Clinical trial NCT04268355: MINDFUL-PC for Portuguese Speakers Pilot Study 2020
Official title: MINDFUL-PC for Portuguese Speakers Pilot #2 Study 2020 (Integrating Mindfulness Into the Patient-Centered Medical Home)
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: 2020-02-13
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single-arm, pre-post, non-randomized, unblinded pilot trial including up to 36 participants over 2 MTPC group cohorts
Primary purpose: TREATMENT

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.

Detailed description: This single-arm, pre-post, non-randomized, unblinded, pilot trial evaluates the effects of Mindfulness Training for Primary Care (MTPC) Portuguese-adapted version on heart rate variability during a demanding cognitive task, i.e., Sustained Attention to Response Task (SART). Secondary aims are the following: 1) to measure pre/post outcomes for a) mental health (anxiety, depression, stress); b) quality of life; c) self-regulation (self-compassion, mindfulness, interoceptive awareness, difficulties in emotion regulation); and to determine the rate of d) chronic disease self-management action plan initiation; and 2) to complete the MTPC cultural adaptation for Brazilian culture through a) Satisfaction and Suggestions Survey; and b) Interviews of MTPC Group Leaders about their experience teaching the program Portuguese-adapted version.

Eligibility criteria: 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.
* 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

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.
* 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.
* Refusal of insurance to cover group psychotherapy treatment may lead to exclusion from 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.

Primary outcomes:
measure: High-Frequency power (HF) - Heart Rate Variability (HRV) during Sustained Attention to Response Task (SART) last 5 minutes
timeFrame: Week 9
Secondary outcomes:
measure: Root Mean Square of the Successive Differences (RMSSD) - Heart Rate Variability (HRV) during Sustained Attention to Response Task (SART) last 5 minutes
timeFrame: Week 9
measure: Perceived Stress Scale (PSS-14)
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
Other outcomes:
measure: High-Frequency power (HF) - Heart Rate Variability (HRV) during four 5-minute Sustained Attention to Response Task (SART) time blocks
timeFrame: Week 9
measure: Root Mean Square of the Successive Differences (RMSSD) - Heart Rate Variability (HRV) during four 5-minute Sustained Attention to Response Task (SART) time blocks
timeFrame: Week 9
measure: Action Plan Initiation Survey (APIS-5)
timeFrame: Week 9
measure: World Health Organization Quality of Life- BREF (WHOQOL-BREF)
timeFrame: Week 8
measure: Multidimensional Assessment of Interoceptive Awareness (MAIA)
timeFrame: Week 8
measure: Difficulty in Emotion Regulation Scale (DERS)
timeFrame: Week 8
measure: Five Facet Mindfulness Questionnaire (FFMQ)
timeFrame: Week 8
measure: Self-Compassion Scale (SCS)
timeFrame: Week 8
measure: Satisfaction Survey
timeFrame: Week 8
measure: Suggestions Survey
timeFrame: Week 8
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: 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.
citation: 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.
citation: 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.