Clinical trial NCT03265600: Integrating Mindfulness Into the Patient-Centered Medical Home (Phase 2)
Official title: MINDFUL-PC: Integrating Mindfulness Into the Patient-Centered Medical Home - A Comparative Effectiveness Trial of Chronic Illness Self-Management and Action Plan Initiation Among Primary Care Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Anxiety
Stress Related Disorder
Adjustment Disorders
Lead sponsor: Cambridge Health Alliance
Sponsor class: OTHER
Collaborators: name: The Arthur Vining Davis Foundations
name: The Arnold P. Gold Foundation
name: National Institutes of Health (NIH)
name: Brown University
name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2017-08-29
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two arms, intervention and low-dose comparator, which are randomly assigned at the same time and are implemented in parallel.
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Action Plan Initiation Survey (APIS-5)
timeFrame: Weeks 8-10
measure: Perceived Stress Scale
timeFrame: Baseline and week 8 (pre to post Intervention)
measure: Patient Reported Outcomes Measurement Information System - Anxiety Short Form (PROMIS-ASF)
timeFrame: Baseline and week 8 (pre to post Intervention)
measure: Patient Reported Outcomes Measurement Information System - Depression Short Form (PROMIS-DSF)
timeFrame: Baseline and week 8 (pre to post Intervention)
Secondary outcomes:
measure: Five Facet Mindfulness Questionnaire (FFMQ)
timeFrame: Baseline and week 8 (pre to post Intervention)
measure: Self-Compassion Scale-Short Form (SCS-SF)
timeFrame: Baseline and week 8 (pre to post Intervention)
measure: Change in Self-Efficacy for Managing Chronic Disease (SECD-6)
timeFrame: Baseline and week 8 (pre to post Intervention)
measure: Perceived Control Questionnaire (PCQ)
timeFrame: Baseline and week 8 (pre to post Intervention)
measure: Difficulty in Emotion Regulation Scale (DERS)
timeFrame: Baseline and week 8 (pre to post Intervention)
measure: Multidimensional Assessment of Interoceptive Awareness (MAIA)
timeFrame: Baseline and week 8 (pre to post Intervention)
Other outcomes:
Locations:
city: Somerville
country: United States
facility: Cambridge Health Alliance
state: Massachusetts
Study officials:
affiliation: Cambridge Health Alliance
name: Zev D Schuman-Olivier, MD
role: PRINCIPAL_INVESTIGATOR
References:
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