Variations of Cognitive Behavior Therapy for Social Anxiety Disorder

Not Applicable

Completed

• Conditions: Social Anxiety Disorder
• Interventions: Behavioral: Cognitive Therapy; Behavioral: Acceptance and Commitment Therapy

• Registration Number: NCT00948974
• Lead Sponsor: Drexel University

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 Timeline

• Study First Submitted: 2009-07-29
• Study First Submitted QC: 2009-07-29
• Study First Posted: 2009-07-30
• Study Start: 2010-01
• Primary Completion: 2015-01
• Study Completion: 2015-12
• Results First Submitted: 2017-05-08
• Status Verified: 2017-12
• Results First Submitted QC: 2017-12-07
• Last Update Submitted: 2017-12-07
• Results First Posted: 2018-10-05
• Last Update Posted: 2018-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
cognitive therapy	Cognitive Therapy	cognitive therapy and exposure
acceptance and committment therapy	Acceptance and Commitment Therapy	acceptance and commitment therapy and exposure

Primary Outcome Measures

Name	Time	Method
Social Phobia and Anxiety Inventory (SPAI) - Social Phobia Subscale	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.

Secondary Outcome Measures

Name	Time	Method
Outcomes Questionnaire	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	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.

Trial Locations

Locations (1)

Drexel University; 🇺🇸 Philadelphia, Pennsylvania, United States