Clinical trial NCT03844321: Healthy Mind Healthy You: A Study of Mindfulness
Official title: Healthy Mind Healthy You: A Study of Mindfulness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: University of South Florida
name: Global Healthy Living Foundation
name: University of North Carolina
name: University of California, Los Angeles
name: Genetic Alliance
name: COPD Foundation
name: The Duchenne Registry
name: University of California, San Francisco
name: Children's Hospital Medical Center, Cincinnati
name: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
name: Accelerated Cure Project for Multiple Sclerosis
name: Mayo Clinic
name: Phelan-McDermid Syndrome Foundation
name: Immune Deficiency Foundation
name: Brigham and Women's Hospital
name: University of Pennsylvania
First posted: 2019-02-18
Enrollment: 4412
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


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

Primary outcomes:
measure: Estimated Weekly Change on World Health Organization-5 (WHO-5)
timeFrame: Baseline to 8 Weeks, Baseline to 20 Weeks
Secondary outcomes:
measure: Estimated Weekly Change on Perceived Stress Scale (PSS)
timeFrame: Baseline to 8 Weeks, Baseline to 20 Weeks
measure: Estimated Weekly Change on Patient Reported Outcomes Measurement Information System (PROMIS): Emotional Distress-Depression Short Form
timeFrame: Baseline to 8 Weeks, Baseline to 20 Weeks
measure: Estimated Weekly Change on Patient Reported Outcomes Measurement Information System (PROMIS): Emotional Distress-Anxiety Short Form
timeFrame: Baseline to 8 Weeks, Baseline to 20 Weeks
measure: Estimated Weekly Change on Patient Reported Outcomes Measurement Information System (PROMIS): Ability to Participate in Social Roles and Activities Short Form
timeFrame: Baseline to 8 Weeks, Baseline to 20 Weeks
measure: Estimated Weekly Change on Five Facet Mindfulness Questionnaire (FFMQ) Abbreviated
timeFrame: Baseline to 8 Weeks, Baseline to 20 Weeks
Other outcomes:
measure: Estimated Weekly Change in World Health Organization-5 (WHO-5) Stratified by Age
timeFrame: Baseline to 8 Weeks, Baseline to 20 Weeks
measure: Estimated Weekly Change in World Health Organization-5 (WHO-5) Stratified by Baseline Perceived Stress Scale (PSS)
timeFrame: Baseline to 8 Weeks, Baseline to 20 Weeks
measure: Estimated Weekly Change in World Health Organization-5 (WHO-5) Stratified by Baseline Patient Reported Outcomes Measurement Information System (PROMIS): Emotional Distress-Depression Short Form (PROMIS: EDD)
timeFrame: Baseline to 8 Weeks, Baseline to 20 Weeks
measure: Estimated Weekly Change in World Health Organization-5 (WHO-5) Stratified by Baseline Patient Reported Outcomes Measurement Information System (PROMIS): Emotional Distress-Anxiety Short Form (PROMIS: EDA)
timeFrame: Baseline to 8 Weeks, Baseline to 20 Weeks
measure: Estimated Weekly Change in World Health Organization-5 (WHO-5) Stratified by Baseline Patient Reported Outcomes Measurement Information System (PROMIS): Ability to Participate in Social Roles and Activities Short Form (PROMIS: APRA)
timeFrame: Baseline to 8 Weeks, Baseline to 20 Weeks
measure: Estimated Weekly Change in World Health Organization-5 (WHO-5) Stratified by Baseline Five Facet Mindfulness Questionnaire (FFMQ) Abbreviated
timeFrame: Baseline to 8 Weeks, Baseline to 20 Weeks
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Andrew A Nierenberg, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sylvia LG, Lunn MR, Obedin-Maliver J, McBurney RN, Nowell WB, Nosheny RL, Mularski RA, Long MD, Merkel PA, Pletcher MJ, Tovey RE, Scalchunes C, Sutphen R, Martin AS, Horn EJ, O'Boyle M, Pitch L, Seid M, Redline S, Greenebaum S, George N, French NJ, Faria CM, Puvanich N, Rabideau DJ, Selvaggi CA, Yu C, Faraone SV, Venkatachalam S, McCall D, Terry SF, Deckersbach T, Nierenberg AA. Web-Based Mindfulness-Based Interventions for Well-being: Randomized Comparative Effectiveness Trial. J Med Internet Res. 2022 Sep 12;24(9):e35620. doi: 10.2196/35620.