Stress
Conditions
Brief summary
Most people experience stress at some point in their lives. Stress, especially when severe, can not only make you feel bad, it can also worsen existing health problems like heart disease, type 2 diabetes, obesity, high blood pressure, depression, and even cancer. Healthy Mind, Healthy You is a new study about how mindfulness can help people cope with stress. Funded by the Patient Centered Outcome Research Institute (PCORI) and involving 19 Patient Powered Research Networks (PPRNs), Healthy Mind Healthy You will be able to study the effects of mindfulness on a wide variety of populations and conditions.
Interventions
BEHAVIORALMindfulness-Based Cognitive Therapy
8 sessions of online mindfulness-based cognitive therapy
BEHAVIORALBrief Mindfulness
3 sessions of online mindfulness therapy
Sponsors
University of South Florida
Global Healthy Living Foundation
University of North Carolina
University of California, Los Angeles
Genetic Alliance
COPD Foundation
The Duchenne Registry
University of California, San Francisco
Children's Hospital Medical Center, Cincinnati
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Accelerated Cure Project for Multiple Sclerosis
Mayo Clinic
Phelan-McDermid Syndrome Foundation
Immune Deficiency Foundation
Brigham and Women's Hospital
University of Pennsylvania
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Must be a member (patient/member of special population or caregiver) of one of the 19 PCORI Patient-Powered Research Networks (PPRN) * Must be age 18 or older
Exclusion criteria
* Under the age of 18 years * Unable to read, understand, and/or participate in mindfulness exercises
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Estimated Weekly Change on World Health Organization-5 (WHO-5) | Baseline to 8 Weeks, Baseline to 20 Weeks | The WHO-5 is a 5-item questionnaire that assesses well-being over the prior two weeks. Scores range 0-100 with higher scores reflecting greater well-being. We used linear mixed effects models to examine the effect of the interventions on weekly WHO-5 scores. Change = estimated average weekly change during time frame. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Estimated Weekly Change on Perceived Stress Scale (PSS) | Baseline to 8 Weeks, Baseline to 20 Weeks | The PSS is a 10-item questionnaire that evaluates an individual's experiences of stress in the previous month. Scores range 0-40, with higher scores representing greater perceived stress. Change = estimated average weekly change during time frame. |
| Estimated Weekly Change on Patient Reported Outcomes Measurement Information System (PROMIS): Emotional Distress-Depression Short Form | Baseline to 8 Weeks, Baseline to 20 Weeks | The PROMIS: Emotional Distress-Depression Short Form is an 8-item questionnaire that measures perceived depressive symptoms over the past week. Scores range 8-40, with higher scores representing more severe depressive symptoms. Change = estimated average weekly change during time frame. |
| Estimated Weekly Change on Patient Reported Outcomes Measurement Information System (PROMIS): Emotional Distress-Anxiety Short Form | Baseline to 8 Weeks, Baseline to 20 Weeks | The PROMIS: Emotional Distress-Anxiety Short Form is a 4-item questionnaire that measures self-reported fear, anxious misery, hyperarousal, and somatic symptoms related to arousal in the past seven days. Scores range 4-20, with higher scores representing more severe anxiety symptoms. Change = estimated average weekly change during time frame. |
| Estimated Weekly Change on Patient Reported Outcomes Measurement Information System (PROMIS): Ability to Participate in Social Roles and Activities Short Form | Baseline to 8 Weeks, Baseline to 20 Weeks | The PROMIS: Ability to Participate in Social Roles and Activities Short Form is a 4-item questionnaire that measures the perceived ability to perform one's everyday social roles and activities. Scores range 4-20 with higher scores representing fewer limitations (greater abilities). Change = estimated average weekly change during time frame. |
| Estimated Weekly Change on Five Facet Mindfulness Questionnaire (FFMQ) Abbreviated | Baseline to 8 Weeks, Baseline to 20 Weeks | The FFMQ is a 39-item questionnaire that examines five aspects of mindfulness: observing, describing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience. Only the questions related to non-judging of inner experience and non-reactivity were administered (15 items total). The total score on these 15 items was used (range: 15-75). Higher scores represent greater mindfulness. Change = estimated average weekly change during time frame. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Estimated Weekly Change in World Health Organization-5 (WHO-5) Stratified by Age | Baseline to 8 Weeks, Baseline to 20 Weeks | The WHO-5 is a 5-item questionnaire that assesses well-being over the prior two weeks. Scores range 0-100 with higher scores reflecting greater well-being. Age was self-reported. |
| Estimated Weekly Change in World Health Organization-5 (WHO-5) Stratified by Baseline Perceived Stress Scale (PSS) | Baseline to 8 Weeks, Baseline to 20 Weeks | The WHO-5 is a 5-item questionnaire that assesses well-being over the prior two weeks. Scores range 0-100 with higher scores reflecting greater well-being. The PSS is a 10-item questionnaire that evaluates an individual's experiences of stress in the previous month. Scores range 0-40, with higher scores representing greater perceived stress. |
| Estimated Weekly Change in World Health Organization-5 (WHO-5) Stratified by Baseline Patient Reported Outcomes Measurement Information System (PROMIS): Emotional Distress-Depression Short Form (PROMIS: EDD) | Baseline to 8 Weeks, Baseline to 20 Weeks | The WHO-5 is a 5-item questionnaire that assesses well-being over the prior two weeks. Scores range 0-100 with higher scores reflecting greater well-being. The PROMIS: EDD is a 4-item questionnaire that measures self-reported fear, anxious misery, hyperarousal, and somatic symptoms related to arousal in the past seven days. Scores range 4-20, with higher scores representing more severe anxiety symptoms. |
