Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of South Florida | OTHER |
| Global Healthy Living Foundation | OTHER |
| University of North Carolina | OTHER |
| University of California, Los Angeles |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mindfulness-Based Cognitive Therapy | Experimental | 8 sessions of online mindfulness-based cognitive therapy |
|
| Brief Mindfulness | Experimental | 3 sessions of online mindfulness therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mindfulness-Based Cognitive Therapy | Behavioral | 8 sessions of online mindfulness-based cognitive therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to 8 Weeks, Baseline to 20 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to 8 Weeks, Baseline to 20 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to 8 Weeks, Baseline to 20 Weeks |
| Estimated Weekly Change in World Health Organization-5 (WHO-5) Stratified by Baseline Perceived Stress Scale (PSS) |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Andrew A Nierenberg, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36094813 | Derived | Sylvia LG, Lunn MR, Obedin-Maliver J, McBurney RN, Nowell WB, Nosheny RL, Mularski RA, Long MD, Merkel PA, Pletcher MJ, Tovey RE, Scalchunes C, Sutphen R, Martin AS, Horn EJ, O'Boyle M, Pitch L, Seid M, Redline S, Greenebaum S, George N, French NJ, Faria CM, Puvanich N, Rabideau DJ, Selvaggi CA, Yu C, Faraone SV, Venkatachalam S, McCall D, Terry SF, Deckersbach T, Nierenberg AA. Web-Based Mindfulness-Based Interventions for Well-being: Randomized Comparative Effectiveness Trial. J Med Internet Res. 2022 Sep 12;24(9):e35620. doi: 10.2196/35620. |
Not provided
Not provided
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.
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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Mindfulness-Based Cognitive Therapy | 8 sessions of online mindfulness-based cognitive therapy Mindfulness-Based Cognitive Therapy: 8 sessions of online mindfulness-based cognitive therapy |
| FG001 | Brief Mindfulness | 3 sessions of online mindfulness therapy Brief Mindfulness: 3 sessions of online mindfulness therapy |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Mindfulness-Based Cognitive Therapy | 8 sessions of online mindfulness-based cognitive therapy Mindfulness-Based Cognitive Therapy: 8 sessions of online mindfulness-based cognitive therapy |
| BG001 | Brief Mindfulness |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | 95% Confidence Interval | estimated weekly change in scale score | Baseline to 8 Weeks, Baseline to 20 Weeks |
|
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Mindfulness-Based Cognitive Therapy | 8 sessions of online mindfulness-based cognitive therapy Mindfulness-Based Cognitive Therapy: 8 sessions of online mindfulness-based cognitive therapy |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac Issue | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac Issue | Cardiac disorders | Systematic Assessment |
Despite having a wide range of clinical and non-clinical samples represented in this study, the sample generalizability was limited in regards to race and gender. A second limitation was not including support for participants to access the study (e.g., technical support, translated versions into other languages) as well as to engage with the study interventions.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Andrew Nierenberg | Massachusetts General Hospital | 617-512-2641 | anierenberg@mgh.harvard.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 19, 2018 | Sep 15, 2020 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D000099025 | