Integrating Mindfulness Into the Patient-Centered Medical Home (Phase 2)
NCT03265600 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 136
Last updated 2020-11-25
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
- Depression
- Anxiety
- Stress Related Disorder
- Adjustment Disorders
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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