Anxiety, Depression
Conditions
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALMindfulness Training for Primary Care
For intervention description see Mindfulness Training for Primary Care (MTPC) in the study MINDFUL-PC: Integrating Mindfulness Into the Patient-Centered Medical Home (Phase 3)
Sponsors
Martinos Center for Biomedical Imaging
National Center for Complementary and Integrative Health (NCCIH)
Brown University
Cambridge Health Alliance
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in orbitofrontal cortex activation during the self-criticism condition in self-appraisal task | Weeks 8 - 10 | This task involves asking the participant to read about situations and imagine him/herself being self-critical or self-reassuring in these conditions. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in insula activation during an interoceptive attention task | Weeks 8 - 10 | This task contrasts an interoceptive attention condition with an exteroceptive attention condition. |
| Changes in the rostral anterior cingulate cortex and adjacent medial prefrontal cortex (rACC/mPFC) during the anticipation of pain | Weeks 8 - 10 | This task involves a pressure cuff which is placed on participant's calf and is inflated for periods of 30 seconds to a medium intense pain, as rated by the participants. |
| Change in activation of the medial prefrontal cortex during the self-criticism condition in self-appraisal task | Weeks 8 - 10 | This task involves asking the participant to read about situations and imagine him/herself being self-critical or self-reassuring in these conditions. |
| Correlations between brain activation changes and chronic disease self-management action plan initiation | Weeks 8 - 10 | Patient self-reported Action Plan Initiation Survey (APIS-5) is a 5-item questionnaire in which patients are asked to list their action plan SMART goal created during the study, and determine whether they met or did not meet the goal using a 7-point Likert scale with scores \>=5 representing self-reported initiation of the goal. |
Countries
United States
Outcome results
None listed