Examining Long-Term Effects and Neural Mediators of Behavioral Treatments for Social Anxiety Disorder
Neural Mediators of Behavior Therapy for Anxiety
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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California
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Los Angeles, California, United States, 90095
- UCLA Psychology Department - Franz Hall
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: 1
Participants will receive standard 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.
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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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Brain activity, assessed using functional magnetic resonance imaging (fMRI)
Time Frame: Measured at baseline and after 3 and 12 months
|
Measured at baseline and after 3 and 12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Social anxiety symptoms
Time Frame: Measured at baseline and after 3, 6, and 12 months
|
Measured at baseline and after 3, 6, and 12 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Michelle G. Craske, PhD, University of California, Los Angeles
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R21MH081299 (U.S. NIH Grant/Contract)
- DATR A3-NSS (Indiana University)
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