NCT03844321

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,412

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 31, 2017

Completed
1.3 years until next milestone

First Posted

Study publicly available on registry

February 18, 2019

Completed
9 days until next milestone

Study Start

First participant enrolled

February 27, 2019

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 19, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 19, 2020

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

May 13, 2021

Completed
Last Updated

May 13, 2021

Status Verified

April 1, 2021

Enrollment Period

12 months

First QC Date

October 31, 2017

Results QC Date

September 15, 2020

Last Update Submit

April 19, 2021

Conditions

Stress

Outcome Measures

Primary Outcomes (1)

  • Estimated Weekly Change on World Health Organization-5 (WHO-5)

    The WHO-5 is a 5-item questionnaire that assesses well-being over the prior two weeks. Scores range 0-100 with higher scores reflecting greater well-being. We used linear mixed effects models to examine the effect of the interventions on weekly WHO-5 scores. Change = estimated average weekly change during time frame.

    Baseline to 8 Weeks, Baseline to 20 Weeks

Secondary Outcomes (5)

  • Estimated Weekly Change on Perceived Stress Scale (PSS)

    Baseline to 8 Weeks, Baseline to 20 Weeks

  • Estimated Weekly Change on Patient Reported Outcomes Measurement Information System (PROMIS): Emotional Distress-Depression Short Form

    Baseline to 8 Weeks, Baseline to 20 Weeks

  • Estimated Weekly Change on Patient Reported Outcomes Measurement Information System (PROMIS): Emotional Distress-Anxiety Short Form

    Baseline to 8 Weeks, Baseline to 20 Weeks

  • Estimated Weekly Change on Patient Reported Outcomes Measurement Information System (PROMIS): Ability to Participate in Social Roles and Activities Short Form

    Baseline to 8 Weeks, Baseline to 20 Weeks

  • Estimated Weekly Change on Five Facet Mindfulness Questionnaire (FFMQ) Abbreviated

    Baseline to 8 Weeks, Baseline to 20 Weeks

Other Outcomes (6)

  • Estimated Weekly Change in World Health Organization-5 (WHO-5) Stratified by Age

    Baseline to 8 Weeks, Baseline to 20 Weeks

  • Estimated Weekly Change in World Health Organization-5 (WHO-5) Stratified by Baseline Perceived Stress Scale (PSS)

    Baseline to 8 Weeks, Baseline to 20 Weeks

  • 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)

    Baseline to 8 Weeks, Baseline to 20 Weeks

  • +3 more other outcomes

Study Arms (2)

Mindfulness-Based Cognitive Therapy

EXPERIMENTAL

8 sessions of online mindfulness-based cognitive therapy

Behavioral: Mindfulness-Based Cognitive Therapy

Brief Mindfulness

EXPERIMENTAL

3 sessions of online mindfulness therapy

Behavioral: Brief Mindfulness

Interventions

Mindfulness-Based Cognitive TherapyBEHAVIORAL

8 sessions of online mindfulness-based cognitive therapy

Mindfulness-Based Cognitive Therapy
Brief MindfulnessBEHAVIORAL

3 sessions of online mindfulness therapy

Brief Mindfulness

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Under the age of 18 years
  • Unable to read, understand, and/or participate in mindfulness exercises

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

  • 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.

    PMID: 36094813DERIVED

MeSH Terms

Interventions

Mindfulness-Based Cognitive Therapy

Intervention Hierarchy (Ancestors)

MindfulnessCognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Limitations and Caveats

Despite having a wide range of clinical and non-clinical samples represented in this study, the sample generalizability was limited in regards to race and gender. A second limitation was not including support for participants to access the study (e.g., technical support, translated versions into other languages) as well as to engage with the study interventions.

Results Point of Contact

Title
Andrew Nierenberg
Organization
Massachusetts General Hospital
anierenberg@mgh.harvard.edu
617-512-2641

Study Officials

  • Andrew A Nierenberg, MD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Dauten Family Center for Bipolar Treatment Innovation

Study Record Dates

First Submitted

October 31, 2017

First Posted

February 18, 2019

Study Start

February 27, 2019

Primary Completion

February 19, 2020

Study Completion

February 19, 2020

Last Updated

May 13, 2021

Results First Posted

May 13, 2021

Record last verified: 2021-04

Locations

US(1)