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Variations of Cognitive Behavior Therapy for Social Anxiety Disorder

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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Social Anxiety Disorder
Interventions Behavioral: Cognitive Therapy
Behavioral: Acceptance and Commitment Therapy
Enrollment 88
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Cognitive Therapy Acceptance and Committment Therapy
Hide Arm/Group Description

cognitive therapy and exposure

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 and exposure

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).

Period Title: Overall Study
Started 40 48
Completed 17 28
Not Completed 23 20
Reason Not Completed
Lost to Follow-up             23             20
Arm/Group Title Cognitive Therapy Acceptance and Committment Therapy Total
Hide Arm/Group Description

cognitive therapy and exposure

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 and exposure

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).

Total of all reporting groups
Overall Number of Baseline Participants 40 48 88
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 40 participants 48 participants 88 participants
30.05  (10.25) 29.90  (11.66) 29.97  (10.98)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 48 participants 88 participants
Female
18
  45.0%
27
  56.3%
45
  51.1%
Male
22
  55.0%
21
  43.8%
43
  48.9%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 48 participants 88 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
5
  12.5%
10
  20.8%
15
  17.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
5
  12.5%
8
  16.7%
13
  14.8%
White
22
  55.0%
21
  43.8%
43
  48.9%
More than one race
8
  20.0%
9
  18.8%
17
  19.3%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Social Phobia and Anxiety Inventory (SPAI) - Social Phobia Subscale
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cognitive Therapy Acceptance and Committment Therapy
Hide Arm/Group Description:

cognitive therapy and exposure

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 and exposure

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).

Overall Number of Participants Analyzed 17 28
Mean (Standard Deviation)
Unit of Measure: units on a scale
Pre-Treatment 131.66  (19.63) 130.17  (17.48)
Post-Treatment 75.47  (27.99) 103.9  (28.72)
2.Secondary Outcome
Title Outcomes Questionnaire
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cognitive Therapy Acceptance and Committment Therapy
Hide Arm/Group Description:

cognitive therapy and exposure

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 and exposure

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).

Overall Number of Participants Analyzed 17 28
Mean (Standard Deviation)
Unit of Measure: units on a scale
Pre-Treatment 120.06  (18.4) 118.36  (25.21)
Post-Treatment 91.34  (24.51) 105.54  (24.39)
3.Secondary Outcome
Title Behavioral Assessment Test
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
A subset of randomized participants (n = 12 for ACT and n = 11 for tCBT) completed this behavioral assessment task.
Arm/Group Title Cognitive Therapy Acceptance and Committment Therapy
Hide Arm/Group Description:

cognitive therapy and exposure

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 and exposure

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).

Overall Number of Participants Analyzed 11 12
Mean (Standard Deviation)
Unit of Measure: units on a scale
Pre-Treatment 9.12  (2.02) 8.33  (1.31)
Post-Treatment 10.2  (2.16) 10.64  (1.37)
Time Frame Adverse event data were collected throughout each participant's 12-week participation in the study.
Adverse Event Reporting Description Adverse events were monitored but no adverse events were reported by any participants.
 
Arm/Group Title Cognitive Therapy Acceptance and Committment Therapy
Hide Arm/Group Description

cognitive therapy and exposure

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 and exposure

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).

All-Cause Mortality
Cognitive Therapy Acceptance and Committment Therapy
Affected / at Risk (%) Affected / at Risk (%)
Total   0/40 (0.00%)   0/48 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Cognitive Therapy Acceptance and Committment Therapy
Affected / at Risk (%) Affected / at Risk (%)
Total   0/40 (0.00%)   0/48 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Cognitive Therapy Acceptance and Committment Therapy
Affected / at Risk (%) Affected / at Risk (%)
Total   0/40 (0.00%)   0/48 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Evan Forman
Organization: Drexel University
Phone: 215.553.7113
EMail: evan.forman@drexel.edu
Layout table for additonal information
Responsible Party: James Herbert, Drexel University
ClinicalTrials.gov Identifier: NCT00948974     History of Changes
Other Study ID Numbers: 18345
First Submitted: July 29, 2009
First Posted: July 30, 2009
Results First Submitted: May 8, 2017
Results First Posted: October 5, 2018
Last Update Posted: October 5, 2018