Integrating Mindfulness Into the Patient-Centered Medical Home (Phase 2)

NCT03265600 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 136

Last updated 2020-11-25

Study results available
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Summary

Among primary care patients, compare the effectiveness of an 8-week mindfulness-based intervention (Mindfulness Training for Primary Care\[MTPC\]) vs. a low-dose mindfulness introduction comparator on self-management of chronic illness and illness-related health behavior action plan initiation, as well as on measures related to anxiety, depression, and stress.

Conditions

Interventions

BEHAVIORAL

Mindfulness Training for Primary Care

MTPC is a referral-based, insurance-reimbursable 8-week program that can be delivered as group psychotherapy by Patient-Centered Medical Home-integrated behavioral clinicians or as an 8-week primary care group visit delivered by a primary care provider. MTPC groups are 2 hours long for 8 weeks with a 7-hour weekend day of silent practice. MTPC emphasizes mindfulness-oriented skills for self-regulation, self-management of chronic illness, and health behavior change. All participants complete an action planning protocol during Week 7.

BEHAVIORAL

60-minute Introduction to Mindfulness

Participants in the low-dose comparator arm receive a 60-minute introduction to mindfulness. Participants are introduced to the definition(s) of mindfulness, brief mindfulness practices, discussion, and an orientation to an 8-week mindfulness group. They are also given a list of leading community, online, print, and smartphone mindfulness resources.

Sponsors & Collaborators

  • The Arthur Vining Davis Foundations

    collaborator UNKNOWN
  • The Arnold P. Gold Foundation

    collaborator OTHER
  • National Institutes of Health (NIH)

    collaborator NIH
  • Brown University

    collaborator OTHER
  • National Center for Complementary and Integrative Health (NCCIH)

    collaborator NIH
  • Cambridge Health Alliance

    lead OTHER

Principal Investigators

  • Zev D Schuman-Olivier, MD · Cambridge Health Alliance

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-01
Primary Completion
2018-09-15
Completion
2020-08-01

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03265600 on ClinicalTrials.gov