Anxiety DisordersNCT00055224

Expectation of Unpleasant Events in Anxiety Disorders

A study testing Threat of shock in people with Anxiety Disorders, run by National Institute of Mental Health (NIMH) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Anxiety Disorders
What is being tested?: Threat of shock
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 921 participants
Where: 1 siteUnited States
Study dates: 24 Mar 2003to 28 Jul 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 50 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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.

Show all 20Show fewer

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.
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

Trial locations and contacts

1 site in 1 country.

United States1 site

National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892

Other trials in United States

About this study

Official title: Predictability and Aversive Expectancies in Anxiety and Depressive Disorders

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....

Read the detailed description

High-generalized anxiety is a concomitant of many anxiety disorders and is often regarded as a vulnerability marker for these disorders. One characteristic of patients with anxiety disorders and high trait-anxious individuals is inappropriate expectancies of aversive events. The overall aim of the present protocol is to investigate mechanisms that may promote the development of these aversive expectancies using expectancy-based, associative-learning models.

During aversive conditioning in which a phasic explicit-cue (e.g., a light) is repeatedly associated with an aversive unconditioned-stimulus (e.g., a shock), the organism develops fear to the explicit cue as well as to the environmental context in which the experiment took place. We have obtained preliminary evidence suggesting that contextual fear represents aspects of aversive states that are central to anxiety disorders. In this protocol, we seek further evidence for the relevance of contextual fear to mood anxiety disorders.

One important determinant of contextual fear in both humans and animals is predictability: contextual fear increases when aversive events (e.g., electric shock) are unpredictable, as opposed to when they are predictable. The present protocol will examine the role of predictability of aversive states and of conditioning on threat appraisal in individuals with mood and anxiety disorders.

A second aim is to examine the interaction between experimentally-induced anxiety and cognitive processes, more specifically working memory, in mood and anxiety disorders.

Conditions: Anxiety Disorders
Being tested: Threat of shock
Keywords: Anxiety Disorder, Psychophysiology, Shock Threat, Context Conditioning, Agoraphobia, Panic Disorder, Generalized Anxiety Disorder, GAD, Healthy Volunteer, HV
Medical subject headings: Anxiety Disorders, Agoraphobia, Panic Disorder, Generalized Anxiety Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Threat of shockDevice
During threat, a participant could receive a shock. During safe, a participant could not receive as shock. Participants selected their highest tolerable level of shock.

Study groups in NCT00055224
Study group	Role	What they receive
Healthy Participants	Experimental	Substudy 1/ Neutral, Predictable, and Unpredictable Responses (NPU): physiological responses to different threat of shock conditions - no shock, unpredictable shock, and predictable-cued shock. Substudy 2/ Working Memory Task: Subjects performed a working memory task under threat of shock and in safety. Substudy 5 /Face Stroop Task: Stimuli were pictures of faces exhibiting anger, disgust, fear, happiness, sadness, and surprise intermixed with pleasant, unpleasant, and neutral pictures. Substudy 7/ Active Avoidance Signal Task (AAST) and Sustained Attention Response Task (SART): In AAST, participants performed paradigms which tested whether threats impact the initiation and the inhibition of behavioral responses. In SART, participants were presented with stimuli and either initiated a go or nogo response. Pilot Tasks: Participants completed one/more tasks: nerve stimulation, short speech, air burst, saliva samples, squeezer task, virtual reality task, or computer-based task. Receives: Device: Threat of shock
Anxiety subjects	Experimental	Substudy 1/ Neutral, Predictable, and Unpredictable Responses (NPU): physiological responses to different threat of shock conditions - no shock, unpredictable shock, and predictable-cued shock. Substudy 2/ Working Memory Task: Subjects performed a working memory task under threat of shock and in safety. Substudy 5 /Face Stroop Task: Stimuli were pictures of faces exhibiting anger, disgust, fear, happiness, sadness, and surprise intermixed with pleasant, unpleasant, and neutral pictures. Substudy 7/ Active Avoidance Signal Task (AAST) and Sustained Attention Response Task (SART): In AAST, participants performed paradigms which tested whether threats impact the initiation and the inhibition of behavioral responses. In SART, participants were presented with stimuli and either initiated a go or nogo response. Pilot Tasks: Participants completed one/more tasks: nerve stimulation, short speech, air burst, saliva samples, squeezer task, virtual reality task, or computer-based task. Receives: Device: Threat of shock

