Anxiety Disorders
Conditions
Keywords
Anxiety Disorder, Psychophysiology, Shock Threat, Context Conditioning, Agoraphobia, Panic Disorder, Generalized Anxiety Disorder, GAD, Healthy Volunteer, HV
Brief 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....
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.
Interventions
DEVICEThreat of shock
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.
Sponsors
National Institute of Mental Health (NIMH)
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion 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
*
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Percent of Correct Button Presses During Threat Compared to the Safe Condition (AAST) | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 Threat Condition | 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. |
| Stroop Effect on Accuracy During Incongruent Task Viewing Neutral Images: Threat Condition | 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 | 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 | 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 | 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. |
Countries
United States
Participant flow
Recruitment details
921 participants were consented and performed one or more tasks. 3 participated did not perform any study related tasks.
Pre-assignment details
All sub-studies were conducted at different time points so subjects had the option to participate in multiple sub-studies.
Participants by arm
| Arm | Count |
|---|---|
| Substudy 1/ Neutral, Predictable, and Unpredictable Responses This experiment examined physiological responses including startle reflex to different threat of shock conditions (neutral (N)- no shock, unpredictable - shock at any time , and predictable -cued shock (P)) in subjects with anxiety disorders and healthy control. Each of these conditions were signaled by a written text displayed on a computer monitor (e.g., shock only when blue square present). | 101 |
| Substudy 2/Working Memory Task Subjects performed a working memory task in two conditions, under threat of shock and in safety (no threat of shock). Subjects included participants with anxiety disorder and healthy volunteer. | 76 |
| Substudy 5/Face Stroop Task Stimuli were pictures of faces exhibiting anger, disgust, fear, happiness, sadness and surprise (Ekman, 1993). Intermixed with the faces were pleasant, unpleasant, and neutral pictures. Subjects indicated which emotion the face displayed. Accurate response was used as measure of facial emotion recognition. Subjects included participants with anxiety disorder and healthy volunteer. | 62 |
| Substudy 7/Active Avoidance and Sustained Attention Tasks In the active avoidance signal task (AAST), participants performed paradigms which tested whether threat impacts the initiation and the inhibition of behavioral responses. In the sustained attention response task (SART), participants were presented with stimuli and either initiated a response (i.e. go) or inhibited their response (i.e. stop) based on what stimuli were presented. Subjects included participants with anxiety disorder and healthy volunteer. | 90 |
| Pilot Task Participants completed one or more pilot tasks: nerve stimulation, short speech in front of a small audience or in a virtual environment, burst of air to neck, provide saliva samples for cortisol analysis, squeeze a grip device, virtual reality task, and/or computer based experimental tasks. | 589 |
| Total | 918 |
Baseline characteristics
| Characteristic | Substudy 1/ Neutral, Predictable, and Unpredictable Responses | Total | Pilot Task | Substudy 7/Active Avoidance and Sustained Attention Tasks | Substudy 5/Face Stroop Task | Substudy 2/Working Memory Task |
|---|---|---|---|---|---|---|
| Age, Categorical Anxiety Subjects <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Anxiety Subjects >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Anxiety Subjects Between 18 and 65 years | 78 Participants | 361 Participants | 183 Participants | 34 Participants | 32 Participants | 34 Participants |
| Age, Categorical Healthy participants <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Healthy participants >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Healthy participants Between 18 and 65 years | 23 Participants | 557 Participants | 406 Participants | 56 Participants | 30 Participants | 42 Participants |
| Ethnicity (NIH/OMB) Anxiety Subjects Hispanic or Latino | 5 Participants | 34 Participants | 20 Participants | 2 Participants | 1 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Anxiety Subjects Not Hispanic or Latino | 71 Participants | 320 Participants | 159 Participants | 32 Participants | 31 Participants | 27 Participants |
| Ethnicity (NIH/OMB) Anxiety Subjects Unknown or Not Reported | 2 Participants | 7 Participants | 4 Participants | 0 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Healthy Participants Hispanic or Latino | 2 Participants | 49 Participants | 36 Participants | 6 Participants | 0 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Healthy Participants Not Hispanic or Latino | 21 Participants | 495 Participants | 359 Participants | 49 Participants | 30 Participants | 36 Participants |
