Clinical trial NCT03609450: Integrating Mindfulness Into the Patient-Centered Medical Home (Phase 3)
Official title: Mindfulness Influences on Self-regulation: Mental and Physical Health Implications -- Integrating Mindfulness Into the Patient-Centered Medical Home (Phase 3)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Depression
Anxiety Disorders
Stress Related Disorder
Adjustment Disorders
Chronic Illness
Lead sponsor: Cambridge Health Alliance
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2018-08-01
Enrollment: 96
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: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Difficulty in Emotion Regulation Scale (DERS)
timeFrame: Week 8
Secondary outcomes:
measure: Multidimensional Assessment of Interoceptive Awareness (MAIA)
timeFrame: Week 8
measure: Sustained Attention to Response Task (SART)
timeFrame: Week 8
measure: Action Plan Initiation Survey (APIS-5)
timeFrame: Weeks 8 - 10
measure: Hypothetical Delay Discounting Task (HDDT)
timeFrame: Week 8
measure: Heart Beat Detection Task (HBDT)
timeFrame: Week 8
measure: Perceived Stress Scale (PSS-14)
timeFrame: Week 8
measure: Five Facet Mindfulness Questionnaire (FFMQ)
timeFrame: Week 8
measure: Self-Compassion Scale-Short Form (SCS-SF)
timeFrame: Week 8
measure: Self-Efficacy for Managing Chronic Disease (SECD-6)
timeFrame: Week 8
measure: Patient Reported Outcomes Measurement Information System - Anxiety Short Form (PROMIS-ASF)
timeFrame: Week 8
measure: Patient Reported Outcomes Measurement Information System - Depression Short Form (PROMIS-DSF)
timeFrame: Week 8
measure: Three Factor Eating Questionnaire -Revised 18 (TFEQ-R18) emotional eating subscale
timeFrame: Week 8
measure: Food, Activity, and Sleep Tracking (FAST) Questionnaire
timeFrame: Weeks 7-8
measure: Mobile Device Accelerometer-Based Activity
timeFrame: Weeks 7-8
Other outcomes:
Locations:
city: Somerville
country: United States
facility: Cambridge Health Alliance
state: Massachusetts
Study officials:
affiliation: Cambridge Health Alliance
name: Zev Schuman-Olivier, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.