| Estimated Weekly Change in World Health Organization-5 (WHO-5) Stratified by Baseline Patient Reported Outcomes Measurement Information System (PROMIS): Emotional Distress-Anxiety Short Form (PROMIS: EDA) | Baseline to 8 Weeks, Baseline to 20 Weeks | The WHO-5 is a 5-item questionnaire that assesses well-being over the prior two weeks. Scores range 0-100 with higher scores reflecting greater well-being. The PROMIS: EDA is a 4-item questionnaire that measures self-reported fear, anxious misery, hyperarousal, and somatic symptoms related to arousal in the past seven days. Scores range 4-20, with higher scores representing more severe anxiety symptoms. |
| 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, 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). |
| Estimated Weekly Change in World Health Organization-5 (WHO-5) Stratified by Baseline Five Facet Mindfulness Questionnaire (FFMQ) Abbreviated | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Mindfulness-Based Cognitive Therapy 8 sessions of online mindfulness-based cognitive therapy
Mindfulness-Based Cognitive Therapy: 8 sessions of online mindfulness-based cognitive therapy | 2,220 |
| Brief Mindfulness 3 sessions of online mindfulness therapy
Brief Mindfulness: 3 sessions of online mindfulness therapy | 2,192 |
| Total | 4,412 |
Baseline characteristics
| Characteristic | Mindfulness-Based Cognitive Therapy | Total | Brief Mindfulness |
|---|---|---|---|
| Age, Continuous | 55.95 years STANDARD_DEVIATION 14.72 | 55.29 years STANDARD_DEVIATION 14.9 | 54.63 years STANDARD_DEVIATION 15.05 |
| Five Facet Mindfulness Questionnaire | 49.9 units on a scale STANDARD_DEVIATION 11.2 | 49.9 units on a scale STANDARD_DEVIATION 11.1 | 49.9 units on a scale STANDARD_DEVIATION 11 |
| Perceived Stress Scale | 20.1 units on a scale STANDARD_DEVIATION 3.71 | 20.2 units on a scale STANDARD_DEVIATION 3.67 | 20.2 units on a scale STANDARD_DEVIATION 3.64 |
| PROMIS: Ability to Participate in Social Roles and Activities Short Form (Adult, 4-item) | 10.6 units on a scale STANDARD_DEVIATION 4.35 | 10.6 units on a scale STANDARD_DEVIATION 4.32 | 10.6 units on a scale STANDARD_DEVIATION 4.29 |
| PROMIS Emotional Distress - Anxiety Short Form (Adult, 4-Item) | 8.94 units on a scale STANDARD_DEVIATION 3.64 | 8.96 units on a scale STANDARD_DEVIATION 3.62 | 8.98 units on a scale STANDARD_DEVIATION 3.61 |
| PROMIS Emotional Distress - Depression Short Form (Adult, v. 8a) | 16.4 units on a scale STANDARD_DEVIATION 7 | 16.4 units on a scale STANDARD_DEVIATION 7.04 | 16.3 units on a scale STANDARD_DEVIATION 7.07 |
| Race/Ethnicity, Customized Asian | 39 Participants | 77 Participants | 38 Participants |
| Race/Ethnicity, Customized Black, African American, African, or AfroCaribbean | 45 Participants | 97 Participants | 52 Participants |
| Race/Ethnicity, Customized Hispanic | 101 Participants | 198 Participants | 97 Participants |
| Race/Ethnicity, Customized Multiple Race | 68 Participants | 127 Participants | 59 Participants |
| Race/Ethnicity, Customized Native American, American Indian, or Alaska Native | 12 Participants | 27 Participants | 15 Participants |
| Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander | 2 Participants | 3 Participants | 1 Participants |
| Race/Ethnicity, Customized Non-Hispanic | 2078 Participants | 4120 Participants | 2042 Participants |
| Race/Ethnicity, Customized No selected answer | 36 Participants | 42 Participants | 41 Participants |
| Race/Ethnicity, Customized Other | 2 Participants | 7 Participants | 5 Participants |
| Race/Ethnicity, Customized Prefer not to answer | 16 Participants | 67 Participants | 43 Participants |
| Race/Ethnicity, Customized Unknown | 5 Participants | 7 Participants | 2 Participants |
| Race/Ethnicity, Customized White | 1957 Participants | 3874 Participants | 1917 Participants |
| Sex/Gender, Customized Ambiguous | 6 Participants | 11 Participants | 5 Participants |
| Sex/Gender, Customized Asexual | 18 Participants | 40 Participants | 22 Participants |
| Sex/Gender, Customized Bisexual | 91 Participants | 193 Participants | 102 Participants |
| Sex/Gender, Customized Female | 1780 Participants | 3548 Participants | 1768 Participants |
| Sex/Gender, Customized Gay | 72 Participants | 150 Participants | 78 Participants |
| Sex/Gender, Customized Genderqueer | 32 Participants | 71 Participants | 39 Participants |
| Sex/Gender, Customized Lesbian | 69 Participants | 147 Participants | 78 Participants |
| Sex/Gender, Customized Male | 429 Participants | 839 Participants | 410 Participants |
| Sex/Gender, Customized Man | 402 Participants | 790 Participants | 388 Participants |
| Sex/Gender, Customized Multiple gender categories | 5 Participants | 9 Participants | 4 Participants |
| Sex/Gender, Customized Multiple sexual orientations | 14 Participants | 22 Participants | 8 Participants |
| Sex/Gender, Customized No selected answer | 49 Participants | 92 Participants | 43 Participants |
| Sex/Gender, Customized Other | 8 Participants | 16 Participants | 1 Participants |
| Sex/Gender, Customized Prefer not to answer | 6 Participants | 16 Participants | 30 Participants |
| Sex/Gender, Customized Queer | 56 Participants | 123 Participants | 67 Participants |
| Sex/Gender, Customized Questioning | 9 Participants | 16 Participants | 7 Participants |
| Sex/Gender, Customized Something else | 4 Participants | 19 Participants | 8 Participants |
| Sex/Gender, Customized Straight | 1816 Participants | 3560 Participants | 1744 Participants |
| Sex/Gender, Customized Transgender female/Trans woman/Male-to-female | 6 Participants | 10 Participants | 4 Participants |
| Sex/Gender, Customized Transgender male/Trans man/Female-to-male | 17 Participants | 49 Participants | 32 Participants |
| Sex/Gender, Customized Unknown | 1 Participants | 13 Participants | 8 Participants |
| Sex/Gender, Customized Woman | 1690 Participants | 3344 Participants | 1654 Participants |
| World Health Organization-5 Well-Being Index | 50.2 units on a scale STANDARD_DEVIATION 20.6 | 50.4 units on a scale STANDARD_DEVIATION 20.7 | 50.6 units on a scale STANDARD_DEVIATION 20.7 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 2,220 | 0 / 2,192 |
| other Total, other adverse events | 33 / 2,220 | 41 / 2,192 |
| serious Total, serious adverse events | 30 / 2,220 | 31 / 2,192 |
Outcome results
Primary
Estimated Weekly Change on World Health Organization-5 (WHO-5)
The WHO-5 is a 5-item questionnaire that assesses well-being over the prior two weeks. Scores range 0-100 with higher scores reflecting greater well-being. We used linear mixed effects models to examine the effect of the interventions on weekly WHO-5 scores. Change = estimated average weekly change during time frame.
