Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
 
ClinicalTrials.gov Identifier: NCT00948974
Recruitment Status : Completed
First Posted : July 30, 2009
Results First Posted : October 5, 2018
Last Update Posted : October 5, 2018
Sponsor:
Information provided by (Responsible Party):
James Herbert, Drexel University

Tracking Information
First Submitted Date  ICMJE July 29, 2009
First Posted Date  ICMJE July 30, 2009
Results First Submitted Date  ICMJE May 8, 2017
Results First Posted Date  ICMJE October 5, 2018
Last Update Posted Date October 5, 2018
Study Start Date  ICMJE January 2010
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 7, 2017)
Social Phobia and Anxiety Inventory (SPAI) - Social Phobia Subscale [ Time Frame: baseline (pre-treatment; immediately prior to beginning treatment); post-treatment (12 weeks) ]
The SPAI social phobia assess symptoms of social anxiety in the presence of (a) strangers, (b) authority figures, (c) members of the opposite sex, and (d) people in general. The subscale ranges from 32 to 192, where higher scores reflect more severe symptoms of social anxiety.
Original Primary Outcome Measures  ICMJE
 (submitted: July 29, 2009)
  • Social Phobia and Anxiety Scale [ Time Frame: pre-treatment, mid-treatment, post-treatment, 3 month followup, 12 month followup ]
  • Social Anxiety Scale [ Time Frame: pre-treatment, mid-treatment, post-treatment, 3 month followup, 12 month followup ]
  • Beck Depression Inventory [ Time Frame: pre-treatment, mid-treatment, post-treatment, 3 month followup, 12 month followup ]
  • Beck Anxiety Inventory [ Time Frame: pre-treatment, mid-treatment, post-treatment, 3 month followup, 12 month followup ]
  • Quality of Life Inventory [ Time Frame: pre-treatment, mid-treatment, post-treatment, 3 month followup, 12 month followup ]
  • Outcomes Questionnaire [ Time Frame: pre-treatment, mid-treatment, post-treatment, 3 month followup, 12 month followup ]
  • Brief Fear of Negative Evaluation Scale [ Time Frame: pre-treatment, mid-treatment, post-treatment, 3 month followup, 12 month followup ]
  • Sheehan Disability Scale [ Time Frame: pre-treatment, mid-treatment, post-treatment, 3 month followup, 12 month followup ]
  • Clinical Global Impression Scale [ Time Frame: pre-treatment, mid-treatment, post-treatment, 3 month followup, 12 month followup ]
  • Client Satisfaction Survey [ Time Frame: Post-Treatment ]
  • Behavioral Assessment Test [ Time Frame: Pre-treatment, Post-treatment ]
  • Five Factor Mindfulness Questionnaire [ Time Frame: pre-treatment, mid-treatment, post-treatment, 3 month followup, 12 month followup ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 7, 2017)
  • Outcomes Questionnaire [ Time Frame: baseline (pre-treatment; just before beginning treatment); post-treatment (12 weeks) ]
    The Outcomes Questionnaire is a 45-item measure that assesses functioning and is comprised of three subscales: symptom distress, interpersonal relationships, and social role performance, that are combined to create a total score. Scores range from 45 to 180, where higher scores reflect greater levels of dysfunction.
  • Behavioral Assessment Test [ Time Frame: baseline (pre-treatment; just prior to beginning treatment); post-treatment (12 weeks) ]
    The assessment consists of two role-played interpersonal interactions and an impromptu speech. The role-plays were video recorded for subsequent rating by two independent assessors. Using a 5-point Likert scale (1 = poor and 5 = excellent), assessors rated global social skills, which were comprised of assessments of verbal content (e.g., amount of speech during task and degree to which speech was relevant and appropriate), nonverbal skills (e.g., degree of fidgeting and eye contact; appropriateness of gestures and posture), and paralinguistic skills (e.g., appropriateness of tone, enunciation, inflection, and rate). Prior research has employed this behavioral assessment protocol (Glassman et al., 2016; Herbert et al., 2005). These results reflect global social skills, which reflect the sum of ratings of verbal, nonverbal, and paralinguistic skills. Scores range from 3 to 15 with higher scores reflecting better social skills.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 29, 2009)
  • Drexel Defusion Scale (DDS) [ Time Frame: pre-treatment, mid-treatment, post-treatment, 3 month followup, 12 month followup ]
  • Philadelphia Mindfulness Scale (PHLMS) [ Time Frame: pre-treatment, mid-treatment, post-treatment, 3 month followup, 12 month followup ]
  • Automatic Thoughts Questionnaire (ATQ) [ Time Frame: pre-treatment, mid-treatment, post-treatment, 3 month followup, 12 month followup ]
  • Before-Session Questionnaire (BSQ) [ Time Frame: weekly ]
  • Reaction to Treatment Questionnaire (RTQ) [ Time Frame: After 2nd session ]
  • Experiences Questionnaire [ Time Frame: pre-treatment, mid-treatment, post-treatment, 3 month followup, 12 month followup ]
  • Social Anxiety Session Change Index [ Time Frame: weekly ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Variations of Cognitive Behavior Therapy for Social Anxiety Disorder
Official Title  ICMJE Variations of Cognitive Behavior Therapy for Social Anxiety Disorder
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Social Anxiety Disorder
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 7, 2017)
88
Original Estimated Enrollment  ICMJE
 (submitted: July 29, 2009)
80
Actual Study Completion Date  ICMJE December 2015
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00948974
Other Study ID Numbers  ICMJE 18345
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party James Herbert, Drexel University
Study Sponsor  ICMJE Drexel University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: James D. Herbert, PhD Drexel University
PRS Account Drexel University
Verification Date December 2017

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