Trial Outcomes & Findings for Healthy Mind Healthy You: A Study of Mindfulness (NCT NCT03844321)

NCT ID: NCT03844321

Last Updated: 2021-05-13

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

4412 participants

Primary outcome timeframe

Baseline to 8 Weeks, Baseline to 20 Weeks

Results posted on

2021-05-13

Participant Flow

Individuals from 17 Patient Centered Outcomes Research Institute (PCORI) Patient Powered Research Networks (PPRNs) who were over the age of 18, able to read and understand English, and/or participate in mindfulness exercises were eligible to participate in Healthy Mind Healthy You Study. Participants were recruited through each PPRN. Recruitment for the study occurred from 2/27/2019 to 10/1/2019 and the follow up period ended on 1/31/2020.

This study was inclusive of all subgroups, with the exception of individuals under the age of 18 or and individuals not able to participate in mindfulness exercises, with broad inclusion and minimal exclusion criteria. Participants' date of birth which was checked for accuracy by the data management system. After consent, participants completed baseline questionnaires on their mindfulness practices in the past, stress, anxiety, well-being, psychosocial functioning and PPRN-specific assessments.

Participant milestones

Participant milestones
Measure	Mindfulness-Based Cognitive Therapy 8 sessions of online mindfulness-based cognitive therapy Mindfulness-Based Cognitive Therapy: 8 sessions of online mindfulness-based cognitive therapy	Brief Mindfulness 3 sessions of online mindfulness therapy Brief Mindfulness: 3 sessions of online mindfulness therapy
Overall Study STARTED	2220	2192
Overall Study COMPLETED	579	533
Overall Study NOT COMPLETED	1641	1659

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Healthy Mind Healthy You: A Study of Mindfulness

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Mindfulness-Based Cognitive Therapy n=2220 Participants 8 sessions of online mindfulness-based cognitive therapy Mindfulness-Based Cognitive Therapy: 8 sessions of online mindfulness-based cognitive therapy	Brief Mindfulness n=2192 Participants 3 sessions of online mindfulness therapy Brief Mindfulness: 3 sessions of online mindfulness therapy	Total n=4412 Participants Total of all reporting groups
Age, Continuous	55.95 years STANDARD_DEVIATION 14.72 • n=5 Participants	54.63 years STANDARD_DEVIATION 15.05 • n=7 Participants	55.29 years STANDARD_DEVIATION 14.90 • n=5 Participants
Sex/Gender, Customized Female	1780 Participants n=5 Participants	1768 Participants n=7 Participants	3548 Participants n=5 Participants
Sex/Gender, Customized Male	429 Participants n=5 Participants	410 Participants n=7 Participants	839 Participants n=5 Participants
Sex/Gender, Customized Other	3 Participants n=5 Participants	6 Participants n=7 Participants	9 Participants n=5 Participants
Sex/Gender, Customized Ambiguous	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Sex/Gender, Customized Unknown	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Sex/Gender, Customized Woman	1690 Participants n=5 Participants	1654 Participants n=7 Participants	3344 Participants n=5 Participants
Sex/Gender, Customized Man	402 Participants n=5 Participants	388 Participants n=7 Participants	790 Participants n=5 Participants
Sex/Gender, Customized No selected answer	39 Participants n=5 Participants	35 Participants n=7 Participants	74 Participants n=5 Participants
Sex/Gender, Customized Genderqueer	32 Participants n=5 Participants	39 Participants n=7 Participants	71 Participants n=5 Participants
Sex/Gender, Customized Transgender male/Trans man/Female-to-male	17 Participants n=5 Participants	32 Participants n=7 Participants	49 Participants n=5 Participants
Sex/Gender, Customized Prefer not to answer	24 Participants n=5 Participants	30 Participants n=7 Participants	54 Participants n=5 Participants
Sex/Gender, Customized Something else	5 Participants n=5 Participants	14 Participants n=7 Participants	19 Participants n=5 Participants
Sex/Gender, Customized Multiple gender categories	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Sex/Gender, Customized Transgender female/Trans woman/Male-to-female	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
Sex/Gender, Customized Straight	1816 Participants n=5 Participants	1744 Participants n=7 Participants	3560 Participants n=5 Participants
Sex/Gender, Customized Bisexual	91 Participants n=5 Participants	102 Participants n=7 Participants	193 Participants n=5 Participants
Sex/Gender, Customized Gay	72 Participants n=5 Participants	78 Participants n=7 Participants	150 Participants n=5 Participants
Sex/Gender, Customized Lesbian	69 Participants n=5 Participants	78 Participants n=7 Participants	147 Participants n=5 Participants
Sex/Gender, Customized Queer	56 Participants n=5 Participants	67 Participants n=7 Participants	123 Participants n=5 Participants
Sex/Gender, Customized Asexual	18 Participants n=5 Participants	22 Participants n=7 Participants	40 Participants n=5 Participants
Sex/Gender, Customized Multiple sexual orientations	14 Participants n=5 Participants	8 Participants n=7 Participants	22 Participants n=5 Participants
Sex/Gender, Customized Questioning	9 Participants n=5 Participants	7 Participants n=7 Participants	16 Participants n=5 Participants
Race/Ethnicity, Customized White	1957 Participants n=5 Participants	1917 Participants n=7 Participants	3874 Participants n=5 Participants
Race/Ethnicity, Customized Multiple Race	68 Participants n=5 Participants	59 Participants n=7 Participants	127 Participants n=5 Participants
Race/Ethnicity, Customized Black, African American, African, or AfroCaribbean	45 Participants n=5 Participants	52 Participants n=7 Participants	97 Participants n=5 Participants
Race/Ethnicity, Customized Asian	39 Participants n=5 Participants	38 Participants n=7 Participants	77 Participants n=5 Participants
Race/Ethnicity, Customized No selected answer	20 Participants n=5 Participants	22 Participants n=7 Participants	42 Participants n=5 Participants
Race/Ethnicity, Customized Prefer not to answer	16 Participants n=5 Participants	24 Participants n=7 Participants	40 Participants n=5 Participants
Race/Ethnicity, Customized Other	2 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants
Race/Ethnicity, Customized Native American, American Indian, or Alaska Native	12 Participants n=5 Participants	15 Participants n=7 Participants	27 Participants n=5 Participants
Race/Ethnicity, Customized Unknown	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race/Ethnicity, Customized Non-Hispanic	2078 Participants n=5 Participants	2042 Participants n=7 Participants	4120 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	101 Participants n=5 Participants	97 Participants n=7 Participants	198 Participants n=5 Participants
World Health Organization-5 Well-Being Index	50.2 units on a scale STANDARD_DEVIATION 20.6 • n=5 Participants	50.6 units on a scale STANDARD_DEVIATION 20.7 • n=7 Participants	50.4 units on a scale STANDARD_DEVIATION 20.7 • n=5 Participants
Five Facet Mindfulness Questionnaire	49.9 units on a scale STANDARD_DEVIATION 11.2 • n=5 Participants	49.9 units on a scale STANDARD_DEVIATION 11.0 • n=7 Participants	49.9 units on a scale STANDARD_DEVIATION 11.1 • n=5 Participants
Perceived Stress Scale	20.1 units on a scale STANDARD_DEVIATION 3.71 • n=5 Participants	20.2 units on a scale STANDARD_DEVIATION 3.64 • n=7 Participants	20.2 units on a scale STANDARD_DEVIATION 3.67 • n=5 Participants
PROMIS Emotional Distress - Anxiety Short Form (Adult, 4-Item)	8.94 units on a scale STANDARD_DEVIATION 3.64 • n=5 Participants	8.98 units on a scale STANDARD_DEVIATION 3.61 • n=7 Participants	8.96 units on a scale STANDARD_DEVIATION 3.62 • n=5 Participants
PROMIS Emotional Distress - Depression Short Form (Adult, v. 8a)	16.4 units on a scale STANDARD_DEVIATION 7.00 • n=5 Participants	16.3 units on a scale STANDARD_DEVIATION 7.07 • n=7 Participants	16.4 units on a scale STANDARD_DEVIATION 7.04 • n=5 Participants
PROMIS: Ability to Participate in Social Roles and Activities Short Form (Adult, 4-item)	10.6 units on a scale STANDARD_DEVIATION 4.35 • n=5 Participants	10.6 units on a scale STANDARD_DEVIATION 4.29 • n=7 Participants	10.6 units on a scale STANDARD_DEVIATION 4.32 • n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Mindfulness-Based Cognitive Therapy n=2220 Participants 8 sessions of online mindfulness-based cognitive therapy Mindfulness-Based Cognitive Therapy: 8 sessions of online mindfulness-based cognitive therapy	Brief Mindfulness n=2192 Participants 3 sessions of online mindfulness therapy Brief Mindfulness: 3 sessions of online mindfulness therapy
Estimated Weekly Change on World Health Organization-5 (WHO-5) Baseline to 8 Weeks	0.78 estimated weekly change in scale score Interval 0.63 to 0.93	0.76 estimated weekly change in scale score Interval 0.6 to 0.91
Estimated Weekly Change on World Health Organization-5 (WHO-5) Baseline to 20 Weeks	0.41 estimated weekly change in scale score Interval 0.34 to 0.48	0.33 estimated weekly change in scale score Interval 0.26 to 0.4