Time frame: Baseline to 8 Weeks, Baseline to 20 Weeks
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Mindfulness-Based Cognitive Therapy | Estimated Weekly Change on World Health Organization-5 (WHO-5) | Baseline to 8 Weeks | 0.78 estimated weekly change in scale score |
| Mindfulness-Based Cognitive Therapy | Estimated Weekly Change on World Health Organization-5 (WHO-5) | Baseline to 20 Weeks | 0.41 estimated weekly change in scale score |
| Brief Mindfulness | Estimated Weekly Change on World Health Organization-5 (WHO-5) | Baseline to 8 Weeks | 0.76 estimated weekly change in scale score |
| Brief Mindfulness | Estimated Weekly Change on World Health Organization-5 (WHO-5) | Baseline to 20 Weeks | 0.33 estimated weekly change in scale score |
Comparison: We used a linear mixed effects model to examine the difference in effect of time on weekly WHO-5 scores in Mindfulness Light vs. Mindfulness-Based Cognitive Therapy conditions from baseline to 8 weeks. This model accounts for the covariance of repeated measurements within subjects, and we used maximum likelihood estimation to adjust for missing assessment scores. The model includes a random slope and intercept, and fixed effects for intervention, time, and an intervention by time interaction.p-value: 0.8295% CI: [-0.24, 0.19]Mixed Models Analysis
Comparison: We used a linear mixed effects model to examine the difference in effect of time on weekly WHO-5 scores in Mindfulness Light vs. Mindfulness-Based Cognitive Therapy conditions from baseline to 20 weeks. This model accounts for the covariance of repeated measurements within subjects, and we used maximum likelihood estimation to adjust for missing assessment scores. The model includes a random slope and intercept, and fixed effects for intervention, time, and an intervention by time interaction.p-value: 0.1195% CI: [-0.18, 0.02]Mixed Models Analysis
Secondary
Estimated Weekly Change on Five Facet Mindfulness Questionnaire (FFMQ) Abbreviated
The FFMQ is a 39-item questionnaire that examines five aspects of mindfulness: observing, describing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience. Only the questions related to non-judging of inner experience and non-reactivity were administered (15 items total). The total score on these 15 items was used (range: 15-75). Higher scores represent greater mindfulness. Change = estimated average weekly change during time frame.
Time frame: Baseline to 8 Weeks, Baseline to 20 Weeks
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Mindfulness-Based Cognitive Therapy | Estimated Weekly Change on Five Facet Mindfulness Questionnaire (FFMQ) Abbreviated | Baseline to 8 Weeks | 0.92 estimated weekly change in scale score |
| Mindfulness-Based Cognitive Therapy | Estimated Weekly Change on Five Facet Mindfulness Questionnaire (FFMQ) Abbreviated | Baseline to 20 Weeks | 0.43 estimated weekly change in scale score |
| Brief Mindfulness | Estimated Weekly Change on Five Facet Mindfulness Questionnaire (FFMQ) Abbreviated | Baseline to 8 Weeks | 0.88 estimated weekly change in scale score |
| Brief Mindfulness | Estimated Weekly Change on Five Facet Mindfulness Questionnaire (FFMQ) Abbreviated | Baseline to 20 Weeks | 0.37 estimated weekly change in scale score |
Comparison: As with the primary outcome, we used a linear mixed effects model to examine the difference in effect of time on weekly FFMQ scores in Mindfulness Light vs. Mindfulness-Based Cognitive Therapy conditions from baseline to 8 weeks.p-value: 0.46995% CI: [-0.16, 0.07]Mixed Models Analysis
Comparison: As with the primary outcome, we used linear mixed effects models to examine the effect of time on weekly FFMQ scores across both intervention conditions from baseline to 20 weeks.p-value: 0.03395% CI: [-0.11, -0.01]Mixed Models Analysis
Secondary
Estimated Weekly Change on Patient Reported Outcomes Measurement Information System (PROMIS): Ability to Participate in Social Roles and Activities Short Form
The PROMIS: Ability to Participate in Social Roles and Activities Short Form is a 4-item questionnaire that measures the perceived ability to perform one's everyday social roles and activities. Scores range 4-20 with higher scores representing fewer limitations (greater abilities). Change = estimated average weekly change during time frame.
