NCT03844321

Healthy Mind Healthy You: A Study of Mindfulness

Completed NA Results posted Last updated 13 May 2021

What this trial tests

NA trial testing Mindfulness-Based Cognitive Therapy in Stress in 4,412 participants. Completed in 19 February 2020.

Timeline

27 February 2019

Primary endpoint
19 February 2020

19 February 2020

Quick facts

Lead sponsor	Massachusetts General Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	4,412
Start date	27 February 2019
Primary completion	19 February 2020
Estimated completion	19 February 2020
Sites	1 location across United States

Drugs / interventions tested

• Mindfulness-Based Cognitive Therapy
• Brief Mindfulness

Conditions studied

• Stress — all drugs for Stress →

Sponsor

Massachusetts General Hospital

Who can join

18 and older, any sex, with Stress. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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

Group	Value	95% CI
Mindfulness-Based Cognitive Therapy	0.78	0.63 – 0.93
Brief Mindfulness	0.76	0.60 – 0.91

Baseline to 20 Weeks

Group	Value	95% CI
Mindfulness-Based Cognitive Therapy	0.41	0.34 – 0.48
Brief Mindfulness	0.33	0.26 – 0.40

Estimated Weekly Change on Perceived Stress Scale (PSS) Secondary · 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

Group	Value	95% CI
Mindfulness-Based Cognitive Therapy	-0.13	-0.16 – -0.09
Brief Mindfulness	-0.15	-0.18 – -0.12

Baseline to 20 Weeks

Group	Value	95% CI
Mindfulness-Based Cognitive Therapy	-0.08	-0.09 – -0.06
Brief Mindfulness	-0.07	-0.08 – -0.05

Estimated Weekly Change on Patient Reported Outcomes Measurement Information System (PROMIS): Emotional Distress-Depression Short Form Secondary · 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 Week 8

Group	Value	95% CI
Mindfulness-Based Cognitive Therapy	-0.19	-0.23 – -0.15
Brief Mindfulness	-0.17	-0.21 – -0.12

Baseline to Week 20

Group	Value	95% CI
Mindfulness-Based Cognitive Therapy	-0.11	-0.13 – -0.09
Brief Mindfulness	-0.06	-0.08 – -0.04

Estimated Weekly Change on Patient Reported Outcomes Measurement Information System (PROMIS): Emotional Distress-Anxiety Short Form Secondary · 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 Week 8

Group	Value	95% CI
Mindfulness-Based Cognitive Therapy	-0.12	-0.15 – -0.10
Brief Mindfulness	-0.13	-0.16 – -0.11

Baseline to Week 20

Group	Value	95% CI
Mindfulness-Based Cognitive Therapy	-0.07	-0.08 – -0.06
Brief Mindfulness	-0.05	-0.06 – -0.04

Estimated Weekly Change on Patient Reported Outcomes Measurement Information System (PROMIS): Ability to Participate in Social Roles and Activities Short Form Secondary · 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 Week 8

Group	Value	95% CI
Mindfulness-Based Cognitive Therapy	-0.12	-0.15 – -0.09
Brief Mindfulness	-0.14	-0.17 – -0.11

Baseline to Week 20

Group	Value	95% CI
Mindfulness-Based Cognitive Therapy	-0.05	-0.06 – -0.04
Brief Mindfulness	-0.04	-0.06 – -0.03

Estimated Weekly Change on Five Facet Mindfulness Questionnaire (FFMQ) Abbreviated Secondary · 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

Group	Value	95% CI
Mindfulness-Based Cognitive Therapy	0.92	0.84 – 1.00
Brief Mindfulness	0.88	0.79 – 0.96

Baseline to 20 Weeks

Group	Value	95% CI
Mindfulness-Based Cognitive Therapy	0.43	0.39 – 0.46
Brief Mindfulness	0.37	0.34 – 0.41

Estimated Weekly Change in World Health Organization-5 (WHO-5) Stratified by Age Secondary · 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: Age 45

