Trial · NCT03844321
Healthy Mind Healthy You: A Study of Mindfulness
NCT03844321, Not applicable, Completed, Massachusetts General Hospital; results first posted 2021-05-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Healthy Mind Healthy You: A Study of Mindfulness. Trials, record NCT03844321. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03844321
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Healthy Mind Healthy You: A Study of Mindfulness
- NCT number
- NCT03844321
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 4,412 participants, actual
- Lead sponsor
- Massachusetts General Hospital
- Conditions
- Stress
- Interventions
- Mindfulness-Based Cognitive Therapy, Brief Mindfulness
- First posted
- 2019-02-18
- Last updated
- 2021-05-13
- Results first posted
- 2021-05-13
- 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.
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Estimated Weekly Change on World Health Organization-5 (WHO-5) | 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. |
| Secondary | Estimated Weekly Change on Perceived Stress Scale (PSS) | 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. |
| Secondary | Estimated Weekly Change on Patient Reported Outcomes Measurement Information System (PROMIS): Emotional Distress-Depression Short Form | 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. |
| Secondary | Estimated Weekly Change on Patient Reported Outcomes Measurement Information System (PROMIS): Emotional Distress-Anxiety Short Form | 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. |
| Secondary | 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 | 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. |
| Secondary | Estimated Weekly Change on Five Facet Mindfulness Questionnaire (FFMQ) Abbreviated | 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. |
| Other | Estimated Weekly Change in World Health Organization-5 (WHO-5) Stratified by Age | 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. |
| Other | 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 | 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. |
| Other | 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 | 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. |
| Other | 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) | 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. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes19
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Estimated Weekly Change on World Health Organization-5 (WHO-5) | Baseline to 8 Weeks, Baseline to 20 Weeks | estimated weekly change in scale score | MEAN | |
| SECONDARY | Estimated Weekly Change on Perceived Stress Scale (PSS) | Baseline to 8 Weeks, Baseline to 20 Weeks | estimated weekly change in scale score | MEAN | |
| SECONDARY | 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 in scale score | MEAN | |
| SECONDARY | 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 in scale score | MEAN | |
| SECONDARY | 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 in scale score | MEAN | |
| SECONDARY | Estimated Weekly Change on Five Facet Mindfulness Questionnaire (FFMQ) Abbreviated | Baseline to 8 Weeks, Baseline to 20 Weeks | estimated weekly change in scale score | MEAN | |
| OTHER_PRE_SPECIFIED | 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 WHO-5 score | MEAN | |
| OTHER_PRE_SPECIFIED | 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 WHO-5 score | MEDIAN | |
| OTHER_PRE_SPECIFIED | 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 | estimated weekly change in WHO-5 score | MEAN | |
| OTHER_PRE_SPECIFIED | 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) | Baseline to 8 Weeks, Baseline to 20 Weeks | estimated weekly change in WHO-5 score | MEAN |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 outcomesResults by group168
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Estimated Weekly Change on World Health Organization-5 (WHO-5) | Mindfulness-Based Cognitive Therapy | Baseline to 8 Weeks | 0.78 | 95% Confidence Interval 0.63 to 0.93 | estimated weekly change in scale score |
| Estimated Weekly Change on World Health Organization-5 (WHO-5) | Brief Mindfulness | Baseline to 8 Weeks | 0.76 | 95% Confidence Interval 0.60 to 0.91 | estimated weekly change in scale score |