Time frame: Baseline to 8 Weeks, Baseline to 20 Weeks
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Mindfulness-Based Cognitive 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 |
| Mindfulness-Based Cognitive 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 20 | -0.05 estimated weekly change in scale score |
| Brief Mindfulness | 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 | -0.14 estimated weekly change in scale score |
| Brief Mindfulness | 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 | -0.04 estimated weekly change in scale score |
Comparison: As with the primary outcome, we used a linear mixed effects model to examine the difference in effect of time on weekly PROMIS: Ability to Participate in Social Roles and Activities Short Form scores (reverse scored) in Mindfulness Light vs. Mindfulness-Based Cognitive Therapy conditions from baseline to 8 weeks.p-value: 0.48895% CI: [-0.06, 0.03]Mixed Models Analysis
Comparison: As with the primary outcome, we used a linear mixed effects model to examine the difference in effect of time on weekly PROMIS: Ability to Participate in Social Roles and Activities Short Form scores (reverse scored) in Mindfulness Light vs. Mindfulness-Based Cognitive Therapy conditions from baseline to 20 weeks.p-value: 0.44695% CI: [-0.01, 0.03]Mixed Models Analysis
Secondary
Estimated Weekly Change on Patient Reported Outcomes Measurement Information System (PROMIS): Emotional Distress-Anxiety Short Form
The PROMIS: Emotional Distress-Anxiety Short Form is a 4-item questionnaire that measures self-reported fear, anxious misery, hyperarousal, and somatic symptoms related to arousal in the past seven days. Scores range 4-20, with higher scores representing more severe anxiety symptoms. Change = estimated average weekly change during time frame.
Time frame: Baseline to 8 Weeks, Baseline to 20 Weeks
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Mindfulness-Based Cognitive 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 |
| Mindfulness-Based Cognitive Therapy | 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 |
| Brief Mindfulness | Estimated Weekly Change on Patient Reported Outcomes Measurement Information System (PROMIS): Emotional Distress-Anxiety Short Form | Baseline to Week 8 | -0.13 estimated weekly change in scale score |
| Brief Mindfulness | Estimated Weekly Change on Patient Reported Outcomes Measurement Information System (PROMIS): Emotional Distress-Anxiety Short Form | Baseline to Week 20 | -0.05 estimated weekly change in scale score |
Comparison: As with the primary outcome, we used a linear mixed effects model to examine the difference in effect of time on weekly PROMIS: Emotional Distress-Anxiety Short Form scores in Mindfulness Light vs. Mindfulness-Based Cognitive Therapy conditions from baseline to 8 weeks.p-value: 0.39995% CI: [-0.05, 0.02]Mixed Models Analysis
Comparison: As with the primary outcome, we used a linear mixed effects model to examine the difference in effect of time on weekly PROMIS: Emotional Distress-Anxiety Short Form scores in Mindfulness Light vs. Mindfulness-Based Cognitive Therapy conditions from baseline to 20 weeks.p-value: 0.04895% CI: [0, 0.03]Mixed Models Analysis
Secondary
Estimated Weekly Change on Patient Reported Outcomes Measurement Information System (PROMIS): Emotional Distress-Depression Short Form
The PROMIS: Emotional Distress-Depression Short Form is an 8-item questionnaire that measures perceived depressive symptoms over the past week. Scores range 8-40, with higher scores representing more severe depressive symptoms. Change = estimated average weekly change during time frame.
Time frame: Baseline to 8 Weeks, Baseline to 20 Weeks
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Mindfulness-Based Cognitive 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 |
| Mindfulness-Based Cognitive Therapy | 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 |
| Brief Mindfulness | Estimated Weekly Change on Patient Reported Outcomes Measurement Information System (PROMIS): Emotional Distress-Depression Short Form | Baseline to Week 8 | -0.17 estimated weekly change in scale score |
| Brief Mindfulness | Estimated Weekly Change on Patient Reported Outcomes Measurement Information System (PROMIS): Emotional Distress-Depression Short Form | Baseline to Week 20 | -0.06 estimated weekly change in scale score |
Comparison: As with the primary outcome, we used a linear mixed effects model to examine the difference in effect of time on weekly PROMIS: Emotional Distress-Depression Short Form scores in Mindfulness Light vs. Mindfulness-Based Cognitive Therapy conditions from baseline to 8 weeks.p-value: 0.43195% CI: [-0.04, 0.09]Mixed Models Analysis
Comparison: As with the primary outcome, we used a linear mixed effects model to examine the difference in effect of time on weekly PROMIS: Emotional Distress-Depression Short Form scores in Mindfulness Light vs. Mindfulness-Based Cognitive Therapy conditions from baseline to 20 weeks.p-value: <0.00195% CI: [0.02, 0.08]Mixed Models Analysis
Secondary
Estimated Weekly Change on Perceived Stress Scale (PSS)
The PSS is a 10-item questionnaire that evaluates an individual's experiences of stress in the previous month. Scores range 0-40, with higher scores representing greater perceived stress. Change = estimated average weekly change during time frame.
Time frame: Baseline to 8 Weeks, Baseline to 20 Weeks
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Mindfulness-Based Cognitive Therapy | Estimated Weekly Change on Perceived Stress Scale (PSS) | Baseline to 8 Weeks | -0.13 estimated weekly change in scale score |
| Mindfulness-Based Cognitive Therapy | Estimated Weekly Change on Perceived Stress Scale (PSS) | Baseline to 20 Weeks | -0.08 estimated weekly change in scale score |
| Brief Mindfulness | Estimated Weekly Change on Perceived Stress Scale (PSS) | Baseline to 8 Weeks | -0.15 estimated weekly change in scale score |
| Brief Mindfulness | Estimated Weekly Change on Perceived Stress Scale (PSS) | Baseline to 20 Weeks | -0.07 estimated weekly change in scale score |
Comparison: As with the primary outcome, we used a linear mixed effects model to examine the difference in effect of time on weekly PSS scores in Mindfulness Light vs. Mindfulness-Based Cognitive Therapy conditions from baseline to 8 weeks.p-value: 0.28495% CI: [-0.07, 0.02]Mixed Models Analysis
Comparison: As with the primary outcome, we used a linear mixed effects model to examine the difference in effect of time on weekly PSS scores in Mindfulness Light vs. Mindfulness-Based Cognitive Therapy conditions from baseline to 20 weeks.p-value: 0.39495% CI: [-0.01, 0.03]Mixed Models Analysis
Other Pre-specified
Estimated Weekly Change in World Health Organization-5 (WHO-5) Stratified by Age
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.
