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Adding Cognitive Behavioral Therapy to Drug Treatment for Social Anxiety Disorder

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00074802
First Posted: December 22, 2003
Last Update Posted: June 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Temple University
Results First Submitted: February 24, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition: Social Anxiety Disorder
Interventions: Drug: Paroxetine
Behavioral: Cognitive behavioral therapy (CBT)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment began in 2003 at the Adult Anxiety Clinic of Temple University and the Anxiety Disorders Clinic of the New York State Psychiatric Institute. 150 patients with Generalized Social Anxiety Disorder were enrolled in Phase I of the study (open treatment with the selective serotonin reuptake inhibitor paroxetine).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Among the 150 patients enrolled in Phase I, a total of 61 patients began Phase II These patients were classified as partial responders at week 12 (LSAS>29 but at least 10% improvement in LSAS score), and were therefore randomized to receive 16 weeks of continued treatment with paroxetine with or without CBT.

Reporting Groups
  Description
Paroxetine Continuation

Participants who showed only partial response to paroxetine in Phase 1 will receive continued treatment with paroxetine for 16 additional weeks.

Paroxetine: Treatment with paroxetine will consist of an immediate release, flexible dosage of 20 to 50 mg per day.

Paroxetine With CBT Augmentation

Participants who showed only partial response to paroxetine in Phase 1 will receive continued treatment with paroxetine plus cognitive behavioral therapy (CBT) for 16 additional weeks.

Paroxetine: Treatment with paroxetine will consist of an immediate release, flexible dosage of 20 to 50 mg per day.

Cognitive behavioral therapy (CBT): CBT will consist of 16 weekly treatment sessions.


Participant Flow:   Overall Study
    Paroxetine Continuation   Paroxetine With CBT Augmentation
STARTED [1]   29   32 
COMPLETED   20   25 
NOT COMPLETED   9   7 
[1] Patients included here were the subset of enrollees completing the open trial as partial responders.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Patients included here were the subset of enrollees completing the open trial as partial responders.

Reporting Groups
  Description
Paroxetine Continuation

Participants who showed only partial response to paroxetine in Phase 1 will receive continued treatment with paroxetine for 16 additional weeks.

Paroxetine: Treatment with paroxetine will consist of an immediate release, flexible dosage of 20 to 50 mg per day.

Paroxetine With CBT Augmentation

Participants who showed only partial response to paroxetine in Phase 1 will receive continued treatment with paroxetine plus cognitive behavioral therapy (CBT) for 16 additional weeks.

Paroxetine: Treatment with paroxetine will consist of an immediate release, flexible dosage of 20 to 50 mg per day.

Cognitive behavioral therapy (CBT): CBT will consist of 16 weekly treatment sessions.

Total Total of all reporting groups

Baseline Measures
   Paroxetine Continuation   Paroxetine With CBT Augmentation   Total 
Overall Participants Analyzed 
[Units: Participants]
 29   32   61 
Age 
[Units: Years]
Mean (Standard Deviation)
 35.38  (12.30)   32.22  (9.73)   33.72  (11.05) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      10  34.5%      8  25.0%      18  29.5% 
Male      19  65.5%      24  75.0%      43  70.5% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      3  10.3%      4  12.5%      7  11.5% 
Not Hispanic or Latino      26  89.7%      28  87.5%      54  88.5% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      3  10.3%      8  25.0%      11  18.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      8  27.6%      4  12.5%      12  19.7% 
White      13  44.8%      15  46.9%      28  45.9% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      5  17.2%      5  15.6%      10  16.4% 
Liebowitz Social Anxiety Scale [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 49.45  (19.23)   44.63  (13.60)   46.92  (16.55) 
[1] The Liebowitz Social Anxiety Scale is a 24-item clinician-administered measure, which provides 0-3 ratings for anxiety and avoidance of social and performance situations. Anxiety and avoidance ratings are summed across items, yielding a range of scores from 0-144, with higher scores representing greater severity of social anxiety symptoms.
Social Interaction Anxiety Scale [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 39.30  (11.08)   35.43  (12.35)   37.19  (11.85) 
[1] The Social Interaction Anxiety Scale is a 20-item self-report measure of anxiety experienced while interacting in dyads or groups. Items are rated on a 0-4 scale, yielding a range of scores from 0-80, with higher scores representing greater anxiety.
Social Phobia Scale [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 20.04  (11.87)   17.43  (10.85)   18.62  (11.29) 
[1] The Social Phobia Scale is a 20-item self-report measure of anxiety experienced when being observed by others. Items are rated on a 0-4 scale, yielding a range of scores from 0-80, with higher scores representing greater anxiety.
Brief Fear of Negative Evaluation Scale [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 26.20  (7.34)   21.83  (6.41)   23.82  (7.13) 
[1] The Brief Fear of Negative Evaluation Scale is a 12-item self-report measure of concern about negative evaluation by others. Items are rated on a 1-5 scale, yielding scores ranging from 12-60, with higher scores indicating greater fear of negative evaluation.
Liebowitz Self-Rated Disability Scale [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 8.42  (4.56)   6.58  (4.40)   7.42  (4.52) 
[1] The Liebowitz Self-Report Disability Scale is an 11-item self-report measure of the degree to which one's emotional problems limit one's ability to function in a variety of domains. Items are rated on a 0-3 scale of severity, and 10 of the 11 items (choosing either school or work as one area and omitting the other) are summed to produce a total score, ranging from 0-30. Higher scores represent greater disability.
Quality of Life Inventory [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 0.67  (1.65)   0.31  (1.67)   0.48  (1.66) 
[1] The Quality of Life Inventory is a 16-item self-report measure of life satisfaction. Each item is rated for importance (0-2) and satisfaction (-3 to +3), and these ratings are multiplied, summed, and divided by the number of non-zero entries to yield an average item score, which can range from -6 to +6. Higher scores represent a higher quality of life.


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Liebowitz Social Anxiety Scale (LSAS)   [ Time Frame: Change measured from Week 12 to Week 28 ]

2.  Secondary:   Clinical Global Impression Improvement Scale (CGI-I)   [ Time Frame: Responder and remitter status measured at Week 28 ]

3.  Secondary:   Social Interaction Anxiety Scale (SIAS)   [ Time Frame: Change measured from Week 12 to Week 28 ]

4.  Secondary:   Social Phobia Scale (SPS)   [ Time Frame: Change measured from Week 12 to Week 28 ]

5.  Secondary:   Brief Fear of Negative Evaluation Scale (BFNE)   [ Time Frame: Change measured from Week 12 to Week 28 ]

6.  Secondary:   Liebowitz Self-Report Disability Scale (LSRDS)   [ Time Frame: Change measured from Week 12 to Week 28 ]

7.  Secondary:   Quality of Life Inventory (QOLI)   [ Time Frame: Change measured from Week 12 to Week 28 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Limitations include the small size of the randomized sample and the lack of a placebo arm in the randomization phase of the study.


  More Information
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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:  
Name/Title: Richard G. Heimberg, Ph.D.
Organization: Temple University
phone: 215.204.7489
e-mail: heimberg@temple.edu



Responsible Party: Temple University
ClinicalTrials.gov Identifier: NCT00074802     History of Changes
Other Study ID Numbers: R01MH064481 ( U.S. NIH Grant/Contract )
DSIR 83-ATAS
R01MH064726 ( U.S. NIH Grant/Contract )
GSK ID: 101618 ( Other Identifier: GlaxoSmithKline )
First Submitted: December 19, 2003
First Posted: December 22, 2003
Results First Submitted: February 24, 2017
Results First Posted: June 14, 2017
Last Update Posted: June 14, 2017