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| Tracking Information | |||||||||
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| First Received Date ICMJE | October 26, 2001 | ||||||||
| Last Updated Date | September 30, 2009 | ||||||||
| Start Date ICMJE | October 2001 | ||||||||
| Estimated Primary Completion Date | May 2003 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE | |||||||||
| Original Primary Outcome Measures ICMJE | |||||||||
| Change History | Complete list of historical versions of study NCT00025844 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||
| Original Secondary Outcome Measures ICMJE | |||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Fear Conditioning Using Computer-Generated Virtual Reality | ||||||||
| Official Title ICMJE | Fear Conditioning Using Computer-Generated Virtual Reality | ||||||||
| Brief 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. 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.... |
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| 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. |
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| Study Phase | |||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | |||||||||
| Condition ICMJE | Anxiety Disorder | ||||||||
| Intervention ICMJE | |||||||||
| Study Arms / Comparison Groups | |||||||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Enrollment ICMJE | 300 | ||||||||
| Completion Date | |||||||||
| Estimated Primary Completion Date | May 2003 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
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. EXCLUSION CRITERIA: 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. |
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| Gender | Both | ||||||||
| Ages | 7 Years to 50 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00025844 | ||||||||
| Responsible Party | |||||||||
| Study ID Numbers ICMJE | 020003, 02-M-0003 | ||||||||
| Study Sponsor ICMJE | National Institute of Mental Health (NIMH) | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE | |||||||||
| Information Provided By | National Institutes of Health Clinical Center (CC) | ||||||||
| Verification Date | September 2009 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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