N/A
N=1,418
Effects of Arousal and Stress in Anxiety
Healthy Volunteers
Bottom Line
View on ClinicalTrials.gov: NCT00026559 ↗Enrolled (actual)
1,418
Serious AEs
0.0%
Results posted
Jan 2024
Primary outcome: Primary: Go Correct Hits Followed by Button Press — 90.9; 91.6 Percentage of correct responses
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Shock Device (Device); Auditory Startle Device (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- National Institute of Mental Health (NIMH)
- Primary completion
- Jul 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Go Correct Hits Followed by Button Press |
90.9; 91.6 | — |
| PRIMARY Nogo Trials Followed by no Button Press |
74.4; 81.2 | — |
| PRIMARY Correct-go Reaction Time (RT) |
358.5; 349.3 | — |
| PRIMARY Response to Startle Reflex |
44.2; 57.5; 42.4; 53 | — |
| PRIMARY Subjective Measures of Level of Anxiety |
1.6; 3.4; 1.6; 3.6 | — |
| SECONDARY Measure of Attention Control |
59.9 | — |
| SECONDARY Measure of Level of Anxiety |
28 | — |
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.
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 Diagnostic and Statistical Manual (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 National Institute of Mental Health (NIMH) or an immediate family member of a NIMH employee.
Data sourced from ClinicalTrials.gov (NCT00026559). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.