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Mindfulness-Based Cognitive Therapy n=2220 Participants 8 sessions of online mindfulness-based cognitive therapy Mindfulness-Based Cognitive Therapy: 8 sessions of online mindfulness-based cognitive therapy	Brief Mindfulness n=2192 Participants 3 sessions of online mindfulness therapy Brief Mindfulness: 3 sessions of online mindfulness therapy
Estimated Weekly Change on Perceived Stress Scale (PSS) Baseline to 8 Weeks	-0.13 estimated weekly change in scale score Interval -0.16 to -0.09	-0.15 estimated weekly change in scale score Interval -0.18 to -0.12
Estimated Weekly Change on Perceived Stress Scale (PSS) Baseline to 20 Weeks	-0.08 estimated weekly change in scale score Interval -0.09 to -0.06	-0.07 estimated weekly change in scale score Interval -0.08 to -0.05

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Mindfulness-Based Cognitive Therapy n=2220 Participants 8 sessions of online mindfulness-based cognitive therapy Mindfulness-Based Cognitive Therapy: 8 sessions of online mindfulness-based cognitive therapy	Brief Mindfulness n=2192 Participants 3 sessions of online mindfulness therapy Brief Mindfulness: 3 sessions of online mindfulness therapy
Estimated Weekly Change on Patient Reported Outcomes Measurement Information System (PROMIS): Emotional Distress-Depression Short Form Baseline to Week 8	-0.19 estimated weekly change in scale score Interval -0.23 to -0.15	-0.17 estimated weekly change in scale score Interval -0.21 to -0.12
Estimated Weekly Change on Patient Reported Outcomes Measurement Information System (PROMIS): Emotional Distress-Depression Short Form Baseline to Week 20	-0.11 estimated weekly change in scale score Interval -0.13 to -0.09	-0.06 estimated weekly change in scale score Interval -0.08 to -0.04

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Mindfulness-Based Cognitive Therapy n=2220 Participants 8 sessions of online mindfulness-based cognitive therapy Mindfulness-Based Cognitive Therapy: 8 sessions of online mindfulness-based cognitive therapy	Brief Mindfulness n=2192 Participants 3 sessions of online mindfulness therapy Brief Mindfulness: 3 sessions of online mindfulness therapy
Estimated Weekly Change on Patient Reported Outcomes Measurement Information System (PROMIS): Emotional Distress-Anxiety Short Form Baseline to Week 8	-0.12 estimated weekly change in scale score Interval -0.15 to -0.1	-0.13 estimated weekly change in scale score Interval -0.16 to -0.11
Estimated Weekly Change on Patient Reported Outcomes Measurement Information System (PROMIS): Emotional Distress-Anxiety Short Form Baseline to Week 20	-0.07 estimated weekly change in scale score Interval -0.08 to -0.06	-0.05 estimated weekly change in scale score Interval -0.06 to -0.04

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Mindfulness-Based Cognitive Therapy n=2220 Participants 8 sessions of online mindfulness-based cognitive therapy Mindfulness-Based Cognitive Therapy: 8 sessions of online mindfulness-based cognitive therapy	Brief Mindfulness n=2192 Participants 3 sessions of online mindfulness therapy Brief Mindfulness: 3 sessions of online mindfulness therapy
Estimated Weekly Change on Patient Reported Outcomes Measurement Information System (PROMIS): Ability to Participate in Social Roles and Activities Short Form Baseline to Week 8	-0.12 estimated weekly change in scale score Interval -0.15 to -0.09	-0.14 estimated weekly change in scale score Interval -0.17 to -0.11
Estimated Weekly Change on Patient Reported Outcomes Measurement Information System (PROMIS): Ability to Participate in Social Roles and Activities Short Form Baseline to Week 20	-0.05 estimated weekly change in scale score Interval -0.06 to -0.04	-0.04 estimated weekly change in scale score Interval -0.06 to -0.03

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Mindfulness-Based Cognitive Therapy n=2220 Participants 8 sessions of online mindfulness-based cognitive therapy Mindfulness-Based Cognitive Therapy: 8 sessions of online mindfulness-based cognitive therapy	Brief Mindfulness n=2192 Participants 3 sessions of online mindfulness therapy Brief Mindfulness: 3 sessions of online mindfulness therapy
Estimated Weekly Change on Five Facet Mindfulness Questionnaire (FFMQ) Abbreviated Baseline to 8 Weeks	0.92 estimated weekly change in scale score Interval 0.84 to 1.0	0.88 estimated weekly change in scale score Interval 0.79 to 0.96
Estimated Weekly Change on Five Facet Mindfulness Questionnaire (FFMQ) Abbreviated Baseline to 20 Weeks	0.43 estimated weekly change in scale score Interval 0.39 to 0.46	0.37 estimated weekly change in scale score Interval 0.34 to 0.41

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Mindfulness-Based Cognitive Therapy n=2220 Participants 8 sessions of online mindfulness-based cognitive therapy Mindfulness-Based Cognitive Therapy: 8 sessions of online mindfulness-based cognitive therapy	Brief Mindfulness n=2192 Participants 3 sessions of online mindfulness therapy Brief Mindfulness: 3 sessions of online mindfulness therapy
Estimated Weekly Change in World Health Organization-5 (WHO-5) Stratified by Age Baseline to 8 Weeks: Age 45	0.98 estimated weekly change in WHO-5 score Interval 0.78 to 1.19	0.75 estimated weekly change in WHO-5 score Interval 0.55 to 0.95
Estimated Weekly Change in World Health Organization-5 (WHO-5) Stratified by Age Baseline to 8 Weeks: Age 55	0.81 estimated weekly change in WHO-5 score Interval 0.66 to 0.96	0.73 estimated weekly change in WHO-5 score Interval 0.58 to 0.89
Estimated Weekly Change in World Health Organization-5 (WHO-5) Stratified by Age Baseline to 8 Weeks: Age 65	0.64 estimated weekly change in WHO-5 score Interval 0.48 to 0.8	0.72 estimated weekly change in WHO-5 score Interval 0.54 to 0.9
Estimated Weekly Change in World Health Organization-5 (WHO-5) Stratified by Age Baseline to 20 Weeks: Age 45	0.53 estimated weekly change in WHO-5 score Interval 0.43 to 0.63	0.38 estimated weekly change in WHO-5 score Interval 0.29 to 0.48
Estimated Weekly Change in World Health Organization-5 (WHO-5) Stratified by Age Baseline to 20 Weeks: Age 55	0.44 estimated weekly change in WHO-5 score Interval 0.36 to 0.51	0.33 estimated weekly change in WHO-5 score Interval 0.25 to 0.4
Estimated Weekly Change in World Health Organization-5 (WHO-5) Stratified by Age Baseline to 20 Weeks: Age 65	0.34 estimated weekly change in WHO-5 score Interval 0.27 to 0.42	0.27 estimated weekly change in WHO-5 score Interval 0.19 to 0.35

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Mindfulness-Based Cognitive Therapy n=2220 Participants 8 sessions of online mindfulness-based cognitive therapy Mindfulness-Based Cognitive Therapy: 8 sessions of online mindfulness-based cognitive therapy	Brief Mindfulness n=2192 Participants 3 sessions of online mindfulness therapy Brief Mindfulness: 3 sessions of online mindfulness therapy
Estimated Weekly Change in World Health Organization-5 (WHO-5) Stratified by Baseline Perceived Stress Scale (PSS) Baseline to Week 8: PSS = 18	0.64 estimated weekly change in WHO-5 score Interval 0.48 to 0.8	0.61 estimated weekly change in WHO-5 score Interval 0.44 to 0.78
Estimated Weekly Change in World Health Organization-5 (WHO-5) Stratified by Baseline Perceived Stress Scale (PSS) Baseline to Week 8: PSS = 20	0.78 estimated weekly change in WHO-5 score Interval 0.63 to 0.93	0.75 estimated weekly change in WHO-5 score Interval 0.6 to 0.9
Estimated Weekly Change in World Health Organization-5 (WHO-5) Stratified by Baseline Perceived Stress Scale (PSS) Baseline to Week 8: PSS = 22	0.92 estimated weekly change in WHO-5 score Interval 0.75 to 1.09	0.89 estimated weekly change in WHO-5 score Interval 0.71 to 1.07
Estimated Weekly Change in World Health Organization-5 (WHO-5) Stratified by Baseline Perceived Stress Scale (PSS) Baseline to Week 20: PSS = 18	0.35 estimated weekly change in WHO-5 score Interval 0.27 to 0.42	0.28 estimated weekly change in WHO-5 score Interval 0.21 to 0.36
Estimated Weekly Change in World Health Organization-5 (WHO-5) Stratified by Baseline Perceived Stress Scale (PSS) Baseline to Week 20: PSS = 20	0.42 estimated weekly change in WHO-5 score Interval 0.35 to 0.48	0.33 estimated weekly change in WHO-5 score Interval 0.25 to 0.4
Estimated Weekly Change in World Health Organization-5 (WHO-5) Stratified by Baseline Perceived Stress Scale (PSS) Baseline to Week 20: PSS = 22	0.48 estimated weekly change in WHO-5 score Interval 0.4 to 0.57	0.37 estimated weekly change in WHO-5 score Interval 0.28 to 0.45