| Ethnicity (NIH/OMB) Healthy Participants Unknown or Not Reported | 0 Participants | 13 Participants | 11 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Anxiety Subjects American Indian or Alaska Native | 2 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Anxiety Subjects Asian | 7 Participants | 27 Participants | 11 Participants | 2 Participants | 2 Participants | 5 Participants |
| Race (NIH/OMB) Anxiety Subjects Black or African American | 25 Participants | 79 Participants | 36 Participants | 4 Participants | 6 Participants | 8 Participants |
| Race (NIH/OMB) Anxiety Subjects More than one race | 6 Participants | 17 Participants | 6 Participants | 1 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Anxiety Subjects Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Anxiety Subjects Unknown or Not Reported | 4 Participants | 27 Participants | 19 Participants | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Anxiety Subjects White | 34 Participants | 208 Participants | 110 Participants | 26 Participants | 21 Participants | 17 Participants |
| Race (NIH/OMB) Healthy Participants American Indian or Alaska Native | 0 Participants | 2 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Healthy Participants Asian | 5 Participants | 62 Participants | 39 Participants | 5 Participants | 6 Participants | 7 Participants |
| Race (NIH/OMB) Healthy Participants Black or African American | 7 Participants | 119 Participants | 79 Participants | 20 Participants | 5 Participants | 8 Participants |
| Race (NIH/OMB) Healthy Participants More than one race | 0 Participants | 18 Participants | 10 Participants | 3 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) Healthy Participants Native Hawaiian or Other Pacific Islander | 0 Participants | 2 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Healthy Participants Unknown or Not Reported | 2 Participants | 37 Participants | 29 Participants | 3 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) Healthy Participants White | 9 Participants | 317 Participants | 245 Participants | 25 Participants | 17 Participants | 21 Participants |
| Sex: Female, Male Anxiety Patients Female | 54 Participants | 244 Participants | 116 Participants | 16 Participants | 28 Participants | 30 Participants |
| Sex: Female, Male Anxiety Patients Male | 24 Participants | 117 Participants | 67 Participants | 18 Participants | 4 Participants | 4 Participants |
| Sex: Female, Male Healthy Participants Female | 13 Participants | 345 Participants | 236 Participants | 43 Participants | 25 Participants | 28 Participants |
| Sex: Female, Male Healthy Participants Male | 10 Participants | 212 Participants | 170 Participants | 13 Participants | 5 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 23 | 0 / 78 | 0 / 42 | 0 / 35 | 0 / 33 | 0 / 36 | 0 / 65 | 0 / 91 | 0 / 406 | 0 / 183 |
| other Total, other adverse events | 0 / 23 | 0 / 78 | 0 / 42 | 0 / 35 | 0 / 33 | 0 / 36 | 0 / 65 | 0 / 91 | 0 / 406 | 0 / 183 |
| serious Total, serious adverse events | 0 / 23 | 0 / 78 | 0 / 42 | 0 / 35 | 0 / 33 | 0 / 36 | 0 / 65 | 0 / 91 | 0 / 406 | 0 / 183 |
Outcome results
Primary
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.
Time frame: 2000 ms during trial
Population: Analysis included only participants in sub-study 7 who completed the active avoidance signal task (AAST). Two healthy controls were excluded from analyses.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Substudy 7/ Active Avoidance Signal Task (AAST) - Healthy Participants | Change in Percent of Correct Button Presses During Threat Compared to the Safe Condition (AAST) | -0.016 Percentage of accurate responses | Standard Error 0.03 |
| Substudy 7/ Active Avoidance Signal Task (AAST) - Anxiety Patients | Change in Percent of Correct Button Presses During Threat Compared to the Safe Condition (AAST) | 0.008 Percentage of accurate responses | Standard Error 0.04 |
Primary
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.
Time frame: 2000 ms during trial
Population: Analysis included only participants in sub-study 7 who completed the active avoidance signal task (AAST). Two healthy controls were excluded from analyses.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Substudy 7/ Active Avoidance Signal Task (AAST) - Healthy Participants | Change in Percent of Correct no Button Presses During Threat Compared to the Safe Condition | -0.002 Percentage of accurate responses | Standard Error 0.03 |
| Substudy 7/ Active Avoidance Signal Task (AAST) - Anxiety Patients | Change in Percent of Correct no Button Presses During Threat Compared to the Safe Condition | 0.028 Percentage of accurate responses | Standard Error 0.04 |
Primary
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.
Time frame: 2000 ms during trial
Population: Analysis included only participants in sub-study 7 who completed the Sustained attention response task (SART).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Substudy 7/ Active Avoidance Signal Task (AAST) - Healthy Participants | Correct-go Reaction Time (RT) - Safe Condition | 387.8 milliseconds (ms) | Standard Error 16.2 |
| Substudy 7/ Active Avoidance Signal Task (AAST) - Anxiety Patients | Correct-go Reaction Time (RT) - Safe Condition | 337.3 milliseconds (ms) | Standard Error 10.7 |
Primary
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.
