Mindful Self-Regulation fMRI Study (MindfulPCfMRI)
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|ClinicalTrials.gov Identifier: NCT03609749|
Recruitment Status : Recruiting
First Posted : August 1, 2018
Last Update Posted : June 7, 2019
|Condition or disease||Intervention/treatment||Phase|
|Anxiety Depression||Behavioral: Mindfulness Training for Primary Care||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Mindfulness Influences on Self-Regulation: Mindful Self-Regulation fMRI Study|
|Actual Study Start Date :||January 30, 2019|
|Estimated Primary Completion Date :||April 1, 2020|
|Estimated Study Completion Date :||June 30, 2020|
Experimental: Mindfulness Training for Primary Care
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.
Behavioral: 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)"
- Change in orbitofrontal cortex activation during the self-criticism condition in self-appraisal task [ Time Frame: Weeks 8 - 10 ]This task involves asking the participant to read about situations and imagine him/herself being self-critical or self-reassuring in these conditions.
- Change in insula activation during an interoceptive attention task [ Time Frame: Weeks 8 - 10 ]This task contrasts an interoceptive attention condition with an exteroceptive attention condition.
- Changes in the rostral anterior cingulate cortex and adjacent medial prefrontal cortex (rACC/mPFC) during the anticipation of pain [ Time Frame: Weeks 8 - 10 ]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.
- Change in activation of the medial prefrontal cortex during the self-criticism condition in self-appraisal task [ Time Frame: Weeks 8 - 10 ]This task involves asking the participant to read about situations and imagine him/herself being self-critical or self-reassuring in these conditions.
- Correlations between brain activation changes and chronic disease self-management action plan initiation [ Time Frame: Weeks 8 - 10 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03609749
|Contact: Zev Schuman-Olivier, MDfirstname.lastname@example.org|
|United States, Massachusetts|
|Cambridge Health Alliance Center for Mindfulness and Compassion||Recruiting|
|Somerville, Massachusetts, United States, 02143|
|Contact: Zev D Schuman-Olivier, MD 617-591-6132 email@example.com|
|Contact: Richa Gawande, PhD 617-591-6429 firstname.lastname@example.org|
|Principal Investigator:||Zev Schuman-Olivier, MD||Cambridge Health Alliance|