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

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

Detailed Description
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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.

Official Title
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Neural Mediators of Behavior Therapy for Anxiety

Conditions
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Social Anxiety Disorder

Intervention / Treatment
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* Behavioral: Acceptance- and commitment-based behavioral therapy
* Behavioral: Cognitive behavioral therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Participants will receive standard cognitive behavioral therapy. | Behavioral: Cognitive behavioral therapy<br>* 12 weekly treatment sessions conducted individually with a therapist; methods for dealing with anxiety will include cognitive and breathing strategies<br>|
| Experimental: 2<br>Participants will receive acceptance- and commitment-based behavioral therapy. | Behavioral: Acceptance- and commitment-based behavioral therapy<br>* 12 weekly treatment sessions conducted individually with a therapist; strategies for dealing with anxiety will include mindfulness and acceptance of negative feelings<br>|
| No Intervention: 3<br>Participants will be placed on a waitlist for 3 months before being offered treatment. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brain activity, assessed using functional magnetic resonance imaging (fMRI) |  | Measured at baseline and after 3 and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Social anxiety symptoms |  | Measured at baseline and after 3, 6, and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cognitive Therapy, Social Anxiety, Social Anxiety Treatment, Mindfulness, Social Phobia, Social Phobia Treatment