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

NCT03609450 | Terminated DMC

• 2 other identifiers: CHA-IRB-1002/08/14_3UH3AT009145
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Difficulty in Emotion Regulation Scale (DERS)

  The Difficulties in Emotion Regulation (DERS) Scale is a 36-item self-report scale designed to assess emotional dysregulation using a 5 point Likert scale. The scale assesses 6 aspects of emotional dysregulation: non-acceptance of emotional responses, difficulties engaging in goal directed behavior, impulse control difficulties, lack of emotional awareness, limited access to emotion regulation strategies, and lack of emotional clarity. Subscales are summed and a lower total score represents a better outcome.

  Week 8

Secondary Outcomes (14)

• Multidimensional Assessment of Interoceptive Awareness (MAIA)

  Week 8

• Sustained Attention to Response Task (SART)

  Week 8

• Action Plan Initiation Survey (APIS-5)

  Weeks 8 - 10

• Hypothetical Delay Discounting Task (HDDT)

  Week 8

• Heart Beat Detection Task (HBDT)

  Week 8

Study Arms (2)

Mindfulness Training for Primary Care

ACTIVE COMPARATOR

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.

Behavioral: Mindfulness Training for Primary Care

Low-Dose Comparator

OTHER

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.

Behavioral: Low-Dose Comparator

Interventions

Mindfulness Training for Primary Care BEHAVIORAL

MTPC is a referral-based, insurance-reimbursable 8-week program 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 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 plan during Week 7. Participants are called every two weeks for the first eight weeks for 5-10 minute engagement calls which focus helping participants cultivate a relationship with study staff, giving participants a place to ask questions, and supporting participants in completing study visits.

Mindfulness Training for Primary Care

Low-Dose Comparator BEHAVIORAL

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, and discussion. They are also given a list of leading community, online, print, and smartphone mindfulness resources. Participants are called every two weeks for the first eight weeks for 5-10 minute engagement calls which focus helping participants cultivate a relationship with study staff, giving participants a place to ask questions, and supporting participants in completing study visits.

Low-Dose Comparator

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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, stress disorders including adjustment disorder related to chronic illness, pain, insomnia, etc.).
• Must have access to a smartphone that is compatible with the activity tracker application.
• Must be willing to use the smartphone application and/or wear a wristband device every day during the study collection periods
• Must be able to fill out the study questionnaires daily on a computer or compatible mobile device.
• Must be willing to attend the two computer task sessions.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Cambridge Health Alliance: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

Cambridge Health Alliance

Somerville, Massachusetts, 02143, United States

Location

Related Publications (11)

• Demarzo MM, Montero-Marin J, Cuijpers P, Zabaleta-del-Olmo E, Mahtani KR, Vellinga A, Vicens C, Lopez-del-Hoyo Y, Garcia-Campayo J. The Efficacy of Mindfulness-Based Interventions in Primary Care: A Meta-Analytic Review. Ann Fam Med. 2015 Nov;13(6):573-82. doi: 10.1370/afm.1863.

  PMID: 26553897 BACKGROUND

• Loucks EB, Schuman-Olivier Z, Britton WB, Fresco DM, Desbordes G, Brewer JA, Fulwiler C. Mindfulness and Cardiovascular Disease Risk: State of the Evidence, Plausible Mechanisms, and Theoretical Framework. Curr Cardiol Rep. 2015 Dec;17(12):112. doi: 10.1007/s11886-015-0668-7.

  PMID: 26482755 BACKGROUND

• Guendelman S, Medeiros S, Rampes H. Mindfulness and Emotion Regulation: Insights from Neurobiological, Psychological, and Clinical Studies. Front Psychol. 2017 Mar 6;8:220. doi: 10.3389/fpsyg.2017.00220. eCollection 2017.

  PMID: 28321194 BACKGROUND

• Farb NA, Anderson AK, Segal ZV. The mindful brain and emotion regulation in mood disorders. Can J Psychiatry. 2012 Feb;57(2):70-7. doi: 10.1177/070674371205700203.

  PMID: 22340146 BACKGROUND

• Holzel BK, Lazar SW, Gard T, Schuman-Olivier Z, Vago DR, Ott U. How Does Mindfulness Meditation Work? Proposing Mechanisms of Action From a Conceptual and Neural Perspective. Perspect Psychol Sci. 2011 Nov;6(6):537-59. doi: 10.1177/1745691611419671.

  PMID: 26168376 BACKGROUND

• Mccubbin T, Dimidjian S, Kempe K, Glassey MS, Ross C, Beck A. Mindfulness-based stress reduction in an integrated care delivery system: one-year impacts on patient-centered outcomes and health care utilization. Perm J. 2014 Fall;18(4):4-9. doi: 10.7812/TPP/14-014.

  PMID: 25662520 BACKGROUND

• Hallion LS, Steinman SA, Tolin DF, Diefenbach GJ. Psychometric Properties of the Difficulties in Emotion Regulation Scale (DERS) and Its Short Forms in Adults With Emotional Disorders. Front Psychol. 2018 Apr 19;9:539. doi: 10.3389/fpsyg.2018.00539. eCollection 2018.

  PMID: 29725312 BACKGROUND

• Mehling WE, Price C, Daubenmier JJ, Acree M, Bartmess E, Stewart A. The Multidimensional Assessment of Interoceptive Awareness (MAIA). PLoS One. 2012;7(11):e48230. doi: 10.1371/journal.pone.0048230. Epub 2012 Nov 1.

  PMID: 23133619 BACKGROUND

• Jha AP, Morrison AB, Dainer-Best J, Parker S, Rostrup N, Stanley EA. Minds "at attention": mindfulness training curbs attentional lapses in military cohorts. PLoS One. 2015 Feb 11;10(2):e0116889. doi: 10.1371/journal.pone.0116889. eCollection 2015.

  PMID: 25671579 BACKGROUND

• Gawande R, To MN, Pine E, Griswold T, Creedon TB, Brunel A, Lozada A, Loucks EB, Schuman-Olivier Z. Mindfulness Training Enhances Self-Regulation and Facilitates Health Behavior Change for Primary Care Patients: a Randomized Controlled Trial. J Gen Intern Med. 2019 Feb;34(2):293-302. doi: 10.1007/s11606-018-4739-5. Epub 2018 Dec 3.

  PMID: 30511291 BACKGROUND

• Gawande R, Smith L, Comeau A, Creedon TB, Wilson CL, Griswold T, Cook BL, Loucks EB, Schuman-Olivier Z. Impact of warm mindfulness on emotion regulation: A randomized controlled effectiveness trial. Health Psychol. 2023 Oct;42(10):699-711. doi: 10.1037/hea0001303. Epub 2023 Jul 6.

  PMID: 37410421 DERIVED

MeSH Terms

Conditions

Depression; Anxiety Disorders; Adjustment Disorders; Chronic Disease

Interventions

Primary Health Care

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Trauma and Stressor Related Disorders; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Comprehensive Health Care; Patient Care Management; Health Services Administration

Study Officials

• Zev Schuman-Olivier, MD

  Cambridge Health Alliance

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two arms, intervention and low-dose comparator, which are randomly assigned at the same time and are implemented in parallel.

Study Record Dates

• First Submitted: July 25, 2018
• First Posted: August 1, 2018
• Study Start: January 30, 2019
• Primary Completion: April 15, 2020
• Study Completion: August 1, 2020
• Last Updated: November 20, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)