N/A
Completed N=4,412
Healthy Mind Healthy You: A Study of Mindfulness
Source: ClinicalTrials.gov NCT03844321 ↗Enrolled (actual)
4,412
Serious AEs
1.4%
Results posted
May 2021
Primary outcomePrimary: Estimated Weekly Change on World Health Organization-5 (WHO-5) — 0.78; 0.76; 0.41; 0.33 estimated weekly change in scale score — p=.820
Summary
Most people experience stress at some point in their lives. Stress, especially when severe, can not only make you feel bad, it can also worsen existing health problems like heart disease, type 2 diabetes, obesity, high blood pressure, depression, and even cancer. Healthy Mind, Healthy You is a new study about how mindfulness can help people cope with stress. Funded by the Patient Centered Outcome Research Institute (PCORI) and involving 19 Patient Powered Research Networks (PPRNs), Healthy Mind Healthy You will be able to study the effects of mindfulness on a wide variety of populations and conditions.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Estimated Weekly Change on World Health Organization-5 (WHO-5) |
0.78; 0.76; 0.41; 0.33 | .820 |
| SECONDARY Estimated Weekly Change on Perceived Stress Scale (PSS) |
-0.13; -0.15; -0.08; -0.07 | .284 |
| SECONDARY Estimated Weekly Change on Patient Reported Outcomes Measurement Information System (PROMIS): Emotional Distress-Depression Short Form |
-0.19; -0.17; -0.11; -0.06 | .431 |
| SECONDARY Estimated Weekly Change on Patient Reported Outcomes Measurement Information System (PROMIS): Emotional Distress-Anxiety Short Form |
-0.12; -0.13; -0.07; -0.05 | .399 |
| SECONDARY Estimated Weekly Change on Patient Reported Outcomes Measurement Information System (PROMIS): Ability to Participate in Social Roles and Activities Short Form |
-0.12; -0.14; -0.05; -0.04 | .488 |
| SECONDARY Estimated Weekly Change on Five Facet Mindfulness Questionnaire (FFMQ) Abbreviated |
0.92; 0.88; 0.43; 0.37 | .469 |
Eligibility Criteria
Inclusion Criteria
- Must be a member (patient/member of special population or caregiver) of one of the 19 PCORI Patient-Powered Research Networks (PPRN)
- Must be age 18 or older
Exclusion Criteria
- Under the age of 18 years
- Unable to read, understand, and/or participate in mindfulness exercises
Data sourced from ClinicalTrials.gov (NCT03844321). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.