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

Completed · Not applicable

Conditions studied: Depression, Anxiety, Stress Related Disorder, Adjustment Disorder

In brief

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.

Key facts

Study ID

NCT02972203

Run by

Cambridge Health Alliance

People needed

87

Starts

2015-10-01

Expected to finish

2018-08-30

Last updated by the study team

2018-12-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.).

You may not qualify if…

• 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.

Where it is running

• Cambridge Health Alliance Center for Mindfulness and Compassion — Somerville, Massachusetts, United States

Full record on ClinicalTrials.gov

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