Mindful Self-Regulation fMRI Pilot Study (MindfulPCMRI)

Cambridge Health Alliance

Status: Completed

Conditions: Neuroimaging; Psychiatric Problem; Depression; Anxiety; Self-Control

Treatments: Behavioral: Mindfulness Training for Primary Care (MTPC)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02972853

1UH2AT009145-01 (U.S. NIH Grant/Contract)

CHA-IRB-1002/08/14

Details and patient eligibility

About

The purpose of this study is to 1) determine whether Mindfulness Training for Primary Care (see study "MINDFUL-PC: Integrating Mindfulness Into the Patient-Centered Medical Home - A Pilot Study") engages self-regulation targets such as emotion regulation, attention, and interoceptive awareness; and 2) changes brain activation in neuroimaging tasks before compared to after the training. Neuroimaging fMRI tasks probe mechanisms related to self-regulation, such as attention/inhibition, emotion regulation, self-compassion, interoception and pain regulation.

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.

Full description

This study aims to test brain activation changes related to self-regulation targets of attention, emotion regulation, self-compassion, interoception and pain regulation that are influenced by mindfulness training within primary care (compare MINDFUL-PC study).

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). .

Enrollment: 26 patients

Sex: All

Ages: 21 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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).
• 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 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.
• 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.
• 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.

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

26 participants in 1 patient group

Mindfulness Training for Primary Care

Experimental group

Description:

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.

Treatment:

Behavioral: Mindfulness Training for Primary Care (MTPC)