MINDFUL-PC: Integrating Mindfulness Into the Patient-Centered Medical Home

NCT02972203 | Completed

• 1 other identifier: IRB number: CHA-IRB-1002/08/14
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

Brief Summary

Specific aims for this pilot study are: (Behavioral health outcomes aim): Among primary care patients, compare the effectiveness of an 8-week mindfulness-based intervention (Mindfulness Training for Primary Care\[MTPC\]) vs. a 60-minute introduction to mindfulness plus referral to community resources on measures related to anxiety, depression, and stress, and self-management of chronic illness. (Medical Regimen Adherence Aim): Among primary care patients, compare the effectiveness of MTPC vs. 60-minute introduction to mindfulness on the initiation and maintenance of an action plan. (Patient-Provider Relationship Aim): To examine the effects of level of primary care provider mindfulness training on successful referral to program, patient-provider relationship measures, and on patient action plan initiation and maintenance.

Conditions

Depression; Anxiety; Stress Related Disorder; Adjustment Disorder

Keywords

Mindfulness; primary care; self-control; self-regulation; adherence

Outcome Measures

Primary Outcomes (5)

• Change in 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).

  Week 8

• Change in Patient Reported Outcomes Measurement Information System - Anxiety Short Form (PROMIS-ASF)

  The Patient Reported Outcomes Measurement Information System - Anxiety Short Form 8a (PROMIS-ASF) is an 8-item scale used to assess patient-reported health status for anxiety. PROMIS instruments are funded by the National Institutes of Health (NIH) and used to reliably and validly measure patient-reported outcomes for clinical research and practice. Participants are asked to rate their experience of the item in the past seven days on a 5-point scale from 1 (Never) to 5 (Always). Ratings from baseline will be compared to ratings from 8 Weeks post-baseline.

  Week 8

• Change in Patient Reported Outcomes Measurement Information System - Depression Short Form (PROMIS-DSF)

  The Patient Reported Outcomes Measurement Information System - Depression Short Form 8a (PROMIS-DSF) is an 8-item scale used to assess patient-reported health status for depression. PROMIS instruments are funded by the National Institutes of Health (NIH) and used to reliably and validly measure patient-reported outcomes for clinical research and practice. Participants are asked to rate their experience of the item in the past seven days on a 5-point scale from 1 (Never) to 5 (Always). Ratings from baseline will be compared to ratings from 8 Weeks post-baseline.

  Week 8

• Change in Self-Efficacy for Managing Chronic Disease (SECD-6)

  The Self-Efficacy for Managing Chronic Disease Scale (SECD-6) is a 6-item scale that is used to evaluate a participant's ability to self-manage care for a chronic disease. SECD-6 asks participants to rate their confidence in their own ability to do certain activities, on a scale from 1 (not at all confident) to 10 (totally confident).

  Week 8

• Action Plan Initiation Survey (APIS-5)

  Patient self-reported Action Plan Initiation Survey (APIS-5) will be administered at post-treatment (PT Study Week 8). This 5-item questionnaire is adapted from a measure used by Guck et al. In this questionnaire, patients are asked to list their action plan goals generated with their PCP, and determine whether they met or did not meet each goal. For each unmet goal, patients are asked to rate the cause of not meeting the goal on an attributional rating scale using a 7-point format.

  Week 8

Secondary Outcomes (6)

• Five Facet Mindfulness Questionnaire (FFMQ)

  Week 8

• Self-Compassion Scale-Short Form (SCS-SF)

  Week 8

• Difficulty in Emotion Regulation Scale (DERS)

  Week 8

• Multidimensional Assessment of Interoceptive Awareness (MAIA)

  Week 8

• Perceived Control Questionnaire (PCQ)

  Week 8

Other Outcomes (2)

• Action Plan Assessment (APA-10)

  Week 6

• Action Plan Follow-Up Interviews

  Week 24

Study Arms (2)

Mindfulness Training for Primary Care

EXPERIMENTAL

• Mindfulness Training for Primary Care (MPTC) is a primary care adaptation that includes core common Mindfulness-Based Intervention (MBI) elements. MTPC is a referral-based, insurance-reimbursable 8-week group psychotherapy delivered primarily by Patient-Centered Medical Home-integrated behavioral clinicians. MTPC groups are 2 hours long for 8 weeks, with a 7-hour day of silent group practice on a weekend. MTPC also emphasizes psychoeducational skills for self-regulation including a collaborative primary care provider (PCP) action-planning appointment during week 6.

Behavioral: Mindfulness Training for Primary Care

Mindfulness Intro. +resources +waitlist

ACTIVE COMPARATOR

Control 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 waitlist for a Cambridge Health Alliance (CHA) mindfulness-based intervention group. All participants are scheduled to meet with their primary care provider during week 6 for a collaborative action planning visit.

Behavioral: Mindfulness Intro. +resources +waitlist

Interventions

Mindfulness Training for Primary Care BEHAVIORAL

• MPTC is a primary care adaptation that includes core common Mindfulness-Based Intervention (MBI) elements. MTPC is a referral-based, insurance-reimbursable 8-week group psychotherapy delivered primarily by Patient-Centered Medical Home-integrated behavioral clinicians. MTPC groups are 2 hours long for 8 weeks, with a 7-hour day of silent group practice on a weekend. MTPC also emphasizes psychoeducational skills for self-regulation including a collaborative primary care provider (PCP) action-planning appointment during week 6.

