Anxiety DisorderNCT00025844
Fear Conditioning Using Computer-Generated Virtual Reality
An observational study of Anxiety Disorder, run by National Institute of Mental Health (NIMH) at 1 site in United States.
Trial summary
The purpose of this study is to use a computer-generated virtual reality environment to study fear conditioning. Fear conditioning is used to explore the causes and persistence of anxiety and anxiety disorders. Read more about this study
- Who is it for?
- Ages 7 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety Disorder
- How many people
- 202 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Oct 2001to 10 Apr 2012
- 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 7 to 50 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Subjects will be healthy volunteers ages 7-50 recruited through advertisements in the local media.
- Subjects will be free of current or past psychotic disorder and organic central nervous system disorders.
- All children will be screened for lifetime history of psychiatric disorders using the K-SADS Interview. The interview will be administered by a trained clinician (at least master level) supervised by Dr. Pine.
- The children/adolescents will be able to give assent and parents will give consent.
- They will have an IQ greater than 70 based on WASI.
Who cannot join
- Ongoing medical illness that could interfere with the study
- Current psychiatric or neurological disorder (including seizure)
- Past psychotic disorder
- Current substance abuse
- Current psychotropic medication
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
The purpose of this study is to use a computer-generated virtual reality environment to study fear conditioning. Fear conditioning is used to explore the causes and persistence of anxiety and anxiety disorders.
When confronted with fearful or unpleasant events, people can develop fear of specific cues that were associated with these events as well as to the environmental context in which the events occurred via a process called classical or aversive conditioning. Advances in computer-generated visual stimulations could facilitate the design of new aversive conditioning studies. This study will develop a virtual reality environment to examine human contextual fear conditioning in the laboratory. During the procedure, moderately painful stimuli will be administered. Participants in this study will be screened with a medical history, physical examination, psychiatric evaluation, and hearing test. Participants will wear headphones and special goggles that will enable them to view a virtual reality environment. Measures will be taken during the study to see how the brain adapts to environmental stimuli.
Read the detailed description
Fear conditioning paradigms are tools to explore symptoms of anxiety disorders. During fear conditioning, the organism develops fear to the phasic explicit cue (e.g., a light) that was associated with the aversive unconditioned stimulus (e.g., a shock) during conditioning as well as to the environmental context (e.g., the experimental room). Explicit cue conditioning and context conditioning are separate processes mediated by distinct brain structures. Whereas explicit cue conditioning is only dependent on the amygdala, context conditioning involves the amygdala, the hippocampus and the bed nucleus of the stria terminalis (BNST). We have been using explicit cue and context conditioning as models of phasic fear and sustained anxiety, respectively. However, contextual fear is relatively difficult to study in humans in the laboratory because it requires two experimental sessions and the use of different experimental rooms. Advances in computer-generated visual stimulation now offer the possibility to develop more sophisticated paradigms in the laboratory that could facilitate the design of fear conditioning studies. In addition, compared to traditional paradigms, computer generated three-dimensional stimulation provides the opportunity to create more realistic virtual environment. The main objective of this study is to use virtual reality to further our understanding of fear conditioning in humans.
- Conditions
- Anxiety Disorder
- Keywords
- Stress, Anxiety, Adults, Fear Conditioning, Normal Volunteers, Associative Learning, Virtual Reality, Context Conditioning, Healthy Volunteer, HV, Normal Control
- Medical subject headings
- Anxiety Disorders
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2001 (estimated)
- Study start22 Oct 2001
- Study completion10 Apr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Anxiety DisorderStudies 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
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Mental Health (NIMH)
- Sponsor type
- US National Institutes of Health
- Investigators
- Thomas C Quinn, M.D., Principal investigator, National Institute of Allergy and Infectious Diseases (NIAID)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00025844
- Sponsor's protocol ID
- 020003
- Other IDs
- 02-M-0003
- Status last verified
- 10 Apr 2012
- First submitted
- 26 Oct 2001
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Grillon C, Davis M. Fear-potentiated startle conditioning in humans: explicit and contextual cue conditioning following paired versus unpaired training. Psychophysiology. 1997 Jul;34(4):451-8. doi: 10.1111/j.1469-8986.1997.tb02389.x.