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Percent of Correct Button Presses During Threat Compared to the Safe Condition (AAST)
Subjects participated in go/no go (GNG) task condition during periods of threat of shocks and periods of safety when no shock could be administered. During the GNG stimuli were presented on a monitor. In the GNG task, participants were asked to respond to frequent 'go' stimuli ('=') by pressing the '2' on the keypad of a computer keyboard and to withhold their response to infrequent 'nogo' stimuli ('O'). Stimuli were randomly distributed. A correct go hit was a response recorded during these 2000 ms to a go trial. Similarly, a correct nogo omission was a no response during the same period to a nogo trial. Performance was determined for each condition (threat, safe) and trial type (go, nogo) by dividing the number of correct responses by the total number of each trial type. Improvement in accuracy was measured as a higher percent of correct button presses during threat compared to safety.
Measured: 2000 ms during trial
Change in Percent of Correct no Button Presses During Threat Compared to the Safe Condition
Subjects participated in go/no go (GNG) task condition during periods of threat of shocks and periods of safety when no shock could be administered. During the GNG stimuli were presented on a monitor. In the GNG task, participants were asked to respond to frequent 'go' stimuli ('=') by pressing the '2' on the keypad of a computer keyboard and to withhold their response to infrequent 'nogo' stimuli ('O'). Stimuli were randomly distributed. A correct go hit was a response recorded during these 2000 ms to a go trial. Similarly, a correct nogo omission was a no response during the same period to a nogo trial. Performance was determined for each condition (threat, safe) and trial type (go, nogo) by dividing the number of correct responses by the total number of each trial type. Improvement in accuracy was measured as a higher percent of correct button presses during threat compared to safety.
Measured: 2000 ms during trial
Correct-go Reaction Time (RT) - Safe Condition
Correct go responses were go trials followed by button press. Reaction time (RT) is the time it takes to respond to stimuli. Participants RTs were measured while undergoing alternating periods of safety and shock threat conditions i.e. while anticipating unpleasant electric shocks (threat) or no shock (safe). Mean reaction time (RT) was calculated for correct-go to evaluate speed-accuracy trade-off.
Measured: 2000 ms during trial
Correct-go Reaction Time (RT) - Threat Condition
Correct go responses were go trials followed by button press. Reaction time (RT) is the time it takes to respond to stimuli. Participants RTs were measured while undergoing alternating periods of safety and shock threat conditions i.e. while anticipating unpleasant electric shocks (threat) or no shock (safe). Mean reaction time (RT) was calculated for correct-go to evaluate speed-accuracy trade-off.
Measured: 2000 ms during trial
Go Correct Hits Followed by Button Press - Safe Condition
Subjects participated in go/no go (GNG) task condition during periods of threat of shocks and periods of safety when no shock could be administered. During the GNG stimuli were presented on a monitor. In the GNG task, participants were asked to respond to frequent 'go' stimuli ('=') by pressing the '2' on the keypad of a computer keyboard and to withhold their response to infrequent 'nogo' stimuli ('O'). Stimuli were randomly distributed. A correct go hit was a response recorded during these 2000 ms to a go trial. Similarly, a correct nogo omission was a no response during the same period to a nogo trial. Performance was determined for each condition (threat, safe) and trial type (go, nogo) by dividing the number of correct response by the total number of each trial type.
Measured: 2000 ms during trial
Go Correct Hits Followed by Button Press - Threat Condition
Subjects participated in go/no go (GNG) task condition during periods of threat of shocks and periods of safety when no shock could be administered. During the GNG stimuli were presented on a monitor. In the GNG task, participants were asked to respond to frequent (91%) 'go' stimuli ('=') by pressing the '2' on the keypad of a computer keyboard and to withhold their response to infrequent (9%) 'nogo' stimuli ('O'). Stimuli were randomly distributed. A correct go hit was a response recorded during these 2000 ms to a go trial. Similarly, a correct nogo omission was a no response during the same period to a nogo trial. Performance was determined for each condition (threat, safe) and trial type (go, nogo) by dividing the number of correct response by the total number of each trial type.
Measured: 2000 ms during trial
Nogo Trials Followed by no Button Press - Safe Condition
Subjects participated in go/no go (GNG) task condition during periods of threat of shocks and periods of safety when no shock could be administered. During the GNG stimuli were presented on a monitor. In the GNG task, participants were asked to respond to frequent 'go' stimuli ('=') by pressing the '2' on the keypad of a computer keyboard and to withhold their response to infrequent 'nogo' stimuli ('O'). Stimuli were randomly distributed. A correct go hit was a response recorded during these 2000 ms to a go trial. Similarly, a correct nogo omission was a no response during the same period to a nogo trial. Performance was determined for each condition (threat, safe) and trial type (go, nogo) by dividing the number of correct response by the total number of each trial type.
Measured: 2000 ms during trial
Nogo Trials Followed by no Button Press - Threat Condition
Subjects participated in go/no go (GNG) task condition during periods of threat of shocks and periods of safety when no shock could be administered. During the GNG stimuli were presented on a monitor. In the GNG task, participants were asked to respond to frequent 'go' stimuli ('=') by pressing the '2' on the keypad of a computer keyboard and to withhold their response to infrequent 'nogo' stimuli ('O'). Stimuli were randomly distributed. A correct go hit was a response recorded during these 2000 ms to a go trial. Similarly, a correct nogo omission was a no response during the same period to a nogo trial. Performance was determined for each condition (threat, safe) and trial type (go, nogo) by dividing the number of correct response by the total number of each trial type.
Measured: 2000 ms during trial
Stroop Effect on Accuracy During Congruent Task Viewing Positive Images: Safe Condition
Participants watched as six trial types differing by congruence and emotion (negative, neutral, positive) were presented during condition blocks (safe, threat) on a computer screen. Each trial began with a fixation point which was then immediately followed by a picture stimulus, followed by a numerical display, followed by a repeat of the picture stimulus, and followed by a blank screen. During threat, a participant could receive a shock. During safe, a participant could not receive a shock. The effect of accuracy on congruence across negative, positive, and neutral images in threat and safe conditions was assessed by participants accurate identification of facial expression.
Measured: 11.2 minutes per run for a total of 22.4 minutes
Stroop Effect on Accuracy During Congruent Task Viewing Positive Images: Threat Condition
Participants watched as six trial types differing by congruence and emotion (negative, neutral, positive) were presented during condition blocks (safe, threat) on a computer screen. Each trial began with a fixation point which was then immediately followed by a picture stimulus, followed by a numerical display, followed by a repeat of the picture stimulus, and followed by a blank screen. During threat, a participant could receive a shock. During safe, a participant could not receive a shock. The effect of accuracy on congruence across negative, positive, and neutral images in threat and safe conditions was assessed by participants accurate identification of facial expression.
Measured: 11.2 minutes per run for a total of 22.4 minutes
Stroop Effect on Accuracy During Congruent Task Viewing Negative Images: Safe Condition
Participants watched as six trial types differing by congruence and emotion (negative, neutral, positive) were presented during condition blocks (safe, threat) on a computer screen. Each trial began with a fixation point which was then immediately followed by a picture stimulus, followed by a numerical display, followed by a repeat of the picture stimulus, and followed by a blank screen. During threat, a participant could receive a shock. During safe, a participant could not receive a shock. The effect of accuracy on congruence across negative, positive, and neutral images in threat and safe conditions was assessed by participants accurate identification of facial expression.
Measured: 11.2 minutes per run for a total of 22.4 minutes
Stroop Effect on Accuracy During Congruent Task Viewing Negative Images: Threat Condition
Participants watched as six trial types differing by congruence and emotion (negative, neutral, positive) were presented during condition blocks (safe, threat) on a computer screen. Each trial began with a fixation point which was then immediately followed by a picture stimulus, followed by a numerical display, followed by a repeat of the picture stimulus, and followed by a blank screen. During threat, a participant could receive a shock. During safe, a participant could not receive a shock. The effect of accuracy on congruence across negative, positive, and neutral images in threat and safe conditions was assessed by participants accurate identification of facial expression.
