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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
Sponsor:
Collaborators:
Martinos Center for Biomedical Imaging
National Center for Complementary and Integrative Health (NCCIH)
Brown University
Information provided by (Responsible Party):
Cambridge Health Alliance

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Anxiety Depression Behavioral: Mindfulness Training for Primary Care Not Applicable

Detailed Description:
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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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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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)"




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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))

  1. Adults 21-60 years old enrolled for participation in the MINDFUL-PC study.
  2. 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).
  3. Does not have a substance use disorder nor intoxication at the time of scanning. Patients 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.
  4. Normal or corrected-to-normal vision, and correction must be with contact lenses.
  5. Right-handed as defined by Edinburgh Handedness Inventory.

Exclusion Criteria:

  1. Current severe panic disorder, active severe PTSD symptoms, or psychosis.
  2. Current suicidality OR severe depression as evidenced by a score of 28 or higher on the DASS-21 Depression subscale.
  3. Standard direct exclusion criteria for undergoing magnetic resonance imaging (MRI) procedures for research purposes (safety standards), i.e., Meniere's disease, epilepsy, strong claustrophobia, currently pregnant or breastfeeding or planning to conceive or breastfeed during the study, cardiac pacemaker, prosthetic heart valve, neurostimulator, implanted pumps, non-MR-compatible implants or devices.
  4. 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. These participants are excluded because they may confound the results of the study due to potential abnormalities in their nervous system.
  5. Severe skin disease, skin allergies, or multiple reactions to topical preparations, dressings or tapes (because we will be placing sensors on the skin to record cardiac activity and skin conductance).
  6. Age greater than 60 years old because age effects may confound the results of the study, because white matter integrity decreases with age and reduced inhibitory control.
  7. Current meditation or intense yoga practice of more than 10 minutes a day of current mindfulness meditation practice, 200 hours of total lifetime meditation practice (non-MBI), or more than 63 lifetime hours of MBI-related mindfulness practice.
  8. Participants with body weight >230 lbs or BMI > 38 will require additional in-person screening and PI approval, because of potential tight fit in the MRI scanner.
  9. Participants with vascular disease, such as peripheral vascular disease, varicose veins, or lymphedema, in both lower limbs.
  10. Based on clinical judgment and safety assessment by the PI, the participant is inappropriate for fMRI or unable to complete experiments.

Information from the National Library of Medicine

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


Contacts
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Contact: Zev Schuman-Olivier, MD 6175916132 zschuman@cha.harvard.edu

Locations
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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    zschuman@cha.harvard.edu   
Contact: Richa Gawande, PhD    617-591-6429    rgawande@challiance.org   
Sponsors and Collaborators
Cambridge Health Alliance
Martinos Center for Biomedical Imaging
National Center for Complementary and Integrative Health (NCCIH)
Brown University
Investigators
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Principal Investigator: Zev Schuman-Olivier, MD Cambridge Health Alliance
  Study Documents (Full-Text)

Documents provided by Cambridge Health Alliance:
Informed Consent Form  [PDF] January 25, 2019