Back to resultsMindful Self-Regulation fMRI Pilot Study (MindfulPCMRI)
Primary Purpose
Psychiatric Problem, Depression, Anxiety
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindfulness Training for Primary Care (MTPC)
Sponsored by
About this trial
This is an interventional basic science trial for Psychiatric Problem
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.
Sites / Locations
- CHA Center for Mindfulness and Compassion
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Mindfulness Training for Primary Care
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Correlations between brain activation changes and self-regulation measures
Self-regulation targets of emotion regulation, interoceptive awareness, and attention from MINDFUL-PC: Integrating Mindfulness Into the Patient-Centered Medical Home."
Correlations between brain activation changes and chronic disease self-management action plan initiation.
In addition, brain activation in regions of interest will be correlated with chronic disease self-management action plan initiation.
Full Information
NCT ID
NCT02972853
First Posted
November 16, 2016
Last Updated
October 20, 2021
Sponsor
Cambridge Health Alliance
Collaborators
Martinos Center for Biomedical Imaging, National Center for Complementary and Integrative Health (NCCIH), Brown University
1. Study Identification
Unique Protocol Identification Number
NCT02972853
Brief Title
Mindful Self-Regulation fMRI Pilot Study
Acronym
MindfulPCMRI
Official Title
Mindfulness Influences on Self-Regulation: Mental and Physical Health Implications: Mindful Self-Regulation fMRI Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
September 2016 (Actual)
Primary Completion Date
June 2020 (Actual)
Study Completion Date
October 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cambridge Health Alliance
Collaborators
Martinos Center for Biomedical Imaging, National Center for Complementary and Integrative Health (NCCIH), Brown University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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). .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychiatric Problem, Depression, Anxiety, Neuroimaging, Self-Control
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mindfulness Training for Primary Care
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness Training for Primary Care (MTPC)
Intervention Description
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"
Primary Outcome Measure Information:
Title
Change in Brain activation in regions of interest
Description
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.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Correlations between brain activation changes and self-regulation measures
Description
Self-regulation targets of emotion regulation, interoceptive awareness, and attention from MINDFUL-PC: Integrating Mindfulness Into the Patient-Centered Medical Home."
Time Frame
8 weeks
Title
Correlations between brain activation changes and chronic disease self-management action plan initiation.
Description
In addition, brain activation in regions of interest will be correlated with chronic disease self-management action plan initiation.
Time Frame
9 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zev D Schuman-Olivier, MD
Organizational Affiliation
Cambridge Health Alliance
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHA Center for Mindfulness and Compassion
City
Somerville
State/Province
Massachusetts
ZIP/Postal Code
02143
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Mindful Self-Regulation fMRI Pilot Study
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