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

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: MINDFUL-PC: Integrating Mindfulness Into the Patient-Centered Medical Home - A Pilot Study

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.


Detailed Summary:

This project aims evaluate the integration of mindfulness training into the heart of the standard healthcare delivery system.

The investigators and collaborators have developed an 8-week mindfulness-based intervention for primary care called Mindfulness Training for Primary Care (MTPC). MTPC combines common Mindfulness-Based Intervention skills with additional attention to patient/provider relationships, cultural and socio-economic diversity, coping with chronic illness, reducing unnecessary medical care, and encouraging self-management skills acquisition.

This project addresses important gaps in the current mindfulness research and delivery system by evaluating the integration of the novel MTPC model into a system of urban, community, multi-cultural, safety-net Patient-Centered Medical Homes.

In this pilot randomized controlled trial, the investigators compare the effectiveness of 8-week MTPC versus a 60-minute introduction to mindfulness plus referral to community mindfulness resources for primary care patients on behavioral health outcomes of anxiety, depression, stress, and self-management of chronic illness. The investigators are also testing the effect of MTPC on rates of initiation and maintenance of health action plans that patients collaborate on with their primary care provider during study Week 6 . This study also enrolls primary care providers who have participated in various levels of mindfulness training, i.e., 16-hour and 8-week mindfulness-based stress reduction and 10-month mindful communication vs. no training.

Outcome assessments are conducted at baseline and study week 8. An action-planning visit with PCPs occurs at week 6 with follow-up during week 8 (initiation) and interview at study week 24 (maintenan
Sponsor: Cambridge Health Alliance

Current Primary Outcome:

  • Change in Perceived Stress Scale [ Time Frame: Week 8 ]
    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).
  • Change in Patient Reported Outcomes Measurement Information System - Anxiety Short Form (PROMIS-ASF) [ Time Frame: Week 8 ]
    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.
  • Change in Patient Reported Outcomes Measurement Information System - Depression Short Form (PROMIS-DSF) [ Time Frame: Week 8 ]
    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).

    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • Five Facet Mindfulness Questionnaire (FFMQ) [ Time Frame: Week 8 ]
      The Five Facet Mindfulness Questionnaire (FFMQ) is a 39-item scale that examines five factors that represent aspects of the current empirical conception of mindfulness. These five facets include: "observing, describing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience." Participants rate their degree of agreement with each of the items on a Likert-type scale ranging from 1 (Never or very rarely true) to 5 (Very often or always true), with higher scores indicating higher experience of mindfulness.
    • Self-Compassion Scale-Short Form (SCS-SF) [ Time Frame: Week 8 ]
      The short-form Self-Compassion Scale (SCS-SF) is an abbreviated 12-item form of the original 26-item Self-Compassion Scale. The scale is scored on a 5 point Likert scale (1 = Almost never; 5 = Almost always), and negative subscale items are reverse scored.
    • Difficulty in Emotion Regulation Scale (DERS) [ Time Frame: Week 8 ]
      The Difficulties in Emotion Regulation (DERS) Scale is a 36-item self-report scale designed to assess emotional dysregulation.
    • Multidimensional Assessment of Interoceptive Awareness (MAIA) [ Time Frame: Week 8 ]
      The Multidimensional Assessment of Interoceptive Awareness (MAIA) is a 32-item self-report scale designed to assess multiple aspects of interoception and interoceptive awareness.
    • Perceived Control Questionnaire (PCQ) [ Time Frame: Week 8 ]
      The Perceived Control Questionnaire (PCQ) is adapted from a 5-item perceived control measure from Jerant et al. and a previously validated survey from Armitage et al. This 5-item scale asks participants to rate their sense of control over chronic illness self-management on a 7-point scale from 1 (None) to 7 (Total).
    • Patient Activation Measure (PAM) [ Time Frame: Week 8 ]
      The Patient Activation Measure (PAM) is a 13-item scale that is designed to evaluate a participant's ability to be an effective and informed manager of his or her own health and health care. Participants are asked to rate their agreement with each statement on a 0-100 metric where 0 = the lowest possible activation and 100 = the highest possible activation as measured by this set of items.


    Original Secondary Outcome: Same as current

    Information By: Cambridge Health Alliance

    Dates:
    Date Received: November 4, 2016
    Date Started: October 2015
    Date Completion: July 2017
    Last Updated: November 22, 2016
    Last Verified: November 2016