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| ID | Type | Description | Link |
|---|---|---|---|
| UH2AT009145 | U.S. NIH Grant/Contract | View source |
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COVID-19 pandemic
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| Name | Class |
|---|---|
| Martinos Center for Biomedical Imaging | OTHER |
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
| Brown University | OTHER |
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The purpose of this study is to investigate changes in functional neural activation during self-regulation tasks before compared to after the Mindfulness Training for Primary Care intervention (see MINDFUL-PC (Phase 3) clinical trial). The study will also look at whether chronic disease self-management action plan initiation and successful engagement of self-report and behavioral self-regulation targets relates to the observed brain activation changes after compared to before the mindfulness intervention.
The investigators will investigate the effects of MTPC on pre/post changes in neural function with self-regulation target engagement, using self-appraisal, cuff pain and pain anticipation, and interoceptive attention fMRI tasks among primary care patients with an anxiety or depressive disorder. Primary outcome for this study is evaluating the changes in OFC activation during self-criticism blocks within a self-appraisal fMRI task. Secondary outcomes include changes in activation during self-appraisal fMRI task, pain regulation task, and interoceptive attention task, and the relationship of these targets with medical regimen adherence.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mindfulness Training for Primary Care | Experimental | Experimental: 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 (Phase 3)". For the Mindfulness Training for Primary Care (MTPC) fMRI - arm, the investigators acquire pre-/post-intervention neuroimaging measures from subjects enrolled in this additional fMRI study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mindfulness Training for Primary Care | Behavioral | For intervention description see Mindfulness Training for Primary Care (MTPC) in the study "MINDFUL-PC: Integrating Mindfulness Into the Patient-Centered Medical Home (Phase 3)" |
| Measure | Description | Time Frame |
|---|---|---|
| Change in orbitofrontal cortex activation during the self-criticism condition in self-appraisal task | This task involves asking the participant to read about situations and imagine him/herself being self-critical or self-reassuring in these conditions. | Weeks 8 - 10 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in insula activation during an interoceptive attention task | This task contrasts an interoceptive attention condition with an exteroceptive attention condition. | Weeks 8 - 10 |
| Changes in the rostral anterior cingulate cortex and adjacent medial prefrontal cortex (rACC/mPFC) during the anticipation of pain |
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Inclusion Criteria:
(In addition to all of the inclusion criteria for the main study, see MINDFUL-PC: Integrating Mindfulness into the Patient-Centered Medical Home (Phase 3))
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zev Schuman-Olivier, MD | Cambridge Health Alliance | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cambridge Health Alliance Center for Mindfulness and Compassion | Somerville | Massachusetts | 02143 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19770047 | Background | Longe O, Maratos FA, Gilbert P, Evans G, Volker F, Rockliff H, Rippon G. Having a word with yourself: neural correlates of self-criticism and self-reassurance. Neuroimage. 2010 Jan 15;49(2):1849-56. doi: 10.1016/j.neuroimage.2009.09.019. Epub 2009 Sep 18. | |
| 22689216 | Background | Farb NA, Segal ZV, Anderson AK. Mindfulness meditation training alters cortical representations of interoceptive attention. Soc Cogn Affect Neurosci. 2013 Jan;8(1):15-26. doi: 10.1093/scan/nss066. Epub 2012 Jun 11. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jan 25, 2019 | May 31, 2019 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D003863 | Depression |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D011320 | Primary Health Care |
| ID | Term |
|---|---|
| D003191 | Comprehensive Health Care |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
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This task involves a pressure cuff which is placed on participant's calf and is inflated for periods of 30 seconds to a medium intense pain, as rated by the participants. |
| Weeks 8 - 10 |
| Change in activation of the medial prefrontal cortex during the self-criticism condition in self-appraisal task | This task involves asking the participant to read about situations and imagine him/herself being self-critical or self-reassuring in these conditions. | Weeks 8 - 10 |
| Correlations between brain activation changes and chronic disease self-management action plan initiation | Patient self-reported Action Plan Initiation Survey (APIS-5) is a 5-item questionnaire in which patients are asked to list their action plan SMART goal created during the study, and determine whether they met or did not meet the goal using a 7-point Likert scale with scores >=5 representing self-reported initiation of the goal. | Weeks 8 - 10 |
| 24449585 | Background | Loggia ML, Berna C, Kim J, Cahalan CM, Gollub RL, Wasan AD, Harris RE, Edwards RR, Napadow V. Disrupted brain circuitry for pain-related reward/punishment in fibromyalgia. Arthritis Rheumatol. 2014 Jan;66(1):203-12. doi: 10.1002/art.38191. |