MINDFUL-PC for Portuguese Speakers Pilot Study 2020

NCT04268355 | Terminated DMC

• 2 other identifiers: CambridgeHAUH3AT009145
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The study evaluates the effects of the Mindfulness Training for Primary Care (MTPC) Portuguese-adapted version on heart rate variability during a demanding cognitive task. The study also evaluates the effects on mental health, quality of life, self-regulation and behavior outcomes. The study will also complete the MTPC cultural adaptation process for Brazilian culture.

Conditions

Depression; Anxiety Disorders; Stress Related Disorder; Adjustment Disorders; Chronic Illness

Outcome Measures

Primary Outcomes (1)

• High-Frequency power (HF) - Heart Rate Variability (HRV) during Sustained Attention to Response Task (SART) last 5 minutes

  High-Frequency power (HF) - Heart Rate Variability (HRV) during Sustained Attention to Response Task (SART) last 5 minutes will be measured using Biostamp nPoint® medical device. During SART participants complete a computerized test measuring sustained attention and response inhibition. They are asked to press a key in response to rapidly displayed integers (1-9) and withhold a response to a designated "no-go" integer.

  Week 9

Secondary Outcomes (4)

• Root Mean Square of the Successive Differences (RMSSD) - Heart Rate Variability (HRV) during Sustained Attention to Response Task (SART) last 5 minutes

  Week 9

• Perceived Stress Scale (PSS-14)

  Week 8

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

  Week 8

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

  Week 8

Other Outcomes (10)

• High-Frequency power (HF) - Heart Rate Variability (HRV) during four 5-minute Sustained Attention to Response Task (SART) time blocks

  Week 9

• Root Mean Square of the Successive Differences (RMSSD) - Heart Rate Variability (HRV) during four 5-minute Sustained Attention to Response Task (SART) time blocks

  Week 9

• Action Plan Initiation Survey (APIS-5)

  Week 9

Study Arms (1)

Mindfulness Training for Primary Care

EXPERIMENTAL

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

Interventions

Mindfulness Training for Primary Care BEHAVIORAL

MTPC is a referral-based, insurance-reimbursable 8-week program 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 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 plan during Week 7. Participants are called every two weeks for the first eight weeks for 5-10 minute engagement calls which focus helping participants cultivate a relationship with study staff, giving participants a place to ask questions, and supporting participants in completing study visits.

Mindfulness Training for Primary Care

Eligibility Criteria

• Age: 18 Years - 70 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.
• 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.).
• Must be able to fill out the study questionnaires on a computer or compatible mobile device.
• Must be willing to attend the two computer task sessions.
• Able to give written consent in Portuguese

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.
• 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.
• 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
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

Cambridge Health Alliance

Somerville, Massachusetts, 02143, United States

Location

Related Publications (3)

• 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

• Gawande R, Pine E, Griswold T, Creedon T, Vallejo Z, Rosenbaum E, Lozada A, Schuman-Olivier Z. Insurance-Reimbursable Mindfulness for Safety-Net Primary Care Patients: A Pilot Randomized Controlled Trial. Mindfulness (N Y). 2019 Sep;10(9):1744-1759. doi: 10.1007/s12671-019-01116-8. Epub 2019 Mar 18.

  PMID: 32042349 BACKGROUND

• Trombka M, Creedon TB, Demarzo M, Cuoco LT, Smith L, Oxnard AC, Rozembaque AT, Hirayama MS, Moreno NB, Comeau A, Gawande R, Griswold T, Cook BL, Rocha NS, Schuman-Olivier Z. Mindfulness Training for Primary Care for Portuguese-Speaking Immigrants: A Pilot Study. Front Psychiatry. 2021 Sep 9;12:664381. doi: 10.3389/fpsyt.2021.664381. eCollection 2021.

  PMID: 34566708 DERIVED

MeSH Terms

Conditions

Depression; Anxiety Disorders; Adjustment Disorders; Chronic Disease

Interventions

Primary Health Care

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Trauma and Stressor Related Disorders; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Comprehensive Health Care; Patient Care Management; Health Services Administration

Study Officials

• Zev Schuman-Olivier, MD

  Cambridge Health Alliance

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-arm, pre-post, non-randomized, unblinded pilot trial including up to 36 participants over 2 MTPC group cohorts

Study Record Dates

• First Submitted: February 11, 2020
• First Posted: February 13, 2020
• Study Start: January 21, 2020
• Primary Completion: April 10, 2020
• Study Completion: April 10, 2020
• Last Updated: February 11, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)