Back to resultsVariations of Cognitive Behavior Therapy for Social Anxiety Disorder
Primary Purpose
Social Anxiety Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Therapy
Acceptance and Commitment Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Social Anxiety Disorder focused on measuring social anxiety, treatment, Cognitive Behavioral Therapy, Acceptance and Commitment Therapy, Cognitive Therapy
Eligibility 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.
Sites / Locations
- Drexel University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
cognitive therapy
acceptance and committment therapy
Arm Description
cognitive therapy and exposure
acceptance and commitment therapy and exposure
Outcomes
Primary Outcome Measures
Social Phobia and Anxiety Inventory (SPAI) - Social Phobia Subscale
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.
Secondary Outcome Measures
Outcomes Questionnaire
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00948974
Brief Title
Variations of Cognitive Behavior Therapy for Social Anxiety Disorder
Official Title
Variations of Cognitive Behavior Therapy for Social Anxiety Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Drexel University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Social Anxiety Disorder
Keywords
social anxiety, treatment, Cognitive Behavioral Therapy, Acceptance and Commitment Therapy, Cognitive Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
88 (Actual)
8. Arms, Groups, and Interventions
Arm Title
cognitive therapy
Arm Type
Active Comparator
Arm Description
cognitive therapy and exposure
Arm Title
acceptance and committment therapy
Arm Type
Active Comparator
Arm Description
acceptance and commitment therapy and exposure
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Therapy
Other Intervention Name(s)
CT
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Acceptance and Commitment Therapy
Other Intervention Name(s)
ACT
Intervention Description
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).
Primary Outcome Measure Information:
Title
Social Phobia and Anxiety Inventory (SPAI) - Social Phobia Subscale
Description
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.
Time Frame
baseline (pre-treatment; immediately prior to beginning treatment); post-treatment (12 weeks)
Secondary Outcome Measure Information:
Title
Outcomes Questionnaire
Description
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.
Time Frame
baseline (pre-treatment; just before beginning treatment); post-treatment (12 weeks)
Title
Behavioral Assessment Test
Description
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.
Time Frame
baseline (pre-treatment; just prior to beginning treatment); post-treatment (12 weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James D. Herbert, PhD
Organizational Affiliation
Drexel University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Drexel University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19102
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Variations of Cognitive Behavior Therapy for Social Anxiety Disorder
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