We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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
  Purpose
This study will examine whether the addition of cognitive behavioral therapy can improve the efficacy of the medication paroxetine (Paxil®) in treating individuals with social anxiety disorder. Patients with social anxiety disorder will undergo a 12-week open trial with paroxetine. Those who complete the open trial having achieved only partial response will be randomized to receive cognitive behavioral therapy (CBT) in addition to paroxetine or to continue on paroxetine alone for an additional 16 weeks.

Condition Intervention Phase
Social Anxiety Disorder Drug: Paroxetine Behavioral: Cognitive behavioral therapy (CBT) Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Open trial of paroxetine (Phase 1) followed by randomization to either continued paroxetine or continued paroxetine plus cognitive behavioral therapy (Phase 2) for patients showing partial response to paroxetine in Phase 1.
Masking: Single (Outcomes Assessor)
Masking Description:
Independent evaluators were unaware of randomized condition in the augmentation phase (Phase 2).
Primary Purpose: Treatment
Official Title: CBT Augmentation of Paroxetine for Social Anxiety

Resource links provided by NLM:


Further study details as provided by Temple University:

Primary Outcome Measures:
  • Liebowitz Social Anxiety Scale (LSAS) [ Time Frame: Change measured from Week 12 to Week 28 ]
    The LSAS 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. We examined amount of change from week 12 to week 28 as the primary outcome. Change was calculated as Week 12 score minus Week 28 score, so a positive score equals greater positive change.


Secondary Outcome Measures:
  • Clinical Global Impression Improvement Scale (CGI-I) [ Time Frame: Responder and remitter status measured at Week 28 ]
    The CGI-I is a 7-point clinician-administered scale measuring improvement in symptoms over time. Lower numbers represent greater improvement. We examined responder status (i.e., percent of patients receiving an endpoint, Week 28, rating of 1 or 2) as well as remission status (i.e., percent of patients receiving an endpoint, Week 28, rating of 1) as secondary outcomes.

  • Social Interaction Anxiety Scale (SIAS) [ Time Frame: Change measured from Week 12 to Week 28 ]
    The SIAS 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. We examined amount of change at from week 12 to week 28 as a secondary outcome. Change was calculated as Week 12 score minus Week 28 score, so a positive score equals greater positive change.

  • Social Phobia Scale (SPS) [ Time Frame: Change measured from Week 12 to Week 28 ]
    The SPS 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. We examined amount of change at from week 12 to week 28 as a secondary outcome. Change was calculated as Week 12 score minus Week 28 score, so a positive score equals greater positive change.

  • Brief Fear of Negative Evaluation Scale (BFNE) [ Time Frame: Change measured from Week 12 to Week 28 ]
    The BFNE 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. We examined amount of change at from week 12 to week 28 as a secondary outcome. Change was calculated as Week 12 score minus Week 28 score, so a positive score equals greater positive change.

  • Liebowitz Self-Report Disability Scale (LSRDS) [ Time Frame: Change measured from Week 12 to Week 28 ]
    The LSRDS 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. We examined amount of change at from week 12 to week 28 as a secondary outcome. Change was calculated as Week 12 score minus Week 28 score, so a positive score equals greater positive change.

  • Quality of Life Inventory (QOLI) [ Time Frame: Change measured from Week 12 to Week 28 ]
    The QOLI 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. We examined amount of change at from week 12 to week 28 as a secondary outcome. Change was calculated as Week 12 score minus Week 28 score, so a positive score equals greater positive change.


Enrollment: 150
Study Start Date: December 2003
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Paroxetine Continuation
Participants who showed only partial response to paroxetine in Phase 1 will receive continued treatment with paroxetine for 16 additional weeks.
Drug: Paroxetine
Treatment with paroxetine will consist of an immediate release, flexible dosage of 20 to 50 mg per day.
Other Name: Paxil
Experimental: 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.
Drug: Paroxetine
Treatment with paroxetine will consist of an immediate release, flexible dosage of 20 to 50 mg per day.
Other Name: Paxil
Behavioral: Cognitive behavioral therapy (CBT)
CBT will consist of 16 weekly treatment sessions.

Detailed Description:

Social anxiety disorder is a prevalent and disabling condition for which effective long-term treatments need to be identified. Paroxetine is effective in treating the acute symptoms of social anxiety, but many patients achieve less than optimal response. CBT has also been effective in treating social anxiety disorder; thus,it may also be effective in augmenting paroxetine response. This study will examine the effects of paroxetine treatment alone and in combination with CBT among patients who achieve less than optimal response after an open trial with paroxetine.

Participants in this study will receive paroxetine for 12 weeks (Phase 1). After 12 weeks, participants who have completed this open trial but have achieved some but less than optimal response will move forward to Phase 2. To be eligible to move forward to Phase 2, patients must have achieved at least a 10% improvement in their open-trial Liebowitz Social Anxiety Scale Scores (LSAS) but still have an LSAS score of 30 or greater. Patients meeting these criteria will be randomly assigned to either add weekly sessions of CBT to their treatment or to continue taking paroxetine alone for another 16 weeks. Social anxiety symptoms, rates of response and remission, fear of negative evaluation, disability and quality of life will be assessed.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnostic and Statistical Manual of Mental Disorders, Fourth edition (DSM-IV) criteria for generalized social phobia
  • Willing and able to give written informed consent
  • English-speaking

Exclusion Criteria:

  • Prior or current diagnosis of schizophrenia, schizoaffective disorder, organic mental disorder, bipolar disorder, or antisocial, schizotypal, and schizoid personality disorders
  • Suicidal thoughts
  • History of failed paroxetine treatment of at least 6 weeks' duration at adequate doses or a history of failed outcome of a previous adequate trial of CBT
  • Clinically significant and/or unstable medical disease
  • Pregnancy or breast-feeding. Women of childbearing potential will be required to sign a statement indicating their intention to avoid pregnancy during the study through the use of an effective method of contraception.
  • Alcohol or substance abuse or dependence within the past 3 months. Patients with a positive drug screen but no substance abuse disorder will be eligible for the study, provided they have not met criteria for abuse/dependence within the last 6 months and provide two clean urine samples 2 weeks apart.
  • Current or past history of seizure disorder (except febrile seizure in childhood)
  • Conditions that contraindicate the use of paroxetine
  • Inability to tolerate or unwillingness to accept a drug-free period of 4 weeks for monoamine oxidase inhibitors (MAOIs) or fluoxetine and 2 weeks for other selective serotonin reuptake inhibitors (SSRIs), neuroleptics, antidepressants, benzodiazepines, mood stabilizers, buspirone, beta-adrenergic blockers, or other psychotropic drugs prior to beginning the study
  • Currently receiving psychotherapy
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00074802


Locations
United States, New York
New York State Psychiatric Institute Anxiety Disorders Clinic
New York, New York, United States, 10032
United States, Pennsylvania
Adult Anxiety Clinic of Temple University
Philadelphia, Pennsylvania, United States, 19122-6085
Sponsors and Collaborators
Temple University
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Richard Heimberg, PhD Adult Anxiety Clinic of Temple University
Principal Investigator: Michael Liebowitz, MD New York State Psychiatric Institute Anxiety Disorders Clinic
  More Information

Additional Information:
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
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Temple University:
Social Phobia

Additional relevant MeSH terms:
Anxiety Disorders
Phobia, Social
Mental Disorders
Phobic Disorders
Paroxetine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors