Mindful Self-Regulation fMRI Study (MindfulPCfMRI)



Status:Recruiting
Conditions:Anxiety, Anxiety, Depression
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:21 - 60
Updated:2/6/2019
Start Date:January 30, 2019
End Date:June 30, 2020
Contact:Zev Schuman-Olivier, MD
Email:zschuman@cha.harvard.edu
Phone:6175916132

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Mindfulness Influences on Self-Regulation: Mindful Self-Regulation fMRI Study

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.

The investigators will investigate the effects of MTPC on pre/post changes in neural function
with self-regulation target engagement, using self-appraisal, cuff pain and pain
anticipation, and interoceptive attention fMRI tasks among primary care patients with an
anxiety or depressive disorder. Primary outcome for this study is evaluating the changes in
OFC activation during self-criticism blocks within a self-appraisal fMRI task. Secondary
outcomes include changes in activation during self-appraisal fMRI task, pain regulation task,
and interoceptive attention task, and the relationship of these targets with medical regimen
adherence.

Inclusion Criteria:

(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))

1. Adults 21-60 years old enrolled for participation in the MINDFUL-PC study.

2. 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).

3. 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.

4. Normal or corrected-to-normal vision, and correction must be with contact lenses.

5. Right-handed as defined by Edinburgh Handedness Inventory.

Exclusion Criteria:

1. Current severe panic disorder, active severe PTSD symptoms, or psychosis.

2. Current suicidality OR severe depression as evidenced by a score of 28 or higher on
the DASS-21 Depression subscale.

3. 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.

4. 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.

5. 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).

6. 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.

7. 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.

8. 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.

9. Participants with vascular disease, such as peripheral vascular disease, varicose
veins, or lymphedema, in both lower limbs.

10. Based on clinical judgment and safety assessment by the PI, the participant is
inappropriate for fMRI or unable to complete experiments.
We found this trial at
1
site
Somerville, Massachusetts 02143
Phone: 617-591-6132
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from
Somerville, MA
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