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Mindfulness-Based Cognitive Therapy n=2220 Participants 8 sessions of online mindfulness-based cognitive therapy Mindfulness-Based Cognitive Therapy: 8 sessions of online mindfulness-based cognitive therapy	Brief Mindfulness n=2192 Participants 3 sessions of online mindfulness therapy Brief Mindfulness: 3 sessions of online mindfulness therapy
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 Week 8: PROMIS: EDD = 10	0.51 estimated weekly change in WHO-5 score Interval 0.32 to 0.7	0.47 estimated weekly change in WHO-5 score Interval 0.28 to 0.66
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 Week 8: PROMIS: EDD = 15	0.72 estimated weekly change in WHO-5 score Interval 0.57 to 0.86	0.69 estimated weekly change in WHO-5 score Interval 0.54 to 0.84
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 Week 8: PROMIS: EDD = 20	0.92 estimated weekly change in WHO-5 score Interval 0.75 to 1.1	0.91 estimated weekly change in WHO-5 score Interval 0.73 to 1.09
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 Week 20: PROMIS: EDD = 10	0.30 estimated weekly change in WHO-5 score Interval 0.21 to 0.39	0.26 estimated weekly change in WHO-5 score Interval 0.17 to 0.34
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 Week 20: PROMIS: EDD = 15	0.39 estimated weekly change in WHO-5 score Interval 0.32 to 0.46	0.31 estimated weekly change in WHO-5 score Interval 0.23 to 0.38
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 Week 20: PROMIS: EDD = 20	0.48 estimated weekly change in WHO-5 score Interval 0.39 to 0.56	0.36 estimated weekly change in WHO-5 score Interval 0.27 to 0.44

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Mindfulness-Based Cognitive Therapy n=2220 Participants 8 sessions of online mindfulness-based cognitive therapy Mindfulness-Based Cognitive Therapy: 8 sessions of online mindfulness-based cognitive therapy	Brief Mindfulness n=2192 Participants 3 sessions of online mindfulness therapy Brief Mindfulness: 3 sessions of online mindfulness therapy
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: PROMIS: EDA = 5	0.46 estimated weekly change in WHO-5 score Interval 0.26 to 0.66	0.47 estimated weekly change in WHO-5 score Interval 0.26 to 0.68
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: PROMIS: EDA = 10	0.85 estimated weekly change in WHO-5 score Interval 0.68 to 1.01	0.83 estimated weekly change in WHO-5 score Interval 0.66 to 0.99
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: PROMIS: EDA = 15	1.23 estimated weekly change in WHO-5 score Interval 0.91 to 1.55	1.18 estimated weekly change in WHO-5 score Interval 0.86 to 1.5
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 20 Weeks: PROMIS: EDA = 5	0.25 estimated weekly change in WHO-5 score Interval 0.16 to 0.35	0.18 estimated weekly change in WHO-5 score Interval 0.08 to 0.28
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 20 Weeks: PROMIS: EDA = 10	0.46 estimated weekly change in WHO-5 score Interval 0.38 to 0.53	0.37 estimated weekly change in WHO-5 score Interval 0.29 to 0.45
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 20 Weeks: PROMIS: EDA = 15	0.66 estimated weekly change in WHO-5 score Interval 0.5 to 0.81	0.56 estimated weekly change in WHO-5 score Interval 0.4 to 0.72

OTHER_PRE_SPECIFIED outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Mindfulness-Based Cognitive Therapy n=2220 Participants 8 sessions of online mindfulness-based cognitive therapy Mindfulness-Based Cognitive Therapy: 8 sessions of online mindfulness-based cognitive therapy	Brief Mindfulness n=2192 Participants 3 sessions of online mindfulness therapy Brief Mindfulness: 3 sessions of online mindfulness therapy
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) Baseline to 8 Weeks: PROMIS: APRA = 10	0.74 estimated weekly change in WHO-5 score Interval 0.6 to 0.89	0.73 estimated weekly change in WHO-5 score Interval 0.58 to 0.88
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) Baseline to 8 Weeks: PROMIS: APRA = 5	0.57 estimated weekly change in WHO-5 score Interval 0.35 to 0.8	0.46 estimated weekly change in WHO-5 score Interval 0.23 to 0.7
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) Baseline to 8 Weeks: PROMIS: APRA = 15	0.91 estimated weekly change in WHO-5 score Interval 0.69 to 1.13	1.00 estimated weekly change in WHO-5 score Interval 0.77 to 1.24
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) Baseline to 20 Weeks: PROMIS: APRA = 5	0.33 estimated weekly change in WHO-5 score Interval 0.23 to 0.44	0.24 estimated weekly change in WHO-5 score Interval 0.13 to 0.34
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) Baseline to 20 Weeks: PROMIS: APRA = 10	0.40 estimated weekly change in WHO-5 score Interval 0.33 to 0.47	0.32 estimated weekly change in WHO-5 score Interval 0.25 to 0.4
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) Baseline to 20 Weeks: PROMIS: APRA = 15	0.47 estimated weekly change in WHO-5 score Interval 0.36 to 0.58	0.41 estimated weekly change in WHO-5 score Interval 0.3 to 0.53

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Mindfulness-Based Cognitive Therapy n=2220 Participants 8 sessions of online mindfulness-based cognitive therapy Mindfulness-Based Cognitive Therapy: 8 sessions of online mindfulness-based cognitive therapy	Brief Mindfulness n=2192 Participants 3 sessions of online mindfulness therapy Brief Mindfulness: 3 sessions of online mindfulness therapy
Estimated Weekly Change in World Health Organization-5 (WHO-5) Stratified by Baseline Five Facet Mindfulness Questionnaire (FFMQ) Abbreviated Baseline to 8 Weeks: FFMQ = 40	1.06 estimated weekly change in WHO-5 score Interval 0.85 to 1.26	0.97 estimated weekly change in WHO-5 score Interval 0.75 to 1.19
Estimated Weekly Change in World Health Organization-5 (WHO-5) Stratified by Baseline Five Facet Mindfulness Questionnaire (FFMQ) Abbreviated Baseline to 8 Weeks: FFMQ = 50	0.78 estimated weekly change in WHO-5 score Interval 0.64 to 0.93	0.75 estimated weekly change in WHO-5 score Interval 0.6 to 0.9
Estimated Weekly Change in World Health Organization-5 (WHO-5) Stratified by Baseline Five Facet Mindfulness Questionnaire (FFMQ) Abbreviated Baseline to 8 Weeks: FFMQ = 60	0.51 estimated weekly change in WHO-5 score Interval 0.32 to 0.7	0.53 estimated weekly change in WHO-5 score Interval 0.34 to 0.73
Estimated Weekly Change in World Health Organization-5 (WHO-5) Stratified by Baseline Five Facet Mindfulness Questionnaire (FFMQ) Abbreviated Baseline to 20 Weeks: FFMQ = 40	0.52 estimated weekly change in WHO-5 score Interval 0.42 to 0.62	0.41 estimated weekly change in WHO-5 score Interval 0.31 to 0.52
Estimated Weekly Change in World Health Organization-5 (WHO-5) Stratified by Baseline Five Facet Mindfulness Questionnaire (FFMQ) Abbreviated Baseline to 20 Weeks: FFMQ = 50	0.41 estimated weekly change in WHO-5 score Interval 0.34 to 0.48	0.33 estimated weekly change in WHO-5 score Interval 0.25 to 0.4
Estimated Weekly Change in World Health Organization-5 (WHO-5) Stratified by Baseline Five Facet Mindfulness Questionnaire (FFMQ) Abbreviated Baseline to 20 Weeks: FFMQ = 60	0.30 estimated weekly change in WHO-5 score Interval 0.22 to 0.39	0.24 estimated weekly change in WHO-5 score Interval 0.15 to 0.33

POST_HOC outcome

Timeframe: 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. Participants reported whether they have a psychiatric illness.

