Psychiatric ProblemMindfulPCMRINCT02972853
Mindful Self-Regulation fMRI Pilot Study
A study testing Mindfulness Training for Primary Care (MTPC) in people with Psychiatric Problem and Depression, run by Cambridge Health Alliance at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 to 60 years
- Conditions the study is for
- Psychiatric Problem, Depression, Anxiety
- What is being tested?
- Mindfulness Training for Primary Care (MTPC)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2016to Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
CHA Center for Mindfulness and Compassion
Somerville, Massachusetts, 02143
About this study
Official title: Mindfulness Influences on Self-Regulation: Mental and Physical Health Implications: Mindful Self-Regulation fMRI Pilot Study
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.
Read the 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). .
- Conditions
- Psychiatric Problem, Depression, Anxiety, Neuroimaging, Self-Control
- Being tested
- Mindfulness Training for Primary Care (MTPC)
- Medical subject headings
- Depression, Anxiety Disorders, Self-Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness Training for Primary Care (MTPC)Behavioural
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"
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Mindfulness Training for Primary Care (MTPC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
Secondary outcomes (2)
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."
Measured: 8 weeks
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.
Measured: 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2016 (estimated)
- Study startSep 2016
- Primary completionJun 2020
- Study completionOct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychiatric ProblemStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cambridge Health Alliance
- Sponsor type
- University, hospital or other
- Collaborators
- Martinos Center for Biomedical Imaging, National Center for Complementary and Integrative Health (NCCIH), Brown University
- Responsible party
- Sponsor
- Investigators
- Zev D Schuman-Olivier, MD, Principal investigator, Cambridge Health Alliance
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02972853
- Sponsor's protocol ID
- CHA-IRB-1002/08/14
- Other IDs
- 1UH2AT009145-01
- Acronym
- MindfulPCMRI
- Status last verified
- Oct 2021
- First submitted
- 16 Nov 2016
- Last updated
- 21 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness Influences on Self-Regulation: Mental and Physical Health Implications: Mindful Self-Regulation fMRI Pilot Study
- ClinicalTrials.gov ID
- NCT02972853
- Acronym / sponsor ID
- MindfulPCMRI / CHA-IRB-1002/08/14
- Conditions
- Psychiatric Problem, Depression, Anxiety, Neuroimaging, Self-Control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Cambridge Health AllianceUniversity, hospital or other
- Collaborators
- Martinos Center for Biomedical Imaging, National Center for Complementary and Integrative Health (NCCIH), Brown University
- Study start
- Sep 2016 (actual)
- Primary completion
- Jun 2020 (actual)
- Study completion
- Oct 2020 (actual)
- First posted
- 25 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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). .
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mindfulness Training for Primary Care | Experimental | Behavioral: Mindfulness Training for Primary Care (MTPC)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. |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness Training for Primary Care (MTPC)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" | Behavioural | Mindfulness Training for Primary Care |
Primary outcome
Change in Brain activation in regions of interest
Time frame: 8 weeks
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.
2 secondary outcomes
Correlations between brain activation changes and self-regulation measures
Time frame: 8 weeks
Correlations between brain activation changes and chronic disease self-management action plan initiation.
Time frame: 9 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zev D Schuman-Olivier, MD principal investigator
Cambridge Health Alliance
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Training for Primary Care (MTPC) in people with Psychiatric Problem and Depression, run by Cambridge Health Alliance at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Brain activation in regions of interest (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2021.