Neural Functioning Underlying Anxiety and Its Treatment (The INSULA Study)
Primary Purpose
Generalized Anxiety Disorder, Panic Disorder, Anxiety Disorders
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Cognitive behavioral therapy for anxiety
Sponsored by
About this trial
This is an interventional basic science trial for Generalized Anxiety Disorder focused on measuring Cognitive Behavioral Therapy, Functional Brain Imaging, Psychotherapy, Treatment, Brain Imaging
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Cognitive behavioral therapy
Arm Description
Participants with panic disorder or generalized anxiety disorder (GAD) will receive a course of individual cognitive behavioral therapy targeted at their principal disorder.
Outcomes
Primary Outcome Measures
Blood oxygen level dependent (BOLD) response in amygdala, insula, and medial prefrontal cortex, as measured with functional magnetic resonance imaging (fMRI)
Secondary Outcome Measures
Full Information
NCT ID
NCT00947570
First Posted
July 27, 2009
Last Updated
December 27, 2012
Sponsor
University of California, San Diego
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT00947570
Brief Title
Neural Functioning Underlying Anxiety and Its Treatment (The INSULA Study)
Official Title
Neural Substrates of Anticipation and Interoception in Anxiety Disorders
Study Type
Interventional
2. Study Status
Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will examine the effects of cognitive behavioral therapy on brain function in people with anxiety disorders.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Generalized Anxiety Disorder, Panic Disorder, Anxiety Disorders
Keywords
Cognitive Behavioral Therapy, Functional Brain Imaging, Psychotherapy, Treatment, Brain Imaging
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cognitive behavioral therapy
Arm Type
Experimental
Arm Description
Participants with panic disorder or generalized anxiety disorder (GAD) will receive a course of individual cognitive behavioral therapy targeted at their principal disorder.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive behavioral therapy for anxiety
Other Intervention Name(s)
CBT, Behavior Therapy
Intervention Description
10 sessions delivered over the course of 14 weeks and aimed at reducing pathological behaviors and patterns of thought
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Murray B. Stein, MD, MPH
Organizational Affiliation
University of California, San Diego
Official's Role
Principal Investigator
12. IPD Sharing Statement
Links:
URL
http://www.veryshy.org/research/
Description
Click here for more information on the UCSD Anxiety Disorders Research Program
Learn more about this trial
Neural Functioning Underlying Anxiety and Its Treatment (The INSULA Study)
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