Variations of Cognitive Behavior Therapy for Social Anxiety Disorder

Social Anxiety Disorder Clinical Trial

Official title:

Variations of Cognitive Behavior Therapy for Social Anxiety Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00948974
• Other study ID #: 18345
• Status: Completed
• Phase: N/A
• Start date: January 2010
• Est. completion date: December 2015

Study information

• Verified date: December 2017
• Source: Drexel University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: December 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety Disorders
• Disease
• Phobia, Social
• Social Anxiety Disorder

Intervention

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).
• 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).

Locations

Country	Name	City	State
United States	Drexel University	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Drexel University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	baseline (pre-treatment; immediately prior to beginning treatment); post-treatment (12 weeks)
Secondary	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.	baseline (pre-treatment; just before beginning treatment); post-treatment (12 weeks)
Secondary	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.	baseline (pre-treatment; just prior to beginning treatment); post-treatment (12 weeks)