N/A N=918 Randomized Basic Science

Expectation of Unpleasant Events in Anxiety Disorders

Anxiety Disorders

Bottom Line

View on ClinicalTrials.gov: NCT00055224 ↗

Enrolled (actual)

918

Serious AEs

0.0%

Results posted

Jan 2024

Primary outcome: Primary: Change in Percent of Correct Button Presses During Threat Compared to the Safe Condition (AAST) — -0.016; 0.008 Percentage of accurate responses

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Threat of shock (Device)
Age: Adult · 18+ yrs
Sex: All
Sponsor: National Institute of Mental Health (NIMH)
Primary completion: Mar 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Percent of Correct Button Presses During Threat Compared to the Safe Condition (AAST)	-0.016; 0.008	—
PRIMARY Change in Percent of Correct no Button Presses During Threat Compared to the Safe Condition	-0.002; 0.028	—
PRIMARY Correct-go Reaction Time (RT) - Safe Condition	387.8; 337.3	—
PRIMARY Correct-go Reaction Time (RT) - Threat Condition	377.4; 332.2	—
PRIMARY Go Correct Hits Followed by Button Press - Safe Condition	0.91; 0.87	—
PRIMARY Go Correct Hits Followed by Button Press - Threat Condition	0.9; 0.87	—
PRIMARY Nogo Trials Followed by no Button Press - Safe Condition	0.76; 0.76	—
PRIMARY Nogo Trials Followed by no Button Press - Threat Condition	0.8; 0.81	—
PRIMARY Stroop Effect on Accuracy During Congruent Task Viewing Positive Images: Safe Condition	93.9; 95.7	—
PRIMARY Stroop Effect on Accuracy During Congruent Task Viewing Positive Images: Threat Condition	94.9; 96.0	—
PRIMARY Stroop Effect on Accuracy During Congruent Task Viewing Negative Images: Safe Condition	94.3; 94.3	—
PRIMARY Stroop Effect on Accuracy During Congruent Task Viewing Negative Images: Threat Condition	95.3; 95.9	—
PRIMARY Stroop Effect on Accuracy During Congruent Task Viewing Neutral Images: Safe Condition	94.9; 95.1	—
PRIMARY Stroop Effect on Accuracy During Congruent Task Viewing Neutral Images: Threat Condition	96.2; 96.7	—
PRIMARY Stroop Effect on Accuracy During Incongruent Task Viewing Positive Images: Safe Condition	94.1; 96.5	—
PRIMARY Stroop Effect on Accuracy During Incongruent Task Viewing Positive Images: Threat Condition	94.3; 94.1	—
PRIMARY Stroop Effect on Accuracy During Incongruent Task Viewing Negative Images: Safe Condition	94.2; 94.0	—
PRIMARY Stroop Effect on Accuracy During Incongruent Task Viewing Negative Images: Threat Condition	95.0; 95.3	—
PRIMARY Stroop Effect on Accuracy During Incongruent Task Viewing Neutral Images: Safe Condition	94.4; 94.8	—
PRIMARY Stroop Effect on Accuracy During Incongruent Task Viewing Neutral Images: Threat Condition	95.8; 95.8	—
PRIMARY Subjective Rating of Difficulty With Attention During Safe Condition	2.9; 4.1	—
PRIMARY Subjective Rating of Difficulty With Attention During Threat Condition	4.4; 6.5	—
PRIMARY Subjective Rating of Level of Anxiety During Safe Condition	2; 3.5	—
PRIMARY Subjective Rating of Level of Anxiety During Threat Condition	6.7; 8.1	—

Summary

Fear and anxiety are normal responses to a threat. However, anxiety is considered abnormal when the response to the threat is excessive or inappropriate. This study will examine changes in the body and brain that occur during unpleasant learning experiences in healthy volunteers with high, moderate, and low levels of anxiety. A high degree of generalized anxiety is a component of many anxiety disorders and is regarded as a marker of vulnerability for these disorders. People with anxiety disorders and individuals with high degrees of anxiety have inappropriate expectations of unpleasant events. This study will investigate the development of expecting unpleasant events in healthy volunteers with varying degrees of anxiety using aversive conditioning models. A later phase of the study will enroll participants with anxiety disorders and compare their responses to those of healthy volunteers. Patients who meet criteria for an anxiety disorder, and healthy volunteers who have no history of psychiatric or major medical illness will be enrolled in this study. Volunteers will come to the NIH Clinical Center three times for outpatient testing....

Eligibility Criteria

INCLUSION CRITERIA:
Inclusion criteria for both patients and healthy controls
All subjects must be able to give written informed consent prior to participation in this study.
PATIENTS ONLY: May have DSM-IV-TR diagnoses of an anxiety disorder (GAD; SAD; Panic disorder; specific phobia) or mood disorder (MDD; BP).
PATIENTS ONLY: May be taking the mood stabilizers, Depakote or Lithium Carbonate.
Speaks English fluently

EXCLUSION CRITERIA

Exclusion criteria for healthy subjects
Female subjects who are currently pregnant
Subjects who meet DSM-IV criteria for current alcohol or substance abuse
Subjects with a history of alcohol or substance dependence within 6 months prior to screening
Current Axis I psychiatric disorders as identified with the Structured Clinical Interview for DSM-IV-TR axis disorders, non-patient edition (SCID-np). Past history of any psychotic disorder or bipolar disorder.
intelligence quotient (I-Q)<80
Medical illnesses (such as diabetes or hypertension) or neurological illnesses (such as carpal tunnel syndrome for shocks to be delivered on affected arm; organic brain impairment; seizure disorder) likely to interfere with the study.
Subjects who are on a medication that may interfere with the study.
Employee of National Institute of Mental Health (NIMH) or an immediate family member who is a NIMH employee.
Exclusion criteria for patients
Patients who would be unable to comply with study procedures or assessments;
Female patients who are currently pregnant;
Patients who meet DSM-IV criteria for current alcohol or substance abuse
Subjects with a history of alcohol or substance dependence within 6 months prior to screening;
Patients who are on a medication (other than mood stabilizers lithium carbonate or Depakote) that may interfere with the study
Medical illnesses (such as diabetes or hypertension) or neurological illnesses (such as carpal tunnel syndrome; organic brain impairment; seizure disorder) likely to interfere with the study.
Patients will be excluded if they have a current or past history of, delirium, dementia, amnestic disorder, any of the pervasive developmental disorders; or cognitive impairment.
Current Axis I psychiatric disorders as identified with the Structured Clinical Interview for DSM-IV-TR axis disorders, non-patient edition (SCID) with the exception of the mood and anxiety disorders. Past history of any psychotic disorder or bipolar disorder..
IQ<80
Employee of NIMH or an immediate family member who is an NIMH employee.
Additional exclusion criteria for the active avoidance task
Color blindness

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00055224). 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.