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

Anxiety Disorders Clinical Trial

Official title:

Neural Substrates of Anticipation and Interoception in Anxiety Disorders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00947570
• Other study ID #: R01MH065413
• Secondary ID: R01MH065413DATR
• Status: Completed
• Phase: N/A
• First received: July 27, 2009
• Last updated: December 27, 2012
• Start date: October 2007
• Est. completion date: August 2012

Study information

• Verified date: December 2012
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Anxiety Disorders
• Disease
• Generalized Anxiety Disorder
• Panic Disorder

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Diego	National Institute of Mental Health (NIMH)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood oxygen level dependent (BOLD) response in amygdala, insula, and medial prefrontal cortex, as measured with functional magnetic resonance imaging (fMRI)		Measured at baseline and after 10 to 14 weeks of treatment	No

External Links

•   Click here for more information on the UCSD Anxiety Disorders Research Program