Last updated on June 2019

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


Brief description of study

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.

Detailed Study Description

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.

Clinical Study Identifier: NCT03609450

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Cambridge Health Alliance

Somerville, MA United States
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Recruitment Status: Open


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