Time frame: 2000 ms during trial
Population: Analysis included only participants in sub-study 7 who completed the Sustained attention response task (SART).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Substudy 7/ Active Avoidance Signal Task (AAST) - Healthy Participants | Correct-go Reaction Time (RT) - Threat Condition | 377.4 milliseconds (ms) | Standard Error 14.7 |
| Substudy 7/ Active Avoidance Signal Task (AAST) - Anxiety Patients | Correct-go Reaction Time (RT) - Threat Condition | 332.2 milliseconds (ms) | Standard Error 10.9 |
Primary
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.
Time frame: 2000 ms during trial
Population: Analysis included only participants in sub-study 7 who completed the Sustained attention response task (SART).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Substudy 7/ Active Avoidance Signal Task (AAST) - Healthy Participants | Go Correct Hits Followed by Button Press - Safe Condition | 0.91 Proportion of correct responses | Standard Error 0.01 |
| Substudy 7/ Active Avoidance Signal Task (AAST) - Anxiety Patients | Go Correct Hits Followed by Button Press - Safe Condition | 0.87 Proportion of correct responses | Standard Error 0.01 |
Primary
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.
Time frame: 2000 ms during trial
Population: Analysis included only participants in sub-study 7 who completed the sustained attention response task (SART).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Substudy 7/ Active Avoidance Signal Task (AAST) - Healthy Participants | Go Correct Hits Followed by Button Press - Threat Condition | 0.9 Proportion of correct responses | Standard Error 0.01 |
| Substudy 7/ Active Avoidance Signal Task (AAST) - Anxiety Patients | Go Correct Hits Followed by Button Press - Threat Condition | 0.87 Proportion of correct responses | Standard Error 0.02 |
Primary
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.
Time frame: 2000 ms during trial
Population: Analysis included only participants in sub-study 7 who completed the sustained attention response task (SART).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Substudy 7/ Active Avoidance Signal Task (AAST) - Healthy Participants | Nogo Trials Followed by no Button Press - Safe Condition | 0.76 Proportion of correct responses | Standard Error 0.02 |
| Substudy 7/ Active Avoidance Signal Task (AAST) - Anxiety Patients | Nogo Trials Followed by no Button Press - Safe Condition | 0.76 Proportion of correct responses | Standard Error 0.01 |
Primary
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.
Time frame: 2000 ms during trial
Population: Analysis included only participants in sub-study 7 who completed the sustained attention response task (SART).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Substudy 7/ Active Avoidance Signal Task (AAST) - Healthy Participants | Nogo Trials Followed by no Button Press - Threat Condition | 0.8 Proportion of correct responses | Standard Error 0.02 |
| Substudy 7/ Active Avoidance Signal Task (AAST) - Anxiety Patients | Nogo Trials Followed by no Button Press - Threat Condition | 0.81 Proportion of correct responses | Standard Error 0.02 |
Primary
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.
Time frame: 11.2 minutes per run for a total of 22.4 minutes
Population: Analysis included only participants in sub-study 5 who completed the face stroop task. Two participants were excluded from the final analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Substudy 7/ Active Avoidance Signal Task (AAST) - Healthy Participants | Stroop Effect on Accuracy During Congruent Task Viewing Negative Images: Safe Condition | 94.3 Percentage of accurate responses | Standard Error 1.1 |
| Substudy 7/ Active Avoidance Signal Task (AAST) - Anxiety Patients | Stroop Effect on Accuracy During Congruent Task Viewing Negative Images: Safe Condition | 94.3 Percentage of accurate responses | Standard Error 0.8 |
Primary
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.
Time frame: 11.2 minutes per run for a total of 22.4 minutes
Population: Analysis included only participants in sub-study 5 who completed the face stroop task. Two participants were excluded from the final analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Substudy 7/ Active Avoidance Signal Task (AAST) - Healthy Participants | Stroop Effect on Accuracy During Congruent Task Viewing Negative Images: Threat Condition | 95.3 Percentage of accurate responses | Standard Error 0.7 |
| Substudy 7/ Active Avoidance Signal Task (AAST) - Anxiety Patients | Stroop Effect on Accuracy During Congruent Task Viewing Negative Images: Threat Condition | 95.9 Percentage of accurate responses | Standard Error 0.8 |
Primary
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.
