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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
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.
Cambridge Health Alliance
Somerville, Massachusetts, United States
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.
Time frame: Week 9
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.
Time frame: Week 9
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).
Time frame: Week 8
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).
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Time frame: Week 8
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).
Time frame: Week 8