Measured: 11.2 minutes per run for a total of 22.4 minutes
Stroop Effect on Accuracy During Congruent Task Viewing Neutral Images: Safe Condition
Participants watched as six trial types differing by congruence and emotion (negative, neutral, positive) were presented during condition blocks (safe, threat) on a computer screen. Each trial began with a fixation point which was then immediately followed by a picture stimulus, followed by a numerical display, followed by a repeat of the picture stimulus, and followed by a blank screen. During threat, a participant could receive a shock. During safe, a participant could not receive a shock. The effect of accuracy on congruence across negative, positive, and neutral images in threat and safe conditions was assessed by participants accurate identification of facial expression.
Measured: 11.2 minutes per run for a total of 22.4 minutes
Stroop Effect on Accuracy During Congruent Task Viewing Neutral Images: Threat Condition
Participants watched as six trial types differing by congruence and emotion (negative, neutral, positive) were presented during condition blocks (safe, threat) on a computer screen. Each trial began with a fixation point which was then immediately followed by a picture stimulus, followed by a numerical display, followed by a repeat of the picture stimulus, and followed by a blank screen. During threat, a participant could receive a shock. During safe, a participant could not receive a shock. The effect of accuracy on congruence across negative, positive, and neutral images in threat and safe conditions was assessed by participants accurate identification of facial expression.
Measured: 11.2 minutes per run for a total of 22.4 minutes
Stroop Effect on Accuracy During Incongruent Task Viewing Positive Images: Safe Condition
Participants watched as six trial types differing by congruence and emotion (negative, neutral, positive) were presented during condition blocks (safe, threat) on a computer screen. Each trial began with a fixation point which was then immediately followed by a picture stimulus, followed by a numerical display, followed by a repeat of the picture stimulus, and followed by a blank screen. During threat, a participant could receive a shock. During safe, a participant could not receive a shock. The effect of accuracy on congruence across negative, positive, and neutral images in threat and safe conditions was assessed by participants accurate identification of facial expression.
Measured: 11.2 minutes per run for a total of 22.4 minutes
Stroop Effect on Accuracy During Incongruent Task Viewing Positive Images: Threat Condition
Participants watched as six trial types differing by congruence and emotion (negative, neutral, positive) were presented during condition blocks (safe, threat) on a computer screen. Each trial began with a fixation point which was then immediately followed by a picture stimulus, followed by a numerical display, followed by a repeat of the picture stimulus, and followed by a blank screen. During threat, a participant could receive a shock. During safe, a participant could not receive a shock. The effect of accuracy on congruence across negative, positive, and neutral images in threat and safe conditions was assessed by participants accurate identification of facial expression.
Measured: 11.2 minutes per run for a total of 22.4 minutes
Stroop Effect on Accuracy During Incongruent Task Viewing Negative Images: Safe Condition
Participants watched as six trial types differing by congruence and emotion (negative, neutral, positive) were presented during condition blocks (safe, threat) on a computer screen. Each trial began with a fixation point which was then immediately followed by a picture stimulus, followed by a numerical display, followed by a repeat of the picture stimulus, and followed by a blank screen. During threat, a participant could receive a shock. During safe, a participant could not receive a shock. The effect of accuracy on congruence across negative, positive, and neutral images in threat and safe conditions was assessed by participants accurate identification of facial expression.
Measured: 11.2 minutes per run for a total of 22.4 minutes
Stroop Effect on Accuracy During Incongruent Task Viewing Negative Images: Threat Condition
Participants watched as six trial types differing by congruence and emotion (negative, neutral, positive) were presented during condition blocks (safe, threat) on a computer screen. Each trial began with a fixation point which was then immediately followed by a picture stimulus, followed by a numerical display, followed by a repeat of the picture stimulus, and followed by a blank screen. During threat, a participant could receive a shock. During safe, a participant could not receive a shock. The effect of accuracy on congruence across negative, positive, and neutral images in threat and safe conditions was assessed by participants accurate identification of facial expression.
Measured: 11.2 minutes per run for a total of 22.4 minutes
Stroop Effect on Accuracy During Incongruent Task Viewing Neutral Images: Safe Condition
Participants watched as six trial types differing by congruence and emotion (negative, neutral, positive) were presented during condition blocks (safe, threat) on a computer screen. Each trial began with a fixation point which was then immediately followed by a picture stimulus, followed by a numerical display, followed by a repeat of the picture stimulus, and followed by a blank screen. During threat, a participant could receive a shock. During safe, a participant could not receive a shock. The effect of accuracy on congruence across negative, positive, and neutral images in threat and safe conditions was assessed by participants accurate identification of facial expression.
Measured: 11.2 minutes per run for a total of 22.4 minutes
Stroop Effect on Accuracy During Incongruent Task Viewing Neutral Images: Threat Condition
Participants watched as six trial types differing by congruence and emotion (negative, neutral, positive) were presented during condition blocks (safe, threat) on a computer screen. Each trial began with a fixation point which was then immediately followed by a picture stimulus, followed by a numerical display, followed by a repeat of the picture stimulus, and followed by a blank screen. During threat, a participant could receive a shock. During safe, a participant could not receive a shock. The effect of accuracy on congruence across negative, positive, and neutral images in threat and safe conditions was assessed by participants accurate identification of facial expression.
Measured: 11.2 minutes per run for a total of 22.4 minutes
Subjective Rating of Difficulty With Attention During Safe Condition
Following tasks completion, participants provided retrospective ratings of: anxiety and attention during safe and threat conditions using an analog scale ranging from 1 (not at all) to 10 (extremely). Participants rated overall subjective difficulty with attention ('How difficult was it to pay attention during threat/safe?') and level of anxiety ('How anxious were you during threat/safe?'). Retrospective ratings of anxiety and difficulty with attention were analyzed with two way Diagnosis x Condition (safe, threat) ANOVA.
Measured: Assessed immediately after completing the affective Stroop task
Subjective Rating of Difficulty With Attention During Threat Condition
Following tasks completion, participants provided retrospective ratings of: anxiety and attention during safe and threat conditions using an analog scale ranging from 1 (not at all) to 10 (extremely). Participants rated overall subjective difficulty with attention ('How difficult was it to pay attention during threat/safe?') and level of anxiety ('How anxious were you during threat/safe?'). Retrospective ratings of anxiety and difficulty with attention were analyzed with two way Diagnosis x Condition (safe, threat) ANOVA.
Measured: Assessed immediately after completing the affective Stroop task
Subjective Rating of Level of Anxiety During Safe Condition
Following tasks completion, participants provided retrospective ratings of: anxiety and attention during safe and threat conditions using an analog scale ranging from 1 (not at all) to 10 (extremely). Participants rated overall subjective difficulty with attention ('How difficult was it to pay attention during threat/safe?') and level of anxiety ('How anxious were you during threat/safe?'). Retrospective ratings of anxiety and difficulty with attention were analyzed with two way Diagnosis x Condition (safe, threat) ANOVA.
Measured: Assessed immediately after completing the affective Stroop task
Subjective Rating of Level of Anxiety During Threat Condition
Following tasks completion, participants provided retrospective ratings of: anxiety and attention during safe and threat conditions using an analog scale ranging from 1 (not at all) to 10 (extremely). Participants rated overall subjective difficulty with attention ('How difficult was it to pay attention during threat/safe?') and level of anxiety ('How anxious were you during threat/safe?'). Retrospective ratings of anxiety and difficulty with attention were analyzed with two way Diagnosis x Condition (safe, threat) ANOVA.
Measured: Assessed immediately after completing the affective Stroop task

