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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Michelle Craske, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT00872820
First received: March 30, 2009
Last updated: June 20, 2013
Last verified: June 2013

March 30, 2009
June 20, 2013
October 2008
September 2013   (final data collection date for primary outcome measure)
Brain activity, assessed using functional magnetic resonance imaging (fMRI) [ Time Frame: Measured at baseline and after 3 and 12 months ] [ Designated as safety issue: No ]
Brain activity, assessed using fMRI [ Time Frame: Measured at baseline and after 3 and 12 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00872820 on ClinicalTrials.gov Archive Site
Social anxiety symptoms [ Time Frame: Measured at baseline and after 3, 6, and 12 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Examining Long-Term Effects and Neural Mediators of Behavioral Treatments for Social Anxiety Disorder
Neural Mediators of Behavior Therapy for Anxiety

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

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Social Anxiety Disorder
  • 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
  • Behavioral: Cognitive behavioral therapy
    12 weekly treatment sessions conducted individually with a therapist; methods for dealing with anxiety will include cognitive and breathing strategies
  • Active Comparator: 1
    Participants will receive standard cognitive behavioral therapy.
    Intervention: Behavioral: Cognitive behavioral therapy
  • Experimental: 2
    Participants will receive acceptance- and commitment-based behavioral therapy.
    Intervention: Behavioral: Acceptance- and commitment-based behavioral therapy
  • No Intervention: 3
    Participants will be placed on a waitlist for 3 months before being offered treatment.
Niles AN, Burklund LJ, Arch JJ, Lieberman MD, Saxbe D, Craske MG. Cognitive mediators of treatment for social anxiety disorder: comparing acceptance and commitment therapy and cognitive-behavioral therapy. Behav Ther. 2014 Sep;45(5):664-77. doi: 10.1016/j.beth.2014.04.006. Epub 2014 May 5.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
60
September 2013
September 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 45 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00872820
R21 MH081299, R21MH081299, DATR A3-NSS
No
Michelle Craske, University of California, Los Angeles
University of California, Los Angeles
National Institute of Mental Health (NIMH)
Principal Investigator: Michelle G. Craske, PhD University of California, Los Angeles
University of California, Los Angeles
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP