Mindful Self-Regulation fMRI Study (MindfulPCfMRI)

NCT03609749 | Terminated

• 2 other identifiers: CHA-IRB-1002/08/14_fMRIUH2AT009145
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety; Depression

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Change in insula activation during an interoceptive attention task

  Weeks 8 - 10

• Changes in the rostral anterior cingulate cortex and adjacent medial prefrontal cortex (rACC/mPFC) during the anticipation of pain

  Weeks 8 - 10

• Change in activation of the medial prefrontal cortex during the self-criticism condition in self-appraisal task

  Weeks 8 - 10

• Correlations between brain activation changes and chronic disease self-management action plan initiation

  Weeks 8 - 10

Study Arms (1)

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.

Behavioral: Mindfulness Training for Primary Care

Interventions

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)"

Mindfulness Training for Primary Care

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Adults 21-60 years old enrolled for participation in the MINDFUL-PC study.
• 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).
• 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.
• Normal or corrected-to-normal vision, and correction must be with contact lenses.
• Right-handed as defined by Edinburgh Handedness Inventory.

You may not qualify if:

• Current severe panic disorder, active severe PTSD symptoms, or psychosis.
• 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. These participants are excluded because they may confound the results of the study due to potential abnormalities in their nervous system.
• 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).
• 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.
• 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.
• 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.
• Participants with vascular disease, such as peripheral vascular disease, varicose veins, or lymphedema, in both lower limbs.
• Based on clinical judgment and safety assessment by the PI, the participant is inappropriate for fMRI or unable to complete experiments.

Sponsors & Collaborators

• Cambridge Health Alliance: lead
• Martinos Center for Biomedical Imaging: collaborator
• National Center for Complementary and Integrative Health (NCCIH): collaborator
• Brown University: collaborator

Study Sites (1)

Cambridge Health Alliance Center for Mindfulness and Compassion

Somerville, Massachusetts, 02143, United States

Location

Related Publications (3)

• 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.

  PMID: 19770047 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.

  PMID: 22689216 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.

  PMID: 24449585 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders; Depression

Interventions

Primary Health Care

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Comprehensive Health Care; Patient Care Management; Health Services Administration

Study Officials

• Zev Schuman-Olivier, MD

  Cambridge Health Alliance

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2018
• First Posted: August 1, 2018
• Study Start: January 30, 2019
• Primary Completion: April 1, 2020
• Study Completion: August 1, 2020
• Last Updated: November 13, 2020

Record last verified: 2020-11

Locations

US (1)