Outcome measures

Outcome measures
Measure	Mindfulness-Based Cognitive Therapy n=2220 Participants 8 sessions of online mindfulness-based cognitive therapy Mindfulness-Based Cognitive Therapy: 8 sessions of online mindfulness-based cognitive therapy	Brief Mindfulness n=2192 Participants 3 sessions of online mindfulness therapy Brief Mindfulness: 3 sessions of online mindfulness therapy
Estimated Weekly Change in World Health Organization-5 (WHO-5) Stratified by Self-Reported Presence of Psychiatric Illness (Yes or No) Baseline to 8 Weeks: No Psychiatric Illness	0.75 estimated weekly change in WHO-5 score Interval 0.57 to 0.92	0.79 estimated weekly change in WHO-5 score Interval 0.6 to 0.97
Estimated Weekly Change in World Health Organization-5 (WHO-5) Stratified by Self-Reported Presence of Psychiatric Illness (Yes or No) Baseline to 8 Weeks: Psychiatric Illness	0.86 estimated weekly change in WHO-5 score Interval 0.59 to 1.13	0.68 estimated weekly change in WHO-5 score Interval 0.4 to 0.96
Estimated Weekly Change in World Health Organization-5 (WHO-5) Stratified by Self-Reported Presence of Psychiatric Illness (Yes or No) Baseline to 20 Weeks: Psychiatric Illness	0.86 estimated weekly change in WHO-5 score Interval 0.86 to 0.86	0.68 estimated weekly change in WHO-5 score Interval 0.68 to 0.68
Estimated Weekly Change in World Health Organization-5 (WHO-5) Stratified by Self-Reported Presence of Psychiatric Illness (Yes or No) Baseline to 20 Weeks: No Psychiatric Illness	0.37 estimated weekly change in WHO-5 score Interval 0.29 to 0.46	0.32 estimated weekly change in WHO-5 score Interval 0.24 to 0.41

POST_HOC outcome

Timeframe: 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. Participants reported whether they have a major medical problem.

Outcome measures

Outcome measures
Measure	Mindfulness-Based Cognitive Therapy n=2220 Participants 8 sessions of online mindfulness-based cognitive therapy Mindfulness-Based Cognitive Therapy: 8 sessions of online mindfulness-based cognitive therapy	Brief Mindfulness n=2192 Participants 3 sessions of online mindfulness therapy Brief Mindfulness: 3 sessions of online mindfulness therapy
Estimated Weekly Change in World Health Organization-5 (WHO-5) Stratified by Self-Reported Presence of Medical Problems (Yes or No) Baseline to 20 Weeks: No Medical Problems	0.38 estimated weekly change in WHO-5 score Interval 0.25 to 0.52	0.37 estimated weekly change in WHO-5 score Interval 0.24 to 0.51
Estimated Weekly Change in World Health Organization-5 (WHO-5) Stratified by Self-Reported Presence of Medical Problems (Yes or No) Baseline to 8 Weeks: Medical Problems	0.79 estimated weekly change in WHO-5 score Interval 0.62 to 0.96	0.80 estimated weekly change in WHO-5 score Interval 0.61 to 0.98
Estimated Weekly Change in World Health Organization-5 (WHO-5) Stratified by Self-Reported Presence of Medical Problems (Yes or No) Baseline to 8 Weeks: No Medical Problems	0.78 estimated weekly change in WHO-5 score Interval 0.5 to 1.06	0.67 estimated weekly change in WHO-5 score Interval 0.38 to 0.96
Estimated Weekly Change in World Health Organization-5 (WHO-5) Stratified by Self-Reported Presence of Medical Problems (Yes or No) Baseline to 20 Weeks: Medical Problems	0.79 estimated weekly change in WHO-5 score Interval 0.79 to 0.79	0.80 estimated weekly change in WHO-5 score Interval 0.8 to 0.8

POST_HOC outcome

Timeframe: 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. Percentage of total study sessions completed was calculated.

Outcome measures

Outcome measures
Measure	Mindfulness-Based Cognitive Therapy n=2220 Participants 8 sessions of online mindfulness-based cognitive therapy Mindfulness-Based Cognitive Therapy: 8 sessions of online mindfulness-based cognitive therapy	Brief Mindfulness n=2192 Participants 3 sessions of online mindfulness therapy Brief Mindfulness: 3 sessions of online mindfulness therapy
Estimated Weekly Change in World Health Organization-5 (WHO-5) Stratified by Percentage of Sessions Completed Baseline to 8 Weeks: 0%	0.27 estimated weekly change in WHO-5 score Interval 0.03 to 0.51	0.64 estimated weekly change in WHO-5 score Interval 0.37 to 0.9
Estimated Weekly Change in World Health Organization-5 (WHO-5) Stratified by Percentage of Sessions Completed Baseline to 8 Weeks: 33%	0.61 estimated weekly change in WHO-5 score Interval 0.45 to 0.77	0.70 estimated weekly change in WHO-5 score Interval 0.52 to 0.87
Estimated Weekly Change in World Health Organization-5 (WHO-5) Stratified by Percentage of Sessions Completed Baseline to 8 Weeks: 100%	1.28 estimated weekly change in WHO-5 score Interval 1.02 to 1.55	0.82 estimated weekly change in WHO-5 score Interval 0.57 to 1.07
Estimated Weekly Change in World Health Organization-5 (WHO-5) Stratified by Percentage of Sessions Completed Baseline to 20 Weeks: 0%	0.26 estimated weekly change in WHO-5 score Interval 0.14 to 0.37	0.26 estimated weekly change in WHO-5 score Interval 0.14 to 0.39
Estimated Weekly Change in World Health Organization-5 (WHO-5) Stratified by Percentage of Sessions Completed Baseline to 20 Weeks: 33%	0.35 estimated weekly change in WHO-5 score Interval 0.27 to 0.42	0.31 estimated weekly change in WHO-5 score Interval 0.22 to 0.39
Estimated Weekly Change in World Health Organization-5 (WHO-5) Stratified by Percentage of Sessions Completed Baseline to 20 Weeks: 100%	0.53 estimated weekly change in WHO-5 score Interval 0.41 to 0.65	0.39 estimated weekly change in WHO-5 score Interval 0.28 to 0.51

POST_HOC outcome

Timeframe: 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. Participants reported their level of education.

Outcome measures

Outcome measures
Measure	Mindfulness-Based Cognitive Therapy n=2220 Participants 8 sessions of online mindfulness-based cognitive therapy Mindfulness-Based Cognitive Therapy: 8 sessions of online mindfulness-based cognitive therapy	Brief Mindfulness n=2192 Participants 3 sessions of online mindfulness therapy Brief Mindfulness: 3 sessions of online mindfulness therapy
Estimated Weekly Change in World Health Organization-5 (WHO-5) Stratified by Education Baseline to 8 Weeks: High School or Less	0.38 estimated weekly change in WHO-5 score Interval -0.35 to 1.11	0.39 estimated weekly change in WHO-5 score Interval -0.31 to 1.08
Estimated Weekly Change in World Health Organization-5 (WHO-5) Stratified by Education Baseline to 8 Weeks: 2 or 4-Year College	0.84 estimated weekly change in WHO-5 score Interval 0.63 to 1.06	0.75 estimated weekly change in WHO-5 score Interval 0.53 to 0.97
Estimated Weekly Change in World Health Organization-5 (WHO-5) Stratified by Education Baseline to 8 Weeks: > College	0.73 estimated weekly change in WHO-5 score Interval 0.52 to 0.95	0.87 estimated weekly change in WHO-5 score Interval 0.64 to 1.1
Estimated Weekly Change in World Health Organization-5 (WHO-5) Stratified by Education Baseline to 20 Weeks: High School or Less	0.40 estimated weekly change in WHO-5 score Interval 0.06 to 0.75	0.20 estimated weekly change in WHO-5 score Interval -0.15 to 0.55
Estimated Weekly Change in World Health Organization-5 (WHO-5) Stratified by Education Baseline to 20 Weeks: 2 or 4-Year College	0.44 estimated weekly change in WHO-5 score Interval 0.34 to 0.54	0.31 estimated weekly change in WHO-5 score Interval 0.2 to 0.41
Estimated Weekly Change in World Health Organization-5 (WHO-5) Stratified by Education Baseline to 20 Weeks: > College	0.37 estimated weekly change in WHO-5 score Interval 0.27 to 0.46	0.37 estimated weekly change in WHO-5 score Interval 0.27 to 0.48

POST_HOC outcome

Timeframe: 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. Participants reported their race.

