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

Cambridge Health Alliance

Status: Terminated

Conditions: Chronic Illness; Adjustment Disorders; Stress Related Disorder; Depression; Anxiety Disorders

Treatments: Behavioral: Low-Dose Comparator; Behavioral: Mindfulness Training for Primary Care

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03609450

CHA-IRB-1002/08/14_3

UH3AT009145 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 96 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Current CHA patient with an enrolled CHA primary care doctor.
2. CHA patients 18 years of age and older.
3. Able to tolerate and participate in interviews and engage in all procedures.
4. Able to give written consent in English OR willing and able to provide consent and complete assessments through a professional language translator when necessary.
5. Diagnosis eligible to be covered by insurance for group visits (e.g., anxiety disorder, depression, stress disorders including adjustment disorder related to chronic illness, pain, insomnia, etc.).
6. Must have access to a smartphone that is compatible with the activity tracker application.
7. Must be willing to use the smartphone application and/or wear a wristband device every day during the study collection periods
8. Must be able to fill out the study questionnaires daily on a computer or compatible mobile device.
9. Must be willing to attend the two computer task sessions.

Exclusion criteria

1. Any cognitive impairment that precludes informed consent.
2. Patients who, in the opinion of the Principal Investigator, pose an imminent risk of suicide or danger to self or others.
3. Likelihood of potential incarceration such as a conviction or pending charges that may potentially result in imprisonment.
4. Previous enrollment or randomization of treatment in the present study within the 12 months.
5. Behaviors that may cause disruption to a mindfulness group.
6. 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.
7. Refusal of insurance to cover group psychotherapy treatment may lead to exclusion from participation in groups.
8. Patients in their third trimester of pregnancy who foresee conflicts that preclude their commitment to completing all activities.
9. Patients with highly unstable medical problems that put them at a high risk of hospitalization.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

96 participants in 2 patient groups

Mindfulness Training for Primary Care

Active Comparator group

Description:

Mindfulness Training for Primary Care (MTPC) is a primary care adaptation that includes core common Mindfulness-Based Intervention (MBI) elements integrated with novel mindfulness-oriented behavior change elements into a format that is adaptable to delivery in primary care health centers.

Treatment:

Behavioral: Mindfulness Training for Primary Care

Low-Dose Comparator

Other group

Description:

Comparator arm: Participants receive a 60-minute introduction to mindfulness group plus referral to a list of community mindfulness resources such as private-pay community mindfulness classes, mobile mindfulness applications, books, and online recordings. These participants are added to a 6-month wait-list for a Cambridge Health Alliance mindfulness-based intervention group, but are allowed to receive behavioral, psychiatric, and medical treatments that are consistent with treatment as usual. All participants complete an action planning protocol during Week 7.

Treatment:

Behavioral: Low-Dose Comparator