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Healthy Mind Healthy You: A Study of Mindfulness

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03844321
Recruitment Status : Active, not recruiting
First Posted : February 18, 2019
Last Update Posted : January 6, 2020
Sponsor:
Collaborators:
University of South Florida
Global Healthy Living Foundation
University of North Carolina
University of California, Los Angeles
Genetic Alliance
COPD Foundation
The Duchenne Registry
University of California, San Francisco
Children's Hospital Medical Center, Cincinnati
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Accelerated Cure Project for Multiple Sclerosis
Mayo Clinic
Phelan-McDermid Syndrome Foundation
Immune Deficiency Foundation
Brigham and Women's Hospital
University of Pennsylvania
Information provided by (Responsible Party):
Andrew A. Nierenberg, MD, Massachusetts General Hospital

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.

Condition or disease Intervention/treatment Phase
Stress Behavioral: Mindfulness-Based Cognitive Therapy Behavioral: Mindfulness Light Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2117 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Healthy Mind Healthy You: A Study of Mindfulness
Actual Study Start Date : February 27, 2019
Actual Primary Completion Date : October 1, 2019
Estimated Study Completion Date : February 2020

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: Mindfulness Light
3 sessions of online mindfulness therapy
Behavioral: Mindfulness Light
3 sessions of online mindfulness therapy




Primary Outcome Measures :
  1. World Health Organization-5 (WHO-5) [ Time Frame: 20 weeks ]
    A brief self-report (5-item) of positively-worded statements related to positive mood (good spirits, relaxation), vitality (being active and waking up fresh and rested), and general interests (being interested in things) over the prior two weeks.


Secondary Outcome Measures :
  1. Perceived Stress Scale (PSS) [ Time Frame: 20 weeks ]
    The most widely used psychological instrument for assessing perception of stress. This scale measures the extent to which situations in one's life are labeled as stressful.

  2. Patient Reported Outcomes Measurement Information System (PROMIS): Emotional Distress-Depression Short Form [ Time Frame: 20 weeks ]
    An 8-item measurement of perceived depressive symptoms over the past week.

  3. PROMIS: Emotional Distress-Anxiety Short Form [ Time Frame: 20 weeks ]
    A 4-item measurement of self-reported fear (fearfulness, panic), anxious misery (worry, dread), hyperarousal (tension, nervousness, restlessness), and somatic symptoms related to arousal (racing heart, dizziness).

  4. PROMIS: Ability to Participate in Social Roles and Activities Short Form [ Time Frame: 20 weeks ]
    A 4-item measurement of the perceived ability to perform one's everyday social roles and activities. Higher scores represent fewer limitations (better abilities).

  5. Five Facet Mindfulness Questionnaire (FFMQ) Abbreviated [ Time Frame: 20 weeks ]
    A 15-item assessment that examines two aspects of mindfulness: non-judging of inner experience and non-reactivity to inner experience. Both of these facets are represented in a different subscale.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03844321


Locations
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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
University of South Florida
Global Healthy Living Foundation
University of North Carolina
University of California, Los Angeles
Genetic Alliance
COPD Foundation
The Duchenne Registry
University of California, San Francisco
Children's Hospital Medical Center, Cincinnati
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Accelerated Cure Project for Multiple Sclerosis
Mayo Clinic
Phelan-McDermid Syndrome Foundation
Immune Deficiency Foundation
Brigham and Women's Hospital
University of Pennsylvania
Investigators
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Principal Investigator: Andrew A Nierenberg, MD Massachusetts General Hospital
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Responsible Party: Andrew A. Nierenberg, MD, Director, Dauten Family Center for Bipolar Treatment Innovation, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT03844321    
Other Study ID Numbers: 2017P001648
First Posted: February 18, 2019    Key Record Dates
Last Update Posted: January 6, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No