Mindfulness Training for Primary Care

Mindfulness Intro. +resources +waitlist BEHAVIORAL

Control 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 waitlist for a Cambridge Health Alliance mindfulness-based intervention group. All participants are scheduled to meet with their primary care provider during week 6 for a collaborative action planning visit.

Also known as: 6-month waitlist

Mindfulness Intro. +resources +waitlist

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, or adjustment disorder related to chronic illness, pain, etc.).

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.
• 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.

Sponsors & Collaborators

• Cambridge Health Alliance: lead
• The Arthur Vining Davis Foundations: collaborator
• The Arnold P. Gold Foundation: collaborator

Study Sites (1)

Cambridge Health Alliance Center for Mindfulness and Compassion

Somerville, Massachusetts, 02143, United States

Location

Related Publications (12)

• 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

• Merkes M. Mindfulness-based stress reduction for people with chronic diseases. Aust J Prim Health. 2010;16(3):200-10. doi: 10.1071/PY09063.

  PMID: 20815988 BACKGROUND

• Goyal M, Singh S, Sibinga EM, Gould NF, Rowland-Seymour A, Sharma R, Berger Z, Sleicher D, Maron DD, Shihab HM, Ranasinghe PD, Linn S, Saha S, Bass EB, Haythornthwaite JA. Meditation programs for psychological stress and well-being: a systematic review and meta-analysis. JAMA Intern Med. 2014 Mar;174(3):357-68. doi: 10.1001/jamainternmed.2013.13018.

  PMID: 24395196 BACKGROUND

• Hofmann SG, Sawyer AT, Witt AA, Oh D. The effect of mindfulness-based therapy on anxiety and depression: A meta-analytic review. J Consult Clin Psychol. 2010 Apr;78(2):169-83. doi: 10.1037/a0018555.

  PMID: 20350028 BACKGROUND

• Chiesa A, Serretti A. Mindfulness based cognitive therapy for psychiatric disorders: a systematic review and meta-analysis. Psychiatry Res. 2011 May 30;187(3):441-53. doi: 10.1016/j.psychres.2010.08.011. Epub 2010 Sep 16.

  PMID: 20846726 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

• Lorig KR, Sobel DS, Ritter PL, Laurent D, Hobbs M. Effect of a self-management program on patients with chronic disease. Eff Clin Pract. 2001 Nov-Dec;4(6):256-62.

  PMID: 11769298 BACKGROUND

• Schuman-Olivier Z, Hoeppner BB, Evins AE, Brewer JA. Finding the right match: mindfulness training may potentiate the therapeutic effect of nonjudgment of inner experience on smoking cessation. Subst Use Misuse. 2014 Apr;49(5):586-94. doi: 10.3109/10826084.2014.850254.

  PMID: 24611853 BACKGROUND

• Alegria M, Sribney W, Perez D, Laderman M, Keefe K. The role of patient activation on patient-provider communication and quality of care for US and foreign born Latino patients. J Gen Intern Med. 2009 Nov;24 Suppl 3(Suppl 3):534-41. doi: 10.1007/s11606-009-1074-x.

  PMID: 19842003 BACKGROUND

• Neff KD, Germer CK. A pilot study and randomized controlled trial of the mindful self-compassion program. J Clin Psychol. 2013 Jan;69(1):28-44. doi: 10.1002/jclp.21923. Epub 2012 Oct 15.

  PMID: 23070875 BACKGROUND

• Wiegner L, Hange D, Bjorkelund C, Ahlborg G Jr. Prevalence of perceived stress and associations to symptoms of exhaustion, depression and anxiety in a working age population seeking primary care--an observational study. BMC Fam Pract. 2015 Mar 19;16:38. doi: 10.1186/s12875-015-0252-7.

  PMID: 25880219 BACKGROUND

• Benzo RP. Mindfulness and motivational interviewing: two candidate methods for promoting self-management. Chron Respir Dis. 2013 Aug;10(3):175-82. doi: 10.1177/1479972313497372.

  PMID: 23897933 BACKGROUND

MeSH Terms

Conditions

Depression; Anxiety Disorders; Adjustment Disorders; Self-Control

Interventions

Primary Health Care; Waiting Lists

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Trauma and Stressor Related Disorders; Social Behavior

Intervention Hierarchy (Ancestors)

Comprehensive Health Care; Patient Care Management; Health Services Administration; Appointments and Schedules; Organization and Administration

Study Officials

• Zev D Schuman-Olivier, MD, 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: PRINCIPAL INVESTIGATOR
• PI Title: Research Director, Center for Mindfulness and Compassion

Study Record Dates

• First Submitted: November 4, 2016
• First Posted: November 23, 2016
• Study Start: October 1, 2015
• Primary Completion: August 30, 2018
• Study Completion: August 30, 2018
• Last Updated: December 12, 2018

Record last verified: 2018-12

Locations

US (1)