Integrating Mindfulness Into the Patient-Centered Medical Home (Phase 2)

Study Overview
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Brief Summary
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Among primary care patients, compare the effectiveness of an 8-week mindfulness-based intervention (Mindfulness Training for Primary Care[MTPC]) vs. a low-dose mindfulness introduction comparator on self-management of chronic illness and illness-related health behavior action plan initiation, as well as on measures related to anxiety, depression, and stress.

Detailed Description
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This study builds on a pilot study that investigated the impact of Mindfulness Training for Primary Care on anxiety, depression, stress, and chronic illness self-management in primary care patients receiving care in an urban, community, multi-cultural safety net healthcare system. The current comparative effectiveness randomized controlled trial takes place in a larger sample, and investigates the impact of a refined MTPC curriculum on specific aspects of self-regulation such as action plan initiation, while examining potential mechanisms of change, including self-efficacy, perceived control, mindfulness, self-compassion, emotion regulation, and body awareness. Participants randomized to MTPC are compared with participants who are randomized to a low-dose comparator condition and receive a 1-hour introduction to mindfulness with a referral to community mindfulness resources. Outcome assessments are conducted at baseline and study weeks 8-10.

Official Title
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MINDFUL-PC: Integrating Mindfulness Into the Patient-Centered Medical Home - A Comparative Effectiveness Trial of Chronic Illness Self-Management and Action Plan Initiation Among Primary Care Patients

Conditions
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Depression, Anxiety, Stress Related Disorder, Adjustment Disorders

Intervention / Treatment
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* Behavioral: Mindfulness Training for Primary Care
* Behavioral: 60-minute Introduction to Mindfulness


