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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Michelle Craske, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT00872820
First received: March 30, 2009
Last updated: June 20, 2013
Last verified: June 2013
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Neural Mediators of Behavior Therapy for Anxiety

Resource links provided by NLM:


Further study details as provided by University of California, Los Angeles:

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: September 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
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
Experimental: 2
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
No Intervention: 3
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00872820

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

Additional Information:
No publications provided by University of California, Los Angeles

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Michelle Craske, PhD, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT00872820     History of Changes
Other Study ID Numbers: R21 MH081299, R21MH081299, DATR A3-NSS
Study First Received: March 30, 2009
Last Updated: June 20, 2013
Health Authority: United States: Federal Government

Keywords provided by University of California, Los Angeles:
Social Anxiety
Social Anxiety Treatment
Cognitive Therapy
Mindfulness
Social Phobia
Social Phobia Treatment

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

ClinicalTrials.gov processed this record on September 30, 2014