Time frame: Baseline to 8 Weeks, Baseline to 20 Weeks
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Mindfulness-Based Cognitive 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 |
| Mindfulness-Based Cognitive Therapy | 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 |
| Mindfulness-Based Cognitive Therapy | 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 |
| Mindfulness-Based Cognitive Therapy | 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 |
| Mindfulness-Based Cognitive Therapy | 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 |
| Mindfulness-Based Cognitive Therapy | 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 |
| Brief Mindfulness | Estimated Weekly Change in World Health Organization-5 (WHO-5) Stratified by Age | Baseline to 20 Weeks: Age 55 | 0.33 estimated weekly change in WHO-5 score |
| Brief Mindfulness | Estimated Weekly Change in World Health Organization-5 (WHO-5) Stratified by Age | Baseline to 8 Weeks: Age 45 | 0.75 estimated weekly change in WHO-5 score |
| Brief Mindfulness | Estimated Weekly Change in World Health Organization-5 (WHO-5) Stratified by Age | Baseline to 20 Weeks: Age 45 | 0.38 estimated weekly change in WHO-5 score |
| Brief Mindfulness | Estimated Weekly Change in World Health Organization-5 (WHO-5) Stratified by Age | Baseline to 8 Weeks: Age 55 | 0.73 estimated weekly change in WHO-5 score |
| Brief Mindfulness | Estimated Weekly Change in World Health Organization-5 (WHO-5) Stratified by Age | Baseline to 20 Weeks: Age 65 | 0.27 estimated weekly change in WHO-5 score |
| Brief Mindfulness | Estimated Weekly Change in World Health Organization-5 (WHO-5) Stratified by Age | Baseline to 8 Weeks: Age 65 | 0.72 estimated weekly change in WHO-5 score |
Comparison: Age measured at the beginning of the intervention period was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 8.p-value: 0.046Mixed Models Analysis
Comparison: Age measured at the beginning of the intervention period was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 20.p-value: 0.275Mixed Models Analysis
Other Pre-specified
Estimated Weekly Change in World Health Organization-5 (WHO-5) Stratified by Baseline Five Facet Mindfulness Questionnaire (FFMQ) Abbreviated
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.
Time frame: Baseline to 8 Weeks, Baseline to 20 Weeks
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Mindfulness-Based Cognitive 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 |
| Mindfulness-Based Cognitive 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 = 50 | 0.78 estimated weekly change in WHO-5 score |
| Mindfulness-Based Cognitive 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 = 60 | 0.51 estimated weekly change in WHO-5 score |
| Mindfulness-Based Cognitive Therapy | 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 |
| Mindfulness-Based Cognitive Therapy | 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 |
| Mindfulness-Based Cognitive Therapy | 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 |
| Brief Mindfulness | 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 | 0.33 estimated weekly change in WHO-5 score |
| Brief Mindfulness | 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 | 0.97 estimated weekly change in WHO-5 score |
| Brief Mindfulness | 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 | 0.41 estimated weekly change in WHO-5 score |
| Brief Mindfulness | 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 | 0.75 estimated weekly change in WHO-5 score |
| Brief Mindfulness | 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 | 0.24 estimated weekly change in WHO-5 score |
| Brief Mindfulness | 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 | 0.53 estimated weekly change in WHO-5 score |
Comparison: FFMQ measured at the beginning of the intervention period was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 8.p-value: 0.582Mixed Models Analysis
Comparison: FFMQ measured at the beginning of the intervention period was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 20.p-value: 0.666Mixed Models Analysis
Other Pre-specified
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)
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).
Time frame: Baseline to 8 Weeks, Baseline to 20 Weeks
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Mindfulness-Based Cognitive 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 = 5 | 0.57 estimated weekly change in WHO-5 score |
| Mindfulness-Based Cognitive 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 |
| Mindfulness-Based Cognitive 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 = 15 | 0.91 estimated weekly change in WHO-5 score |
| Mindfulness-Based Cognitive 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 20 Weeks: PROMIS: APRA = 5 | 0.33 estimated weekly change in WHO-5 score |
| Mindfulness-Based Cognitive 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 20 Weeks: PROMIS: APRA = 10 | 0.40 estimated weekly change in WHO-5 score |
| Mindfulness-Based Cognitive 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 20 Weeks: PROMIS: APRA = 15 | 0.47 estimated weekly change in WHO-5 score |
| Brief Mindfulness | 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 | 0.32 estimated weekly change in WHO-5 score |
| Brief Mindfulness | 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 | 0.46 estimated weekly change in WHO-5 score |
| Brief Mindfulness | 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 | 0.24 estimated weekly change in WHO-5 score |
| Brief Mindfulness | 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 | 0.73 estimated weekly change in WHO-5 score |
| Brief Mindfulness | 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 | 0.41 estimated weekly change in WHO-5 score |
| Brief Mindfulness | 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 | 1.00 estimated weekly change in WHO-5 score |
Comparison: PROMIS: APRA measured at the beginning of the intervention period was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 8.p-value: 0.425Mixed Models Analysis
Comparison: PROMIS: APRA measured at the beginning of the intervention period was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 20.p-value: 0.733Mixed Models Analysis
Other Pre-specified
Estimated Weekly Change in World Health Organization-5 (WHO-5) Stratified by Baseline Patient Reported Outcomes Measurement Information System (PROMIS): Emotional Distress-Anxiety Short Form (PROMIS: EDA)
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.
