Mindful Self-Regulation fMRI Pilot Study

NCT02972853 | Completed

• 2 other identifiers: CHA-IRB-1002/08/141UH2AT009145-01
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Change in Brain activation in regions of interest

  Change in brain activation will be measured with functional magnetic resonance imaging (fMRI) during four different tasks: an affective go/nogo regulation task, an interoceptive attention task, a self-compassion task and a pain regulation task. Brain activation will be compared between baseline and Week 8.

  8 weeks

Secondary Outcomes (2)

• Correlations between brain activation changes and self-regulation measures

  8 weeks

• Correlations between brain activation changes and chronic disease self-management action plan initiation.

  9 weeks

Study Arms (1)

Mindfulness Training for Primary Care

EXPERIMENTAL

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.

Behavioral: Mindfulness Training for Primary Care (MTPC)

Interventions

Mindfulness Training for Primary Care (MTPC) BEHAVIORAL

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"

Mindfulness Training for Primary Care

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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.
• 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.

Sponsors & Collaborators

• Cambridge Health Alliance: lead
• Martinos Center for Biomedical Imaging: collaborator
• National Center for Complementary and Integrative Health (NCCIH): collaborator
• Brown University: collaborator

Study Sites (1)

CHA Center for Mindfulness and Compassion

Somerville, Massachusetts, 02143, United States

Location

MeSH Terms

Conditions

Depression; Anxiety Disorders; Self-Control

Interventions

Primary Health Care

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Social Behavior

Intervention Hierarchy (Ancestors)

Comprehensive Health Care; Patient Care Management; Health Services Administration

Study Officials

• Zev D Schuman-Olivier, MD

  Cambridge Health Alliance

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2016
• First Posted: November 25, 2016
• Study Start: September 1, 2016
• Primary Completion: June 1, 2020
• Study Completion: October 1, 2020
• Last Updated: October 21, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)