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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
University of California, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    July 27, 2009
    Last Updated
    December 27, 2012
    Sponsor
    University of California, San Diego
    Collaborators
    National Institute of Mental Health (NIMH)
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    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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