Clinical trial NCT02972203: MINDFUL-PC: Integrating Mindfulness Into the Patient-Centered Medical Home
Official title: MINDFUL-PC: Integrating Mindfulness Into the Patient-Centered Medical Home - A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Anxiety
Stress Related Disorder
Adjustment Disorder
Keywords: Mindfulness
primary care
self-control
self-regulation
adherence
Lead sponsor: Cambridge Health Alliance
Sponsor class: OTHER
Collaborators: name: The Arthur Vining Davis Foundations
name: The Arnold P. Gold Foundation
First posted: 2016-11-23
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Specific aims for this pilot study are:

(Behavioral health outcomes aim): Among primary care patients, compare the effectiveness of an 8-week mindfulness-based intervention (Mindfulness Training for Primary Care\[MTPC\]) vs. a 60-minute introduction to mindfulness plus referral to community resources on measures related to anxiety, depression, and stress, and self-management of chronic illness.

(Medical Regimen Adherence Aim): Among primary care patients, compare the effectiveness of MTPC vs. 60-minute introduction to mindfulness on the initiation and maintenance of an action plan.

(Patient-Provider Relationship Aim): To examine the effects of level of primary care provider mindfulness training on successful referral to program, patient-provider relationship measures, and on patient action plan initiation and maintenance.

Detailed description: This project aims evaluate the integration of mindfulness training into the heart of the standard healthcare delivery system.

The investigators and collaborators have developed an 8-week mindfulness-based intervention for primary care called Mindfulness Training for Primary Care (MTPC). MTPC combines common Mindfulness-Based Intervention skills with additional attention to patient/provider relationships, cultural and socio-economic diversity, coping with chronic illness, reducing unnecessary medical care, and encouraging self-management skills acquisition.

This project addresses important gaps in the current mindfulness research and delivery system by evaluating the integration of the novel MTPC model into a system of urban, community, multi-cultural, safety-net Patient-Centered Medical Homes.

In this pilot randomized controlled trial, the investigators compare the effectiveness of 8-week MTPC versus a 60-minute introduction to mindfulness plus referral to community mindfulness resources for primary care patients on behavioral health outcomes of anxiety, depression, stress, and self-management of chronic illness. The investigators are also testing the effect of MTPC on rates of initiation and maintenance of health action plans that patients collaborate on with their primary care provider during study Week 6 . This study also enrolls primary care providers who have participated in various levels of mindfulness training, i.e., 16-hour and 8-week mindfulness-based stress reduction and 10-month mindful communication vs. no training.

Outcome assessments are conducted at baseline and study week 8. An action-planning visit with PCPs occurs at week 6 with follow-up during week 8 (initiation) and interview at study week 24 (maintenance).

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Perceived Stress Scale
timeFrame: Week 8
measure: Change in Patient Reported Outcomes Measurement Information System - Anxiety Short Form (PROMIS-ASF)
timeFrame: Week 8
measure: Change in Patient Reported Outcomes Measurement Information System - Depression Short Form (PROMIS-DSF)
timeFrame: Week 8
measure: Change in Self-Efficacy for Managing Chronic Disease (SECD-6)
timeFrame: Week 8
measure: Action Plan Initiation Survey (APIS-5)
timeFrame: Week 8
Secondary outcomes:
measure: Five Facet Mindfulness Questionnaire (FFMQ)
timeFrame: Week 8
measure: Self-Compassion Scale-Short Form (SCS-SF)
timeFrame: Week 8
measure: Difficulty in Emotion Regulation Scale (DERS)
timeFrame: Week 8
measure: Multidimensional Assessment of Interoceptive Awareness (MAIA)
timeFrame: Week 8
measure: Perceived Control Questionnaire (PCQ)
timeFrame: Week 8
measure: Patient Activation Measure (PAM)
timeFrame: Week 8
Other outcomes:
measure: Action Plan Assessment (APA-10)
timeFrame: Week 6
measure: Action Plan Follow-Up Interviews
timeFrame: Week 24
Locations:
city: Somerville
country: United States
facility: Cambridge Health Alliance Center for Mindfulness and Compassion
state: Massachusetts
Study officials:
affiliation: Cambridge Health Alliance
name: Zev D Schuman-Olivier, MD, MD
role: PRINCIPAL_INVESTIGATOR
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