Effects of Arousal and Stress in Anxiety

Sponsor

National Institute of Mental Health (NIMH) (NIH)

Overall Status

Completed

CT.gov ID

NCT00026559

Collaborator

(none)

1,530

Enrollment

Location

Arm

258.5

Actual Duration (Months)

5.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Device: Shock Device Device: Auditory Startle Device	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

1530 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

Effects of Arousal and Stress on Classical Conditioning

Actual Study Start Date :

Jan 10, 2001

Actual Primary Completion Date :

Jul 28, 2022

Actual Study Completion Date :

Jul 28, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Threat Conditions threat of shock and auditory startle	Device: Shock Device Shock Device Device: Auditory Startle Device Auditory Startle Device

Arm

Intervention/Treatment

Experimental: Threat Conditions

threat of shock and auditory startle

Device: Shock Device

Shock Device

Device: Auditory Startle Device

Auditory Startle Device

Outcome Measures

Primary Outcome Measures

Startle Reflex [study visit]
startle reflex
Performance on cognitive tasks [study visit]
performance on cognitive tasks

Secondary Outcome Measures

Cognitive tests [during study visit]
performance on standard cognitive tests (e.g. working memory capacity
psychological questionnaires [during study visit]
psychological questionnaires (Spielberger state and trait anxiety)
Skin conductance [during study visit]
Skin conductance

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.
Positive urine toxicology screen
Employees of NIMH or an immediate family member of a NIMH employee.