- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00948974
Variations of Cognitive Behavior Therapy for Social Anxiety Disorder
December 7, 2017 updated by: James Herbert, Drexel University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Enrollment (Actual)
88
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19102
- Drexel University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: cognitive therapy
cognitive therapy and exposure
|
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 Names:
|
Active Comparator: acceptance and committment therapy
acceptance and commitment therapy and exposure
|
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
baseline (pre-treatment; immediately prior to beginning treatment); post-treatment (12 weeks)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
baseline (pre-treatment; just before beginning treatment); post-treatment (12 weeks)
|
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.
|
baseline (pre-treatment; just prior to beginning treatment); post-treatment (12 weeks)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: James D. Herbert, PhD, Drexel University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2010
Primary Completion (Actual)
January 1, 2015
Study Completion (Actual)
December 1, 2015
Study Registration Dates
First Submitted
July 29, 2009
First Submitted That Met QC Criteria
July 29, 2009
First Posted (Estimate)
July 30, 2009
Study Record Updates
Last Update Posted (Actual)
October 5, 2018
Last Update Submitted That Met QC Criteria
December 7, 2017
Last Verified
December 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18345
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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