Neural Functioning Underlying Anxiety and Its Treatment (The INSULA Study)
Neural Substrates of Anticipation and Interoception in Anxiety Disorders
2 other identifiers
interventional
60
0 countries
N/A
Brief Summary
This study will examine the effects of cognitive behavioral therapy on brain function in people with anxiety disorders.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2007
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2007
CompletedFirst Submitted
Initial submission to the registry
July 27, 2009
CompletedFirst Posted
Study publicly available on registry
July 28, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2012
CompletedDecember 31, 2012
December 1, 2012
4.8 years
July 27, 2009
December 27, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
Cognitive behavioral therapy
EXPERIMENTALParticipants with panic disorder or generalized anxiety disorder (GAD) will receive a course of individual cognitive behavioral therapy targeted at their principal disorder.
Interventions
10 sessions delivered over the course of 14 weeks and aimed at reducing pathological behaviors and patterns of thought
Eligibility Criteria
You may qualify if:
- High school or higher education
- DSM-IV diagnosis of panic disorder (with ongoing symptoms), generalized anxiety disorder, or both
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Murray B. Stein, MD, MPH
University of California, San Diego
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
July 27, 2009
First Posted
July 28, 2009
Study Start
October 1, 2007
Primary Completion
August 1, 2012
Study Completion
August 1, 2012
Last Updated
December 31, 2012
Record last verified: 2012-12