Time frame: Baseline to 8 Weeks, Baseline to 20 Weeks
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Mindfulness-Based Cognitive 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 |
| Mindfulness-Based Cognitive 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 = 10 | 0.85 estimated weekly change in WHO-5 score |
| Mindfulness-Based Cognitive 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 = 15 | 1.23 estimated weekly change in WHO-5 score |
| Mindfulness-Based Cognitive 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 20 Weeks: PROMIS: EDA = 5 | 0.25 estimated weekly change in WHO-5 score |
| Mindfulness-Based Cognitive 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 20 Weeks: PROMIS: EDA = 10 | 0.46 estimated weekly change in WHO-5 score |
| Mindfulness-Based Cognitive 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 20 Weeks: PROMIS: EDA = 15 | 0.66 estimated weekly change in WHO-5 score |
| Brief Mindfulness | 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 | 0.37 estimated weekly change in WHO-5 score |
| Brief Mindfulness | 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 | 0.47 estimated weekly change in WHO-5 score |
| Brief Mindfulness | 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 | 0.18 estimated weekly change in WHO-5 score |
| Brief Mindfulness | 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 | 0.83 estimated weekly change in WHO-5 score |
| Brief Mindfulness | 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 | 0.56 estimated weekly change in WHO-5 score |
| Brief Mindfulness | 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 | 1.18 estimated weekly change in WHO-5 score |
Comparison: PROMIS: EDA measured at the beginning of the intervention period was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 8.p-value: 0.838Mixed Models Analysis
Comparison: PROMIS: EDA measured at the beginning of the intervention period was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 20.p-value: 0.89Mixed Models Analysis
Other Pre-specified
Estimated Weekly Change in World Health Organization-5 (WHO-5) Stratified by Baseline Patient Reported Outcomes Measurement Information System (PROMIS): Emotional Distress-Depression Short Form (PROMIS: EDD)
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.
Time frame: Baseline to 8 Weeks, Baseline to 20 Weeks
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Mindfulness-Based Cognitive 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 |
| Mindfulness-Based Cognitive 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 = 15 | 0.72 estimated weekly change in WHO-5 score |
| Mindfulness-Based Cognitive 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 = 20 | 0.92 estimated weekly change in WHO-5 score |
| Mindfulness-Based Cognitive 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 20: PROMIS: EDD = 10 | 0.30 estimated weekly change in WHO-5 score |
| Mindfulness-Based Cognitive 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 20: PROMIS: EDD = 15 | 0.39 estimated weekly change in WHO-5 score |
| Mindfulness-Based Cognitive 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 20: PROMIS: EDD = 20 | 0.48 estimated weekly change in WHO-5 score |
| Brief Mindfulness | 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 | 0.31 estimated weekly change in WHO-5 score |
| Brief Mindfulness | 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 | 0.47 estimated weekly change in WHO-5 score |
| Brief Mindfulness | 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 | 0.26 estimated weekly change in WHO-5 score |
| Brief Mindfulness | 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 | 0.69 estimated weekly change in WHO-5 score |
| Brief Mindfulness | 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 | 0.36 estimated weekly change in WHO-5 score |
| Brief Mindfulness | 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 | 0.91 estimated weekly change in WHO-5 score |
Comparison: PROMIS: EDD measured at the beginning of the intervention period was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 8.p-value: 0.885Mixed Models Analysis
Comparison: PROMIS: EDD measured at the beginning of the intervention period was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 20.p-value: 0.319Mixed Models Analysis
Other Pre-specified
Estimated Weekly Change in World Health Organization-5 (WHO-5) Stratified by Baseline Perceived Stress Scale (PSS)
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.
Time frame: Baseline to 8 Weeks, Baseline to 20 Weeks
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Mindfulness-Based Cognitive 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 |
| Mindfulness-Based Cognitive Therapy | 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 |
| Mindfulness-Based Cognitive Therapy | 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 |
| Mindfulness-Based Cognitive Therapy | 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 |
| Mindfulness-Based Cognitive Therapy | 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 |
| Mindfulness-Based Cognitive Therapy | 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 |
| Brief Mindfulness | Estimated Weekly Change in World Health Organization-5 (WHO-5) Stratified by Baseline Perceived Stress Scale (PSS) | Baseline to Week 20: PSS = 20 | 0.33 estimated weekly change in WHO-5 score |
| Brief Mindfulness | Estimated Weekly Change in World Health Organization-5 (WHO-5) Stratified by Baseline Perceived Stress Scale (PSS) | Baseline to Week 8: PSS = 18 | 0.61 estimated weekly change in WHO-5 score |
| Brief Mindfulness | Estimated Weekly Change in World Health Organization-5 (WHO-5) Stratified by Baseline Perceived Stress Scale (PSS) | Baseline to Week 20: PSS = 18 | 0.28 estimated weekly change in WHO-5 score |
| Brief Mindfulness | Estimated Weekly Change in World Health Organization-5 (WHO-5) Stratified by Baseline Perceived Stress Scale (PSS) | Baseline to Week 8: PSS = 20 | 0.75 estimated weekly change in WHO-5 score |
| Brief Mindfulness | Estimated Weekly Change in World Health Organization-5 (WHO-5) Stratified by Baseline Perceived Stress Scale (PSS) | Baseline to Week 20: PSS = 22 | 0.37 estimated weekly change in WHO-5 score |
| Brief Mindfulness | Estimated Weekly Change in World Health Organization-5 (WHO-5) Stratified by Baseline Perceived Stress Scale (PSS) | Baseline to Week 8: PSS = 22 | 0.89 estimated weekly change in WHO-5 score |
Comparison: PSS measured at the beginning of the intervention period was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 8.p-value: 0.977Mixed Models Analysis
Comparison: PSS measured at the beginning of the intervention period was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 20.p-value: 0.341Mixed Models Analysis
Post Hoc
Estimated Weekly Change in World Health Organization-5 (WHO-5) Stratified by Education
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.