Time frame: 11.2 minutes per run for a total of 22.4 minutes
Population: Analysis included only participants in sub-study 5 who completed the face stroop task. Two participants were excluded from the final analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Substudy 7/ Active Avoidance Signal Task (AAST) - Healthy Participants | Stroop Effect on Accuracy During Congruent Task Viewing Neutral Images: Safe Condition | 94.9 Percentage of accurate responses | Standard Error 0.8 |
| Substudy 7/ Active Avoidance Signal Task (AAST) - Anxiety Patients | Stroop Effect on Accuracy During Congruent Task Viewing Neutral Images: Safe Condition | 95.1 Percentage of accurate responses | Standard Error 0.8 |
Primary
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.
Time frame: 11.2 minutes per run for a total of 22.4 minutes
Population: Analysis included only participants in sub-study 5 who completed the face stroop task. Two participants were excluded from the final analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Substudy 7/ Active Avoidance Signal Task (AAST) - Healthy Participants | Stroop Effect on Accuracy During Congruent Task Viewing Neutral Images: Threat Condition | 96.2 Percentage of accurate responses | Standard Error 0.8 |
| Substudy 7/ Active Avoidance Signal Task (AAST) - Anxiety Patients | Stroop Effect on Accuracy During Congruent Task Viewing Neutral Images: Threat Condition | 96.7 Percentage of accurate responses | Standard Error 0.5 |
Primary
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.
Time frame: 11.2 minutes per run for a total of 22.4 minutes
Population: Analysis included only participants in sub-study 5 who completed the face stroop task.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Substudy 7/ Active Avoidance Signal Task (AAST) - Healthy Participants | Stroop Effect on Accuracy During Congruent Task Viewing Positive Images: Safe Condition | 93.9 Percentage of accurate responses | Standard Error 0.8 |
| Substudy 7/ Active Avoidance Signal Task (AAST) - Anxiety Patients | Stroop Effect on Accuracy During Congruent Task Viewing Positive Images: Safe Condition | 95.7 Percentage of accurate responses | Standard Error 0.7 |
Primary
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.
Time frame: 11.2 minutes per run for a total of 22.4 minutes
Population: Analysis included only participants in sub-study 5 who completed the face stroop task. Two participants were excluded from the final analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Substudy 7/ Active Avoidance Signal Task (AAST) - Healthy Participants | Stroop Effect on Accuracy During Congruent Task Viewing Positive Images: Threat Condition | 94.9 Percentage of accurate responses | Standard Error 0.9 |
| Substudy 7/ Active Avoidance Signal Task (AAST) - Anxiety Patients | Stroop Effect on Accuracy During Congruent Task Viewing Positive Images: Threat Condition | 96.0 Percentage of accurate responses | Standard Error 0.8 |
Primary
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.
Time frame: 11.2 minutes per run for a total of 22.4 minutes
Population: Analysis included only participants in sub-study 5 who completed the face stroop task. Two participants were excluded from the final analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Substudy 7/ Active Avoidance Signal Task (AAST) - Healthy Participants | Stroop Effect on Accuracy During Incongruent Task Viewing Negative Images: Safe Condition | 94.2 Percentage of accurate responses | Standard Error 0.9 |
| Substudy 7/ Active Avoidance Signal Task (AAST) - Anxiety Patients | Stroop Effect on Accuracy During Incongruent Task Viewing Negative Images: Safe Condition | 94.0 Percentage of accurate responses | Standard Error 0.7 |
Primary
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.
Time frame: 11.2 minutes per run for a total of 22.4 minutes
Population: Analysis included only participants in sub-study 5 who completed the face stroop task. Two participants were excluded from the final analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Substudy 7/ Active Avoidance Signal Task (AAST) - Healthy Participants | Stroop Effect on Accuracy During Incongruent Task Viewing Negative Images: Threat Condition | 95.0 Percentage of accurate responses | Standard Error 0.7 |
| Substudy 7/ Active Avoidance Signal Task (AAST) - Anxiety Patients | Stroop Effect on Accuracy During Incongruent Task Viewing Negative Images: Threat Condition | 95.3 Percentage of accurate responses | Standard Error 0.8 |
Primary
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.
Time frame: 11.2 minutes per run for a total of 22.4 minutes
Population: Analysis included only participants in sub-study 5 who completed the face stroop task. Two participants were excluded from the final analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Substudy 7/ Active Avoidance Signal Task (AAST) - Healthy Participants | Stroop Effect on Accuracy During Incongruent Task Viewing Neutral Images: Safe Condition | 94.4 Percentage of accurate responses | Standard Error 1.1 |
| Substudy 7/ Active Avoidance Signal Task (AAST) - Anxiety Patients | Stroop Effect on Accuracy During Incongruent Task Viewing Neutral Images: Safe Condition | 94.8 Percentage of accurate responses | Standard Error 0.7 |
Primary
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.
