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Examining Long-Term Effects and Neural Mediators of Behavioral Treatments for Social Anxiety Disorder
This study is currently recruiting participants.
Verified by National Institute of Mental Health (NIMH), April 2009
First Received: March 30, 2009   Last Updated: April 3, 2009   History of Changes
Sponsored by: National Institute of Mental Health (NIMH)
Information provided by: National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT00872820
  Purpose

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


Condition Intervention
Social Anxiety Disorder
Behavioral: Acceptance- and commitment-based behavioral therapy
Behavioral: Cognitive behavioral therapy

MedlinePlus related topics: Anxiety Phobias
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title: Neural Mediators of Behavior Therapy for Anxiety

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:
  • Brain activity, assessed using functional magnetic resonance imaging (fMRI) [ Time Frame: Measured at baseline and after 3 and 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Social anxiety symptoms [ Time Frame: Measured at baseline and after 3, 6, and 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: October 2008
Estimated Study Completion Date: October 2011
Estimated Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Active Comparator
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
2: Experimental
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
3: No Intervention
Participants will be placed on a waitlist for 3 months before being offered 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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00872820

Contacts
Contact: Andrea N. Niles, BA 310-206-9191 niles@psych.ucla.edu
Contact: Daniel Dickson, BA 310-206-9191 ddickson@ucla.edu

Locations
United States, California
UCLA Psychology Department - Franz Hall Recruiting
Los Angeles, California, United States, 90095
Sponsors and Collaborators
Investigators
Principal Investigator: Michelle G. Craske, PhD University of California, Los Angeles
  More Information

Additional Information:
No publications provided

Responsible Party: University of California, Los Angeles ( Michelle G. Craske, PhD )
Study ID Numbers: R21 MH081299, DATR A3-NSS
Study First Received: March 30, 2009
Last Updated: April 3, 2009
ClinicalTrials.gov Identifier: NCT00872820     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):
Social Anxiety
Social Anxiety Treatment
Cognitive Therapy
Mindfulness
Social Phobia
Social Phobia Treatment

Study placed in the following topic categories:
Anxiety Disorders
Mental Disorders
Phobic Disorders

Additional relevant MeSH terms:
Pathologic Processes
Disease
Anxiety Disorders
Mental Disorders
Phobic Disorders

ClinicalTrials.gov processed this record on May 07, 2009