Group	Value	95% CI
Mindfulness-Based Cognitive Therapy	0.98	0.78 – 1.19
Brief Mindfulness	0.75	0.55 – 0.95

Baseline to 8 Weeks: Age 55

Group	Value	95% CI
Mindfulness-Based Cognitive Therapy	0.81	0.66 – 0.96
Brief Mindfulness	0.73	0.58 – 0.89

Baseline to 8 Weeks: Age 65

Group	Value	95% CI
Mindfulness-Based Cognitive Therapy	0.64	0.48 – 0.80
Brief Mindfulness	0.72	0.54 – 0.90

Baseline to 20 Weeks: Age 45

Group	Value	95% CI
Mindfulness-Based Cognitive Therapy	0.53	0.43 – 0.63
Brief Mindfulness	0.38	0.29 – 0.48

Baseline to 20 Weeks: Age 55

Group	Value	95% CI
Mindfulness-Based Cognitive Therapy	0.44	0.36 – 0.51
Brief Mindfulness	0.33	0.25 – 0.40

Baseline to 20 Weeks: Age 65

Group	Value	95% CI
Mindfulness-Based Cognitive Therapy	0.34	0.27 – 0.42
Brief Mindfulness	0.27	0.19 – 0.35

Estimated Weekly Change in World Health Organization-5 (WHO-5) Stratified by Baseline Perceived Stress Scale (PSS) Secondary · 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 Week 8: PSS = 18

Group	Value	95% CI
Mindfulness-Based Cognitive Therapy	0.64	0.48 – 0.80
Brief Mindfulness	0.61	0.44 – 0.78

Baseline to Week 8: PSS = 20

Group	Value	95% CI
Mindfulness-Based Cognitive Therapy	0.78	0.63 – 0.93
Brief Mindfulness	0.75	0.60 – 0.90

Baseline to Week 8: PSS = 22

Group	Value	95% CI
Mindfulness-Based Cognitive Therapy	0.92	0.75 – 1.09
Brief Mindfulness	0.89	0.71 – 1.07

Baseline to Week 20: PSS = 18

Group	Value	95% CI
Mindfulness-Based Cognitive Therapy	0.35	0.27 – 0.42
Brief Mindfulness	0.28	0.21 – 0.36

Baseline to Week 20: PSS = 20

Group	Value	95% CI
Mindfulness-Based Cognitive Therapy	0.42	0.35 – 0.48
Brief Mindfulness	0.33	0.25 – 0.40

Baseline to Week 20: PSS = 22

Group	Value	95% CI
Mindfulness-Based Cognitive Therapy	0.48	0.40 – 0.57
Brief Mindfulness	0.37	0.28 – 0.45

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) Secondary · 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 Week 8: PROMIS: EDD = 10

Group	Value	95% CI
Mindfulness-Based Cognitive Therapy	0.51	0.32 – 0.70
Brief Mindfulness	0.47	0.28 – 0.66

Baseline to Week 8: PROMIS: EDD = 15

Group	Value	95% CI
Mindfulness-Based Cognitive Therapy	0.72	0.57 – 0.86
Brief Mindfulness	0.69	0.54 – 0.84

Baseline to Week 8: PROMIS: EDD = 20

Group	Value	95% CI
Mindfulness-Based Cognitive Therapy	0.92	0.75 – 1.10
Brief Mindfulness	0.91	0.73 – 1.09

Baseline to Week 20: PROMIS: EDD = 10

Group	Value	95% CI
Mindfulness-Based Cognitive Therapy	0.30	0.21 – 0.39
Brief Mindfulness	0.26	0.17 – 0.34

Baseline to Week 20: PROMIS: EDD = 15

Group	Value	95% CI
Mindfulness-Based Cognitive Therapy	0.39	0.32 – 0.46
Brief Mindfulness	0.31	0.23 – 0.38

