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

NCT03265600 | Completed Results

• 2 other identifiers: CHA-IRB-1002/08/14_2UH2AT009145
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression; Anxiety; Stress Related Disorder; Adjustment Disorders

Outcome Measures

Primary Outcomes (4)

• 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.

  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).

  Baseline and week 8 (pre to post Intervention)

• 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 Likert scale from 1 (Never) to 5 (Always). The values of the response to each question are summed into a raw score ranging from 8-40. The raw score is then rescaled with use of the PROMIS Assessment Center Scoring Service into a T score, a standardized score with a mean of 50 and a standard deviation (SD) of 10. Higher T-Score reflects worse results (greater symptom severity).

  Baseline and week 8 (pre to post Intervention)

• 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 Likert scale from 1 (Never) to 5 (Always). The values of the response to each question are summed into a raw score ranging from 8-40. The raw score is then rescaled with use of the PROMIS Assessment Center Scoring Service into a T score, a standardized score with a mean of 50 and a standard deviation (SD) of 10. Higher T-Score reflects reflect worse results (greater symptom severity).

  Baseline and week 8 (pre to post Intervention)

Secondary Outcomes (6)

• Five Facet Mindfulness Questionnaire (FFMQ)

  Baseline and week 8 (pre to post Intervention)

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

  Baseline and week 8 (pre to post Intervention)

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

  Baseline and week 8 (pre to post Intervention)

• Perceived Control Questionnaire (PCQ)

  Baseline and week 8 (pre to post Intervention)

• Difficulty in Emotion Regulation Scale (DERS)

  Baseline and week 8 (pre to post Intervention)

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 and allowed to receive behavioral and medical referrals and treatment as usual. All participants complete an action planning protocol during Week 7.

Behavioral: 60-minute Introduction to Mindfulness

Interventions

Mindfulness Training for Primary Care BEHAVIORAL

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.

Mindfulness Training for Primary Care

60-minute Introduction to Mindfulness 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, 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.

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, 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
• National Institutes of Health (NIH): collaborator
• Brown University: collaborator
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

Cambridge Health Alliance

Somerville, Massachusetts, 02143, United States

Location

Related Publications (14)

• 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

• 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

• Sundquist J, Lilja A, Palmer K, Memon AA, Wang X, Johansson LM, Sundquist K. Mindfulness group therapy in primary care patients with depression, anxiety and stress and adjustment disorders: randomised controlled trial. Br J Psychiatry. 2015 Feb;206(2):128-35. doi: 10.1192/bjp.bp.114.150243. Epub 2014 Nov 27.

  PMID: 25431430 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

• 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

• 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

MeSH Terms

Conditions

Depression; Anxiety Disorders; Adjustment Disorders

Interventions

Primary Health Care

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Comprehensive Health Care; Patient Care Management; Health Services Administration

Results Point of Contact

• Title: Dr. Zev Schuman-Olivier
• Organization: Cambridge Health Alliance

zschuman@cha.harvard.edu

617-591-6132

Study Officials

• Zev D Schuman-Olivier, MD

  Cambridge Health Alliance

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

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: August 28, 2017
• First Posted: August 29, 2017
• Study Start: February 1, 2017
• Primary Completion: September 15, 2018
• Study Completion: August 1, 2020
• Last Updated: November 25, 2020
• Results First Posted: December 3, 2019

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)