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

Depression Clinical Trial

— MINDFUL-PC-2  

Official title:

MINDFUL-PC: Integrating Mindfulness Into the Patient-Centered Medical Home - A Comparative Effectiveness Trial of Chronic Illness Self-Management and Action Plan Initiation Among Primary Care Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03265600
• Other study ID #: CHA-IRB-1002/08/14_2
• Secondary ID: UH2AT009145
• Status: Completed
• Phase: N/A
• Start date: February 1, 2017
• Est. completion date: August 1, 2020

Study information

• Verified date: November 2020
• Source: Cambridge Health Alliance
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This study builds on a pilot study that investigated the impact of Mindfulness Training for Primary Care on anxiety, depression, stress, and chronic illness self-management in primary care patients receiving care in an urban, community, multi-cultural safety net healthcare system. The current comparative effectiveness randomized controlled trial takes place in a larger sample, and investigates the impact of a refined MTPC curriculum on specific aspects of self-regulation such as action plan initiation, while examining potential mechanisms of change, including self-efficacy, perceived control, mindfulness, self-compassion, emotion regulation, and body awareness. Participants randomized to MTPC are compared with participants who are randomized to a low-dose comparator condition and 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 136
• Est. completion date: August 1, 2020
• Est. primary completion date: September 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.).

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Adjustment Disorders
• Anxiety
• Depression
• Disease
• Stress Related Disorder

Intervention

Behavioral:
• Mindfulness Training for Primary Care
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.
• 60-minute Introduction to Mindfulness
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.

Locations

Country	Name	City	State
United States	Cambridge Health Alliance	Somerville	Massachusetts

Sponsors (6)

Lead Sponsor	Collaborator
Cambridge Health Alliance	Brown University, National Center for Complementary and Integrative Health (NCCIH), National Institutes of Health (NIH), The Arnold P. Gold Foundation, The Arthur Vining Davis Foundations

Country where clinical trial is conducted

United States, 

References & Publications (14)

Alegría 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 3:534-41. doi: 10.1007/s11606-009-1074-x. — View Citation

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. — View Citation

Demarzo MM, Montero-Marin J, Cuijpers P, Zabaleta-del-Olmo E, Mahtani KR, Vellinga A, Vicens C, López-del-Hoyo Y, García-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. Review. — View 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. — View Citation

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. Review. — View Citation

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. — View Citation

Hölzel 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. — View Citation

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. — View 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. — View Citation

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

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. — View Citation

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. — View Citation

Sundquist J, Lilja Å, Palmér 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. — View Citation

Wiegner L, Hange D, Björkelund 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. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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)
Primary	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)
Primary	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	Five Facet Mindfulness Questionnaire (FFMQ)	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). Facet scores range from 8-40, with the exception of the nonreactivity facet, which ranges from 7-35. Total scores range from 39-195, with higher scores reflecting higher levels of mindfulness (a better outcome).	Baseline and week 8 (pre to post Intervention)
Secondary	Self-Compassion Scale-Short Form (SCS-SF)	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, with higher scores indicating greater levels of self-compassion.	Baseline and week 8 (pre to post Intervention)
Secondary	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). Higher scores indicate better results (higher levels of self-efficacy).	Baseline and week 8 (pre to post Intervention)
Secondary	Perceived Control Questionnaire (PCQ)	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). Scores range from 5-35, with higher scores indicating better results (greater sense of control).	Baseline and week 8 (pre to post Intervention)
Secondary	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. Participants are asked to rate how often they have emotional dysregulation on a 5-point Likert scale from 1 (almost never [0-10%]) to 5 (almost always [91-100%]). The scale assess 6 aspects of emotional dysregulation: non-acceptance of emotional responses, difficulties engaging in goal directed behavior, impulse control difficulties, lack of emotional awareness (reverse-scored), limited access to emotion regulation strategies, and lack of emotional clarity. Total scores range from 5-180, with higher scores indicating worse results (more difficulty in emotional regulation).	Baseline and week 8 (pre to post Intervention)
Secondary	Multidimensional Assessment of Interoceptive Awareness (MAIA)	The Multidimensional Assessment of Interoceptive Awareness (MAIA) is a 32-item self-report scale designed to assess 8 aspects of interoceptive awareness : noticing, not-distracting, not-worrying, attention regulation, emotional awareness, self-regulation, body listening, and trusting. Participants are asked to rate their awareness of interoceptive experiences on a 6-point Likert scale from 0 (Never) to 5 (Always). Each subscale has 3-7 items, and scores are obtained by reverse coding items 5, 6, 7, 8, 9, and then taking the average of items in each scale. Scores range from 0-5, with higher scores indicating better results (greater interoception).	Baseline and week 8 (pre to post Intervention)