Baseline to Week 20: PROMIS: EDD = 20

Group	Value	95% CI
Mindfulness-Based Cognitive Therapy	0.48	0.39 – 0.56
Brief Mindfulness	0.36	0.27 – 0.44

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) Secondary · 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: PROMIS: EDA = 5

Group	Value	95% CI
Mindfulness-Based Cognitive Therapy	0.46	0.26 – 0.66
Brief Mindfulness	0.47	0.26 – 0.68

Baseline to 8 Weeks: PROMIS: EDA = 10

Group	Value	95% CI
Mindfulness-Based Cognitive Therapy	0.85	0.68 – 1.01
Brief Mindfulness	0.83	0.66 – 0.99

Baseline to 8 Weeks: PROMIS: EDA = 15

Group	Value	95% CI
Mindfulness-Based Cognitive Therapy	1.23	0.91 – 1.55
Brief Mindfulness	1.18	0.86 – 1.50

Baseline to 20 Weeks: PROMIS: EDA = 5

Group	Value	95% CI
Mindfulness-Based Cognitive Therapy	0.25	0.16 – 0.35
Brief Mindfulness	0.18	0.08 – 0.28

Baseline to 20 Weeks: PROMIS: EDA = 10

Group	Value	95% CI
Mindfulness-Based Cognitive Therapy	0.46	0.38 – 0.53
Brief Mindfulness	0.37	0.29 – 0.45

Baseline to 20 Weeks: PROMIS: EDA = 15

Group	Value	95% CI
Mindfulness-Based Cognitive Therapy	0.66	0.50 – 0.81
Brief Mindfulness	0.56	0.40 – 0.72

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) Secondary · 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: PROMIS: APRA = 5

Group	Value	95% CI
Mindfulness-Based Cognitive Therapy	0.57	0.35 – 0.80
Brief Mindfulness	0.46	0.23 – 0.70

Baseline to 8 Weeks: PROMIS: APRA = 10

Group	Value	95% CI
Mindfulness-Based Cognitive Therapy	0.74	0.60 – 0.89
Brief Mindfulness	0.73	0.58 – 0.88

Baseline to 8 Weeks: PROMIS: APRA = 15

Group	Value	95% CI
Mindfulness-Based Cognitive Therapy	0.91	0.69 – 1.13
Brief Mindfulness	1.00	0.77 – 1.24

Baseline to 20 Weeks: PROMIS: APRA = 5

Group	Value	95% CI
Mindfulness-Based Cognitive Therapy	0.33	0.23 – 0.44
Brief Mindfulness	0.24	0.13 – 0.34

Baseline to 20 Weeks: PROMIS: APRA = 10

Group	Value	95% CI
Mindfulness-Based Cognitive Therapy	0.40	0.33 – 0.47
Brief Mindfulness	0.32	0.25 – 0.40

Baseline to 20 Weeks: PROMIS: APRA = 15

Group	Value	95% CI
Mindfulness-Based Cognitive Therapy	0.47	0.36 – 0.58
Brief Mindfulness	0.41	0.30 – 0.53

Estimated Weekly Change in World Health Organization-5 (WHO-5) Stratified by Baseline Five Facet Mindfulness Questionnaire (FFMQ) Abbreviated Secondary · 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: FFMQ = 40

Group	Value	95% CI
Mindfulness-Based Cognitive Therapy	1.06	0.85 – 1.26
Brief Mindfulness	0.97	0.75 – 1.19

Baseline to 8 Weeks: FFMQ = 50

Group	Value	95% CI
Mindfulness-Based Cognitive Therapy	0.78	0.64 – 0.93
Brief Mindfulness	0.75	0.60 – 0.90

Baseline to 8 Weeks: FFMQ = 60

Group	Value	95% CI
Mindfulness-Based Cognitive Therapy	0.51	0.32 – 0.70
Brief Mindfulness	0.53	0.34 – 0.73

