Integrating Mindfulness Into the Patient-Centered Medical Home (Phase 3)

The current Phase 3 comparative effectiveness randomized controlled trial examines impact of
MTPC on specific mechanisms of change such as emotion regulation (primary outcome),
interoceptive awareness and sustained attention/response inhibition (secondary outcomes).
This study will also investigate the extent to which these self-regulation targets mediate
the impact of MTPC group on action plan initiation. Participants randomized to 8-week MTPC
are compared with participants randomized to a low-dose mindfulness comparator condition, in
which they 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.
This study builds on the Phase 2 study, which demonstrated that Mindfulness Training for
Primary Care enhanced chronic illness self-management action plan initiation among primary
care patients receiving care in an urban, community, multi-cultural safety net healthcare
system.

Inclusion Criteria:

1. Current CHA patient with an enrolled CHA primary care doctor.

2. CHA patients 18 years of age and older.

3. Able to tolerate and participate in interviews and engage in all procedures.

4. Able to give written consent in English OR willing and able to provide consent and
complete assessments through a professional language translator when necessary.

5. Diagnosis eligible to be covered by insurance for group visits (e.g., anxiety
disorder, depression, stress disorders including adjustment disorder related to
chronic illness, pain, insomnia, etc.).

6. Must have access to a smartphone that is compatible with the activity tracker
application.

7. Must be willing to use the smartphone application and/or wear a wristband device every
day during the study collection periods

8. Must be able to fill out the study questionnaires daily on a computer or compatible
mobile device.

9. Must be willing to attend the two computer task sessions.

Exclusion Criteria:

1. Any cognitive impairment that precludes informed consent.

2. Patients who, in the opinion of the Principal Investigator, pose an imminent risk of
suicide or danger to self or others.

3. Likelihood of potential incarceration such as a conviction or pending charges that may
potentially result in imprisonment.

4. Previous enrollment or randomization of treatment in the present study within the 12
months.

5. Behaviors that may cause disruption to a mindfulness group.

6. 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.

7. Refusal of insurance to cover group psychotherapy treatment may lead to exclusion from
participation in groups.

8. Patients in their third trimester of pregnancy who foresee conflicts that preclude
their commitment to completing all activities.

9. Patients with highly unstable medical problems that put them at a high risk of
hospitalization.