Anxiety DisordersNCT02423044
Spatial Context and Fear Learning
An observational study of Anxiety Disorders, run by National Institute of Mental Health (NIMH) at 1 site in United States.
Trial summary
Background: Fear is a normal response to a threat. Learning fear can be helpful sometimes. For people with anxiety disorders, fear can be long-lasting and too intense. Researchers want to study how people become fearful of situations. 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
- How many people
- 82 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Apr 2015to 30 Oct 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Ages 18-50
- Subjects able to give their consent
- Right handed
- Patients only: a primary diagnosis of GAD, panic disorder, SAD, or PTSD according to the Structured Clinical Interview for DSM-IV-TR
Who cannot join
- Non-English speaking individual
- Any significant medical or neurological problems (e.g. cardiovascular illness, respiratory illness, neurological illness, seizure, etc.)
- High or low blood pressure (SBP>140 or SBP<90; SDP<50 or SDP>90)
- Alcohol/drug abuse in the past year or lifetime alcohol or drug dependence according to the Structured Clinical Interview for DSM-IV-TR
- Medications that act on the central nervous system (e.g., Lorazepam, Codeine) and thus may interfere with the interpretation of study results. Specific exclusionary drug classes include but are not limited to: (opioid analgesics, DA receptor agonists, anticholinergics, MAO inhibitors, COMT inhibitors, as well as any illicit substances)
- Pregnancy or positive pregnancy test
Show all 24Show fewer
- Neurological syndrome of the wrist (e.g., carpal tunnel syndrome, cubital tunnel syndrome, etc.)
- Positive urine toxicology screen
- IQ <80
- Participants who report getting severe motion sickness, especially by playing video games
- Any medical condition that increases risk for fMRI:
- Any metal implants (clips, screws, plates, pins, etc) or metal fragments cause by injuries or metal working
- Any sort of medical implants (aneurysm clips, pacemaker, insulin pump, Hickman line, etc.)
- Permanent eye liner and tattoos above the neck
- Patients who have difficulty lying flat on their back for up to 60 min in the scanner
- Participants who are uncomfortable in small closed spaces (have claustrophobia) and would feel uncomfortable in the MRI machine
- Additional Exclusion Criteria for Healthy Volunteers:
- Current or past Axis I psychiatric disorders as identified with the Structured Clinical Interview for DSM-IV-TR, non-patient edition (SCID-np)
- Current use of psychotropic medications (i.e. fluoxetine (Prozac), fluvoxamine (Luvox), sertraline (Zoloft), paroxetine (Paxil), citalopram (Celexa) or escitalopram (Lexapro), etc.).
- <TAB>
- Additional Exclusion Criteria for Patients:
- Patients who are currently on psychotropic medications. (Patients are required to be free of all psychotropics medication (i.e. fluvoxamine (Luvox), sertraline (Zoloft), paroxetine (Paxil), citalopram (Celexa) or escitalopram (Lexapro), etc.) for 2 weeks, 5 weeks for fluoxetine prior to testing. Patients will not be taken off medications for the purpose of the study)
- Patients will be excluded if they have a current or past history of any psychotic disorder, delirium, dementia, amnestic disorder, cognitive disorder not otherwise specified, any of the pervasive developmental disorders, or mental retardation
- Patients who have a primary diagnosis of major depressive disorder.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: fMRI Spatial Context and Fear Conditioning
Background:
- Fear is a normal response to a threat. Learning fear can be helpful sometimes. For people with anxiety disorders, fear can be long-lasting and too intense. Researchers want to study how people become fearful of situations. They want to understand how the brain learns when it is helpful to feel fear and when it is not.
Read more
Objective:
- To better understand brain processes related to fear and anxiety.
Eligibility:
- Right-handed adults ages 18 50 with generalized anxiety disorder, panic disorder, social anxiety disorder, or post-traumatic stress disorder.
- Right handed volunteers ages 18-50 without psychiatric disorders.
- And free of psychiatric medication for 2 weeks
Design:
- Participants will first be screened under another protocol.
- Participants will play a video game inside a magnetic resonance imaging (MRI) scanner. The scanner is a metal cylinder It is surrounded by a strong magnetic field. Participants will lie on a table that can slide in and out of the scanner. A device called a coil will be placed over the head.
- During the scan, participants may play a virtual reality video game. Game instructions will be explained before they enter the scanner.
- While playing the game, participants will wear 2 electrodes on their fingers. These measure sweat on the skin. They will also have 2 small electrodes attached to the left hand. These can give brief mild electrical shocks.