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Mar 200328 Jul 2022

First posted21 Feb 2003 (estimated)
Study start24 Mar 2003
Primary completion11 Mar 2020
Study completion28 Jul 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Anxiety DisordersStudies of the same condition, open and under way.
More trials run by National Institute of Mental Health (NIMH)The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 921 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00055224
Sponsor's protocol ID: 030093
Other IDs: 03-M-0093
Status last verified: Aug 2022
First submitted: 21 Feb 2003
Last updated: 9 Jan 2024
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: Yes: .We plan to only share de-identified data in a repository. No identified data will be shared.

Publications

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. doi: 10.1016/0006-3223(94)90040-x.
PubMed 8018793
Grillon C, Morgan CA 3rd, Davis M, Southwick SM. Effects of experimental context and explicit threat cues on acoustic startle in Vietnam veterans with posttraumatic stress disorder. Biol Psychiatry. 1998 Nov 15;44(10):1027-36. doi: 10.1016/s0006-3223(98)00034-1.
PubMed 9821567
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. doi: 10.1037//0021-843x.108.1.134.
PubMed 10066999

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 9 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Predictability and Aversive Expectancies in Anxiety and Depressive Disorders
ClinicalTrials.gov ID: NCT00055224
Acronym / sponsor ID: 030093
Conditions: Anxiety Disorders
Keywords: Anxiety Disorder, Psychophysiology, Shock Threat, Context Conditioning, Agoraphobia, Panic Disorder, Generalized Anxiety Disorder, GAD
Study type: Interventional
Recruitment status: Completed
Enrolment: 921 participants (actual)
Lead sponsor: National Institute of Mental Health (NIMH)US National Institutes of Health
Study start: 24 Mar 2003 (actual)
Primary completion: 11 Mar 2020 (actual)
Study completion: 28 Jul 2022 (actual)
First posted: 21 Feb 2003 (estimated)
Results: Posted 9 Jan 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

