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
26 participants
INTERVENTIONAL
2016-09-30
2020-10-31
Brief Summary
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The study will also look at whether chronic disease self-management and successful engagement of self-report and behavioral self-regulation targets (emotion regulation, attention, and interoceptive awareness) relates to the observed brain activation changes after compared to before the mindfulness intervention.
Detailed Description
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The study will also look at whether successful chronic disease self-management relates to the observed brain activation changes after compared to before the mindfulness intervention.
The study will examine the relationship between mindfulness training within primary care and medical regimen adherence (initiation and maintenance) as well as the underlying neural correlates associated with changes in self-regulation.
This is a single-arm pilot trial, recruiting from a randomized controlled trial (see MINDFUL-PC study). .
Conditions
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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Mindfulness Training for Primary Care
For intervention description see Mindfulness Training for Primary Care (MTPC) in the study "MINDFUL-PC: Integrating Mindfulness Into the Patient-Centered Medical Home - A Pilot Study". For the Mindfulness Training for Primary Care (MTPC) fMRI - arm, we acquire pre-/post-intervention neuroimaging measures from subjects enrolled in this additional pilot fMRI study.
Mindfulness Training for Primary Care (MTPC)
For intervention description see Mindfulness Training for Primary Care (MTPC) in the study "MINDFUL-PC: Integrating Mindfulness Into the Patient-Centered Medical Home - A Pilot Study"
Interventions
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Mindfulness Training for Primary Care (MTPC)
For intervention description see Mindfulness Training for Primary Care (MTPC) in the study "MINDFUL-PC: Integrating Mindfulness Into the Patient-Centered Medical Home - A Pilot Study"
Eligibility Criteria
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Inclusion Criteria
* During baseline visit, patient has a history of either major depressive disorder, dysthymia, or generalized anxiety disorder, OR has current mild to moderate symptoms of depression (score range of 10-28 on DASS-21 Depression subscale) or anxiety (score \>7 on DASS-21 anxiety subscale).
* Participant does not have a substance use disorder nor intoxication at the time of scanning. Participants must report no more than infrequent recreational cannabis use (i.e., no more than two times a month) and must report capacity for abstinence from both cannabis and ethyl alcohol for the 72 hours prior to the scan.
* Normal or corrected-to-normal vision, and correction must be with contact lenses.
* Right-handed as defined by Edinburgh Handedness Inventory.
Exclusion Criteria
* Current suicidality OR severe depression as evidenced by a score of 28 or higher on the DASS-21 Depression subscale.
* A history of neurological disease or injury, including a history of seizures or significant head trauma (i.e., extended loss of consciousness, neurological sequelae, or known structural brain lesion), or previous brain surgery.
* Severe skin disease, skin allergies, or multiple reactions to topical preparations, dressings or tapes.
* Current meditation or intense yoga practice or extensive previous experience.
* Participants with vascular disease, such as peripheral vascular disease, varicose veins, or lymphedema, in both lower limbs.
21 Years
60 Years
ALL
No
Sponsors
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Martinos Center for Biomedical Imaging
OTHER
National Center for Complementary and Integrative Health (NCCIH)
NIH
Brown University
OTHER
Cambridge Health Alliance
OTHER
Responsible Party
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Principal Investigators
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Zev D Schuman-Olivier, MD
Role: PRINCIPAL_INVESTIGATOR
Cambridge Health Alliance
Locations
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CHA Center for Mindfulness and Compassion
Somerville, Massachusetts, United States
Countries
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Other Identifiers
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CHA-IRB-1002/08/14
Identifier Type: -
Identifier Source: org_study_id