Clinical trial NCT02972853: Mindful Self-Regulation fMRI Pilot Study
Official title: Mindfulness Influences on Self-Regulation: Mental and Physical Health Implications: Mindful Self-Regulation fMRI Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psychiatric Problem
Depression
Anxiety
Neuroimaging
Self-Control
Lead sponsor: Cambridge Health Alliance
Sponsor class: OTHER
Collaborators: name: Martinos Center for Biomedical Imaging
name: National Center for Complementary and Integrative Health (NCCIH)
name: Brown University
First posted: 2016-11-25
Enrollment: 26
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Detailed 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). .

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Brain activation in regions of interest
timeFrame: 8 weeks
Secondary outcomes:
measure: Correlations between brain activation changes and self-regulation measures
timeFrame: 8 weeks
measure: Correlations between brain activation changes and chronic disease self-management action plan initiation.
timeFrame: 9 weeks
Other outcomes:
Locations:
city: Somerville
country: United States
facility: CHA Center for Mindfulness and Compassion
state: Massachusetts
Study officials:
affiliation: Cambridge Health Alliance
name: Zev D Schuman-Olivier, MD
role: PRINCIPAL_INVESTIGATOR
References: