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



Status:Active, not recruiting
Conditions:Anxiety, Anxiety, Depression, Depression
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - Any
Updated:2/6/2019
Start Date:February 1, 2017
End Date:July 30, 2020

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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

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.

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.

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.
We found this trial at
1
site
Somerville, Massachusetts 02144
Principal Investigator: Zev D Schuman-Olivier, MD
Phone: 617-591-6055
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from
Somerville, MA
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