A second aim is to examine the interaction between experimentally-induced anxiety and cognitive processes, more specifically working memory, in mood and anxiety disorders.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Healthy Participants	Experimental	Device: Threat of shockSubstudy 1/ Neutral, Predictable, and Unpredictable Responses (NPU): physiological responses to different threat of shock conditions - no shock, unpredictable shock, and predictable-cued shock. Substudy 2/ Working Memory Task: Subjects performed a working memory task under threat of shock and in safety. Substudy 5 /Face Stroop Task: Stimuli were pictures of faces exhibiting anger, disgust, fear, happiness, sadness, and surprise intermixed with pleasant, unpleasant, and neutral pictures. Substudy 7/ Active Avoidance Signal Task (AAST) and Sustained Attention Response Task (SART): In AAST, participants performed paradigms which tested whether threats impact the initiation and the inhibition of behavioral responses. In SART, participants were presented with stimuli and either initiated a go or nogo response. Pilot Tasks: Participants completed one/more tasks: nerve stimulation, short speech, air burst, saliva samples, squeezer task, virtual reality task, or computer-based task.
Anxiety subjects	Experimental	Device: Threat of shockSubstudy 1/ Neutral, Predictable, and Unpredictable Responses (NPU): physiological responses to different threat of shock conditions - no shock, unpredictable shock, and predictable-cued shock. Substudy 2/ Working Memory Task: Subjects performed a working memory task under threat of shock and in safety. Substudy 5 /Face Stroop Task: Stimuli were pictures of faces exhibiting anger, disgust, fear, happiness, sadness, and surprise intermixed with pleasant, unpleasant, and neutral pictures. Substudy 7/ Active Avoidance Signal Task (AAST) and Sustained Attention Response Task (SART): In AAST, participants performed paradigms which tested whether threats impact the initiation and the inhibition of behavioral responses. In SART, participants were presented with stimuli and either initiated a go or nogo response. Pilot Tasks: Participants completed one/more tasks: nerve stimulation, short speech, air burst, saliva samples, squeezer task, virtual reality task, or computer-based task.

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Key exclusion criteria (20 listed)

Additional exclusion criteria for the active avoidance task

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Threat of shockDuring threat, a participant could receive a shock. During safe, a participant could not receive as shock. Participants selected their highest tolerable level of shock.	Device	Anxiety subjects, Healthy Participants

