MINDFUL-PC for Portuguese Speakers Pilot Study 2020

Cambridge Health Alliance

Status: Terminated

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

Treatments: Behavioral: Mindfulness Training for Primary Care

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04268355

CambridgeHA

UH3AT009145 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Mindfulness Training for Primary Care

Experimental group

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

Treatment:

Behavioral: Mindfulness Training for Primary Care