Time frame: Baseline to 8 Weeks, Baseline to 20 Weeks
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Mindfulness-Based Cognitive Therapy | 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 |
| Mindfulness-Based Cognitive Therapy | 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 |
| Mindfulness-Based Cognitive Therapy | 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 |
| Mindfulness-Based Cognitive 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 |
| Mindfulness-Based Cognitive Therapy | 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 |
| Mindfulness-Based Cognitive Therapy | 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 |
| Brief Mindfulness | 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 |
| Brief Mindfulness | Estimated Weekly Change in World Health Organization-5 (WHO-5) Stratified by Education | Baseline to 20 Weeks: High School or Less | 0.20 estimated weekly change in WHO-5 score |
| Brief Mindfulness | Estimated Weekly Change in World Health Organization-5 (WHO-5) Stratified by Education | Baseline to 8 Weeks: High School or Less | 0.39 estimated weekly change in WHO-5 score |
| Brief Mindfulness | Estimated Weekly Change in World Health Organization-5 (WHO-5) Stratified by Education | Baseline to 8 Weeks: 2 or 4-Year College | 0.75 estimated weekly change in WHO-5 score |
| Brief Mindfulness | Estimated Weekly Change in World Health Organization-5 (WHO-5) Stratified by Education | Baseline to 20 Weeks: 2 or 4-Year College | 0.31 estimated weekly change in WHO-5 score |
| Brief Mindfulness | Estimated Weekly Change in World Health Organization-5 (WHO-5) Stratified by Education | Baseline to 8 Weeks: > College | 0.87 estimated weekly change in WHO-5 score |
Comparison: Level of education was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 8.p-value: 0.603Mixed Models Analysis
Comparison: Level of education was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 20.p-value: 0.333Mixed Models Analysis
Post Hoc
Estimated Weekly Change in World Health Organization-5 (WHO-5) Stratified by Ethnicity
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.
Time frame: Baseline to 8 Weeks, Baseline to 20 Weeks
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Mindfulness-Based Cognitive Therapy | 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 |
| Mindfulness-Based Cognitive Therapy | 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 |
| Mindfulness-Based Cognitive Therapy | 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 |
| Mindfulness-Based Cognitive 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 |
| Mindfulness-Based Cognitive Therapy | 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 |
| Mindfulness-Based Cognitive Therapy | 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 |
| Brief Mindfulness | Estimated Weekly Change in World Health Organization-5 (WHO-5) Stratified by Ethnicity | Baseline to 20 Weeks: Non-Hispanic | 0.34 estimated weekly change in WHO-5 score |
| Brief Mindfulness | Estimated Weekly Change in World Health Organization-5 (WHO-5) Stratified by Ethnicity | Baseline to 8 Weeks: Hispanic | 0.88 estimated weekly change in WHO-5 score |
| Brief Mindfulness | Estimated Weekly Change in World Health Organization-5 (WHO-5) Stratified by Ethnicity | Baseline to 20 Weeks: Hispanic | 0.23 estimated weekly change in WHO-5 score |
| Brief Mindfulness | Estimated Weekly Change in World Health Organization-5 (WHO-5) Stratified by Ethnicity | Baseline to 8 Weeks: Non-Hispanic | 0.77 estimated weekly change in WHO-5 score |
| Brief Mindfulness | Estimated Weekly Change in World Health Organization-5 (WHO-5) Stratified by Ethnicity | Baseline to 20 Weeks: Other | 0.68 estimated weekly change in WHO-5 score |
| Brief Mindfulness | Estimated Weekly Change in World Health Organization-5 (WHO-5) Stratified by Ethnicity | Baseline to 8 Weeks: Other | 0.68 estimated weekly change in WHO-5 score |
Comparison: Ethnicity was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 8.p-value: 0.928Mixed Models Analysis
Comparison: Ethnicity was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 20.p-value: 0.307Mixed Models Analysis
Post Hoc
Estimated Weekly Change in World Health Organization-5 (WHO-5) Stratified by Percentage of Sessions Completed
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.
Time frame: Baseline to 8 Weeks, Baseline to 20 Weeks
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Mindfulness-Based Cognitive 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 |
| Mindfulness-Based Cognitive Therapy | 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 |
| Mindfulness-Based Cognitive Therapy | 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 |
| Mindfulness-Based Cognitive Therapy | 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 |
| Mindfulness-Based Cognitive Therapy | 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 |
| Mindfulness-Based Cognitive Therapy | 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 |
| Brief Mindfulness | Estimated Weekly Change in World Health Organization-5 (WHO-5) Stratified by Percentage of Sessions Completed | Baseline to 20 Weeks: 33% | 0.31 estimated weekly change in WHO-5 score |
| Brief Mindfulness | Estimated Weekly Change in World Health Organization-5 (WHO-5) Stratified by Percentage of Sessions Completed | Baseline to 8 Weeks: 0% | 0.64 estimated weekly change in WHO-5 score |
| Brief Mindfulness | 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 |
| Brief Mindfulness | Estimated Weekly Change in World Health Organization-5 (WHO-5) Stratified by Percentage of Sessions Completed | Baseline to 8 Weeks: 33% | 0.70 estimated weekly change in WHO-5 score |
| Brief Mindfulness | Estimated Weekly Change in World Health Organization-5 (WHO-5) Stratified by Percentage of Sessions Completed | Baseline to 20 Weeks: 100% | 0.39 estimated weekly change in WHO-5 score |
| Brief Mindfulness | Estimated Weekly Change in World Health Organization-5 (WHO-5) Stratified by Percentage of Sessions Completed | Baseline to 8 Weeks: 100% | 0.82 estimated weekly change in WHO-5 score |
Comparison: Percentage of sessions completed was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 8.p-value: 0.004Mixed Models Analysis
Comparison: Percentage of sessions completed was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 20.p-value: 0.291Mixed Models Analysis
Post Hoc
Estimated Weekly Change in World Health Organization-5 (WHO-5) Stratified by Race
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.