Outcome measures

Outcome measures
Measure	Mindfulness-Based Cognitive Therapy n=2220 Participants 8 sessions of online mindfulness-based cognitive therapy Mindfulness-Based Cognitive Therapy: 8 sessions of online mindfulness-based cognitive therapy	Brief Mindfulness n=2192 Participants 3 sessions of online mindfulness therapy Brief Mindfulness: 3 sessions of online mindfulness therapy
Estimated Weekly Change in World Health Organization-5 (WHO-5) Stratified by Race Baseline to 8 Weeks: White	0.82 estimated weekly change in WHO-5 score Interval 0.66 to 0.97	0.77 estimated weekly change in WHO-5 score Interval 0.61 to 0.94
Estimated Weekly Change in World Health Organization-5 (WHO-5) Stratified by Race Baseline to 8 Weeks: Non-White	0.29 estimated weekly change in WHO-5 score Interval -0.28 to 0.87	0.78 estimated weekly change in WHO-5 score Interval 0.2 to 1.35
Estimated Weekly Change in World Health Organization-5 (WHO-5) Stratified by Race Baseline to 20 Weeks: White	0.40 estimated weekly change in WHO-5 score Interval 0.33 to 0.47	0.34 estimated weekly change in WHO-5 score Interval 0.26 to 0.41
Estimated Weekly Change in World Health Organization-5 (WHO-5) Stratified by Race Baseline to 20 Weeks: Non-White	0.41 estimated weekly change in WHO-5 score Interval 0.15 to 0.67	0.37 estimated weekly change in WHO-5 score Interval 0.1 to 0.64

POST_HOC outcome

Timeframe: 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. Participants reported sex assigned at birth.

Outcome measures

Outcome measures
Measure	Mindfulness-Based Cognitive Therapy n=2220 Participants 8 sessions of online mindfulness-based cognitive therapy Mindfulness-Based Cognitive Therapy: 8 sessions of online mindfulness-based cognitive therapy	Brief Mindfulness n=2192 Participants 3 sessions of online mindfulness therapy Brief Mindfulness: 3 sessions of online mindfulness therapy
Estimated Weekly Change in World Health Organization-5 (WHO-5) Stratified by Sex Baseline to 8 Weeks: Male	0.49 estimated weekly change in WHO-5 score Interval 0.18 to 0.81	0.51 estimated weekly change in WHO-5 score Interval 0.17 to 0.84
Estimated Weekly Change in World Health Organization-5 (WHO-5) Stratified by Sex Baseline to 8 Weeks: Female	0.85 estimated weekly change in WHO-5 score Interval 0.68 to 1.01	0.82 estimated weekly change in WHO-5 score Interval 0.65 to 1.0
Estimated Weekly Change in World Health Organization-5 (WHO-5) Stratified by Sex Baseline to 8 Weeks: Other	1.85 estimated weekly change in WHO-5 score Interval -0.22 to 3.91	0.18 estimated weekly change in WHO-5 score Interval -1.58 to 1.94
Estimated Weekly Change in World Health Organization-5 (WHO-5) Stratified by Sex Baseline to 20 Weeks: Male	0.27 estimated weekly change in WHO-5 score Interval 0.13 to 0.41	0.27 estimated weekly change in WHO-5 score Interval 0.12 to 0.42
Estimated Weekly Change in World Health Organization-5 (WHO-5) Stratified by Sex Baseline to 20 Weeks: Female	0.45 estimated weekly change in WHO-5 score Interval 0.37 to 0.52	0.35 estimated weekly change in WHO-5 score Interval 0.26 to 0.43
Estimated Weekly Change in World Health Organization-5 (WHO-5) Stratified by Sex Baseline to 20 Weeks: Other	1.29 estimated weekly change in WHO-5 score Interval 0.34 to 2.24	0.34 estimated weekly change in WHO-5 score Interval -0.42 to 1.1

POST_HOC outcome

Timeframe: 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. Participants reported their ethnicity.

Outcome measures

Outcome measures
Measure	Mindfulness-Based Cognitive Therapy n=2220 Participants 8 sessions of online mindfulness-based cognitive therapy Mindfulness-Based Cognitive Therapy: 8 sessions of online mindfulness-based cognitive therapy	Brief Mindfulness n=2192 Participants 3 sessions of online mindfulness therapy Brief Mindfulness: 3 sessions of online mindfulness therapy
Estimated Weekly Change in World Health Organization-5 (WHO-5) Stratified by Ethnicity Baseline to 20 Weeks: Hispanic	0.56 estimated weekly change in WHO-5 score Interval 0.17 to 0.95	0.23 estimated weekly change in WHO-5 score Interval -0.13 to 0.58
Estimated Weekly Change in World Health Organization-5 (WHO-5) Stratified by Ethnicity Baseline to 20 Weeks: Non-Hispanic	0.40 estimated weekly change in WHO-5 score Interval 0.33 to 0.47	0.34 estimated weekly change in WHO-5 score Interval 0.27 to 0.41
Estimated Weekly Change in World Health Organization-5 (WHO-5) Stratified by Ethnicity Baseline to 8 Weeks: Hispanic	0.92 estimated weekly change in WHO-5 score Interval 0.12 to 1.71	0.88 estimated weekly change in WHO-5 score Interval 0.13 to 1.63
Estimated Weekly Change in World Health Organization-5 (WHO-5) Stratified by Ethnicity Baseline to 8 Weeks: Non-Hispanic	0.76 estimated weekly change in WHO-5 score Interval 0.61 to 0.91	0.77 estimated weekly change in WHO-5 score Interval 0.61 to 0.93
Estimated Weekly Change in World Health Organization-5 (WHO-5) Stratified by Ethnicity Baseline to 8 Weeks: Other	0.67 estimated weekly change in WHO-5 score Interval -3.14 to 4.48	0.68 estimated weekly change in WHO-5 score Interval -3.12 to 4.49
Estimated Weekly Change in World Health Organization-5 (WHO-5) Stratified by Ethnicity Baseline to 20 Weeks: Other	0.74 estimated weekly change in WHO-5 score Interval -2.6 to 4.08	0.68 estimated weekly change in WHO-5 score Interval -2.66 to 4.02

