Effects of Arousal and Stress in Anxiety

Tracking Information
First Submitted Date	November 10, 2001
First Posted Date	November 12, 2001
Last Update Posted Date	April 4, 2018
Study Start Date	June 27, 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 Outcome Measures	Not Provided
Original Other 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. Fear can best be studied using Pavlovian fear conditioning. Studies 1 and 2 examine learning processes underlying fear conditioning as well as the influence of cognitive and affective processes on these learning processes. Anxiety is a more sustained state of apprehension evoked by unpredictable threat. Study 2 examines the interactions between anxiety induced experimentally and cognitive processes. Specifically, we seek to 1) characterize the effect of anxiety on key cognitive processes including working memory, attention control, conflict, and learning and memory. 2) examine the extent to which performance of cognitive tasks distract from anxiety, and 3) how physical exertion influences anxiety and its effects on cognition. Study 3 examines the effects of memory retrieval on extinction. 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 or prior to giving a speech. 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 *	Grillon C, Morgan CA 3rd. Fear-potentiated startle conditioning to explicit and contextual cues in Gulf War veterans with posttraumatic stress disorder. J Abnorm Psychol. 1999 Feb;108(1):134-42.; Grillon C, Ameli R, Goddard A, Woods SW, Davis M. Baseline and fear-potentiated startle in panic disorder patients. Biol Psychiatry. 1994 Apr 1;35(7):431-9.; Phillips RG, LeDoux JE. Differential contribution of amygdala and hippocampus to cued and contextual fear conditioning. Behav Neurosci. 1992 Apr;106(2):274-85.; Grillon C, Robinson OJ, Krimsky M, O'Connell K, Alvarez G, Ernst M. Anxiety-mediated facilitation of behavioral inhibition: Threat processing and defensive reactivity during a go/no-go task. Emotion. 2017 Mar;17(2):259-266. doi: 10.1037/emo0000214. Epub 2016 Sep 19.; Lago T, Davis A, Grillon C, Ernst M. Striatum on the anxiety map: Small detours into adolescence. Brain Res. 2017 Jan 1;1654(Pt B):177-184. doi: 10.1016/j.brainres.2016.06.006. Epub 2016 Jun 6. Review.
* 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: February 7, 2017)	1427
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; For exercise substudy: History of exercise intolerance History of heart disease History of pulmonary disease, other than controlled, non-exercise-induced asthma History of uncontrolled diabetes Resting heart rate > 90 BPM Resting systolic blood pressure > 140 mmHg or diastolic blood pressure > 90 mmHg Peripheral condition making completion of the exercise protocol impossible, such as severe osteoarthritis or chronic pain Clinically significant abnormal EKG as determined by MD or DNP; For active avoidance substudy: Diagnosis of color blindness
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	March 22, 2018