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Current CHA patient with an enrolled CHA primary care doctor. CHA patients 18 years of age and older. Able to tolerate and participate in interviews and engage in all procedures. Able to give written consent in English OR willing and able to provide consent and complete assessments through a professional language translator when necessary. Diagnosis eligible to be covered by insurance for group visits (e.g., anxiety disorder, depression, or adjustment disorder related to chronic illness, pain, etc.). Exclusion Criteria: Any cognitive impairment that precludes informed consent. Patients who, in the opinion of the Principal Investigator, pose an imminent risk of suicide or danger to self or others. Likelihood of potential incarceration such as a conviction or pending charges that may potentially result in imprisonment. Previous enrollment or randomization of treatment in the present study within the 12 months. Behaviors that may cause disruption to a mindfulness group. Patients with symptoms of psychosis, thought disorder, and/or severe mental illness, including schizophrenia, schizoaffective, bipolar disorder, or a current severe episode of major depressive disorder. Lack of insurance coverage for group psychotherapy may preclude participation in groups. Patients in their third trimester of pregnancy who foresee conflicts that preclude their commitment to completing all activities. Patients with highly unstable medical problems that put them at a high risk of hospitalization.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Two arms, intervention and low-dose comparator, which are randomly assigned at the same time and are implemented in parallel.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Mindfulness Training for Primary Care<br>Mindfulness Training for Primary Care (MTPC) is a primary care adaptation that includes core common Mindfulness-Based Intervention (MBI) elements integrated with novel mindfulness-oriented behavior change elements into a format that is adaptable to delivery in primary care health centers. | Behavioral: Mindfulness Training for Primary Care<br>* MTPC is a referral-based, insurance-reimbursable 8-week program that can be delivered as group psychotherapy by Patient-Centered Medical Home-integrated behavioral clinicians or as an 8-week primary care group visit delivered by a primary care provider. MTPC groups are 2 hours long for 8 weeks with a 7-hour weekend day of silent practice. MTPC emphasizes mindfulness-oriented skills for self-regulation, self-management of chronic illness, and health behavior change. All participants complete an action planning protocol during Week 7.<br>|
| Other: Low-dose Comparator<br>Comparator arm: Participants receive a 60-minute introduction to mindfulness group plus referral to a list of community mindfulness resources such as private-pay community mindfulness classes, mobile mindfulness applications, books, and online recordings. These participants are added to a 6-month wait-list for a Cambridge Health Alliance mindfulness-based intervention group and allowed to receive behavioral and medical referrals and treatment as usual. All participants complete an action planning protocol during Week 7. | Behavioral: 60-minute Introduction to Mindfulness<br>* Participants in the low-dose comparator arm receive a 60-minute introduction to mindfulness. Participants are introduced to the definition(s) of mindfulness, brief mindfulness practices, discussion, and an orientation to an 8-week mindfulness group. They are also given a list of leading community, online, print, and smartphone mindfulness resources.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Action Plan Initiation Survey (APIS-5) | The Action Plan Initiation Survey (APIS-5) is a 5-item self-report questionnaire adapted from a measure used by Guck et al. Participants are asked to indicate how successful they were in meeting a previously set Action Plan by using a 7-point Likert scale from 1 (Not met at all) to 7 (Totally met), with a score of 5 or above indicating successful initiation of the goal. For each unmet goal, patients are asked to further rate the cause of not meeting the goal by using a 7-point Likert rating scale from 1 (Extremely controllable) to 7 (Not at all controllable). For this outcome we reported the number of participants in each arm who successfully initiated an Action Plan, as indicated by a score of 5 or above in reporting whether they were able to meet their action plan goal. | Weeks 8-10 | 
| Perceived Stress Scale | The Perceived Stress Scale (PSS) (10 items) measures the degree to which situations in life are stressful. Items are designed to evaluate how overloaded, unpredictable, and uncontrollable one finds one's life. Each item is scored on a 5 point Likert scale from 0 (Never) to 4 (Very often). Scores range from 0-40 with higher scores reflecting worse results (more stress). | Baseline and week 8 (pre to post Intervention) | 
| Patient Reported Outcomes Measurement Information System - Anxiety Short Form (PROMIS-ASF) | The Patient Reported Outcomes Measurement Information System - Anxiety Short Form 8a (PROMIS-ASF) is an 8-item scale used to assess patient-reported health status for anxiety. PROMIS instruments are funded by the National Institutes of Health (NIH) and used to reliably and validly measure patient-reported outcomes for clinical research and practice. Participants are asked to rate their experience of the item in the past seven days on a 5-point Likert scale from 1 (Never) to 5 (Always). The values of the response to each question are summed into a raw score ranging from 8-40. The raw score is then rescaled with use of the PROMIS Assessment Center Scoring Service into a T score, a standardized score with a mean of 50 and a standard deviation (SD) of 10. Higher T-Score reflects worse results (greater symptom severity). | Baseline and week 8 (pre to post Intervention) | 
| Patient Reported Outcomes Measurement Information System - Depression Short Form (PROMIS-DSF) | The Patient Reported Outcomes Measurement Information System - Depression Short Form 8a (PROMIS-DSF) is an 8-item scale used to assess patient-reported health status for depression. PROMIS instruments are funded by the National Institutes of Health (NIH) and used to reliably and validly measure patient-reported outcomes for clinical research and practice. Participants are asked to rate their experience of the item in the past seven days on a 5-point Likert scale from 1 (Never) to 5 (Always). The values of the response to each question are summed into a raw score ranging from 8-40. The raw score is then rescaled with use of the PROMIS Assessment Center Scoring Service into a T score, a standardized score with a mean of 50 and a standard deviation (SD) of 10. Higher T-Score reflects reflect worse results (greater symptom severity). | Baseline and week 8 (pre to post Intervention) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Five Facet Mindfulness Questionnaire (FFMQ) | The Five Facet Mindfulness Questionnaire (FFMQ) is a 39-item scale that examines five factors that represent aspects of the current empirical conception of mindfulness. These five facets include: observing, describing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience. Participants rate their degree of agreement with each of the items on a Likert-type scale ranging from 1 (Never or very rarely true) to 5 (Very often or always true). Facet scores range from 8-40, with the exception of the nonreactivity facet, which ranges from 7-35. Total scores range from 39-195, with higher scores reflecting higher levels of mindfulness (a better outcome). | Baseline and week 8 (pre to post Intervention) | 
| Self-Compassion Scale-Short Form (SCS-SF) | The short-form Self-Compassion Scale (SCS-SF) is an abbreviated 12-item form of the original 26-item Self-Compassion Scale. The scale is scored on a 5 point Likert scale (1 = Almost never; 5 = Almost always), and negative subscale items are reverse scored, with higher scores indicating greater levels of self-compassion. | Baseline and week 8 (pre to post Intervention) | 
| Change in Self-Efficacy for Managing Chronic Disease (SECD-6) | The Self-Efficacy for Managing Chronic Disease Scale (SECD-6) is a 6-item scale that is used to evaluate a participant's ability to self-manage care for a chronic disease. SECD-6 asks participants to rate their confidence in their own ability to do certain activities, on a scale from 1 (not at all confident) to 10 (totally confident). Higher scores indicate better results (higher levels of self-efficacy). | Baseline and week 8 (pre to post Intervention) | 
| Perceived Control Questionnaire (PCQ) | The Perceived Control Questionnaire (PCQ) is adapted from a 5-item perceived control measure from Jerant et al. and a previously validated survey from Armitage et al. This 5-item scale asks participants to rate their sense of control over chronic illness self-management on a 7-point scale from 1 (None) to 7 (Total). Scores range from 5-35, with higher scores indicating better results (greater sense of control). | Baseline and week 8 (pre to post Intervention) | 
| Difficulty in Emotion Regulation Scale (DERS) | The Difficulties in Emotion Regulation (DERS) Scale is a 36-item self-report scale designed to assess emotional dysregulation. Participants are asked to rate how often they have emotional dysregulation on a 5-point Likert scale from 1 (almost never [0-10%]) to 5 (almost always [91-100%]). The scale assess 6 aspects of emotional dysregulation: non-acceptance of emotional responses, difficulties engaging in goal directed behavior, impulse control difficulties, lack of emotional awareness (reverse-scored), limited access to emotion regulation strategies, and lack of emotional clarity. Total scores range from 5-180, with higher scores indicating worse results (more difficulty in emotional regulation). | Baseline and week 8 (pre to post Intervention) | 
| Multidimensional Assessment of Interoceptive Awareness (MAIA) | The Multidimensional Assessment of Interoceptive Awareness (MAIA) is a 32-item self-report scale designed to assess 8 aspects of interoceptive awareness : noticing, not-distracting, not-worrying, attention regulation, emotional awareness, self-regulation, body listening, and trusting. Participants are asked to rate their awareness of interoceptive experiences on a 6-point Likert scale from 0 (Never) to 5 (Always). Each subscale has 3-7 items, and scores are obtained by reverse coding items 5, 6, 7, 8, 9, and then taking the average of items in each scale. Scores range from 0-5, with higher scores indicating better results (greater interoception). | Baseline and week 8 (pre to post Intervention) |