- Participants will be asked questions when playing the game during the scan.
- Before and after the scan, participants will fill out questionnaires about their emotions. They may complete questionnaires online while at the clinic.
Read the detailed description
Objective:
To examine the processes involved in distinguishing between threatening and safe conditions, we aim to investigate the neural bases of contextual fear learning using functional magnetic resonance imaging (fMRI). To do this, we will study behavioral, physiological, and brain responses as aversive stimuli are encountered in a virtual environment, and will explore how fear-related responses depend on the surrounding environment. In addition, we will examine how these responses differ in clinical anxiety.
We are interested in studying Pavlovian aversive context conditioning in healthy controls and patients with anxiety disorders. We will examine the extent to which participants learn to discriminate between dangerous and safe virtual contexts, and how this learning maps to the neural networks underlying anxiety and context coding. We expect successful learning of the contextual fear response in healthy controls, as evidenced by differential skin conductance response and neural activation to safe vs. threat context. Accordingly, we anticipate higher neuronal activity in the hippocampus, prefrontal cortex, and amygdala. These findings will be accompanied with increased hippocampus-prefrontal cortex connectivity during approach and exploration of the dangerous context, and increased amygdala activation during anticipation of shock in the dangerous context. Physiologically, SCR will increase in threat context compared to safe context. However, anxious patients are expected to fail to learn to differentiate safe from threat context, exhibiting increased SCR and neural activation in both safe and threat contexts, an index of contextual generalization of fear. Particularly, the lack of contextual fear discrimination in anxious patients will be associated with weaker hippocampal activation to contextual learning. To examine differential context fear conditioning, we will use a virtual reality (VR) paradigm. VR provides an optimal way to probe spatial navigation and simulates context. The VR task presents an outdoor space, which comprises a dangerous (probabilistic electrical shocks) and a safe (no shocks) location. Healthy controls and patients with anxiety disorders will be compared on their physiological and neural reactivity during task performance. Preliminary psychophysiological data suggest that the proposed procedure is an effective way to promote different responses to a safe and dangerous spatial location. Hence, we anticipate that this procedure will allow us to examine brain correlates of differential contextual fear responses in humans and compare them between healthy participants and patients diagnosed with an anxiety disorder.
Study population:
Two study populations, healthy volunteers and patients diagnosed with an anxiety disorder (generalized anxiety disorder (GAD), social anxiety disorder (SAD), panic disorder, and post-traumatic stress disorder) will complete the protocol. Participants will be adult males and females, aged 18 to 50 years.
Design:
This fMRI study will compare performance, physiological and neural measures between healthy adults and patients with anxiety disorders, who perform a threat VR task in the scanner.
The VR task entails navigating in a virtual outdoor environment, which, unbeknownst to the participants is divided into a safe and a dangerous context, which are recognizable by environmental characteristics (e.g., mountain, clouds). The dangerous context is associated with probabilistic shocks, which are never encountered in the safe context. Participants learn about these two contexts as they collect flowers (cues), one at a time, in either context. In the dangerous context, the flowers are associated with 50% chance of a shock
Outcome measures:
The primary outcome measures will be the cerebral fMRI blood-oxygen-level dependent (BOLD) responses to three events: (1) shock anticipation: after collecting the cues (flowers) during anticipation of a potential shock, (2) context exploration: as participants navigate in the threat context or safe context in between trials (which start when a flower appears in the environment), and (3) cue approach: during approach towards the flower, in the threat or safe context. The secondary outcome measures will consist of the changes in psychophysiological responses, such as SCR, heart rate, pupil dilatation, and respiratory rate, which will validate fear responses.
- Conditions
- Anxiety Disorders
- Keywords
- Anxiety, fMRI, Virtual Reality, Shock Threat, Healthy Volunteer
- Medical subject headings
- Anxiety Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective is to investigate the neural bases of contextual fear learning measures by the event-related hemodynamic response (fMRI).
Measured: 12/29/16
Secondary outcomes (1)
The secondary objective is to see learning of the contextual fear response that will be measured by psychophysiological responses such as SCR, heart rate, pupil dilatation, and breathing.
Measured: 12/29/16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2015 (estimated)
- Study start18 Apr 2015
- Primary completion30 Oct 2018
- Study completion30 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Anxiety DisordersStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Mental Health (NIMH)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Monique Ernst, M.D., Principal investigator, National Institute of Mental Health (NIMH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02423044
- Sponsor's protocol ID
- 150114
- Other IDs
- 15-M-0114
- Status last verified
- 30 Oct 2018
- First submitted
- 18 Apr 2015
- Last updated
- 4 Nov 2019
- Results posted
- No
Publications
Britton JC, Lissek S, Grillon C, Norcross MA, Pine DS. Development of anxiety: the role of threat appraisal and fear learning. Depress Anxiety. 2011 Jan;28(1):5-17. doi: 10.1002/da.20733. Epub 2010 Aug 23.
