MINDFUL-PC: Integrating Mindfulness Into the Patient-Centered Medical Home



Status:Completed
Conditions:Anxiety, Anxiety, Depression
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - Any
Updated:12/14/2018
Start Date:October 2015
End Date:August 30, 2018

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MINDFUL-PC: Integrating Mindfulness Into the Patient-Centered Medical Home - A Pilot Study

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.

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).

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.
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