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Variations of Cognitive Behavior Therapy for Social Anxiety Disorder

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Drexel University
Sponsor:
Information provided by (Responsible Party):
James Herbert, Drexel University
ClinicalTrials.gov Identifier:
NCT00948974
First received: July 29, 2009
Last updated: March 27, 2014
Last verified: March 2014
  Purpose

The purpose of this study is to compare the efficacy of two variants of cognitive behavioral therapy (CBT) (cognitive therapy (CT) and acceptance and commitment therapy (ACT)), for the treatment of generalized social anxiety disorder.


Condition Intervention
Social Anxiety Disorder
Behavioral: Cognitive Therapy
Behavioral: Acceptance and Commitment Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Variations of Cognitive Behavior Therapy for Social Anxiety Disorder

Resource links provided by NLM:


Further study details as provided by Drexel University:

Primary Outcome Measures:
  • Social Phobia and Anxiety Inventory [ Time Frame: pre-treatment, mid-treatment, post-treatment, 3 month followup, 12 month followup ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Philadelphia Mindfulness Scale (PHLMS) [ Time Frame: pre-treatment, mid-treatment, post-treatment, 3 month followup, 12 month followup ] [ Designated as safety issue: No ]
  • Outcomes Questionnaire [ Time Frame: pre-treatment, mid-treatment, post-treatment, 3-month followup ] [ Designated as safety issue: No ]
  • Behavioral Assessment Test [ Time Frame: pre-treatment, mid-treatment, post-treatment, 3-month, 12-month follow-up ] [ Designated as safety issue: No ]
  • Quality of Life Inventory [ Time Frame: pre-treatment, mid-treatment, post-treatment, 3 month followup, 12 month followup ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: January 2010
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: cognitive therapy
cognitive therapy and exposure
Behavioral: Cognitive Therapy
Cognitive therapy (CT) highlights the identification and reappraisal of distorted or dysfunctional cognitions in the treatment of psychopathology. For example, socially anxious patients are taught to identify the thoughts and underlying beliefs that trigger strong emotional reactions (e.g., "if I attempt to initiate a conversation I'll humiliate myself"), and then replace these with more accurate, functional thoughts. There is a large body of research supporting the efficacy of CT for mood and anxiety disorders, and for social anxiety disorder in particular (Beck, 2005).
Other Name: CT
Active Comparator: acceptance and committment therapy
acceptance and commitment therapy and exposure
Behavioral: Acceptance and Commitment Therapy
ACT does not attempt to modify cognitions directly, but rather seeks to foster a mindful acceptance of whatever thoughts or feelings arise, while still pursuing specific behavioral goals. For example, the individual would be taught simply to notice the thoughts as if from a distance without attempting to modify them, and initiate a conversation. Like other newer mindfulness and acceptance-based models of CBT, ACT also expands the traditional focus on symptom reduction to include an emphasis on broader life goals. The scientific literature on ACT has expanded rapidly over the past ten years. Recent reviews conclude that it appears to be at least as effective as CT, and may work at least in part via distinct treatment mechanisms (Powers, Zum Vörde Sive Vörding, & Emmelkamp, 2009).
Other Name: ACT

Detailed Description:

We are recruiting a clinical sample of patients who meet diagnostic criteria (per DSM-5) for the generalized subtype of social anxiety disorder. Participants are randomly assigned to the two active intervention conditions; no placebo or sham treatments will be employed. Assessments take place at baseline, pre-treatment, mid-treatment, post-treatment, and at 3- and 12-months follow-up; participants also complete a brief weekly assessment of functioning. Treatment is administered individually by trained graduate students in clinical psychology, directly trained and supervised by the PI and Co-PI. Participants receive 12 weekly 1-hour long sessions. The study design is a 2 (treatment condition) by 5 (assessment occasion) mixed factorial design.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinically diagnosable social anxiety disorder (generalized subtype per DSM-IV-TR criteria)
  • aged 18-65
  • working fluency in English
  • residence in the greater Philadelphia area.

Exclusion Criteria:

  • Pervasive developmental disability
  • acute suicide potential
  • inability to travel to the treatment site
  • schizophrenia or other psychotic disorder
  • current substance dependence
  • Comorbid diagnoses of Major Depressive or other mood or anxiety disorders are acceptable ONLY if clearly secondary to the diagnosis of social anxiety disorder.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00948974

Contacts
Contact: James Herbert, Ph.D. 215.571.4253 james.herbert@drexel.edu
Contact: Evan Forman, Ph.D. 215.553-7113 evan.forman@drexel.edu

Locations
United States, Pennsylvania
Drexel University Recruiting
Philadelphia, Pennsylvania, United States, 19102
Contact: James Herbert, Ph.D.    215-762-1692    james.herbert@drexel.edu   
Principal Investigator: James D. Herbert, PhD         
Sponsors and Collaborators
Drexel University
Investigators
Principal Investigator: James D. Herbert, PhD Drexel University
  More Information

No publications provided

Responsible Party: James Herbert, Investigator, Drexel University
ClinicalTrials.gov Identifier: NCT00948974     History of Changes
Other Study ID Numbers: 18345
Study First Received: July 29, 2009
Last Updated: March 27, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Drexel University:
social anxiety
treatment
Cognitive Behavioral Therapy
Acceptance and Commitment Therapy
Cognitive Therapy

Additional relevant MeSH terms:
Anxiety Disorders
Disease
Phobic Disorders
Mental Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on November 20, 2014