Healthy Mind Healthy You: A Study of Mindfulness

NCT ID: NCT03844321

Last Updated: 2021-05-13

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

4412 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-27

Study Completion Date

2020-02-19

Brief Summary

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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.

Detailed Description

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Conditions

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Stress

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Mindfulness-Based Cognitive Therapy

8 sessions of online mindfulness-based cognitive therapy

Group Type EXPERIMENTAL

Mindfulness-Based Cognitive Therapy

Intervention Type BEHAVIORAL

8 sessions of online mindfulness-based cognitive therapy

Brief Mindfulness

3 sessions of online mindfulness therapy

Group Type EXPERIMENTAL

Brief Mindfulness

Intervention Type BEHAVIORAL

3 sessions of online mindfulness therapy

Interventions

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Mindfulness-Based Cognitive Therapy

8 sessions of online mindfulness-based cognitive therapy

Intervention Type BEHAVIORAL

Brief Mindfulness

3 sessions of online mindfulness therapy

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of South Florida

OTHER

Sponsor Role collaborator

Global Healthy Living Foundation

OTHER

Sponsor Role collaborator

University of North Carolina

OTHER

Sponsor Role collaborator

University of California, Los Angeles

OTHER

Sponsor Role collaborator

Genetic Alliance

OTHER

Sponsor Role collaborator

COPD Foundation

OTHER

Sponsor Role collaborator

The Duchenne Registry

OTHER

Sponsor Role collaborator

University of California, San Francisco

OTHER

Sponsor Role collaborator

Children's Hospital Medical Center, Cincinnati

OTHER

Sponsor Role collaborator

Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

OTHER

Sponsor Role collaborator

Accelerated Cure Project for Multiple Sclerosis

OTHER

Sponsor Role collaborator

Mayo Clinic

OTHER

Sponsor Role collaborator

Phelan-McDermid Syndrome Foundation

OTHER

Sponsor Role collaborator

Immune Deficiency Foundation

OTHER

Sponsor Role collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role collaborator

University of Pennsylvania

OTHER

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Andrew A. Nierenberg, MD

Director, Dauten Family Center for Bipolar Treatment Innovation

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andrew A Nierenberg, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

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Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 36094813 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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2017P001648

Identifier Type: -

Identifier Source: org_study_id

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