Primary outcome

Change in Percent of Correct Button Presses During Threat Compared to the Safe Condition (AAST)
Time frame: 2000 ms during trial
Subjects participated in go/no go (GNG) task condition during periods of threat of shocks and periods of safety when no shock could be administered. During the GNG stimuli were presented on a monitor. In the GNG task, participants were asked to respond to frequent 'go' stimuli ('=') by pressing the '2' on the keypad of a computer keyboard and to withhold their response to infrequent 'nogo' stimuli ('O'). Stimuli were randomly distributed. A correct go hit was a response recorded during these 2000 ms to a go trial. Similarly, a correct nogo omission was a no response during the same period to a nogo trial. Performance was determined for each condition (threat, safe) and trial type (go, nogo) by dividing the number of correct responses by the total number of each trial type. Improvement in accuracy was measured as a higher percent of correct button presses during threat compared to safety.
Change in Percent of Correct no Button Presses During Threat Compared to the Safe Condition
Time frame: 2000 ms during trial
Subjects participated in go/no go (GNG) task condition during periods of threat of shocks and periods of safety when no shock could be administered. During the GNG stimuli were presented on a monitor. In the GNG task, participants were asked to respond to frequent 'go' stimuli ('=') by pressing the '2' on the keypad of a computer keyboard and to withhold their response to infrequent 'nogo' stimuli ('O'). Stimuli were randomly distributed. A correct go hit was a response recorded during these 2000 ms to a go trial. Similarly, a correct nogo omission was a no response during the same period to a nogo trial. Performance was determined for each condition (threat, safe) and trial type (go, nogo) by dividing the number of correct responses by the total number of each trial type. Improvement in accuracy was measured as a higher percent of correct button presses during threat compared to safety.
Correct-go Reaction Time (RT) - Safe Condition
Time frame: 2000 ms during trial
Correct go responses were go trials followed by button press. Reaction time (RT) is the time it takes to respond to stimuli. Participants RTs were measured while undergoing alternating periods of safety and shock threat conditions i.e. while anticipating unpleasant electric shocks (threat) or no shock (safe). Mean reaction time (RT) was calculated for correct-go to evaluate speed-accuracy trade-off.
Correct-go Reaction Time (RT) - Threat Condition
Time frame: 2000 ms during trial
Correct go responses were go trials followed by button press. Reaction time (RT) is the time it takes to respond to stimuli. Participants RTs were measured while undergoing alternating periods of safety and shock threat conditions i.e. while anticipating unpleasant electric shocks (threat) or no shock (safe). Mean reaction time (RT) was calculated for correct-go to evaluate speed-accuracy trade-off.
Go Correct Hits Followed by Button Press - Safe Condition
Time frame: 2000 ms during trial
Subjects participated in go/no go (GNG) task condition during periods of threat of shocks and periods of safety when no shock could be administered. During the GNG stimuli were presented on a monitor. In the GNG task, participants were asked to respond to frequent 'go' stimuli ('=') by pressing the '2' on the keypad of a computer keyboard and to withhold their response to infrequent 'nogo' stimuli ('O'). Stimuli were randomly distributed. A correct go hit was a response recorded during these 2000 ms to a go trial. Similarly, a correct nogo omission was a no response during the same period to a nogo trial. Performance was determined for each condition (threat, safe) and trial type (go, nogo) by dividing the number of correct response by the total number of each trial type.
Go Correct Hits Followed by Button Press - Threat Condition
Time frame: 2000 ms during trial
Subjects participated in go/no go (GNG) task condition during periods of threat of shocks and periods of safety when no shock could be administered. During the GNG stimuli were presented on a monitor. In the GNG task, participants were asked to respond to frequent (91%) 'go' stimuli ('=') by pressing the '2' on the keypad of a computer keyboard and to withhold their response to infrequent (9%) 'nogo' stimuli ('O'). Stimuli were randomly distributed. A correct go hit was a response recorded during these 2000 ms to a go trial. Similarly, a correct nogo omission was a no response during the same period to a nogo trial. Performance was determined for each condition (threat, safe) and trial type (go, nogo) by dividing the number of correct response by the total number of each trial type.
Nogo Trials Followed by no Button Press - Safe Condition
Time frame: 2000 ms during trial
Subjects participated in go/no go (GNG) task condition during periods of threat of shocks and periods of safety when no shock could be administered. During the GNG stimuli were presented on a monitor. In the GNG task, participants were asked to respond to frequent 'go' stimuli ('=') by pressing the '2' on the keypad of a computer keyboard and to withhold their response to infrequent 'nogo' stimuli ('O'). Stimuli were randomly distributed. A correct go hit was a response recorded during these 2000 ms to a go trial. Similarly, a correct nogo omission was a no response during the same period to a nogo trial. Performance was determined for each condition (threat, safe) and trial type (go, nogo) by dividing the number of correct response by the total number of each trial type.
Nogo Trials Followed by no Button Press - Threat Condition
Time frame: 2000 ms during trial
Subjects participated in go/no go (GNG) task condition during periods of threat of shocks and periods of safety when no shock could be administered. During the GNG stimuli were presented on a monitor. In the GNG task, participants were asked to respond to frequent 'go' stimuli ('=') by pressing the '2' on the keypad of a computer keyboard and to withhold their response to infrequent 'nogo' stimuli ('O'). Stimuli were randomly distributed. A correct go hit was a response recorded during these 2000 ms to a go trial. Similarly, a correct nogo omission was a no response during the same period to a nogo trial. Performance was determined for each condition (threat, safe) and trial type (go, nogo) by dividing the number of correct response by the total number of each trial type.
Stroop Effect on Accuracy During Congruent Task Viewing Positive Images: Safe Condition
Time frame: 11.2 minutes per run for a total of 22.4 minutes
Participants watched as six trial types differing by congruence and emotion (negative, neutral, positive) were presented during condition blocks (safe, threat) on a computer screen. Each trial began with a fixation point which was then immediately followed by a picture stimulus, followed by a numerical display, followed by a repeat of the picture stimulus, and followed by a blank screen. During threat, a participant could receive a shock. During safe, a participant could not receive a shock. The effect of accuracy on congruence across negative, positive, and neutral images in threat and safe conditions was assessed by participants accurate identification of facial expression.
Stroop Effect on Accuracy During Congruent Task Viewing Positive Images: Threat Condition
Time frame: 11.2 minutes per run for a total of 22.4 minutes
Participants watched as six trial types differing by congruence and emotion (negative, neutral, positive) were presented during condition blocks (safe, threat) on a computer screen. Each trial began with a fixation point which was then immediately followed by a picture stimulus, followed by a numerical display, followed by a repeat of the picture stimulus, and followed by a blank screen. During threat, a participant could receive a shock. During safe, a participant could not receive a shock. The effect of accuracy on congruence across negative, positive, and neutral images in threat and safe conditions was assessed by participants accurate identification of facial expression.
Stroop Effect on Accuracy During Congruent Task Viewing Negative Images: Safe Condition
Time frame: 11.2 minutes per run for a total of 22.4 minutes
Participants watched as six trial types differing by congruence and emotion (negative, neutral, positive) were presented during condition blocks (safe, threat) on a computer screen. Each trial began with a fixation point which was then immediately followed by a picture stimulus, followed by a numerical display, followed by a repeat of the picture stimulus, and followed by a blank screen. During threat, a participant could receive a shock. During safe, a participant could not receive a shock. The effect of accuracy on congruence across negative, positive, and neutral images in threat and safe conditions was assessed by participants accurate identification of facial expression.
Stroop Effect on Accuracy During Congruent Task Viewing Negative Images: Threat Condition
Time frame: 11.2 minutes per run for a total of 22.4 minutes
Participants watched as six trial types differing by congruence and emotion (negative, neutral, positive) were presented during condition blocks (safe, threat) on a computer screen. Each trial began with a fixation point which was then immediately followed by a picture stimulus, followed by a numerical display, followed by a repeat of the picture stimulus, and followed by a blank screen. During threat, a participant could receive a shock. During safe, a participant could not receive a shock. The effect of accuracy on congruence across negative, positive, and neutral images in threat and safe conditions was assessed by participants accurate identification of facial expression.