Time frame: Baseline to 8 Weeks, Baseline to 20 Weeks
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Mindfulness-Based Cognitive 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 |
| Mindfulness-Based Cognitive Therapy | 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 |
| Mindfulness-Based Cognitive Therapy | 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 |
| Mindfulness-Based Cognitive Therapy | 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 |
| Brief Mindfulness | Estimated Weekly Change in World Health Organization-5 (WHO-5) Stratified by Race | Baseline to 20 Weeks: Non-White | 0.37 estimated weekly change in WHO-5 score |
| Brief Mindfulness | Estimated Weekly Change in World Health Organization-5 (WHO-5) Stratified by Race | Baseline to 8 Weeks: White | 0.77 estimated weekly change in WHO-5 score |
| Brief Mindfulness | Estimated Weekly Change in World Health Organization-5 (WHO-5) Stratified by Race | Baseline to 20 Weeks: White | 0.34 estimated weekly change in WHO-5 score |
| Brief Mindfulness | Estimated Weekly Change in World Health Organization-5 (WHO-5) Stratified by Race | Baseline to 8 Weeks: Non-White | 0.78 estimated weekly change in WHO-5 score |
Comparison: Race was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 20.p-value: 0.224Mixed Models Analysis
Comparison: Race was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 20.p-value: 0.885Mixed Models Analysis
Post Hoc
Estimated Weekly Change in World Health Organization-5 (WHO-5) Stratified by Self-Reported Presence of Medical Problems (Yes or No)
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.
Time frame: Baseline to 8 Weeks, Baseline to 20 Weeks
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Mindfulness-Based Cognitive Therapy | 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 |
| Mindfulness-Based Cognitive Therapy | 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 |
| Mindfulness-Based Cognitive 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: Medical Problems | 0.79 estimated weekly change in WHO-5 score |
| Mindfulness-Based Cognitive 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 |
| Brief Mindfulness | 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 | 0.37 estimated weekly change in WHO-5 score |
| Brief Mindfulness | 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 | 0.80 estimated weekly change in WHO-5 score |
| Brief Mindfulness | 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 | 0.80 estimated weekly change in WHO-5 score |
| Brief Mindfulness | 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 | 0.67 estimated weekly change in WHO-5 score |
Comparison: Presence of medical problems at the beginning of the intervention period was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 8.p-value: 0.64Mixed Models Analysis
Comparison: Presence of medical problems at the beginning of the intervention period was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 20.p-value: 0.396Mixed Models Analysis
Post Hoc
Estimated Weekly Change in World Health Organization-5 (WHO-5) Stratified by Self-Reported Presence of Psychiatric Illness (Yes or No)
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.
Time frame: Baseline to 8 Weeks, Baseline to 20 Weeks
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Mindfulness-Based Cognitive 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: Psychiatric Illness | 0.86 estimated weekly change in WHO-5 score |
| Mindfulness-Based Cognitive 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 |
| Mindfulness-Based Cognitive Therapy | 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 |
| Mindfulness-Based Cognitive Therapy | 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 |
| Brief Mindfulness | 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 | 0.32 estimated weekly change in WHO-5 score |
| Brief Mindfulness | 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 | 0.68 estimated weekly change in WHO-5 score |
| Brief Mindfulness | 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 | 0.68 estimated weekly change in WHO-5 score |
| Brief Mindfulness | 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 | 0.79 estimated weekly change in WHO-5 score |
Comparison: Presence of psychiatric illness at the beginning of the intervention period was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 8.p-value: 0.355Mixed Models Analysis
Comparison: Presence of psychiatric illness at the beginning of the intervention period was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 20.p-value: 0.361Mixed Models Analysis
Post Hoc
Estimated Weekly Change in World Health Organization-5 (WHO-5) Stratified by Sex
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.
Time frame: Baseline to 8 Weeks, Baseline to 20 Weeks
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Mindfulness-Based Cognitive 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 |
| Mindfulness-Based Cognitive Therapy | 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 |
| Mindfulness-Based Cognitive Therapy | 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 |
| Mindfulness-Based Cognitive Therapy | 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 |
| Mindfulness-Based Cognitive Therapy | 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 |
| Mindfulness-Based Cognitive Therapy | 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 |
| Brief Mindfulness | Estimated Weekly Change in World Health Organization-5 (WHO-5) Stratified by Sex | Baseline to 20 Weeks: Female | 0.35 estimated weekly change in WHO-5 score |
| Brief Mindfulness | Estimated Weekly Change in World Health Organization-5 (WHO-5) Stratified by Sex | Baseline to 8 Weeks: Male | 0.51 estimated weekly change in WHO-5 score |
| Brief Mindfulness | 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 |
| Brief Mindfulness | Estimated Weekly Change in World Health Organization-5 (WHO-5) Stratified by Sex | Baseline to 8 Weeks: Female | 0.82 estimated weekly change in WHO-5 score |
| Brief Mindfulness | Estimated Weekly Change in World Health Organization-5 (WHO-5) Stratified by Sex | Baseline to 20 Weeks: Other | 0.34 estimated weekly change in WHO-5 score |
| Brief Mindfulness | Estimated Weekly Change in World Health Organization-5 (WHO-5) Stratified by Sex | Baseline to 8 Weeks: Other | 0.18 estimated weekly change in WHO-5 score |
Comparison: Sex was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 8.p-value: 0.49Mixed Models Analysis
Comparison: Sex was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 20.p-value: 0.266Mixed Models Analysis