PubMed 20734364Huff NC, Zeilinski DJ, Fecteau ME, Brady R, LaBar KS. Human fear conditioning conducted in full immersion 3-dimensional virtual reality. J Vis Exp. 2010 Aug 9;(42):1993. doi: 10.3791/1993.
PubMed 20736913
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- fMRI Spatial Context and Fear Conditioning
- ClinicalTrials.gov ID
- NCT02423044
- Acronym / sponsor ID
- 150114
- Conditions
- Anxiety Disorders
- Keywords
- Anxiety, fMRI, Virtual Reality, Shock Threat, Healthy Volunteer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- National Institute of Mental Health (NIMH)US National Institutes of Health
- Study start
- 18 Apr 2015
- Primary completion
- 30 Oct 2018 (actual)
- Study completion
- 30 Oct 2018 (actual)
- First posted
- 22 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
- Fear is a normal response to a threat. Learning fear can be helpful sometimes. For people with anxiety disorders, fear can be long-lasting and too intense. Researchers want to study how people become fearful of situations. They want to understand how the brain learns when it is helpful to feel fear and when it is not.
Objective:
- To better understand brain processes related to fear and anxiety.
Eligibility:
- Right-handed adults ages 18 50 with generalized anxiety disorder, panic disorder, social anxiety disorder, or post-traumatic stress disorder.
- Right handed volunteers ages 18-50 without psychiatric disorders.
- And free of psychiatric medication for 2 weeks
Design:
- Participants will first be screened under another protocol.
- Participants will play a video game inside a magnetic resonance imaging (MRI) scanner. The scanner is a metal cylinder It is surrounded by a strong magnetic field. Participants will lie on a table that can slide in and out of the scanner. A device called a coil will be placed over the head.
- During the scan, participants may play a virtual reality video game. Game instructions will be explained before they enter the scanner.
- While playing the game, participants will wear 2 electrodes on their fingers. These measure sweat on the skin. They will also have 2 small electrodes attached to the left hand. These can give brief mild electrical shocks.
- Participants will be asked questions when playing the game during the scan.
- Before and after the scan, participants will fill out questionnaires about their emotions. They may complete questionnaires online while at the clinic.
Detailed description
Objective:
To examine the processes involved in distinguishing between threatening and safe conditions, we aim to investigate the neural bases of contextual fear learning using functional magnetic resonance imaging (fMRI). To do this, we will study behavioral, physiological, and brain responses as aversive stimuli are encountered in a virtual environment, and will explore how fear-related responses depend on the surrounding environment. In addition, we will examine how these responses differ in clinical anxiety.
We are interested in studying Pavlovian aversive context conditioning in healthy controls and patients with anxiety disorders. We will examine the extent to which participants learn to discriminate between dangerous and safe virtual contexts, and how this learning maps to the neural networks underlying anxiety and context coding. We expect successful learning of the contextual fear response in healthy controls, as evidenced by differential skin conductance response and neural activation to safe vs. threat context. Accordingly, we anticipate higher neuronal activity in the hippocampus, prefrontal cortex, and amygdala. These findings will be accompanied with increased hippocampus-prefrontal cortex connectivity during approach and exploration of the dangerous context, and increased amygdala activation during anticipation of shock in the dangerous context. Physiologically, SCR will increase in threat context compared to safe context. However, anxious patients are expected to fail to learn to differentiate safe from threat context, exhibiting increased SCR and neural activation in both safe and threat contexts, an index of contextual generalization of fear. Particularly, the lack of contextual fear discrimination in anxious patients will be associated with weaker hippocampal activation to contextual learning. To examine differential context fear conditioning, we will use a virtual reality (VR) paradigm. VR provides an optimal way to probe spatial navigation and simulates context. The VR task presents an outdoor space, which comprises a dangerous (probabilistic electrical shocks) and a safe (no shocks) location. Healthy controls and patients with anxiety disorders will be compared on their physiological and neural reactivity during task performance. Preliminary psychophysiological data suggest that the proposed procedure is an effective way to promote different responses to a safe and dangerous spatial location. Hence, we anticipate that this procedure will allow us to examine brain correlates of differential contextual fear responses in humans and compare them between healthy participants and patients diagnosed with an anxiety disorder.