Adverse Events

Mindfulness-Based Cognitive Therapy

Serious events: 30 serious events

Other events: 33 other events

Deaths: 0 deaths

Brief Mindfulness

Serious events: 31 serious events

Other events: 41 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Mindfulness-Based Cognitive Therapy n=2220 participants at risk 8 sessions of online mindfulness-based cognitive therapy Mindfulness-Based Cognitive Therapy: 8 sessions of online mindfulness-based cognitive therapy	Brief Mindfulness n=2192 participants at risk 3 sessions of online mindfulness therapy Brief Mindfulness: 3 sessions of online mindfulness therapy
Cardiac disorders Cardiac Issue	0.05% 1/2220 • Number of events 1 • 20 weeks. Data on adverse events (AEs) were collected with a 3-item questionnaire at all study sessions after study randomization. Participants provided a written description of the event, and three study staff sorted these into appropriate organ systems: two coded responses independently and the third resolved discrepancies. Participants reported the event severity, based on a plain-English definition of a serious adverse event (SAE). No AEs/SAEs were reported by participants to be study-related.	0.00% 0/2192 • 20 weeks. Data on adverse events (AEs) were collected with a 3-item questionnaire at all study sessions after study randomization. Participants provided a written description of the event, and three study staff sorted these into appropriate organ systems: two coded responses independently and the third resolved discrepancies. Participants reported the event severity, based on a plain-English definition of a serious adverse event (SAE). No AEs/SAEs were reported by participants to be study-related.
Gastrointestinal disorders Gastrointestinal Issue	0.14% 3/2220 • Number of events 3 • 20 weeks. Data on adverse events (AEs) were collected with a 3-item questionnaire at all study sessions after study randomization. Participants provided a written description of the event, and three study staff sorted these into appropriate organ systems: two coded responses independently and the third resolved discrepancies. Participants reported the event severity, based on a plain-English definition of a serious adverse event (SAE). No AEs/SAEs were reported by participants to be study-related.	0.27% 6/2192 • Number of events 6 • 20 weeks. Data on adverse events (AEs) were collected with a 3-item questionnaire at all study sessions after study randomization. Participants provided a written description of the event, and three study staff sorted these into appropriate organ systems: two coded responses independently and the third resolved discrepancies. Participants reported the event severity, based on a plain-English definition of a serious adverse event (SAE). No AEs/SAEs were reported by participants to be study-related.
General disorders Undefined Health Issue	0.09% 2/2220 • Number of events 2 • 20 weeks. Data on adverse events (AEs) were collected with a 3-item questionnaire at all study sessions after study randomization. Participants provided a written description of the event, and three study staff sorted these into appropriate organ systems: two coded responses independently and the third resolved discrepancies. Participants reported the event severity, based on a plain-English definition of a serious adverse event (SAE). No AEs/SAEs were reported by participants to be study-related.	0.18% 4/2192 • Number of events 4 • 20 weeks. Data on adverse events (AEs) were collected with a 3-item questionnaire at all study sessions after study randomization. Participants provided a written description of the event, and three study staff sorted these into appropriate organ systems: two coded responses independently and the third resolved discrepancies. Participants reported the event severity, based on a plain-English definition of a serious adverse event (SAE). No AEs/SAEs were reported by participants to be study-related.
Immune system disorders Immune System Issue	0.09% 2/2220 • Number of events 2 • 20 weeks. Data on adverse events (AEs) were collected with a 3-item questionnaire at all study sessions after study randomization. Participants provided a written description of the event, and three study staff sorted these into appropriate organ systems: two coded responses independently and the third resolved discrepancies. Participants reported the event severity, based on a plain-English definition of a serious adverse event (SAE). No AEs/SAEs were reported by participants to be study-related.	0.00% 0/2192 • 20 weeks. Data on adverse events (AEs) were collected with a 3-item questionnaire at all study sessions after study randomization. Participants provided a written description of the event, and three study staff sorted these into appropriate organ systems: two coded responses independently and the third resolved discrepancies. Participants reported the event severity, based on a plain-English definition of a serious adverse event (SAE). No AEs/SAEs were reported by participants to be study-related.
Infections and infestations Infection	0.05% 1/2220 • Number of events 1 • 20 weeks. Data on adverse events (AEs) were collected with a 3-item questionnaire at all study sessions after study randomization. Participants provided a written description of the event, and three study staff sorted these into appropriate organ systems: two coded responses independently and the third resolved discrepancies. Participants reported the event severity, based on a plain-English definition of a serious adverse event (SAE). No AEs/SAEs were reported by participants to be study-related.	0.00% 0/2192 • 20 weeks. Data on adverse events (AEs) were collected with a 3-item questionnaire at all study sessions after study randomization. Participants provided a written description of the event, and three study staff sorted these into appropriate organ systems: two coded responses independently and the third resolved discrepancies. Participants reported the event severity, based on a plain-English definition of a serious adverse event (SAE). No AEs/SAEs were reported by participants to be study-related.
Musculoskeletal and connective tissue disorders Musculoskeletal or Connective Tissue Issue	0.18% 4/2220 • Number of events 4 • 20 weeks. Data on adverse events (AEs) were collected with a 3-item questionnaire at all study sessions after study randomization. Participants provided a written description of the event, and three study staff sorted these into appropriate organ systems: two coded responses independently and the third resolved discrepancies. Participants reported the event severity, based on a plain-English definition of a serious adverse event (SAE). No AEs/SAEs were reported by participants to be study-related.	0.23% 5/2192 • Number of events 6 • 20 weeks. Data on adverse events (AEs) were collected with a 3-item questionnaire at all study sessions after study randomization. Participants provided a written description of the event, and three study staff sorted these into appropriate organ systems: two coded responses independently and the third resolved discrepancies. Participants reported the event severity, based on a plain-English definition of a serious adverse event (SAE). No AEs/SAEs were reported by participants to be study-related.
Nervous system disorders Nervous System Issue	0.14% 3/2220 • Number of events 3 • 20 weeks. Data on adverse events (AEs) were collected with a 3-item questionnaire at all study sessions after study randomization. Participants provided a written description of the event, and three study staff sorted these into appropriate organ systems: two coded responses independently and the third resolved discrepancies. Participants reported the event severity, based on a plain-English definition of a serious adverse event (SAE). No AEs/SAEs were reported by participants to be study-related.	0.00% 0/2192 • 20 weeks. Data on adverse events (AEs) were collected with a 3-item questionnaire at all study sessions after study randomization. Participants provided a written description of the event, and three study staff sorted these into appropriate organ systems: two coded responses independently and the third resolved discrepancies. Participants reported the event severity, based on a plain-English definition of a serious adverse event (SAE). No AEs/SAEs were reported by participants to be study-related.
Psychiatric disorders Psychiatric Issue	0.05% 1/2220 • Number of events 1 • 20 weeks. Data on adverse events (AEs) were collected with a 3-item questionnaire at all study sessions after study randomization. Participants provided a written description of the event, and three study staff sorted these into appropriate organ systems: two coded responses independently and the third resolved discrepancies. Participants reported the event severity, based on a plain-English definition of a serious adverse event (SAE). No AEs/SAEs were reported by participants to be study-related.	0.09% 2/2192 • Number of events 2 • 20 weeks. Data on adverse events (AEs) were collected with a 3-item questionnaire at all study sessions after study randomization. Participants provided a written description of the event, and three study staff sorted these into appropriate organ systems: two coded responses independently and the third resolved discrepancies. Participants reported the event severity, based on a plain-English definition of a serious adverse event (SAE). No AEs/SAEs were reported by participants to be study-related.
Renal and urinary disorders Renal Issue	0.05% 1/2220 • Number of events 1 • 20 weeks. Data on adverse events (AEs) were collected with a 3-item questionnaire at all study sessions after study randomization. Participants provided a written description of the event, and three study staff sorted these into appropriate organ systems: two coded responses independently and the third resolved discrepancies. Participants reported the event severity, based on a plain-English definition of a serious adverse event (SAE). No AEs/SAEs were reported by participants to be study-related.	0.05% 1/2192 • Number of events 1 • 20 weeks. Data on adverse events (AEs) were collected with a 3-item questionnaire at all study sessions after study randomization. Participants provided a written description of the event, and three study staff sorted these into appropriate organ systems: two coded responses independently and the third resolved discrepancies. Participants reported the event severity, based on a plain-English definition of a serious adverse event (SAE). No AEs/SAEs were reported by participants to be study-related.
Respiratory, thoracic and mediastinal disorders Respiratory Issue/Flu	0.09% 2/2220 • Number of events 2 • 20 weeks. Data on adverse events (AEs) were collected with a 3-item questionnaire at all study sessions after study randomization. Participants provided a written description of the event, and three study staff sorted these into appropriate organ systems: two coded responses independently and the third resolved discrepancies. Participants reported the event severity, based on a plain-English definition of a serious adverse event (SAE). No AEs/SAEs were reported by participants to be study-related.	0.18% 4/2192 • Number of events 4 • 20 weeks. Data on adverse events (AEs) were collected with a 3-item questionnaire at all study sessions after study randomization. Participants provided a written description of the event, and three study staff sorted these into appropriate organ systems: two coded responses independently and the third resolved discrepancies. Participants reported the event severity, based on a plain-English definition of a serious adverse event (SAE). No AEs/SAEs were reported by participants to be study-related.
Social circumstances Negative Life Event	0.45% 10/2220 • Number of events 10 • 20 weeks. Data on adverse events (AEs) were collected with a 3-item questionnaire at all study sessions after study randomization. Participants provided a written description of the event, and three study staff sorted these into appropriate organ systems: two coded responses independently and the third resolved discrepancies. Participants reported the event severity, based on a plain-English definition of a serious adverse event (SAE). No AEs/SAEs were reported by participants to be study-related.	0.46% 10/2192 • Number of events 11 • 20 weeks. Data on adverse events (AEs) were collected with a 3-item questionnaire at all study sessions after study randomization. Participants provided a written description of the event, and three study staff sorted these into appropriate organ systems: two coded responses independently and the third resolved discrepancies. Participants reported the event severity, based on a plain-English definition of a serious adverse event (SAE). No AEs/SAEs were reported by participants to be study-related.
Surgical and medical procedures Surgical or Medical Procedure	0.14% 3/2220 • Number of events 3 • 20 weeks. Data on adverse events (AEs) were collected with a 3-item questionnaire at all study sessions after study randomization. Participants provided a written description of the event, and three study staff sorted these into appropriate organ systems: two coded responses independently and the third resolved discrepancies. Participants reported the event severity, based on a plain-English definition of a serious adverse event (SAE). No AEs/SAEs were reported by participants to be study-related.	0.05% 1/2192 • Number of events 1 • 20 weeks. Data on adverse events (AEs) were collected with a 3-item questionnaire at all study sessions after study randomization. Participants provided a written description of the event, and three study staff sorted these into appropriate organ systems: two coded responses independently and the third resolved discrepancies. Participants reported the event severity, based on a plain-English definition of a serious adverse event (SAE). No AEs/SAEs were reported by participants to be study-related.
Blood and lymphatic system disorders Blood/Lymphatic Issue	0.00% 0/2220 • 20 weeks. Data on adverse events (AEs) were collected with a 3-item questionnaire at all study sessions after study randomization. Participants provided a written description of the event, and three study staff sorted these into appropriate organ systems: two coded responses independently and the third resolved discrepancies. Participants reported the event severity, based on a plain-English definition of a serious adverse event (SAE). No AEs/SAEs were reported by participants to be study-related.	0.05% 1/2192 • Number of events 1 • 20 weeks. Data on adverse events (AEs) were collected with a 3-item questionnaire at all study sessions after study randomization. Participants provided a written description of the event, and three study staff sorted these into appropriate organ systems: two coded responses independently and the third resolved discrepancies. Participants reported the event severity, based on a plain-English definition of a serious adverse event (SAE). No AEs/SAEs were reported by participants to be study-related.

