Variations of Cognitive Behavior Therapy for Social Anxiety Disorder - Full Text View

Purpose

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.

Condition	Intervention
Social Anxiety	Behavioral: Cognitive Therapy Behavioral: Acceptance and Commitment Therapy

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Variations of Cognitive Behavior Therapy for Social Anxiety Disorder

Resource links provided by NLM:

MedlinePlus related topics: Anxiety

U.S. FDA Resources

Further study details as provided by Drexel University:

Primary Outcome Measures:

Social Phobia and Anxiety Scale [ Time Frame: pre-treatment, mid-treatment, post-treatment, 3 month followup, 12 month followup ] [ Designated as safety issue: No ]
Social Anxiety Scale [ Time Frame: pre-treatment, mid-treatment, post-treatment, 3 month followup, 12 month followup ] [ Designated as safety issue: No ]
Beck Depression Inventory [ Time Frame: pre-treatment, mid-treatment, post-treatment, 3 month followup, 12 month followup ] [ Designated as safety issue: No ]
Beck Anxiety Inventory [ Time Frame: pre-treatment, mid-treatment, post-treatment, 3 month followup, 12 month followup ] [ Designated as safety issue: No ]
Quality of Life Inventory [ Time Frame: pre-treatment, mid-treatment, post-treatment, 3 month followup, 12 month followup ] [ Designated as safety issue: No ]
Outcomes Questionnaire [ Time Frame: pre-treatment, mid-treatment, post-treatment, 3 month followup, 12 month followup ] [ Designated as safety issue: No ]
Brief Fear of Negative Evaluation Scale [ Time Frame: pre-treatment, mid-treatment, post-treatment, 3 month followup, 12 month followup ] [ Designated as safety issue: No ]
Sheehan Disability Scale [ Time Frame: pre-treatment, mid-treatment, post-treatment, 3 month followup, 12 month followup ] [ Designated as safety issue: No ]
Clinical Global Impression Scale [ Time Frame: pre-treatment, mid-treatment, post-treatment, 3 month followup, 12 month followup ] [ Designated as safety issue: No ]
Client Satisfaction Survey [ Time Frame: Post-Treatment ] [ Designated as safety issue: No ]
Behavioral Assessment Test [ Time Frame: Pre-treatment, Post-treatment ] [ Designated as safety issue: No ]
Five Factor Mindfulness Questionnaire [ Time Frame: pre-treatment, mid-treatment, post-treatment, 3 month followup, 12 month followup ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Drexel Defusion Scale (DDS) [ Time Frame: pre-treatment, mid-treatment, post-treatment, 3 month followup, 12 month followup ] [ Designated as safety issue: No ]
Philadelphia Mindfulness Scale (PHLMS) [ Time Frame: pre-treatment, mid-treatment, post-treatment, 3 month followup, 12 month followup ] [ Designated as safety issue: No ]
Automatic Thoughts Questionnaire (ATQ) [ Time Frame: pre-treatment, mid-treatment, post-treatment, 3 month followup, 12 month followup ] [ Designated as safety issue: No ]
Before-Session Questionnaire (BSQ) [ Time Frame: weekly ] [ Designated as safety issue: No ]
Reaction to Treatment Questionnaire (RTQ) [ Time Frame: After 2nd session ] [ Designated as safety issue: No ]
Experiences Questionnaire [ Time Frame: pre-treatment, mid-treatment, post-treatment, 3 month followup, 12 month followup ] [ Designated as safety issue: No ]
Social Anxiety Session Change Index [ Time Frame: weekly ] [ Designated as safety issue: No ]

Estimated Enrollment:	80
Estimated Study Completion Date:	May 2012
Estimated Primary Completion Date:	May 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: cognitive therapy cognitive therapy and exposure	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). Other Name: CT
Active Comparator: acceptance and committment therapy acceptance and commitment therapy and exposure	Behavioral: 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 to go ahead 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 Name: ACT

Arms

Assigned Interventions

Active Comparator: cognitive therapy

cognitive therapy and exposure

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).

Other Name: CT

Active Comparator: acceptance and committment therapy

acceptance and commitment therapy and exposure

Behavioral: 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 to go ahead 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 Name: ACT

Detailed Description:

We will recruit a clinical sample of patients who meet diagnostic criteria (per the DSM-IV) for the generalized subtype of social anxiety disorder. Participants will be randomly assigned to the two active intervention conditions; no placebo or sham treatments will be employed. Assessments will take place at baseline, pre-treatment, mid-treatment, post-treatment, and at 3- and 12-months follow-up; participants will also complete a brief weekly assessment of functioning. Treatment will be administered individually by trained graduate students in clinical psychology, directly trained and supervised by the PI and Co-PI. Participants will receive 12 weekly 1-hour long sessions. The study design is a 2 (treatment condition) by 5 (assessment occasion) mixed factorial design.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00948974

Contacts

Contact: James Herbert, Ph.D.	215.762.1692	james.herbert@drexel.edu
Contact: Evan Forman, Ph.D.	215.762.4021	evan.forman@drexel.edu

Locations

United States, Pennsylvania
Drexel University	Not yet recruiting
Philadelphia, Pennsylvania, United States, 19102
Contact: James Herbert, Ph.D. 215-762-1692 james.herbert@drexel.edu

Sponsors and Collaborators

Drexel University

More Information

No publications provided

Responsible Party:	James Herbert, Ph.D., Drexel University
ClinicalTrials.gov Identifier:	NCT00948974 History of Changes
Other Study ID Numbers:	18345
Study First Received:	July 29, 2009
Last Updated:	May 24, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Drexel University:

social anxiety
treatment

Additional relevant MeSH terms:

Anxiety Disorders
Phobic Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 21, 2013