MINDFUL-PC for Portuguese Speakers Pilot Study 2020

Stopped early · Not applicable

Conditions studied: Depression, Anxiety Disorders, Stress Related Disorder, Adjustment Disorders, Chronic Illness

In brief

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.

Key facts

Study ID

NCT04268355

Run by

Cambridge Health Alliance

People needed

15

Starts

2020-01-21

Expected to finish

2020-04-10

Last updated by the study team

2021-02-11

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

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.
• 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.

Where it is running

• Cambridge Health Alliance — Somerville, Massachusetts, United States

Full record on ClinicalTrials.gov

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