Mindful Self-Regulation fMRI Study (MindfulPCfMRI)

Stopped early · Not applicable

Conditions studied: Anxiety, Depression

In brief

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.

Key facts

Study ID

NCT03609749

Run by

Cambridge Health Alliance

People needed

21

Starts

2019-01-30

Expected to finish

2020-08-01

Last updated by the study team

2020-11-13

Who can join

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

You may qualify if…

• (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))
• 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.
• 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. 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.

Where it is running

• Cambridge Health Alliance Center for Mindfulness and Compassion — Somerville, Massachusetts, United States

Full record on ClinicalTrials.gov

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