Healthy Mind Healthy You: A Study of Mindfulness

April 19, 2021 updated by: Andrew A. Nierenberg, MD, Massachusetts General Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

4412

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Mindfulness-Based Cognitive Therapy
8 sessions of online mindfulness-based cognitive therapy
Behavioral: Mindfulness-Based Cognitive Therapy
8 sessions of online mindfulness-based cognitive therapy
EXPERIMENTAL: Brief Mindfulness
3 sessions of online mindfulness therapy
Behavioral: Brief Mindfulness
3 sessions of online mindfulness therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Estimated Weekly Change on World Health Organization-5 (WHO-5)
Time Frame: Baseline to 8 Weeks, Baseline to 20 Weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Estimated Weekly Change on Perceived Stress Scale (PSS)
Time Frame: Baseline to 8 Weeks, Baseline to 20 Weeks
The PSS is a 10-item questionnaire that evaluates an individual's experiences of stress in the previous month. Scores range 0-40, with higher scores representing greater perceived stress. Change = estimated average weekly change during time frame.
Baseline to 8 Weeks, Baseline to 20 Weeks
Estimated Weekly Change on Patient Reported Outcomes Measurement Information System (PROMIS): Emotional Distress-Depression Short Form
Time Frame: Baseline to 8 Weeks, Baseline to 20 Weeks
The PROMIS: Emotional Distress-Depression Short Form is an 8-item questionnaire that measures perceived depressive symptoms over the past week. Scores range 8-40, with higher scores representing more severe depressive symptoms. Change = estimated average weekly change during time frame.
Baseline to 8 Weeks, Baseline to 20 Weeks
Estimated Weekly Change on Patient Reported Outcomes Measurement Information System (PROMIS): Emotional Distress-Anxiety Short Form
Time Frame: Baseline to 8 Weeks, Baseline to 20 Weeks
The PROMIS: Emotional Distress-Anxiety Short Form is a 4-item questionnaire that measures self-reported fear, anxious misery, hyperarousal, and somatic symptoms related to arousal in the past seven days. Scores range 4-20, with higher scores representing more severe anxiety symptoms. Change = estimated average weekly change during time frame.
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
Time Frame: Baseline to 8 Weeks, Baseline to 20 Weeks
The PROMIS: Ability to Participate in Social Roles and Activities Short Form is a 4-item questionnaire that measures the perceived ability to perform one's everyday social roles and activities. Scores range 4-20 with higher scores representing fewer limitations (greater abilities). Change = estimated average weekly change during time frame.
Baseline to 8 Weeks, Baseline to 20 Weeks
Estimated Weekly Change on Five Facet Mindfulness Questionnaire (FFMQ) Abbreviated
Time Frame: Baseline to 8 Weeks, Baseline to 20 Weeks
The FFMQ is a 39-item questionnaire that examines five aspects of mindfulness: observing, describing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience. Only the questions related to non-judging of inner experience and non-reactivity were administered (15 items total). The total score on these 15 items was used (range: 15-75). Higher scores represent greater mindfulness. Change = estimated average weekly change during time frame.
Baseline to 8 Weeks, Baseline to 20 Weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Estimated Weekly Change in World Health Organization-5 (WHO-5) Stratified by Age
Time Frame: Baseline to 8 Weeks, Baseline to 20 Weeks
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. Age was self-reported.
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)
Time Frame: Baseline to 8 Weeks, Baseline to 20 Weeks
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. The PSS is a 10-item questionnaire that evaluates an individual's experiences of stress in the previous month. Scores range 0-40, with higher scores representing greater perceived stress.
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)
Time Frame: Baseline to 8 Weeks, Baseline to 20 Weeks
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. The PROMIS: EDD is a 4-item questionnaire that measures self-reported fear, anxious misery, hyperarousal, and somatic symptoms related to arousal in the past seven days. Scores range 4-20, with higher scores representing more severe anxiety symptoms.
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-Anxiety Short Form (PROMIS: EDA)
Time Frame: Baseline to 8 Weeks, Baseline to 20 Weeks
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. The PROMIS: EDA is a 4-item questionnaire that measures self-reported fear, anxious misery, hyperarousal, and somatic symptoms related to arousal in the past seven days. Scores range 4-20, with higher scores representing more severe anxiety symptoms.
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): Ability to Participate in Social Roles and Activities Short Form (PROMIS: APRA)
Time Frame: Baseline to 8 Weeks, Baseline to 20 Weeks
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. The PROMIS: APRA is a 4-item questionnaire that measures the perceived ability to perform one's everyday social roles and activities. Scores range 4-20 with higher scores representing fewer limitations (greater abilities).
Baseline to 8 Weeks, Baseline to 20 Weeks
Estimated Weekly Change in World Health Organization-5 (WHO-5) Stratified by Baseline Five Facet Mindfulness Questionnaire (FFMQ) Abbreviated
Time Frame: Baseline to 8 Weeks, Baseline to 20 Weeks
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. The FFMQ is a 39-item questionnaire that examines five aspects of mindfulness: observing, describing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience. Only the questions related to non-judging of inner experience and non-reactivity were administered (15 items total). The total score on these 15 items was used (range: 15-75). Higher scores represent greater mindfulness.
Baseline to 8 Weeks, Baseline to 20 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Collaborators

Mayo Clinic
University of Pennsylvania
University of South Florida
University of California, Los Angeles
Brigham and Women's Hospital
University of California, San Francisco
Children's Hospital Medical Center, Cincinnati
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
COPD Foundation
University of North Carolina
Global Healthy Living Foundation
Phelan-McDermid Syndrome Foundation
Genetic Alliance
Accelerated Cure Project for Multiple Sclerosis
The Duchenne Registry
Immune Deficiency Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 27, 2019

Primary Completion (ACTUAL)

February 19, 2020

Study Completion (ACTUAL)

February 19, 2020

Study Registration Dates

First Submitted

October 31, 2017

First Submitted That Met QC Criteria

February 15, 2019

First Posted (ACTUAL)

February 18, 2019

Study Record Updates

Last Update Posted (ACTUAL)

May 13, 2021

Last Update Submitted That Met QC Criteria

April 19, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • 2017P001648

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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