MINDFUL-PC for Portuguese Speakers Pilot Study 2020

Clinical Trial ID: NCT04268355

Description

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.

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.


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.

  • Start Date

    2020-01-21

  • Last Updated

    2020-02-11

  • Sponsor

    National Center for Complementary and Integrative Health (NCCIH)

  • Condition Name

    Anxiety Disorders

Learn about this trial.

Check the eligibility requirements, study details, and more.

Related Trials

Different trials target different symptoms, condition types, and patients. Learn more about other emergeing treatments being investigated now.