Stroop Effect on Accuracy During Congruent Task Viewing Neutral Images: Safe Condition
Time frame: 11.2 minutes per run for a total of 22.4 minutes
Participants watched as six trial types differing by congruence and emotion (negative, neutral, positive) were presented during condition blocks (safe, threat) on a computer screen. Each trial began with a fixation point which was then immediately followed by a picture stimulus, followed by a numerical display, followed by a repeat of the picture stimulus, and followed by a blank screen. During threat, a participant could receive a shock. During safe, a participant could not receive a shock. The effect of accuracy on congruence across negative, positive, and neutral images in threat and safe conditions was assessed by participants accurate identification of facial expression.
Stroop Effect on Accuracy During Congruent Task Viewing Neutral Images: Threat Condition
Time frame: 11.2 minutes per run for a total of 22.4 minutes
Participants watched as six trial types differing by congruence and emotion (negative, neutral, positive) were presented during condition blocks (safe, threat) on a computer screen. Each trial began with a fixation point which was then immediately followed by a picture stimulus, followed by a numerical display, followed by a repeat of the picture stimulus, and followed by a blank screen. During threat, a participant could receive a shock. During safe, a participant could not receive a shock. The effect of accuracy on congruence across negative, positive, and neutral images in threat and safe conditions was assessed by participants accurate identification of facial expression.
Stroop Effect on Accuracy During Incongruent Task Viewing Positive Images: Safe Condition
Time frame: 11.2 minutes per run for a total of 22.4 minutes
Participants watched as six trial types differing by congruence and emotion (negative, neutral, positive) were presented during condition blocks (safe, threat) on a computer screen. Each trial began with a fixation point which was then immediately followed by a picture stimulus, followed by a numerical display, followed by a repeat of the picture stimulus, and followed by a blank screen. During threat, a participant could receive a shock. During safe, a participant could not receive a shock. The effect of accuracy on congruence across negative, positive, and neutral images in threat and safe conditions was assessed by participants accurate identification of facial expression.
Stroop Effect on Accuracy During Incongruent Task Viewing Positive Images: Threat Condition
Time frame: 11.2 minutes per run for a total of 22.4 minutes
Participants watched as six trial types differing by congruence and emotion (negative, neutral, positive) were presented during condition blocks (safe, threat) on a computer screen. Each trial began with a fixation point which was then immediately followed by a picture stimulus, followed by a numerical display, followed by a repeat of the picture stimulus, and followed by a blank screen. During threat, a participant could receive a shock. During safe, a participant could not receive a shock. The effect of accuracy on congruence across negative, positive, and neutral images in threat and safe conditions was assessed by participants accurate identification of facial expression.
Stroop Effect on Accuracy During Incongruent Task Viewing Negative Images: Safe Condition
Time frame: 11.2 minutes per run for a total of 22.4 minutes
Participants watched as six trial types differing by congruence and emotion (negative, neutral, positive) were presented during condition blocks (safe, threat) on a computer screen. Each trial began with a fixation point which was then immediately followed by a picture stimulus, followed by a numerical display, followed by a repeat of the picture stimulus, and followed by a blank screen. During threat, a participant could receive a shock. During safe, a participant could not receive a shock. The effect of accuracy on congruence across negative, positive, and neutral images in threat and safe conditions was assessed by participants accurate identification of facial expression.
Stroop Effect on Accuracy During Incongruent Task Viewing Negative Images: Threat Condition
Time frame: 11.2 minutes per run for a total of 22.4 minutes
Participants watched as six trial types differing by congruence and emotion (negative, neutral, positive) were presented during condition blocks (safe, threat) on a computer screen. Each trial began with a fixation point which was then immediately followed by a picture stimulus, followed by a numerical display, followed by a repeat of the picture stimulus, and followed by a blank screen. During threat, a participant could receive a shock. During safe, a participant could not receive a shock. The effect of accuracy on congruence across negative, positive, and neutral images in threat and safe conditions was assessed by participants accurate identification of facial expression.
Stroop Effect on Accuracy During Incongruent Task Viewing Neutral Images: Safe Condition
Time frame: 11.2 minutes per run for a total of 22.4 minutes
Participants watched as six trial types differing by congruence and emotion (negative, neutral, positive) were presented during condition blocks (safe, threat) on a computer screen. Each trial began with a fixation point which was then immediately followed by a picture stimulus, followed by a numerical display, followed by a repeat of the picture stimulus, and followed by a blank screen. During threat, a participant could receive a shock. During safe, a participant could not receive a shock. The effect of accuracy on congruence across negative, positive, and neutral images in threat and safe conditions was assessed by participants accurate identification of facial expression.
Stroop Effect on Accuracy During Incongruent Task Viewing Neutral Images: Threat Condition
Time frame: 11.2 minutes per run for a total of 22.4 minutes
Participants watched as six trial types differing by congruence and emotion (negative, neutral, positive) were presented during condition blocks (safe, threat) on a computer screen. Each trial began with a fixation point which was then immediately followed by a picture stimulus, followed by a numerical display, followed by a repeat of the picture stimulus, and followed by a blank screen. During threat, a participant could receive a shock. During safe, a participant could not receive a shock. The effect of accuracy on congruence across negative, positive, and neutral images in threat and safe conditions was assessed by participants accurate identification of facial expression.
Subjective Rating of Difficulty With Attention During Safe Condition
Time frame: Assessed immediately after completing the affective Stroop task
Following tasks completion, participants provided retrospective ratings of: anxiety and attention during safe and threat conditions using an analog scale ranging from 1 (not at all) to 10 (extremely). Participants rated overall subjective difficulty with attention ('How difficult was it to pay attention during threat/safe?') and level of anxiety ('How anxious were you during threat/safe?'). Retrospective ratings of anxiety and difficulty with attention were analyzed with two way Diagnosis x Condition (safe, threat) ANOVA.
Subjective Rating of Difficulty With Attention During Threat Condition
Time frame: Assessed immediately after completing the affective Stroop task
Following tasks completion, participants provided retrospective ratings of: anxiety and attention during safe and threat conditions using an analog scale ranging from 1 (not at all) to 10 (extremely). Participants rated overall subjective difficulty with attention ('How difficult was it to pay attention during threat/safe?') and level of anxiety ('How anxious were you during threat/safe?'). Retrospective ratings of anxiety and difficulty with attention were analyzed with two way Diagnosis x Condition (safe, threat) ANOVA.
Subjective Rating of Level of Anxiety During Safe Condition
Time frame: Assessed immediately after completing the affective Stroop task
Following tasks completion, participants provided retrospective ratings of: anxiety and attention during safe and threat conditions using an analog scale ranging from 1 (not at all) to 10 (extremely). Participants rated overall subjective difficulty with attention ('How difficult was it to pay attention during threat/safe?') and level of anxiety ('How anxious were you during threat/safe?'). Retrospective ratings of anxiety and difficulty with attention were analyzed with two way Diagnosis x Condition (safe, threat) ANOVA.
Subjective Rating of Level of Anxiety During Threat Condition
Time frame: Assessed immediately after completing the affective Stroop task
Following tasks completion, participants provided retrospective ratings of: anxiety and attention during safe and threat conditions using an analog scale ranging from 1 (not at all) to 10 (extremely). Participants rated overall subjective difficulty with attention ('How difficult was it to pay attention during threat/safe?') and level of anxiety ('How anxious were you during threat/safe?'). Retrospective ratings of anxiety and difficulty with attention were analyzed with two way Diagnosis x Condition (safe, threat) ANOVA.