Other adverse events

Other adverse events
Measure	Mindfulness-Based Cognitive Therapy n=2220 participants at risk 8 sessions of online mindfulness-based cognitive therapy Mindfulness-Based Cognitive Therapy: 8 sessions of online mindfulness-based cognitive therapy	Brief Mindfulness n=2192 participants at risk 3 sessions of online mindfulness therapy Brief Mindfulness: 3 sessions of online mindfulness therapy
Cardiac disorders Cardiac Issue	0.05% 1/2220 • Number of events 1 • 20 weeks. Data on adverse events (AEs) were collected with a 3-item questionnaire at all study sessions after study randomization. Participants provided a written description of the event, and three study staff sorted these into appropriate organ systems: two coded responses independently and the third resolved discrepancies. Participants reported the event severity, based on a plain-English definition of a serious adverse event (SAE). No AEs/SAEs were reported by participants to be study-related.	0.05% 1/2192 • Number of events 1 • 20 weeks. Data on adverse events (AEs) were collected with a 3-item questionnaire at all study sessions after study randomization. Participants provided a written description of the event, and three study staff sorted these into appropriate organ systems: two coded responses independently and the third resolved discrepancies. Participants reported the event severity, based on a plain-English definition of a serious adverse event (SAE). No AEs/SAEs were reported by participants to be study-related.
Endocrine disorders Endocrine Issue	0.00% 0/2220 • 20 weeks. Data on adverse events (AEs) were collected with a 3-item questionnaire at all study sessions after study randomization. Participants provided a written description of the event, and three study staff sorted these into appropriate organ systems: two coded responses independently and the third resolved discrepancies. Participants reported the event severity, based on a plain-English definition of a serious adverse event (SAE). No AEs/SAEs were reported by participants to be study-related.	0.05% 1/2192 • Number of events 1 • 20 weeks. Data on adverse events (AEs) were collected with a 3-item questionnaire at all study sessions after study randomization. Participants provided a written description of the event, and three study staff sorted these into appropriate organ systems: two coded responses independently and the third resolved discrepancies. Participants reported the event severity, based on a plain-English definition of a serious adverse event (SAE). No AEs/SAEs were reported by participants to be study-related.
Gastrointestinal disorders Gastrointestinal Issue	0.18% 4/2220 • Number of events 4 • 20 weeks. Data on adverse events (AEs) were collected with a 3-item questionnaire at all study sessions after study randomization. Participants provided a written description of the event, and three study staff sorted these into appropriate organ systems: two coded responses independently and the third resolved discrepancies. Participants reported the event severity, based on a plain-English definition of a serious adverse event (SAE). No AEs/SAEs were reported by participants to be study-related.	0.46% 10/2192 • Number of events 14 • 20 weeks. Data on adverse events (AEs) were collected with a 3-item questionnaire at all study sessions after study randomization. Participants provided a written description of the event, and three study staff sorted these into appropriate organ systems: two coded responses independently and the third resolved discrepancies. Participants reported the event severity, based on a plain-English definition of a serious adverse event (SAE). No AEs/SAEs were reported by participants to be study-related.
General disorders Undefined Health Issue	0.23% 5/2220 • Number of events 6 • 20 weeks. Data on adverse events (AEs) were collected with a 3-item questionnaire at all study sessions after study randomization. Participants provided a written description of the event, and three study staff sorted these into appropriate organ systems: two coded responses independently and the third resolved discrepancies. Participants reported the event severity, based on a plain-English definition of a serious adverse event (SAE). No AEs/SAEs were reported by participants to be study-related.	0.41% 9/2192 • Number of events 10 • 20 weeks. Data on adverse events (AEs) were collected with a 3-item questionnaire at all study sessions after study randomization. Participants provided a written description of the event, and three study staff sorted these into appropriate organ systems: two coded responses independently and the third resolved discrepancies. Participants reported the event severity, based on a plain-English definition of a serious adverse event (SAE). No AEs/SAEs were reported by participants to be study-related.
Injury, poisoning and procedural complications Injury or Procedural Complication	0.05% 1/2220 • Number of events 1 • 20 weeks. Data on adverse events (AEs) were collected with a 3-item questionnaire at all study sessions after study randomization. Participants provided a written description of the event, and three study staff sorted these into appropriate organ systems: two coded responses independently and the third resolved discrepancies. Participants reported the event severity, based on a plain-English definition of a serious adverse event (SAE). No AEs/SAEs were reported by participants to be study-related.	0.00% 0/2192 • 20 weeks. Data on adverse events (AEs) were collected with a 3-item questionnaire at all study sessions after study randomization. Participants provided a written description of the event, and three study staff sorted these into appropriate organ systems: two coded responses independently and the third resolved discrepancies. Participants reported the event severity, based on a plain-English definition of a serious adverse event (SAE). No AEs/SAEs were reported by participants to be study-related.
Musculoskeletal and connective tissue disorders Musculoskeletal or Connective Tissue Issue	0.41% 9/2220 • Number of events 10 • 20 weeks. Data on adverse events (AEs) were collected with a 3-item questionnaire at all study sessions after study randomization. Participants provided a written description of the event, and three study staff sorted these into appropriate organ systems: two coded responses independently and the third resolved discrepancies. Participants reported the event severity, based on a plain-English definition of a serious adverse event (SAE). No AEs/SAEs were reported by participants to be study-related.	0.41% 9/2192 • Number of events 9 • 20 weeks. Data on adverse events (AEs) were collected with a 3-item questionnaire at all study sessions after study randomization. Participants provided a written description of the event, and three study staff sorted these into appropriate organ systems: two coded responses independently and the third resolved discrepancies. Participants reported the event severity, based on a plain-English definition of a serious adverse event (SAE). No AEs/SAEs were reported by participants to be study-related.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer	0.05% 1/2220 • Number of events 1 • 20 weeks. Data on adverse events (AEs) were collected with a 3-item questionnaire at all study sessions after study randomization. Participants provided a written description of the event, and three study staff sorted these into appropriate organ systems: two coded responses independently and the third resolved discrepancies. Participants reported the event severity, based on a plain-English definition of a serious adverse event (SAE). No AEs/SAEs were reported by participants to be study-related.	0.09% 2/2192 • Number of events 2 • 20 weeks. Data on adverse events (AEs) were collected with a 3-item questionnaire at all study sessions after study randomization. Participants provided a written description of the event, and three study staff sorted these into appropriate organ systems: two coded responses independently and the third resolved discrepancies. Participants reported the event severity, based on a plain-English definition of a serious adverse event (SAE). No AEs/SAEs were reported by participants to be study-related.
Nervous system disorders Nervous System Issue	0.23% 5/2220 • Number of events 6 • 20 weeks. Data on adverse events (AEs) were collected with a 3-item questionnaire at all study sessions after study randomization. Participants provided a written description of the event, and three study staff sorted these into appropriate organ systems: two coded responses independently and the third resolved discrepancies. Participants reported the event severity, based on a plain-English definition of a serious adverse event (SAE). No AEs/SAEs were reported by participants to be study-related.	0.05% 1/2192 • Number of events 1 • 20 weeks. Data on adverse events (AEs) were collected with a 3-item questionnaire at all study sessions after study randomization. Participants provided a written description of the event, and three study staff sorted these into appropriate organ systems: two coded responses independently and the third resolved discrepancies. Participants reported the event severity, based on a plain-English definition of a serious adverse event (SAE). No AEs/SAEs were reported by participants to be study-related.
Product Issues Medication Side-Effect	0.05% 1/2220 • Number of events 1 • 20 weeks. Data on adverse events (AEs) were collected with a 3-item questionnaire at all study sessions after study randomization. Participants provided a written description of the event, and three study staff sorted these into appropriate organ systems: two coded responses independently and the third resolved discrepancies. Participants reported the event severity, based on a plain-English definition of a serious adverse event (SAE). No AEs/SAEs were reported by participants to be study-related.	0.05% 1/2192 • Number of events 1 • 20 weeks. Data on adverse events (AEs) were collected with a 3-item questionnaire at all study sessions after study randomization. Participants provided a written description of the event, and three study staff sorted these into appropriate organ systems: two coded responses independently and the third resolved discrepancies. Participants reported the event severity, based on a plain-English definition of a serious adverse event (SAE). No AEs/SAEs were reported by participants to be study-related.
Psychiatric disorders Psychiatric Issue	0.09% 2/2220 • Number of events 2 • 20 weeks. Data on adverse events (AEs) were collected with a 3-item questionnaire at all study sessions after study randomization. Participants provided a written description of the event, and three study staff sorted these into appropriate organ systems: two coded responses independently and the third resolved discrepancies. Participants reported the event severity, based on a plain-English definition of a serious adverse event (SAE). No AEs/SAEs were reported by participants to be study-related.	0.05% 1/2192 • Number of events 1 • 20 weeks. Data on adverse events (AEs) were collected with a 3-item questionnaire at all study sessions after study randomization. Participants provided a written description of the event, and three study staff sorted these into appropriate organ systems: two coded responses independently and the third resolved discrepancies. Participants reported the event severity, based on a plain-English definition of a serious adverse event (SAE). No AEs/SAEs were reported by participants to be study-related.