Baseline to 20 Weeks: FFMQ = 40

Group	Value	95% CI
Mindfulness-Based Cognitive Therapy	0.52	0.42 – 0.62
Brief Mindfulness	0.41	0.31 – 0.52

Baseline to 20 Weeks: FFMQ = 50

Group	Value	95% CI
Mindfulness-Based Cognitive Therapy	0.41	0.34 – 0.48
Brief Mindfulness	0.33	0.25 – 0.40

Baseline to 20 Weeks: FFMQ = 60

Group	Value	95% CI
Mindfulness-Based Cognitive Therapy	0.30	0.22 – 0.39
Brief Mindfulness	0.24	0.15 – 0.33

Adverse events — posted to ClinicalTrials.gov

Time frame: 20 weeks.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Mindfulness-Based Cognitive Therapy

Serious: 30/2220 (1%)

Deaths: 0/2220

Brief Mindfulness

Serious: 31/2192 (1%)

Deaths: 0/2192

Serious adverse events (13 terms)

Reaction	System	Mindfulness-Based Cognitiv…	Brief Mindfulness
Negative Life Event	Social circumstances	—	—
Gastrointestinal Issue	Gastrointestinal disorders	—	—
Musculoskeletal or Connective Tissue Issue	Musculoskeletal and connective tissue disorders	—	—
Undefined Health Issue	General disorders	—	—
Respiratory Issue/Flu	Respiratory, thoracic and mediastinal disorders	—	—
Nervous System Issue	Nervous system disorders	—	—
Surgical or Medical Procedure	Surgical and medical procedures	—	—
Immune System Issue	Immune system disorders	—	—
Psychiatric Issue	Psychiatric disorders	—	—
Cardiac Issue	Cardiac disorders	—	—
Infection	Infections and infestations	—	—
Renal Issue	Renal and urinary disorders	—	—
Blood/Lymphatic Issue	Blood and lymphatic system disorders	—	—

Other adverse events (21 terms — click to expand)

Reaction	System	Mindfulness-Based Cognitiv…	Brief Mindfulness
Gastrointestinal Issue	Gastrointestinal disorders	—	—
Undefined Health Issue	General disorders	—	—
Musculoskeletal or Connective Tissue Issue	Musculoskeletal and connective tissue disorders	—	—
Nervous System Issue	Nervous system disorders	—	—
Injury or Procedural Complication	Injury, poisoning and procedural complications	—	—
Renal Issue	Renal and urinary disorders	—	—
Skin Condition	Skin and subcutaneous tissue disorders	—	—
Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—
Psychiatric Issue	Psychiatric disorders	—	—
Respiratory Issue/Flu	Respiratory, thoracic and mediastinal disorders	—	—
Negative Life Event	Social circumstances	—	—
Immune System Issue	Immune system disorders	—	—
Cardiac Issue	Cardiac disorders	—	—
Endocrine Issue	Endocrine disorders	—	—
Medication Side-Effect	Product Issues	—	—
Surgical or Medical Procedure	Surgical and medical procedures	—	—
Vascular Issue	Vascular disorders	—	—
Blood or Lymphatic Issue	Blood and lymphatic system disorders	—	—
Vision/Eye Issue	Eye disorders	—	—
Injury or Procedural Complication	Injury, poisoning and procedural complications	—	—
Reproductive Issue	Reproductive system and breast disorders	—	—

Most-reported serious reactions: Negative Life Event, Gastrointestinal Issue, Musculoskeletal or Connective Tissue Issue, Undefined Health Issue, Respiratory Issue/Flu, Nervous System Issue, Surgical or Medical Procedure, Immune System Issue.

Data from ClinicalTrials.gov NCT03844321 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Web-Based Mindfulness-Based Interventions for Well-being: Randomized Comparative Effectiveness Trial.
   Sylvia LG, Lunn MR, Obedin-Maliver J, McBurney RN, et al · · 2022 · cited 8× · PMID 36094813 · DOI 10.2196/35620