Study population:
Two study populations, healthy volunteers and patients diagnosed with an anxiety disorder (generalized anxiety disorder (GAD), social anxiety disorder (SAD), panic disorder, and post-traumatic stress disorder) will complete the protocol. Participants will be adult males and females, aged 18 to 50 years.
Design:
This fMRI study will compare performance, physiological and neural measures between healthy adults and patients with anxiety disorders, who perform a threat VR task in the scanner.
The VR task entails navigating in a virtual outdoor environment, which, unbeknownst to the participants is divided into a safe and a dangerous context, which are recognizable by environmental characteristics (e.g., mountain, clouds). The dangerous context is associated with probabilistic shocks, which are never encountered in the safe context. Participants learn about these two contexts as they collect flowers (cues), one at a time, in either context. In the dangerous context, the flowers are associated with 50% chance of a shock
Outcome measures:
The primary outcome measures will be the cerebral fMRI blood-oxygen-level dependent (BOLD) responses to three events: (1) shock anticipation: after collecting the cues (flowers) during anticipation of a potential shock, (2) context exploration: as participants navigate in the threat context or safe context in between trials (which start when a flower appears in the environment), and (3) cue approach: during approach towards the flower, in the threat or safe context. The secondary outcome measures will consist of the changes in psychophysiological responses, such as SCR, heart rate, pupil dilatation, and respiratory rate, which will validate fear responses.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Ages 18-50
- Subjects able to give their consent
- Right handed
- Patients only: a primary diagnosis of GAD, panic disorder, SAD, or PTSD according to the Structured Clinical Interview for DSM-IV-TR
Key exclusion criteria (24 listed)
- Non-English speaking individual
- Any significant medical or neurological problems (e.g. cardiovascular illness, respiratory illness, neurological illness, seizure, etc.)
- High or low blood pressure (SBP>140 or SBP<90; SDP<50 or SDP>90)
- Alcohol/drug abuse in the past year or lifetime alcohol or drug dependence according to the Structured Clinical Interview for DSM-IV-TR
- Medications that act on the central nervous system (e.g., Lorazepam, Codeine) and thus may interfere with the interpretation of study results. Specific exclusionary drug classes include but are not limited to: (opioid analgesics, DA receptor agonists, anticholinergics, MAO inhibitors, COMT inhibitors, as well as any illicit substances)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The primary objective is to investigate the neural bases of contextual fear learning measures by the event-related hemodynamic response (fMRI).
Time frame: 12/29/16
1 secondary outcome
The secondary objective is to see learning of the contextual fear response that will be measured by psychophysiological responses such as SCR, heart rate, pupil dilatation, and breathing.
Time frame: 12/29/16
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2019.
- Background: PubMed 20734364Britton JC, Lissek S, Grillon C, Norcross MA, Pine DS. Development of anxiety: the role of threat appraisal and fear learning. Depress Anxiety. 2011 Jan;28(1):5-17. doi: 10.1002/da.20733. Epub 2010 Aug 23.
- Background: PubMed 20736913Huff NC, Zeilinski DJ, Fecteau ME, Brady R, LaBar KS. Human fear conditioning conducted in full immersion 3-dimensional virtual reality. J Vis Exp. 2010 Aug 9;(42):1993. doi: 10.3791/1993.
Related trials for Anxiety Disorders
Recruiting
TOUCHminds: Help-seeking in Adolescents With Anxiety
Anxiety Symptoms, Anxiety Disorders
Recruiting
Focused Ultrasound for Behavioral Health
Depression, Anxiety
Recruiting
A Comparison of Heart Rate Variability Biofeedback, Mindfulness, and Psychoeducation-based Interventions on Clinical Recovery Outcomes in Patients Undergoing Total Knee Arthroplasty
Pain (Knee), Pain and Anxiety
Active, not recruiting
Relaxation Techniques and Pilates for Menopause Symptoms
Women Over 40 Years of Age in the Perimenopausal or Menopausal Stage, Presenting With Associated Symptoms
RecruitingObservational study
Evaluation of Preoperative Anxiety in Digestive Surgery
Digestive System Neoplasms, Anxiety
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?
An observational study of 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 24 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 4 Nov 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The primary objective is to investigate the neural bases of contextual fear learning measures by the event-related hemodynamic response (fMRI). (time frame: 12/29/16). 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 NCT02423044, which also lists 2 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 4 Nov 2019; AzTrials last refreshed its copy on 28 Oct 2026.