Renal and urinary disorders Renal Issue	0.00% 0/2220 • 20 weeks. Data on adverse events (AEs) were collected with a 3-item questionnaire at all study sessions after study randomization. Participants provided a written description of the event, and three study staff sorted these into appropriate organ systems: two coded responses independently and the third resolved discrepancies. Participants reported the event severity, based on a plain-English definition of a serious adverse event (SAE). No AEs/SAEs were reported by participants to be study-related.	0.14% 3/2192 • Number of events 3 • 20 weeks. Data on adverse events (AEs) were collected with a 3-item questionnaire at all study sessions after study randomization. Participants provided a written description of the event, and three study staff sorted these into appropriate organ systems: two coded responses independently and the third resolved discrepancies. Participants reported the event severity, based on a plain-English definition of a serious adverse event (SAE). No AEs/SAEs were reported by participants to be study-related.
Respiratory, thoracic and mediastinal disorders Respiratory Issue/Flu	0.09% 2/2220 • Number of events 2 • 20 weeks. Data on adverse events (AEs) were collected with a 3-item questionnaire at all study sessions after study randomization. Participants provided a written description of the event, and three study staff sorted these into appropriate organ systems: two coded responses independently and the third resolved discrepancies. Participants reported the event severity, based on a plain-English definition of a serious adverse event (SAE). No AEs/SAEs were reported by participants to be study-related.	0.05% 1/2192 • Number of events 1 • 20 weeks. Data on adverse events (AEs) were collected with a 3-item questionnaire at all study sessions after study randomization. Participants provided a written description of the event, and three study staff sorted these into appropriate organ systems: two coded responses independently and the third resolved discrepancies. Participants reported the event severity, based on a plain-English definition of a serious adverse event (SAE). No AEs/SAEs were reported by participants to be study-related.
Skin and subcutaneous tissue disorders Skin Condition	0.14% 3/2220 • Number of events 3 • 20 weeks. Data on adverse events (AEs) were collected with a 3-item questionnaire at all study sessions after study randomization. Participants provided a written description of the event, and three study staff sorted these into appropriate organ systems: two coded responses independently and the third resolved discrepancies. Participants reported the event severity, based on a plain-English definition of a serious adverse event (SAE). No AEs/SAEs were reported by participants to be study-related.	0.05% 1/2192 • Number of events 2 • 20 weeks. Data on adverse events (AEs) were collected with a 3-item questionnaire at all study sessions after study randomization. Participants provided a written description of the event, and three study staff sorted these into appropriate organ systems: two coded responses independently and the third resolved discrepancies. Participants reported the event severity, based on a plain-English definition of a serious adverse event (SAE). No AEs/SAEs were reported by participants to be study-related.
Social circumstances Negative Life Event	0.05% 1/2220 • Number of events 1 • 20 weeks. Data on adverse events (AEs) were collected with a 3-item questionnaire at all study sessions after study randomization. Participants provided a written description of the event, and three study staff sorted these into appropriate organ systems: two coded responses independently and the third resolved discrepancies. Participants reported the event severity, based on a plain-English definition of a serious adverse event (SAE). No AEs/SAEs were reported by participants to be study-related.	0.09% 2/2192 • Number of events 2 • 20 weeks. Data on adverse events (AEs) were collected with a 3-item questionnaire at all study sessions after study randomization. Participants provided a written description of the event, and three study staff sorted these into appropriate organ systems: two coded responses independently and the third resolved discrepancies. Participants reported the event severity, based on a plain-English definition of a serious adverse event (SAE). No AEs/SAEs were reported by participants to be study-related.
Surgical and medical procedures Surgical or Medical Procedure	0.05% 1/2220 • Number of events 1 • 20 weeks. Data on adverse events (AEs) were collected with a 3-item questionnaire at all study sessions after study randomization. Participants provided a written description of the event, and three study staff sorted these into appropriate organ systems: two coded responses independently and the third resolved discrepancies. Participants reported the event severity, based on a plain-English definition of a serious adverse event (SAE). No AEs/SAEs were reported by participants to be study-related.	0.05% 1/2192 • Number of events 2 • 20 weeks. Data on adverse events (AEs) were collected with a 3-item questionnaire at all study sessions after study randomization. Participants provided a written description of the event, and three study staff sorted these into appropriate organ systems: two coded responses independently and the third resolved discrepancies. Participants reported the event severity, based on a plain-English definition of a serious adverse event (SAE). No AEs/SAEs were reported by participants to be study-related.
Vascular disorders Vascular Issue	0.00% 0/2220 • 20 weeks. Data on adverse events (AEs) were collected with a 3-item questionnaire at all study sessions after study randomization. Participants provided a written description of the event, and three study staff sorted these into appropriate organ systems: two coded responses independently and the third resolved discrepancies. Participants reported the event severity, based on a plain-English definition of a serious adverse event (SAE). No AEs/SAEs were reported by participants to be study-related.	0.05% 1/2192 • Number of events 1 • 20 weeks. Data on adverse events (AEs) were collected with a 3-item questionnaire at all study sessions after study randomization. Participants provided a written description of the event, and three study staff sorted these into appropriate organ systems: two coded responses independently and the third resolved discrepancies. Participants reported the event severity, based on a plain-English definition of a serious adverse event (SAE). No AEs/SAEs were reported by participants to be study-related.
Blood and lymphatic system disorders Blood or Lymphatic Issue	0.05% 1/2220 • Number of events 2 • 20 weeks. Data on adverse events (AEs) were collected with a 3-item questionnaire at all study sessions after study randomization. Participants provided a written description of the event, and three study staff sorted these into appropriate organ systems: two coded responses independently and the third resolved discrepancies. Participants reported the event severity, based on a plain-English definition of a serious adverse event (SAE). No AEs/SAEs were reported by participants to be study-related.	0.00% 0/2192 • 20 weeks. Data on adverse events (AEs) were collected with a 3-item questionnaire at all study sessions after study randomization. Participants provided a written description of the event, and three study staff sorted these into appropriate organ systems: two coded responses independently and the third resolved discrepancies. Participants reported the event severity, based on a plain-English definition of a serious adverse event (SAE). No AEs/SAEs were reported by participants to be study-related.
Eye disorders Vision/Eye Issue	0.05% 1/2220 • Number of events 1 • 20 weeks. Data on adverse events (AEs) were collected with a 3-item questionnaire at all study sessions after study randomization. Participants provided a written description of the event, and three study staff sorted these into appropriate organ systems: two coded responses independently and the third resolved discrepancies. Participants reported the event severity, based on a plain-English definition of a serious adverse event (SAE). No AEs/SAEs were reported by participants to be study-related.	0.00% 0/2192 • 20 weeks. Data on adverse events (AEs) were collected with a 3-item questionnaire at all study sessions after study randomization. Participants provided a written description of the event, and three study staff sorted these into appropriate organ systems: two coded responses independently and the third resolved discrepancies. Participants reported the event severity, based on a plain-English definition of a serious adverse event (SAE). No AEs/SAEs were reported by participants to be study-related.
Immune system disorders Immune System Issue	0.09% 2/2220 • Number of events 2 • 20 weeks. Data on adverse events (AEs) were collected with a 3-item questionnaire at all study sessions after study randomization. Participants provided a written description of the event, and three study staff sorted these into appropriate organ systems: two coded responses independently and the third resolved discrepancies. Participants reported the event severity, based on a plain-English definition of a serious adverse event (SAE). No AEs/SAEs were reported by participants to be study-related.	0.00% 0/2192 • 20 weeks. Data on adverse events (AEs) were collected with a 3-item questionnaire at all study sessions after study randomization. Participants provided a written description of the event, and three study staff sorted these into appropriate organ systems: two coded responses independently and the third resolved discrepancies. Participants reported the event severity, based on a plain-English definition of a serious adverse event (SAE). No AEs/SAEs were reported by participants to be study-related.
Reproductive system and breast disorders Reproductive Issue	0.05% 1/2220 • Number of events 1 • 20 weeks. Data on adverse events (AEs) were collected with a 3-item questionnaire at all study sessions after study randomization. Participants provided a written description of the event, and three study staff sorted these into appropriate organ systems: two coded responses independently and the third resolved discrepancies. Participants reported the event severity, based on a plain-English definition of a serious adverse event (SAE). No AEs/SAEs were reported by participants to be study-related.	0.00% 0/2192 • 20 weeks. Data on adverse events (AEs) were collected with a 3-item questionnaire at all study sessions after study randomization. Participants provided a written description of the event, and three study staff sorted these into appropriate organ systems: two coded responses independently and the third resolved discrepancies. Participants reported the event severity, based on a plain-English definition of a serious adverse event (SAE). No AEs/SAEs were reported by participants to be study-related.

Additional Information

Andrew Nierenberg

Massachusetts General Hospital

Phone: 617-512-2641

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place