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

Stopped early · Not applicable

Conditions studied: Depression, Anxiety Disorders, Stress Related Disorder, Adjustment Disorders, Chronic Illness

In brief

This study compares the effectiveness of an 8-week mindfulness-based intervention (Mindfulness Training for Primary Care\[MTPC\]) vs. a low-dose mindfulness comparator on self-regulation targets, specifically the primary outcome of emotion regulation. Secondary outcomes include sustained attention/response inhibition and interoceptive awareness. A secondary analysis will investigate the extent to which these self-regulation targets mediate the impact of MTPC group on action plan initiation.

Key facts

Study ID

NCT03609450

Run by

Cambridge Health Alliance

People needed

96

Starts

2019-01-30

Expected to finish

2020-08-01

Last updated by the study team

2020-11-20

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, stress disorders including adjustment disorder related to chronic illness, pain, insomnia, etc.).
• Must have access to a smartphone that is compatible with the activity tracker application.
• Must be willing to use the smartphone application and/or wear a wristband device every day during the study collection periods
• Must be able to fill out the study questionnaires daily on a computer or compatible mobile device.
• Must be willing to attend the two computer task sessions.

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.
• Refusal of insurance to cover group psychotherapy treatment may lead to exclusion from 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 — Somerville, Massachusetts, United States

Full record on ClinicalTrials.gov

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