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MINDFUL-PC for Portuguese Speakers Pilot Study 2020

Primary Purpose

Depression, Anxiety Disorders, Stress Related Disorder

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Mindfulness Training for Primary Care

About this trial

This is an interventional treatment trial for Depression

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Cambridge Health Alliance

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Mindfulness Training for Primary Care

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Root Mean Square of the Successive Differences (RMSSD) - 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.

Perceived Stress Scale (PSS-14)

The Perceived Stress Scale (PSS-14) (14 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).

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 scale from 1 (Never) to 5 (Always).

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 scale from 1 (Never) to 5 (Always).

Full Information

NCT ID

NCT04268355

First Posted

February 11, 2020

Last Updated

February 9, 2021

Sponsor

Cambridge Health Alliance

Collaborators

National Center for Complementary and Integrative Health (NCCIH)

1. Study Identification

Unique Protocol Identification Number

NCT04268355

Brief Title

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

2. Study Status

Record Verification Date

February 2021

Overall Recruitment Status

Terminated

Why Stopped

In order to ensure patients and research staff safety due to COVID-19 pandemic

Study Start Date

January 21, 2020 (Actual)

Primary Completion Date

April 10, 2020 (Actual)

Study Completion Date

April 10, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Cambridge Health Alliance

Collaborators

National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

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

Masking

None (Open Label)

Allocation

N/A

Enrollment

15 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Mindfulness Training for Primary Care

Arm Type

Experimental

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Mindfulness Training for Primary Care

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Description

Time Frame

Week 9

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

Week 9

Title

Perceived Stress Scale (PSS-14)

Description

Time Frame

Week 8

Title

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

Description

Time Frame

Week 8

Title

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

Description

Time Frame

Week 8

Other Pre-specified Outcome Measures:

Title

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

Description

High-Frequency power (HF) - Heart Rate Variability (HRV) during four 5-minute Sustained Attention to Response Task (SART) time blocks 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. Relationship between HF-HRV and SART performance will be evaluated and the effect of over time during the demanding SART task will also be evaluated.

Time Frame

Week 9

Title

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

Description

Root Mean Square of the Successive Differences (RMSSD) - Heart Rate Variability (HRV) during four 5-minute Sustained Attention to Response Task (SART) time blocks 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. Relationship between RMSSD and SART performance will be evaluated and the effect of over time during the demanding SART task will also be evaluated.

Time Frame

Week 9

Title

Action Plan Initiation Survey (APIS-5)

Description

Patient self-reported Action Plan Initiation is based on two-item in the APIS-5 self-report survey in which patients are asked to list their action plan SMART goal, if they met the goal and how much control they had over meeting the goal. The main outcome is a single-item response determining whether they met or did not meet the goal using a 7-point Likert scale (ranging from 1-7) with scores >=5 representing self-reported initiation of the goal.

Time Frame

Week 9

Title

World Health Organization Quality of Life- BREF (WHOQOL-BREF)

Description

The World Health Organization has developed a quality of life instrument, the WHOQOL, which captures many subjective aspects of quality of life. The WHOQOL-BREF is a WHOQOL shorter version, comprises 26 items that produces scores for four domains related to quality of life: physical health, psychological, social relationships and environment. It also includes one facet on overall quality of life and general health.

Time Frame

Week 8

Title

Multidimensional Assessment of Interoceptive Awareness (MAIA)

Description

The Multidimensional Assessment of Interoceptive Awareness (MAIA) is a 32-item self-report scale designed to assess multiple aspects of interoception and interoceptive awareness. The 6 point Likert scale (ranging from 0-6) assesses 8 aspects of interoceptive awareness: noticing, not-distracting, not-worrying, attention regulation, emotional awareness, self-regulation, body listening, and trusting. Subscales are averaged, and a higher total score represents a better outcome.

Time Frame

Week 8

Title

Difficulty in Emotion Regulation Scale (DERS)

Description

The Difficulties in Emotion Regulation (DERS) Scale is a 36-item self-report scale designed to assess emotional dysregulation using a 5 point Likert scale. The scale assesses 6 aspects of emotional dysregulation: non-acceptance of emotional responses, difficulties engaging in goal directed behavior, impulse control difficulties, lack of emotional awareness, limited access to emotion regulation strategies, and lack of emotional clarity. Subscales are summed and a lower total score represents a better outcome.

Time Frame

Week 8

Title

Five Facet Mindfulness Questionnaire (FFMQ)

Description

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.

Time Frame

Week 8

Title

Self-Compassion Scale (SCS)

Description

The Self-Compassion Scale is composed by 26 items measuring six components of self-compassion: self-kindness, self-judgment, common humanity, isolation, mindfulness and over-identification.The items are rated on a five-point response scale ranging from 1 (almost never) to 5 (almost always).

Time Frame

Week 8

Title

Satisfaction Survey

Description

Satisfaction Survey is an 18-item survey contains two parts. First is a series of 12 questions scored on a 5-point Likert scale from 1 (Strongly Disagree/Poor) to 5 (Strongly Agree/Excellent), with statements such as "I found this program helpful." Next is a series of six open-ended questions in which patients enter a written response to statements including "The most important thing I learned during this program."

Time Frame

Week 8

Title

Suggestions Survey

Description

The Suggestions Survey consist of 4 questions focusing on the intervention cultural aspects.

Time Frame

Week 8

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Zev Schuman-Olivier, MD

Organizational Affiliation

Cambridge Health Alliance

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cambridge Health Alliance

City

Somerville

State/Province

Massachusetts

ZIP/Postal Code

02143

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

30511291

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.

Results Reference

background

PubMed Identifier

32042349

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.

Results Reference

background

PubMed Identifier

34566708

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.

Results Reference

derived

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MINDFUL-PC for Portuguese Speakers Pilot Study 2020

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