Results and safety

Results posted to the registry on 9 Jan 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Healthy Participants	557	557
Anxiety Subjects	361	361

Primary outcome: Change in Percent of Correct Button Presses During Threat Compared to the Safe Condition (AAST)

Time frame: 2000 ms during trial. Mean (Standard Error). Unit: Percentage of accurate responses

Measure	Substudy 7/ Active Avoidance Signal Task (AAST) - Healthy Participants n = 22	Substudy 7/ Active Avoidance Signal Task (AAST) - Anxiety Patients n = 23
Value	-0.016 (0.03)	0.008 (0.04)

Population analysed: Analysis included only participants in sub-study 7 who completed the active avoidance signal task (AAST). Two healthy controls were excluded from analyses.

Primary outcome: Change in Percent of Correct no Button Presses During Threat Compared to the Safe Condition

Time frame: 2000 ms during trial. Mean (Standard Error). Unit: Percentage of accurate responses

Measure	Substudy 7/ Active Avoidance Signal Task (AAST) - Healthy Participants n = 22	Substudy 7/ Active Avoidance Signal Task (AAST) - Anxiety Patients n = 23
Value	-0.002 (0.03)	0.028 (0.04)

Population analysed: Analysis included only participants in sub-study 7 who completed the active avoidance signal task (AAST). Two healthy controls were excluded from analyses.

Primary outcome: Correct-go Reaction Time (RT) - Safe Condition

Time frame: 2000 ms during trial. Mean (Standard Error). Unit: milliseconds (ms)

Measure	Substudy 7/ Sustained Attention Response Task (SART) - Healthy Participants n = 41	Substudy 7/ Sustained Attention Response Task (SART) - Anxiety Patients n = 41
Value	387.8 (16.2)	337.3 (10.7)

Population analysed: Analysis included only participants in sub-study 7 who completed the Sustained attention response task (SART).

Primary outcome: Correct-go Reaction Time (RT) - Threat Condition

Time frame: 2000 ms during trial. Mean (Standard Error). Unit: milliseconds (ms)

Measure	Substudy 7/ Sustained Attention Response Task (SART) - Healthy Participants n = 41	Substudy 7/ Sustained Attention Response Task (SART) - Anxiety Patients n = 41
Value	377.4 (14.7)	332.2 (10.9)

Population analysed: Analysis included only participants in sub-study 7 who completed the Sustained attention response task (SART).

Adverse events

Time frame: 1 day. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Substudy 1/ Neutral, Predictable, and Unpredictable Responses - Healthy Participants	0 of 23 (0%)	0 of 23 (0%)	0 of 23
Substudy 1/ Neutral, Predictable, and Unpredictable Responses - Anxiety Subjects	0 of 78 (0%)	0 of 78 (0%)	0 of 78
Substudy 2/Working Memory Task - Healthy Participants	0 of 42 (0%)	0 of 42 (0%)	0 of 42
Substudy 2/Working Memory Task - Anxiety Subjects	0 of 35 (0%)	0 of 35 (0%)	0 of 35
Substudy 5/Face Stroop Task - Healthy Participants	0 of 33 (0%)	0 of 33 (0%)	0 of 33
Substudy 5/Face Stroop Task - Anxiety Subjects	0 of 36 (0%)	0 of 36 (0%)	0 of 36
Substudy 7/Active Avoidance and Sustained Attention Tasks - Healthy Participants	0 of 65 (0%)	0 of 65 (0%)	0 of 65
Substudy 7/Active Avoidance and Sustained Attention Tasks - Anxiety Subjects	0 of 91 (0%)	0 of 91 (0%)	0 of 91
Pilot Tasks - Healthy Participants	0 of 406 (0%)	0 of 406 (0%)	0 of 406
Pilot Tasks - Anxiety Subjects	0 of 183 (0%)	0 of 183 (0%)	0 of 183

Limitations and caveats (from the sponsor): This protocol was a series of sub-studies using sample subjects which explains the low numbers of participants per study.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 8018793Grillon 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. doi: 10.1016/0006-3223(94)90040-x.
Background: PubMed 9821567Grillon C, Morgan CA 3rd, Davis M, Southwick SM. Effects of experimental context and explicit threat cues on acoustic startle in Vietnam veterans with posttraumatic stress disorder. Biol Psychiatry. 1998 Nov 15;44(10):1027-36. doi: 10.1016/s0006-3223(98)00034-1.
Background: PubMed 10066999Grillon 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. doi: 10.1037//0021-843x.108.1.134.
NIH Clinical Center Detailed Web PageLink provided by the sponsor.
Individual participant dataSharing planned: Yes. .We plan to only share de-identified data in a repository. No identified data will be shared.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Monique Ernst, M.D. principal investigator

National Institute of Mental Health (NIMH)

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Threat of shock in people with Anxiety Disorders, run by National Institute of Mental Health (NIMH) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Percent of Correct Button Presses During Threat Compared to the Safe Condition (AAST) (time frame: 2000 ms during trial). The study lists 24 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00055224, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2024.