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

Depression Clinical Trial

Official title: Mindfulness Influences on Self-regulation: Mental and Physical Health Implications -- Integrating Mindfulness Into the Patient-Centered Medical Home (Phase 3)

Status Terminated

Clinical Trial Summary

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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Adjustment Disorders
• Anxiety Disorders
• Chronic Disease
• Chronic Illness
• Depression
• Disease
• Stress Related Disorder

• NCT number: NCT03609450
• Study type: Interventional
• Source: Cambridge Health Alliance
• Status: Terminated
• Phase: N/A
• Start date: January 30, 2019
• Completion date: August 1, 2020