Adding Cognitive Behavioral Therapy to Drug Treatment for Social Anxiety Disorder

Social Anxiety Disorder Clinical Trial

Official title:

CBT Augmentation of Paroxetine for Social Anxiety

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00074802
• Other study ID #: R01MH064481
• Secondary ID: R01MH064481DSIR
• Status: Completed
• Phase: Phase 3
• First received: December 19, 2003
• Last updated: March 8, 2016
• Start date: December 2003
• Est. completion date: May 2008

Study information

• Verified date: September 2008
• Source: Temple University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 153
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety Disorders
• Phobic Disorders
• Social Anxiety Disorder

Intervention

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

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

Locations

Country	Name	City	State
United States	New York State Psychiatric Institute Anxiety Disorders Clinic	New York	New York
United States	Adult Anxiety Clinic of Temple University	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Temple University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Liebowitz Social Anxiety Scale		Measured at baseline and Weeks 12, 28, and 52	No
Secondary	Social Interaction Anxiety Scale		Measured at baseline and Weeks 12, 28, and 52	No
Secondary	Sheehan Disability Scale		Measured at baseline and Weeks 12, 28, and 52	No
Secondary	Quality of Life Inventory		Measured at baseline and Weeks 12, 28, and 52	No
Secondary	Clinical Global Impression Improvement Scale		Measured at baseline and Weeks 12, 28, and 52	No

External Links

•   Adult Anxiety Clinic of Temple University