MINDFUL-PC for Portuguese Speakers Pilot Study 2020

  • STATUS
    Recruiting
  • participants needed
    36
  • sponsor
    Cambridge Health Alliance
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Updated on 16 February 2024
See if I qualify
anxiety
insomnia
depression
chronic disease
traumatic stress disorder
adjustment disorder
stress disorders

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.

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.

Details
Condition Endogenous depression, Depression, Depression, Adjustment Disorder, Chronic disease, ANXIETY NEUROSIS, Stress Related Disorder
Age 18years - 70years
Treatment Mindfulness Training for Primary Care
Clinical Study IdentifierNCT04268355
SponsorCambridge Health Alliance
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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