- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01320969
Could Meditation Modulate the Neurobiology of Learning Not to Fear?
Effects of Mindfulness Practice on the Neural Circuitry of Conditioned Fear Extinction in Healthy Participants
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Massachusetts
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Charlestown, Massachusetts, Forenede Stater, 02129
- Massachusetts General Hospital
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
18-65 years of age Proficient in English Right-handed Free of medication that affect cerebral metabolism Able to give informed consent High stress level (defined as a score of >= 3 on the 4-item Perceived Stress Scale).
Exclusion Criteria:
More than 10 meditation sessions of any tradition in their lifetime, or more than 5 sessions within the last year.
More than 10 yoga sessions of any tradition in their lifetime, or more than 5 sessions within the last year.
History of neurologic or psychiatric disease, substance abuse or dependence that is current or within the last year.
Major/chronic medical conditions History of head injury resulting in prolonged loss of consciousness and/or neurological sequelae History of seizures History of stroke Prior neurosurgical procedure Metal in the body, metal injury to the eyes Implanted pacemaker, medication pump, vagal stimulator, deep brain stimulator, TENS unit, or ventriculo-peritoneal shunt Pregnancy; breastfeeding or nursing Claustrophobia Weight > 350 lbs.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Grundvidenskab
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Mindfulness-Based Stress Reduction course
an eight week mindfulness-based stress reduction course
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an eight-week mindfulness-based stress reduction course
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Ingen indgriben: Waitlist group
waitlist group
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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change in MRI data
Tidsramme: pre and post intervention or wait period; first set of MRIs within 3 weeks before the course, second set of MRIs within 3 weeks after course; MRIs will take 1.5 hours each and will occur on 2 consecutive days
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We will measure the change in functional MRI during fear conditioning, extinction, and extinction retention memory pre to post intervention.
Furthermore, we will measure changes in structural MRI data, DTI data and resting state fMRI data.
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pre and post intervention or wait period; first set of MRIs within 3 weeks before the course, second set of MRIs within 3 weeks after course; MRIs will take 1.5 hours each and will occur on 2 consecutive days
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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change in well-being
Tidsramme: pre and post intervention or waitlist period; collected when the MRIs take place; will take about one hour each
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questionnaire data will also be collected pre and post the intervention / wait period; change in the scores will be assessed
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pre and post intervention or waitlist period; collected when the MRIs take place; will take about one hour each
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Britta K Holzel, PhD, Massachusetts General Hospital
- Ledende efterforsker: Mohammed R Milad, PhD, Massachusetts General Hospital
Publikationer og nyttige links
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- 2010-P-002025
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