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Neural Functioning Underlying Anxiety and Its Treatment (The INSULA Study)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00947570
Recruitment Status : Completed
First Posted : July 28, 2009
Last Update Posted : December 31, 2012
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Murray B. Stein, University of California, San Diego

Brief Summary:
This study will examine the effects of cognitive behavioral therapy on brain function in people with anxiety disorders.

Condition or disease Intervention/treatment Phase
Generalized Anxiety Disorder Panic Disorder Anxiety Disorders Behavioral: Cognitive behavioral therapy for anxiety Not Applicable

Detailed Description:

Anxiety disorders are characterized by excessive and irrational fears of common situations that impair normal functioning. Neuroimaging allows researchers to examine brain functioning as people are presented with tasks that provoke or model anxiety. Neuroimaging research suggests that anxiety is moderated by a neural circuit involving three parts of the brain: the amygdala, the insula, and the prefrontal cortex (PFC). Increased activation of the amygdala and insula is associated with high anxiety, although activation of the PFC is thought to reduce anxiety. Cognitive behavioral therapy (CBT) is the only type of psychotherapy with strong evidence for effectively treating panic disorder (PD) and generalized anxiety disorder (GAD), but it only works about half the time. This study will use neuroimaging to examine when and how CBT affects brain functioning in people with PD and GAD. The long-term goals of the research are to develop neuroimaging as a diagnostic tool, to use neuroimaging to predict treatment response, and to understand which changes in brain functioning are related to successful treatment.

Participation in this study will last approximately 3 months. Four groups of participants will be recruited: healthy controls and people with PD, GAD, or social phobia (SP). All participants will undergo functional magnetic resonance imaging (fMRI) scanning—a measure of brain functioning—at the first visit. During the fMRI scan, participants will be asked to perform computerized tasks that involve responding to images. This will be the only visit that the healthy controls and people with SP complete; their inclusion in the study establishes a comparison point for the brain scans of the other participants. People with PD and GAD will then be asked to complete 10 sessions of CBT over a 10- to 14-week period. After 3 months, these participants will again undergo fMRI scanning. At 3 and 6 months after the completion of CBT, these participants will be asked to complete follow-up questionnaires about their anxiety.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Neural Substrates of Anticipation and Interoception in Anxiety Disorders
Study Start Date : October 2007
Actual Primary Completion Date : August 2012
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: Cognitive behavioral therapy
Participants with panic disorder or generalized anxiety disorder (GAD) will receive a course of individual cognitive behavioral therapy targeted at their principal disorder.
Behavioral: Cognitive behavioral therapy for anxiety
10 sessions delivered over the course of 14 weeks and aimed at reducing pathological behaviors and patterns of thought
Other Names:
  • CBT
  • Behavior Therapy

Primary Outcome Measures :
  1. Blood oxygen level dependent (BOLD) response in amygdala, insula, and medial prefrontal cortex, as measured with functional magnetic resonance imaging (fMRI) [ Time Frame: Measured at baseline and after 10 to 14 weeks of treatment ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • High school or higher education
  • DSM-IV diagnosis of panic disorder (with ongoing symptoms), generalized anxiety disorder, or both

Exclusion Criteria:

  • Lifetime diagnosis of psychotic disorder, organic mental disorder, or bipolar I disorder
  • Substance dependence within the last 12 months or diagnosis of alcohol or substance abuse within the past month
  • Use of psychotropic or anti-epileptic medications within the past 6 weeks
  • Heavy caffeine use, defined as drinking more than 6 caffeinated beverages per day
  • Current smoker
  • Possibility of pregnancy
  • History of claustrophobia or difficulty lying flat for long periods
  • Ferrous metal in the body

Exclusion Criteria for Healthy Controls only:

  • Lifetime diagnosis of major depressive disorder (MDD), bipolar I or II disorder, panic disorder (PD), agoraphobia without panic, generalized anxiety disorder (GAD), social phobia (SP), post-traumatic stress disorder (PTSD), obsessive-compulsive disorder (OCD), or an eating disorder

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00947570

Sponsors and Collaborators
University of California, San Diego
National Institute of Mental Health (NIMH)
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Principal Investigator: Murray B. Stein, MD, MPH University of California, San Diego

Additional Information:
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Responsible Party: Murray B. Stein, Professor, University of California, San Diego Identifier: NCT00947570     History of Changes
Other Study ID Numbers: R01MH065413 ( U.S. NIH Grant/Contract )
R01MH065413 ( U.S. NIH Grant/Contract )
First Posted: July 28, 2009    Key Record Dates
Last Update Posted: December 31, 2012
Last Verified: December 2012

Keywords provided by Murray B. Stein, University of California, San Diego:
Cognitive Behavioral Therapy
Functional Brain Imaging
Brain Imaging

Additional relevant MeSH terms:
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Anxiety Disorders
Panic Disorder
Pathologic Processes
Mental Disorders