PubMed 9260498Grillon C, Ameli R, Woods SW, Merikangas K, Davis M. Fear-potentiated startle in humans: effects of anticipatory anxiety on the acoustic blink reflex. Psychophysiology. 1991 Sep;28(5):588-95. doi: 10.1111/j.1469-8986.1991.tb01999.x.
PubMed 1758934Grillon 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
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fear Conditioning Using Computer-Generated Virtual Reality
- ClinicalTrials.gov ID
- NCT00025844
- Acronym / sponsor ID
- 020003
- Conditions
- Anxiety Disorder
- Keywords
- Stress, Anxiety, Adults, Fear Conditioning, Normal Volunteers, Associative Learning, Virtual Reality, Context Conditioning
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- National Institute of Mental Health (NIMH)US National Institutes of Health
- Study start
- 22 Oct 2001
- Study completion
- 10 Apr 2012
- First posted
- 29 Oct 2001 (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.
The purpose of this study is to use a computer-generated virtual reality environment to study fear conditioning. Fear conditioning is used to explore the causes and persistence of anxiety and anxiety disorders.
When confronted with fearful or unpleasant events, people can develop fear of specific cues that were associated with these events as well as to the environmental context in which the events occurred via a process called classical or aversive conditioning. Advances in computer-generated visual stimulations could facilitate the design of new aversive conditioning studies. This study will develop a virtual reality environment to examine human contextual fear conditioning in the laboratory. During the procedure, moderately painful stimuli will be administered. Participants in this study will be screened with a medical history, physical examination, psychiatric evaluation, and hearing test. Participants will wear headphones and special goggles that will enable them to view a virtual reality environment. Measures will be taken during the study to see how the brain adapts to environmental stimuli.
Detailed description
Fear conditioning paradigms are tools to explore symptoms of anxiety disorders. During fear conditioning, the organism develops fear to the phasic explicit cue (e.g., a light) that was associated with the aversive unconditioned stimulus (e.g., a shock) during conditioning as well as to the environmental context (e.g., the experimental room). Explicit cue conditioning and context conditioning are separate processes mediated by distinct brain structures. Whereas explicit cue conditioning is only dependent on the amygdala, context conditioning involves the amygdala, the hippocampus and the bed nucleus of the stria terminalis (BNST). We have been using explicit cue and context conditioning as models of phasic fear and sustained anxiety, respectively. However, contextual fear is relatively difficult to study in humans in the laboratory because it requires two experimental sessions and the use of different experimental rooms. Advances in computer-generated visual stimulation now offer the possibility to develop more sophisticated paradigms in the laboratory that could facilitate the design of fear conditioning studies. In addition, compared to traditional paradigms, computer generated three-dimensional stimulation provides the opportunity to create more realistic virtual environment. The main objective of this study is to use virtual reality to further our understanding of fear conditioning in humans.
Study design
Who may qualify
- Ages
- 7 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Subjects will be healthy volunteers ages 7-50 recruited through advertisements in the local media.
- Subjects will be free of current or past psychotic disorder and organic central nervous system disorders.
- All children will be screened for lifetime history of psychiatric disorders using the K-SADS Interview. The interview will be administered by a trained clinician (at least master level) supervised by Dr. Pine.
- The children/adolescents will be able to give assent and parents will give consent.
- They will have an IQ greater than 70 based on WASI.
Key exclusion criteria (5 listed)
- Ongoing medical illness that could interfere with the study
- Current psychiatric or neurological disorder (including seizure)
- Past psychotic disorder
- Current substance abuse
- Current psychotropic medication
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
Not reported in the source record.
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 2 Jul 2017.
- Background: PubMed 9260498Grillon C, Davis M. Fear-potentiated startle conditioning in humans: explicit and contextual cue conditioning following paired versus unpaired training. Psychophysiology. 1997 Jul;34(4):451-8. doi: 10.1111/j.1469-8986.1997.tb02389.x.
- Background: PubMed 1758934Grillon C, Ameli R, Woods SW, Merikangas K, Davis M. Fear-potentiated startle in humans: effects of anticipatory anxiety on the acoustic blink reflex. Psychophysiology. 1991 Sep;28(5):588-95. doi: 10.1111/j.1469-8986.1991.tb01999.x.
- 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.
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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.
Thomas C Quinn, M.D. principal investigator
National Institute of Allergy and Infectious Diseases (NIAID)
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 Disorder, 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 5 inclusion and 5 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 2 Jul 2017. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00025844, 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 2 Jul 2017.