StressNCT03844321

Healthy Mind Healthy You: A Study of Mindfulness

A study testing Mindfulness-Based Cognitive Therapy and Brief Mindfulness in people with Stress, run by Massachusetts General Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Stress
What is being tested?: Mindfulness-Based Cognitive Therapy and Brief Mindfulness
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 4,412 participants
Where: 1 siteUnited States
Study dates: 27 Feb 2019to 19 Feb 2020
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Massachusetts General Hospital
Boston, Massachusetts, 02114

Other trials in United States

About this study

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.

Conditions: Stress
Being tested: Mindfulness-Based Cognitive Therapy, Brief Mindfulness

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Mindfulness-Based Cognitive TherapyBehavioural
8 sessions of online mindfulness-based cognitive therapy
Brief MindfulnessBehavioural
3 sessions of online mindfulness therapy

Study groups in NCT03844321
Study group	Role	What they receive
Mindfulness-Based Cognitive Therapy	Experimental	8 sessions of online mindfulness-based cognitive therapy Receives: Behavioral: Mindfulness-Based Cognitive Therapy
Brief Mindfulness	Experimental	3 sessions of online mindfulness therapy Receives: Behavioral: Brief Mindfulness

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline to 8 Weeks, Baseline to 20 Weeks

Secondary outcomes (5)

Estimated Weekly Change on Perceived Stress Scale (PSS)
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.
Measured: Baseline to 8 Weeks, Baseline to 20 Weeks
Estimated Weekly Change on Patient Reported Outcomes Measurement Information System (PROMIS): Emotional Distress-Depression Short Form
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.
Measured: Baseline to 8 Weeks, Baseline to 20 Weeks
Estimated Weekly Change on Patient Reported Outcomes Measurement Information System (PROMIS): Emotional Distress-Anxiety Short Form
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.
Measured: 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
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.
Measured: Baseline to 8 Weeks, Baseline to 20 Weeks
Estimated Weekly Change on Five Facet Mindfulness Questionnaire (FFMQ) Abbreviated
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.
Measured: Baseline to 8 Weeks, Baseline to 20 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Feb 201919 Feb 2020

First posted18 Feb 2019
Study start27 Feb 2019
Primary completion19 Feb 2020
Study completion19 Feb 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for StressStudies of the same condition, open and under way.
More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 4,412 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03844321
Sponsor's protocol ID: 2017P001648
Status last verified: Apr 2021
First submitted: 31 Oct 2017
Last updated: 13 May 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Publications

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.
PubMed 36094813

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 13 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Healthy Mind Healthy You: A Study of Mindfulness
ClinicalTrials.gov ID: NCT03844321
Acronym / sponsor ID: 2017P001648
Conditions: Stress
Study type: Interventional
Recruitment status: Completed
Enrolment: 4,412 participants (actual)
Lead sponsor: Massachusetts General HospitalUniversity, hospital or other
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
Study start: 27 Feb 2019 (actual)
Primary completion: 19 Feb 2020 (actual)
Study completion: 19 Feb 2020 (actual)
First posted: 18 Feb 2019 (actual)
Results: Posted 13 May 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Mindfulness-Based Cognitive Therapy	Experimental	Behavioral: Mindfulness-Based Cognitive Therapy8 sessions of online mindfulness-based cognitive therapy
Brief Mindfulness	Experimental	Behavioral: Brief Mindfulness3 sessions of online mindfulness therapy

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (2 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Mindfulness-Based Cognitive Therapy8 sessions of online mindfulness-based cognitive therapy	Behavioural	Mindfulness-Based Cognitive Therapy
Brief Mindfulness3 sessions of online mindfulness therapy	Behavioural	Brief Mindfulness

Primary outcome

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.

5 secondary outcomes

Estimated Weekly Change on Perceived Stress Scale (PSS)
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
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
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
Estimated Weekly Change on Five Facet Mindfulness Questionnaire (FFMQ) Abbreviated
Time frame: Baseline to 8 Weeks, Baseline to 20 Weeks

Results and safety

Results posted to the registry on 13 May 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Mindfulness-Based Cognitive Therapy	2,220	579
Brief Mindfulness	2,192	533

Primary outcome: Estimated Weekly Change on World Health Organization-5 (WHO-5)

Time frame: Baseline to 8 Weeks, Baseline to 20 Weeks. Mean (95% Confidence Interval). Unit: estimated weekly change in scale score

Measure	Mindfulness-Based Cognitive Therapy n = 2220	Brief Mindfulness n = 2192
Baseline to 8 Weeks	0.78 (0.63 to 0.93)	0.76 (0.60 to 0.91)
Baseline to 20 Weeks	0.41 (0.34 to 0.48)	0.33 (0.26 to 0.40)

Mindfulness-Based Cognitive Therapy vs Brief Mindfulness: Difference in Slopes: -0.02 (95% CI -0.24 to 0.19), p = .820, Mixed Models Analysis
Mindfulness-Based Cognitive Therapy vs Brief Mindfulness: Difference in Slopes: -0.08 (95% CI -0.18 to 0.02), p = .110, Mixed Models Analysis

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: 20 weeks.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Mindfulness-Based Cognitive Therapy	30 of 2,220 (1.4%)	33 of 2,220 (1.5%)	0 of 2,220
Brief Mindfulness	31 of 2,192 (1.4%)	41 of 2,192 (1.9%)	0 of 2,192

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 36094813Sylvia 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Andrew A Nierenberg, MD principal investigator

Massachusetts General Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Mindfulness-Based Cognitive Therapy and Brief Mindfulness in people with Stress, run by Massachusetts General Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Estimated Weekly Change on World Health Organization-5 (WHO-5) (time frame: Baseline to 8 Weeks, Baseline to 20 Weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03844321, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2021.