Variations of Cognitive Behavior Therapy for Social Anxiety Disorder

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. Identifier: NCT00948974
Recruitment Status : Completed
First Posted : July 30, 2009
Last Update Posted : January 22, 2016
Information provided by (Responsible Party):
James Herbert, Drexel University

Brief Summary:
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 or disease Intervention/treatment Phase
Social Anxiety Disorder Behavioral: Cognitive Therapy Behavioral: Acceptance and Commitment Therapy Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 132 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Variations of Cognitive Behavior Therapy for Social Anxiety Disorder
Study Start Date : January 2010
Actual Primary Completion Date : January 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety
U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Social Phobia and Anxiety Inventory [ Time Frame: pre-treatment, mid-treatment, post-treatment, 3 month followup, 12 month followup ]

Secondary Outcome Measures :
  1. Philadelphia Mindfulness Scale (PHLMS) [ Time Frame: pre-treatment, mid-treatment, post-treatment, 3 month followup, 12 month followup ]
  2. Outcomes Questionnaire [ Time Frame: pre-treatment, mid-treatment, post-treatment, 3-month followup ]
  3. Behavioral Assessment Test [ Time Frame: pre-treatment, mid-treatment, post-treatment, 3-month, 12-month follow-up ]
  4. Quality of Life Inventory [ Time Frame: pre-treatment, mid-treatment, post-treatment, 3 month followup, 12 month followup ]

Information from the National Library of Medicine

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

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.

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 identifier (NCT number): NCT00948974

United States, Pennsylvania
Drexel University
Philadelphia, Pennsylvania, United States, 19102
Sponsors and Collaborators
Drexel University
Principal Investigator: James D. Herbert, PhD Drexel University

Responsible Party: James Herbert, Investigator, Drexel University Identifier: NCT00948974     History of Changes
Other Study ID Numbers: 18345
First Posted: July 30, 2009    Key Record Dates
Last Update Posted: January 22, 2016
Last Verified: January 2016

Keywords provided by James Herbert, Drexel University:
social anxiety
Cognitive Behavioral Therapy
Acceptance and Commitment Therapy
Cognitive Therapy

Additional relevant MeSH terms:
Anxiety Disorders
Phobia, Social
Pathologic Processes
Mental Disorders
Phobic Disorders