Effect of Mindfulness Meditation on Physiological Response to Unpredictable Stimuli
NCT ID: NCT03206437
Last Updated: 2022-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
45 participants
INTERVENTIONAL
2017-06-20
2022-11-25
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Mindfulness-Based Stress Reduction
This group will take the 8 week MBSR course within 4 weeks of their first testing visit. When the course is finished they will come in for their second testing visit. The course meets once a week in person for 2.5 hours and participants are expected to do practices at home.
Mindfulness-Based Stress Reduction
The MBSR course teaches mindfulness meditation skills. This 8-week course meets in person once a week for 2.5 hours. Participants are expected to complete practice assignments at home.
Waitlist
The wait-list group will not participate in the MBSR course within 4 weeks of their first testing visit. They will wait 8-16 weeks and come on for a second testing visit. After their data is collected they will be offered an MBSR course to take.
Waitlist
This group will wait 8-16 weeks after their first testing visit and after their second study visit is completed they will be able to participate in an 8-week MBSR course.
Interventions
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Mindfulness-Based Stress Reduction
The MBSR course teaches mindfulness meditation skills. This 8-week course meets in person once a week for 2.5 hours. Participants are expected to complete practice assignments at home.
Waitlist
This group will wait 8-16 weeks after their first testing visit and after their second study visit is completed they will be able to participate in an 8-week MBSR course.
Eligibility Criteria
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Inclusion Criteria
2. Have an anxiety disorder, including: social anxiety disorder (SAD), generalized anxiety disorder (GAD), panic disorder, posttraumatic stress disorder (PTSD), agoraphobia, or simple phobia.
3. Must understand study procedure and willing to participate in 2 testing visits, and MBSR course as assigned.
4. Participants must be able to give informed consent to the study procedures.
Exclusion Criteria
2. Lack of measurable eye blink/eye twitch response (3 times the baseline eye blink muscle activity as measured by electromyography) for at least 5 of 9 startles used during the habituation visit.
3. A serious medical condition that may result in surgery or hospitalization.
4. Subjects who will be non-compliant with the study procedures. This may include planned travel out of town.
5. Women who are pregnant.
6. Current evidence of median nerve entrapment or carpal tunnel syndrome.
7. Subject who has resting blood pressure outside of a systolic blood pressure range of 90-140 mmHg, or a diastolic blood pressure outside a range of 50-90 mmHg on two consecutive measurements, taken up to 10 minutes apart.
8. Subjects taking benzodiazepines, barbiturates, antidepressants, antipsychotics, or sedative medications
9. Subjects currently receiving concomitant psychotherapy directed at treating anxiety symptoms (i.e. CBT).
10. Individuals with implanted electronic devices, such as a cardiac pacemaker.
11. Individuals who have completed a full course of MBSR, an equivalent meditation training, or have a daily meditation practice.
18 Years
65 Years
ALL
No
Sponsors
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Georgetown University
OTHER
Responsible Party
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Principal Investigators
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Elizabeth A Hoge
Role: PRINCIPAL_INVESTIGATOR
Georgetown University
Locations
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Georgetown University Medical Center
Washington D.C., District of Columbia, United States
Countries
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References
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Schmitz A, Grillon C. Assessing fear and anxiety in humans using the threat of predictable and unpredictable aversive events (the NPU-threat test). Nat Protoc. 2012 Feb 23;7(3):527-32. doi: 10.1038/nprot.2012.001.
Other Identifiers
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2017-0698
Identifier Type: -
Identifier Source: org_study_id