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

July 29, 2009
March 27, 2014
January 2010
January 2015   (final data collection date for primary outcome measure)
Social Phobia and Anxiety Inventory [ Time Frame: pre-treatment, mid-treatment, post-treatment, 3 month followup, 12 month followup ] [ Designated as safety issue: No ]
  • Social Phobia and Anxiety Scale [ Time Frame: pre-treatment, mid-treatment, post-treatment, 3 month followup, 12 month followup ] [ Designated as safety issue: No ]
  • Social Anxiety Scale [ Time Frame: pre-treatment, mid-treatment, post-treatment, 3 month followup, 12 month followup ] [ Designated as safety issue: No ]
  • Beck Depression Inventory [ Time Frame: pre-treatment, mid-treatment, post-treatment, 3 month followup, 12 month followup ] [ Designated as safety issue: No ]
  • Beck Anxiety Inventory [ Time Frame: pre-treatment, mid-treatment, post-treatment, 3 month followup, 12 month followup ] [ 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 ]
  • Outcomes Questionnaire [ Time Frame: pre-treatment, mid-treatment, post-treatment, 3 month followup, 12 month followup ] [ Designated as safety issue: No ]
  • Brief Fear of Negative Evaluation Scale [ Time Frame: pre-treatment, mid-treatment, post-treatment, 3 month followup, 12 month followup ] [ Designated as safety issue: No ]
  • Sheehan Disability Scale [ Time Frame: pre-treatment, mid-treatment, post-treatment, 3 month followup, 12 month followup ] [ Designated as safety issue: No ]
  • Clinical Global Impression Scale [ Time Frame: pre-treatment, mid-treatment, post-treatment, 3 month followup, 12 month followup ] [ Designated as safety issue: No ]
  • Client Satisfaction Survey [ Time Frame: Post-Treatment ] [ Designated as safety issue: No ]
  • Behavioral Assessment Test [ Time Frame: Pre-treatment, Post-treatment ] [ Designated as safety issue: No ]
  • Five Factor Mindfulness Questionnaire [ Time Frame: pre-treatment, mid-treatment, post-treatment, 3 month followup, 12 month followup ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00948974 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Drexel Defusion Scale (DDS) [ Time Frame: pre-treatment, mid-treatment, post-treatment, 3 month followup, 12 month followup ] [ Designated as safety issue: No ]
  • Philadelphia Mindfulness Scale (PHLMS) [ Time Frame: pre-treatment, mid-treatment, post-treatment, 3 month followup, 12 month followup ] [ Designated as safety issue: No ]
  • Automatic Thoughts Questionnaire (ATQ) [ Time Frame: pre-treatment, mid-treatment, post-treatment, 3 month followup, 12 month followup ] [ Designated as safety issue: No ]
  • Before-Session Questionnaire (BSQ) [ Time Frame: weekly ] [ Designated as safety issue: No ]
  • Reaction to Treatment Questionnaire (RTQ) [ Time Frame: After 2nd session ] [ Designated as safety issue: No ]
  • Experiences Questionnaire [ Time Frame: pre-treatment, mid-treatment, post-treatment, 3 month followup, 12 month followup ] [ Designated as safety issue: No ]
  • Social Anxiety Session Change Index [ Time Frame: weekly ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Variations of Cognitive Behavior Therapy for Social Anxiety Disorder
Variations of Cognitive Behavior Therapy for Social Anxiety Disorder

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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Social Anxiety Disorder
  • 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
  • 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
  • Active Comparator: cognitive therapy
    cognitive therapy and exposure
    Intervention: Behavioral: Cognitive Therapy
  • Active Comparator: acceptance and committment therapy
    acceptance and commitment therapy and exposure
    Intervention: Behavioral: Acceptance and Commitment Therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
January 2016
January 2015   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
No
Contact: James Herbert, Ph.D. 215.571.4253 james.herbert@drexel.edu
Contact: Evan Forman, Ph.D. 215.553-7113 evan.forman@drexel.edu
United States
 
NCT00948974
18345
No
James Herbert, Drexel University
Drexel University
Not Provided
Principal Investigator: James D. Herbert, PhD Drexel University
Drexel University
March 2014

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