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.|
|ClinicalTrials.gov Identifier: NCT00872820|
Recruitment Status : Completed
First Posted : March 31, 2009
Last Update Posted : December 11, 2014
|Condition or disease||Intervention/treatment||Phase|
|Social Anxiety Disorder||Behavioral: Acceptance- and commitment-based behavioral therapy Behavioral: Cognitive behavioral therapy||Not Applicable|
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|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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
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.
- Brain activity, assessed using functional magnetic resonance imaging (fMRI) [ Time Frame: Measured at baseline and after 3 and 12 months ]
- Social anxiety symptoms [ Time Frame: Measured at baseline and after 3, 6, and 12 months ]
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 ClinicalTrials.gov identifier (NCT number): NCT00872820
|United States, California|
|UCLA Psychology Department - Franz Hall|
|Los Angeles, California, United States, 90095|
|Principal Investigator:||Michelle G. Craske, PhD||University of California, Los Angeles|