| Estimated Weekly Change on World Health Organization-5 (WHO-5) | Mindfulness-Based Cognitive Therapy | Baseline to 20 Weeks | 0.41 | 95% Confidence Interval 0.34 to 0.48 | estimated weekly change in scale score |
| Estimated Weekly Change on World Health Organization-5 (WHO-5) | Brief Mindfulness | Baseline to 20 Weeks | 0.33 | 95% Confidence Interval 0.26 to 0.40 | estimated weekly change in scale score |
| Estimated Weekly Change on Perceived Stress Scale (PSS) | Mindfulness-Based Cognitive Therapy | Baseline to 8 Weeks | -0.13 | 95% Confidence Interval -0.16 to -0.09 | estimated weekly change in scale score |
| Estimated Weekly Change on Perceived Stress Scale (PSS) | Brief Mindfulness | Baseline to 8 Weeks | -0.15 | 95% Confidence Interval -0.18 to -0.12 | estimated weekly change in scale score |
| Estimated Weekly Change on Perceived Stress Scale (PSS) | Mindfulness-Based Cognitive Therapy | Baseline to 20 Weeks | -0.08 | 95% Confidence Interval -0.09 to -0.06 | estimated weekly change in scale score |
| Estimated Weekly Change on Perceived Stress Scale (PSS) | Brief Mindfulness | Baseline to 20 Weeks | -0.07 | 95% Confidence Interval -0.08 to -0.05 | estimated weekly change in scale score |
| Estimated Weekly Change on Patient Reported Outcomes Measurement Information System (PROMIS): Emotional Distress-Depression Short Form | Mindfulness-Based Cognitive Therapy | Baseline to Week 8 | -0.19 | 95% Confidence Interval -0.23 to -0.15 | estimated weekly change in scale score |
| Estimated Weekly Change on Patient Reported Outcomes Measurement Information System (PROMIS): Emotional Distress-Depression Short Form | Brief Mindfulness | Baseline to Week 8 | -0.17 | 95% Confidence Interval -0.21 to -0.12 | estimated weekly change in scale score |
1 to 10 of 168Source ClinicalTrials.gov
See all 168 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Mindfulness-Based Cognitive Therapy | 2,220 | |
| Overall Study | STARTED | Brief Mindfulness | 2,192 | |
| Overall Study | COMPLETED | Mindfulness-Based Cognitive Therapy | 579 | |
| Overall Study | COMPLETED | Brief Mindfulness | 533 | |
| Overall Study | NOT COMPLETED | Mindfulness-Based Cognitive Therapy | 1,641 | |
| Overall Study | NOT COMPLETED | Brief Mindfulness | 1,659 |
Source ClinicalTrials.gov
Adverse events68
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Cardiac Issue | Cardiac disorders | Mindfulness-Based Cognitive Therapy | 1 | 2,220 | 1 |
| other | Cardiac Issue | Cardiac disorders | Brief Mindfulness | 1 | 2,192 | 1 |
| other | Endocrine Issue | Endocrine disorders | Mindfulness-Based Cognitive Therapy | 0 | 2,220 | 0 |
| other | Endocrine Issue | Endocrine disorders | Brief Mindfulness | 1 | 2,192 | 1 |
| other | Gastrointestinal Issue | Gastrointestinal disorders | Mindfulness-Based Cognitive Therapy | 4 | 2,220 | 4 |
| other | Gastrointestinal Issue | Gastrointestinal disorders | Brief Mindfulness | 10 | 2,192 | 14 |
| other | Undefined Health Issue | General disorders | Mindfulness-Based Cognitive Therapy | 5 | 2,220 | 6 |
| other | Undefined Health Issue | General disorders | Brief Mindfulness | 9 | 2,192 | 10 |
| other | Injury or Procedural Complication | Injury, poisoning and procedural complications | Mindfulness-Based Cognitive Therapy | 0 | 2,220 | 0 |
| other | Injury or Procedural Complication | Injury, poisoning and procedural complications | Brief Mindfulness | 3 | 2,192 | 3 |
1 to 10 of 68Source ClinicalTrials.gov
See all 68 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Mindfulness-Based Cognitive Therapy | 0 | 2,220 |
| Total, all-cause mortality | Brief Mindfulness | 0 | 2,192 |
| Total, other adverse events | Mindfulness-Based Cognitive Therapy | 33 | 2,220 |
| Total, other adverse events | Brief Mindfulness | 41 | 2,192 |
| Total, serious adverse events | Mindfulness-Based Cognitive Therapy | 30 | 2,220 |
| Total, serious adverse events | Brief Mindfulness | 31 | 2,192 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 36094813 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Mindfulness-Based Cognitive Therapy vs Brief Mindfulness: deaths from any cause | Trial comparisons |
| Mindfulness-Based Cognitive Therapy vs Brief Mindfulness: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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