. Beidel, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT00073333     History of Changes
Other Study ID Numbers: R01MH062547 ( U.S. NIH Grant/Contract )
R01MH062547 ( U.S. NIH Grant/Contract )
First Submitted: November 19, 2003
First Posted: November 21, 2003
Results First Submitted: May 14, 2013
Results First Posted: July 2, 2013
Last Update Posted: July 18, 2013