Generalized Anxiety Disorder and Social Anxiety Disorder: Their Impact on the Processing of Information and Learning

October 5, 2017 updated by: National Institute of Mental Health (NIMH)

Generalized Anxiety Disorder and Social Anxiety Disorder: Their Impact on the Processing of Social Emotional Information and Instrumental Learning

The purpose of this study is to increase researchers understanding of the biological basis of generalized anxiety disorder and social anxiety disorder. They will investigate how the brain activity associated with specific thoughts and feelings may play a role in these anxiety disorders. This knowledge will be used to design interventions to help those with these illnesses.

To qualify for this study, participants must be evaluated via an initial telephone screening interview and material sent through the mail.

Participants will then be required to make three visits to NIH. During the first visit, they will be asked questions about their general mood, degree of nervousness, thinking skills, and behavior. They will undergo a thorough physical exam, including an EKG, blood work, urinalysis, and a pregnancy test for women of childbearing potential. During the second visit, participants will spend about 2.5 hours doing various tasks while sitting and looking at a computer screen. These tasks will guide them to experience specific kinds of thoughts and emotions. Researchers will attach electrodes to the participants hands to monitor the amount of electricity conducted by the skin. The third visit will be similar to the second visit, but participants will perform the tasks while lying in a MRI scanner.

Participants will be compensated up to $400 for their involvement in this study.

Study Overview

Status

Completed

Conditions

Detailed Description

There have been suggestions that the threshold for amygdala activity is lower in individuals with anxiety disorders than in healthy individuals. However, despite it's immediate plausibility, there have been relatively few tests of this hypothesis. Specifically, there have been very few explorations of the performance of patients with anxiety disorders on measures known to implicate the amygdala.

Although the high co-morbidity of Generalized Anxiety Disorder (GAD) and Social Anxiety Disorder (SAD) complicates the issue, the fact that the disorders doubly dissociate suggests that they are due to dysfunctional activity in separable neurocognitive systems. We would suggest that the hyper-responsive amygdala hypothesis is more likely to be linked to the explanation of GAD. In contrast, SAD may be due to reduced activation thresholds for units in a system that responds to social threat and which recruits lateral orbital frontal cortex. Thus, the current project will determine the performance of patients with GAD and SAD on measures in which the amygdala is known to play a role and also measures that recruit lateral orbital frontal cortex and the system for social response reversal. In addition, two proposed neuro-imaging studies will directly assess neural responses in these two systems in both patient populations. The project should provide clear data that will constrain future theorizing on the pathology implicated in these two disorders.

Study Type

Observational

Enrollment (Actual)

497

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Maryland
      • Bethesda, Maryland, United States, 20892
        • National Institutes of Health Clinical Center, 9000 Rockville Pike

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  • INCLUSION CRITERIA:

Age: Participants will be males and females, 18-50 years of age.

IQ: IQ, as measured by 4 subscales from the Wechsler Adult Intelligence Scale-Revised (WAIS-R), must be > 80.

Medication status: No regular use of psychotropic medication within 2 weeks of the study (or fluoxetine within 8 weeks of the study). No regular use of any benzodiazepine. We intend to identify patients whose GAD/SAD is currently untreated.

EXCLUSION CRITERIA:

Because factors such as psychiatric disease, or CNS disease, can influence functional brain activity, and pregnancy precludes participation in fMRI studies, these factors are exclusionary.

  1. Psychiatric history: Participants will be assessed using DSM-IV criteria via standardized psychiatric interviews conducted by trained examiners (i.e., SCID). Any current suicidal ideation will be exclusionary.

    1. Healthy comparison individuals (Group 1): All participants will be free of any current psychiatric disorder as well as lifetime history of psychosis, pervasive developmental disorder, major affective disorder, panic disorder, obsessive compulsive disorder, conduct disorder, ADHD, anorexia.
    2. Patients with GAD (Group 2): Any history of an axis I diagnosis excluding SAD but not including adjustment disorder, simple phobia or dysthymia is exclusionary. There must be no current mood disoder (MD) though patients with past MD, which occurred after the onset of GAD, will be admitted to the study. We recognize the difficulty of recruiting patients with GAD without co-morbid SAD and will therefore allow patients who are comorbid into the study in this group. We have faced difficulties with our studies of children with psychopathic tendencies where, although it is possible to identify populations who only meet criteria for ADHD most children who meet criteria for psychopathic tendencies are co-morbid for ADHD. We will adopt a similar strategy to our work with children; i.e., in contrasts of patients with GAD with comparison individuals, we will use SAD symptomatology as a covariate to reduce, and evaluate, the impact of pathology associated with SAD on the data.
    3. Patients with SAD (Group 3): Any current history of an axis I diagnosis including GAD, but excluding adjustment disorder, simple phobia or dysthymia is exclusionary. There must be no current mood disorder (MD) though patients with past MD, which occurred after the onset of SAD, will be admitted to the study.
  2. History of Drug Abuse: Axis I diagnoses of substance use disorders will be exclusionary.
  3. Severe acute and chronic medical illnesses.
  4. CNS disease: History of brain abnormalities (e.g., neoplasms, subarachnoid cysts), cerebrovascular disease, infectious disease (e.g., abscess), or other neurological disease, or history of head trauma (defined as loss of consciousness > 3 min).
  5. Metal or electronic objects: Metal plates, certain types of dental braces, cardiac pacemakers, etc., that are sensitive to electromagnetic fields contraindicate MRI scans.
  6. Claustrophobia: Participants will be questioned about potential discomfort in being in an enclosed space, such as an MRI scanner.
  7. Pregnancy status: Because of the potential effects of hormonal changes on brain function as well as the unknown effects of electromagnetic field on the fetus, known pregnancy is an exclusion criterion.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Association of GAD/SAD with amygdala act
Time Frame: Ongoing
Ongoing

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Karina S Peschardt, Ph.D., National Institute of Mental Health (NIMH)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 5, 2003

Study Completion

September 21, 2016

Study Registration Dates

First Submitted

June 6, 2003

First Submitted That Met QC Criteria

June 6, 2003

First Posted (Estimate)

June 9, 2003

Study Record Updates

Last Update Posted (Actual)

October 6, 2017

Last Update Submitted That Met QC Criteria

October 5, 2017

Last Verified

September 21, 2016

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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