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Adding Cognitive Behavioral Therapy to Drug Treatment for Social Anxiety Disorder

This study has been completed.
Sponsor:
Information provided by:
National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT00074802
First received: December 19, 2003
Last updated: September 18, 2008
Last verified: September 2008
History of Changes

December 19, 2003
September 18, 2008
December 2003
May 2008   (final data collection date for primary outcome measure)
Liebowitz Social Anxiety Scale [ Time Frame: Measured at baseline and Weeks 12, 28, and 52 ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00074802 on ClinicalTrials.gov Archive Site
  • Social Interaction Anxiety Scale [ Time Frame: Measured at baseline and Weeks 12, 28, and 52 ] [ Designated as safety issue: No ]
  • Sheehan Disability Scale [ Time Frame: Measured at baseline and Weeks 12, 28, and 52 ] [ Designated as safety issue: No ]
  • Quality of Life Inventory [ Time Frame: Measured at baseline and Weeks 12, 28, and 52 ] [ Designated as safety issue: No ]
  • Clinical Global Impression Improvement Scale [ Time Frame: Measured at baseline and Weeks 12, 28, and 52 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Adding Cognitive Behavioral Therapy to Drug Treatment for Social Anxiety Disorder
CBT Augmentation of Paroxetine for Social Anxiety

This study will determine whether the addition of cognitive behavioral therapy can improve the effectiveness of the medication paroxetine (Paxil®) in treating individuals with social anxiety disorder.

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 longer-term management remains a challenge. Cognitive behavioral therapy (CBT) has been effective in treating depression and panic disorder symptoms; it may also be effective in augmenting paroxetine response and reducing relapse after medication discontinuation. This study will examine the effects of paroxetine treatment alone and in combination with CBT.

Participants in this study will receive paroxetine for 12 weeks. After 12 weeks, participants will be randomly assigned to either add weekly sessions of CBT to their treatment or to continue taking paroxetine alone for another 16 weeks. After the 16-week treatment period, participants will have their treatments tapered and will be followed for an additional 24 weeks. Social anxiety symptoms, rates of remission, and quality of life will be assessed.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Social Anxiety Disorder
  • 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.
  • Experimental: 1
    Participants will receive treatment with paroxetine
    Intervention: Drug: Paroxetine
  • Experimental: 2
    Participants will receive treatment with paroxetine plus cognitive behavioral therapy
    Interventions:
    • Drug: Paroxetine
    • Behavioral: Cognitive behavioral therapy (CBT)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
153
May 2008
May 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00074802
R01 MH64481, DSIR 83-ATAS, R01 MH64726, GSK ID: 101618
Yes
Richard Heimberg, Principal Investigator, Temple University
National Institute of Mental Health (NIMH)
Not Provided
Principal Investigator: Richard Heimberg, PhD Adult Anxiety Clinic of Temple University
Principal Investigator: Michael Liebowitz, MD New York State Psychiatric Institute Anxiety Disorders Clinic
National Institute of Mental Health (NIMH)
September 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP