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

Cambridge Health Alliance136 enrolled

Overview

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.

This study builds on a pilot study that investigated the impact of Mindfulness Training for Primary Care on anxiety, depression, stress, and chronic illness self-management in primary care patients receiving care in an urban, community, multi-cultural safety net healthcare system. The current comparative effectiveness randomized controlled trial takes place in a larger sample, and investigates the impact of a refined MTPC curriculum on specific aspects of self-regulation such as action plan initiation, while examining potential mechanisms of change, including self-efficacy, perceived control, mindfulness, self-compassion, emotion regulation, and body awareness. Participants randomized to MTPC are compared with participants who are randomized to a low-dose comparator condition and 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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

136

Conditions

Depression Anxiety Stress Related Disorder Adjustment Disorders

Interventions

Mindfulness Training for Primary CareBEHAVIORAL

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.

60-minute Introduction to MindfulnessBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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, or adjustment disorder related to chronic illness, pain, etc.). Exclusion Criteria: * 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. * Lack of insurance coverage for group psychotherapy may preclude 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.

Locations (1)

Cambridge Health Alliance

Somerville, Massachusetts, United States

Outcomes

Primary Outcomes

Action Plan Initiation Survey (APIS-5)

The Action Plan Initiation Survey (APIS-5) is a 5-item self-report questionnaire adapted from a measure used by Guck et al. Participants are asked to indicate how successful they were in meeting a previously set Action Plan by using a 7-point Likert scale from 1 (Not met at all) to 7 (Totally met), with a score of 5 or above indicating successful initiation of the goal. For each unmet goal, patients are asked to further rate the cause of not meeting the goal by using a 7-point Likert rating scale from 1 (Extremely controllable) to 7 (Not at all controllable). For this outcome we reported the number of participants in each arm who successfully initiated an Action Plan, as indicated by a score of 5 or above in reporting whether they were able to meet their action plan goal.

Time frame: Weeks 8-10

Perceived Stress Scale

The Perceived Stress Scale (PSS) (10 items) measures the degree to which situations in life are stressful. Items are designed to evaluate how overloaded, unpredictable, and uncontrollable one finds one's life. Each item is scored on a 5 point Likert scale from 0 (Never) to 4 (Very often). Scores range from 0-40 with higher scores reflecting worse results (more stress).