Mindful Self-Regulation fMRI Pilot Study

Completed · Not applicable

Conditions studied: Psychiatric Problem, Depression, Anxiety, Neuroimaging, Self-Control

In brief

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.

Key facts

Study ID

NCT02972853

Run by

Cambridge Health Alliance

People needed

26

Starts

2016-09-01

Expected to finish

2020-10-01

Last updated by the study team

2021-10-21

Who can join

Age: 21 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

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).
• 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.

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.
• 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.

Where it is running

• CHA Center for Mindfulness and Compassion — Somerville, Massachusetts, United States

Full record on ClinicalTrials.gov

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