Time frame: 11.2 minutes per run for a total of 22.4 minutes
Population: Analysis included only participants in sub-study 5 who completed the face stroop task. Two participants were excluded from the final analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Substudy 7/ Active Avoidance Signal Task (AAST) - Healthy Participants | Stroop Effect on Accuracy During Incongruent Task Viewing Neutral Images: Threat Condition | 95.8 Percentage of accurate responses | Standard Error 0.7 |
| Substudy 7/ Active Avoidance Signal Task (AAST) - Anxiety Patients | Stroop Effect on Accuracy During Incongruent Task Viewing Neutral Images: Threat Condition | 95.8 Percentage of accurate responses | Standard Error 0.7 |
Primary
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.
Time frame: 11.2 minutes per run for a total of 22.4 minutes
Population: Analysis included only participants in sub-study 5 who completed the face stroop task. Two participants were excluded from the final analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Substudy 7/ Active Avoidance Signal Task (AAST) - Healthy Participants | Stroop Effect on Accuracy During Incongruent Task Viewing Positive Images: Safe Condition | 94.1 Percentage of accurate responses | Standard Error 1 |
| Substudy 7/ Active Avoidance Signal Task (AAST) - Anxiety Patients | Stroop Effect on Accuracy During Incongruent Task Viewing Positive Images: Safe Condition | 96.5 Percentage of accurate responses | Standard Error 0.6 |
Primary
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.
Time frame: 11.2 minutes per run for a total of 22.4 minutes
Population: Analysis included only participants in sub-study 5 who completed the face stroop task. Two participants were excluded from the final analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Substudy 7/ Active Avoidance Signal Task (AAST) - Healthy Participants | Stroop Effect on Accuracy During Incongruent Task Viewing Positive Images: Threat Condition | 94.3 Percentage of accurate responses | Standard Error 0.9 |
| Substudy 7/ Active Avoidance Signal Task (AAST) - Anxiety Patients | Stroop Effect on Accuracy During Incongruent Task Viewing Positive Images: Threat Condition | 94.1 Percentage of accurate responses | Standard Error 1 |
Primary
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.
Time frame: Assessed immediately after completing the affective Stroop task
Population: Analysis included only participants in sub-study 5 who completed the face stroop task. Two participants were excluded from the final analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Substudy 7/ Active Avoidance Signal Task (AAST) - Healthy Participants | Subjective Rating of Difficulty With Attention During Safe Condition | 2.9 units on a scale | Standard Error 0.4 |
| Substudy 7/ Active Avoidance Signal Task (AAST) - Anxiety Patients | Subjective Rating of Difficulty With Attention During Safe Condition | 4.1 units on a scale | Standard Error 0.4 |
Primary
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.
Time frame: Assessed immediately after completing the affective Stroop task
Population: Analysis included only participants in sub-study 5 who completed the face stroop task. Two participants were excluded from the final analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Substudy 7/ Active Avoidance Signal Task (AAST) - Healthy Participants | Subjective Rating of Difficulty With Attention During Threat Condition | 4.4 Units on a scale | Standard Error 0.5 |
| Substudy 7/ Active Avoidance Signal Task (AAST) - Anxiety Patients | Subjective Rating of Difficulty With Attention During Threat Condition | 6.5 Units on a scale | Standard Error 0.4 |
Primary
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.
Time frame: Assessed immediately after completing the affective Stroop task
Population: Analysis included only participants in sub-study 5 who completed the face stroop task. Two participants were excluded from the final analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Substudy 7/ Active Avoidance Signal Task (AAST) - Healthy Participants | Subjective Rating of Level of Anxiety During Safe Condition | 2 Units on a scale | Standard Error 0.3 |
| Substudy 7/ Active Avoidance Signal Task (AAST) - Anxiety Patients | Subjective Rating of Level of Anxiety During Safe Condition | 3.5 Units on a scale | Standard Error 0.4 |
Primary
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.
Time frame: Assessed immediately after completing the affective Stroop task
Population: Analysis included only participants in sub-study 5 who completed the face stroop task. Two participants were excluded from the final analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Substudy 7/ Active Avoidance Signal Task (AAST) - Healthy Participants | Subjective Rating of Level of Anxiety During Threat Condition | 6.7 Units on a scale | Standard Error 0.5 |
| Substudy 7/ Active Avoidance Signal Task (AAST) - Anxiety Patients | Subjective Rating of Level of Anxiety During Threat Condition | 8.1 Units on a scale | Standard Error 0.3 |