Examining Long-Term Effects and Neural Mediators of Behavioral Treatments for Social Anxiety Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00872820
Recruitment Status : Completed
First Posted : March 31, 2009
Last Update Posted : December 11, 2014
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Michelle Craske, University of California, Los Angeles

Brief Summary:
This study will compare the effects that two types of behavioral therapy have on brain function in people with social anxiety disorder.

Condition or disease Intervention/treatment Phase
Social Anxiety Disorder Behavioral: Acceptance- and commitment-based behavioral therapy Behavioral: Cognitive behavioral therapy Not Applicable

Detailed Description:

Social anxiety disorder (SAD) is characterized by intense and debilitating anxiety in common social situations. Cognitive behavioral therapy (CBT) is a talking treatment that aims to reduce immediate anxiety symptoms. However, some anxiety symptoms and comorbid disorders not directly addressed by CBT may only improve in the short term, while recurring in the long term. Behavioral therapy based on acceptance and mindfulness is thought to have longer lasting effects, because this approach emphasizes accepting anxiety instead of controlling anxiety. This study will compare standard CBT to acceptance and commitment therapy (ACT), which uses acceptance and mindfulness, to determine which is more effective on both a short- and long-term basis. Participants with SAD will undergo brain scans to determine how the two therapies affect brain functioning.

Participation in this study will last 12 months. Participants with SAD will be randomly assigned to receive CBT, ACT, or a waitlist condition. Both CBT and ACT treatments will include 12 weekly sessions that will deal with objects and situations that provoke anxiety. All sessions will be audio- and videotaped. The waitlist group will complete weekly self-monitoring forms to track anxiety and panic and will receive a phone call from a research coordinator every 2 weeks to make sure symptoms have not worsened. After 12 weeks, participants on the waitlist will be offered treatment.

All participants will attend study visits to undergo brain scanning at baseline, after 3 months, and after 12 months. Each study visit will involve MRI scanning (to evaluate brain structure), functional MRI (fMRI) scanning (to evaluate brain function), questionnaires about a participant's experience in the scanner, and collection of saliva samples before, during, and after scanning. While undergoing the fMRI scan, participants will be asked to remain at rest for a certain period of time, and then to perform tasks that will engage certain parts of the brain. Assessments for all participants will occur at baseline and after 3, 6, and 12 months. These assessments will include diagnostic evaluations by a therapist, self-report questionnaires, ongoing self-monitoring, physiological measurements, cognitive assessments, and behavioral observation.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Neural Mediators of Behavior Therapy for Anxiety
Study Start Date : October 2008
Actual Primary Completion Date : September 2013
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Active Comparator: 1
Participants will receive standard cognitive behavioral therapy.
Behavioral: Cognitive behavioral therapy
12 weekly treatment sessions conducted individually with a therapist; methods for dealing with anxiety will include cognitive and breathing strategies

Experimental: 2
Participants will receive acceptance- and commitment-based behavioral therapy.
Behavioral: Acceptance- and commitment-based behavioral therapy
12 weekly treatment sessions conducted individually with a therapist; strategies for dealing with anxiety will include mindfulness and acceptance of negative feelings

No Intervention: 3
Participants will be placed on a waitlist for 3 months before being offered treatment.

Primary Outcome Measures :
  1. Brain activity, assessed using functional magnetic resonance imaging (fMRI) [ Time Frame: Measured at baseline and after 3 and 12 months ]

Secondary Outcome Measures :
  1. Social anxiety symptoms [ Time Frame: Measured at baseline and after 3, 6, and 12 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Meets diagnostic criteria for social anxiety disorder
  • Right-handed
  • If taking medications, stabilized on current dose for 3 months
  • If undergoing psychotherapy, stabilized for 6 months
  • Speaks English

Exclusion Criteria:

  • Currently undergoing cognitive behavioral therapy
  • History of psychiatric hospitalization in the last 5 years
  • Presence of serious medical condition, such as respiratory, cardiovascular, pulmonary, neurological, or muscular-skeletal disease or pregnancy
  • Active suicidal ideation
  • Current severe depression
  • History of bipolar disorder, psychosis, mental retardation, or brain damage
  • History of substance abuse or dependence in the last 6 months
  • Presence of irremovable metal objects in the body that are not fMRI-safe
  • Suffers from claustrophobia

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00872820

United States, California
UCLA Psychology Department - Franz Hall
Los Angeles, California, United States, 90095
Sponsors and Collaborators
University of California, Los Angeles
National Institute of Mental Health (NIMH)
Principal Investigator: Michelle G. Craske, PhD University of California, Los Angeles

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Michelle Craske, PhD, University of California, Los Angeles Identifier: NCT00872820     History of Changes
Other Study ID Numbers: R21MH081299 ( U.S. NIH Grant/Contract )
R21MH081299 ( U.S. NIH Grant/Contract )
First Posted: March 31, 2009    Key Record Dates
Last Update Posted: December 11, 2014
Last Verified: December 2014

Keywords provided by Michelle Craske, University of California, Los Angeles:
Social Anxiety
Social Anxiety Treatment
Cognitive Therapy
Social Phobia
Social Phobia Treatment

Additional relevant MeSH terms:
Anxiety Disorders
Phobia, Social
Mental Disorders
Phobic Disorders