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Effects of Arousal and Stress in Anxiety

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ClinicalTrials.gov Identifier: NCT00026559
Recruitment Status : Recruiting
First Posted : November 12, 2001
Last Update Posted : May 24, 2019
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) )

Tracking Information
First Submitted Date November 10, 2001
First Posted Date November 12, 2001
Last Update Posted Date May 24, 2019
Actual Study Start Date July 3, 2001
Primary Completion Date Not Provided
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT00026559 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Effects of Arousal and Stress in Anxiety
Official Title Effects of Arousal and Stress on Classical Conditioning
Brief Summary

This study has several parts. One part will examine the influence of factors such as personality and past experience on reactions to unpleasant stimuli. Others will examine the effect of personality and emotional and attentional states on learning and memory.

When confronted with fearful or unpleasant events, people can develop fear of specific cues that were associated with these events as well as to the environmental context in which the events occurred via a process called classical conditioning. Classical conditioning has been used to model anxiety disorders, but the relationship between stress and anxiety and conditioned responses remains unclear. This study will examine the relationship between cued conditioning and context conditioning . This study will also explore the acquisition and retention of different types of motor, emotional, and cognitive associative processes during various tasks that range from mildly arousing to stressful.

Detailed Description

Objective: Fear and anxiety are adaptive responses to different types of threats. Fear is a short-duration response evoked by explicit threat cues and anxiety a more sustained state of apprehension evoked by unpredictable threat. This protocol studied fear using Pavlovian fear conditioning in two studies. Studies 1 and 3. Study 2 focused on anxiety. Studies 1 and 3 will be discontinued to focus uniquely on the study of anxiety. Specifically, we will examine the interactions between anxiety induced experimentally using verbal threat and cognitive processes. We will seek to 1) characterize the effect of anxiety on key cognitive processes including working memory and attention control and 2) examine the extent to which performance of cognitive tasks distract from anxiety.

Study population: This more-than-minimal-risk protocol will test medically and psychiatrically healthy volunteers aged 18-50. Pregnant or nursing women will be excluded.

Method: Fear and anxiety will be measured using the startle reflex to brief and loud sounds. Fear conditioning will be assessed using shock as unconditioned stimulus. Cognitive performance will be examined during periods of unpredictable shock anticipation.

Outcome measures: The study will include cognitive performance and measure of aversive states, primarily the startle reflex.

Study Type Observational
Study Design Not Provided
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Not Provided
Study Population Not Provided
Condition Anxiety Disorder
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: September 13, 2018)
1575
Original Enrollment
 (submitted: June 23, 2005)
570
Study Completion Date Not Provided
Primary Completion Date Not Provided
Eligibility Criteria
  • INCLUSION CRITERIA:
  • Males and females
  • Age 18-50

EXCLUSION CRITERIA:

  • Pregnancy
  • Any current ongoing medical illness
  • Current Axis I disorders
  • Past significant psychiatric disorders (e.g., psychotic disorders) according to DSM-IV
  • Current alcohol or substance abuse according to DSM-IV criteria
  • History of alcohol or substance dependence based on DSM-IV criteria within 6 months prior to screening
  • Current psychotropic medication use
  • Current or past organic central nervous system disorders, including but not limited to seizure disorder or neurological symptoms of the wrist and arms (e.g., carpal tunnel syndrome). The latter exclusion is for shock studies only.
  • Negative urine toxicology screen
  • Employees of NIMH or an immediate family member of a NIMH employee.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Christian Grillon, Ph.D. (301) 594-2894 grillonc@mail.nih.gov
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00026559
Other Study ID Numbers 010185
01-M-0185
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) )
Study Sponsor National Institute of Mental Health (NIMH)
Collaborators Not Provided
Investigators
Principal Investigator: Christian Grillon, Ph.D. National Institute of Mental Health (NIMH)
PRS Account National Institutes of Health Clinical Center (CC)
Verification Date May 20, 2019