Clinical trial NCT00872820: Examining Long-Term Effects and Neural Mediators of Behavioral Treatments for Social Anxiety Disorder
Official title: Neural Mediators of Behavior Therapy for Anxiety
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Social Anxiety Disorder
Keywords: Social Anxiety
Social Anxiety Treatment
Cognitive Therapy
Mindfulness
Social Phobia
Social Phobia Treatment
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2009-03-31
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Brain activity, assessed using functional magnetic resonance imaging (fMRI)
timeFrame: Measured at baseline and after 3 and 12 months
Secondary outcomes:
measure: Social anxiety symptoms
timeFrame: Measured at baseline and after 3, 6, and 12 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA Psychology Department - Franz Hall
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Michelle G. Craske, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.