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

Social Anxiety Disorder Clinical Trial

Official title:

Neural Mediators of Behavior Therapy for Anxiety

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00872820
• Other study ID #: R21MH081299
• Secondary ID: R21MH081299DATR
• Status: Completed
• Phase: N/A
• First received: March 30, 2009
• Last updated: December 9, 2014
• Start date: October 2008
• Est. completion date: September 2013

Study information

• Verified date: December 2014
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety Disorders
• Phobic Disorders
• Social Anxiety Disorder

Intervention

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
• Cognitive behavioral therapy
12 weekly treatment sessions conducted individually with a therapist; methods for dealing with anxiety will include cognitive and breathing strategies

Locations

Country	Name	City	State
United States	UCLA Psychology Department - Franz Hall	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Los Angeles	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Brain activity, assessed using functional magnetic resonance imaging (fMRI)		Measured at baseline and after 3 and 12 months	No
Secondary	Social anxiety symptoms		Measured at baseline and after 3, 6, and 12 months	No

External Links

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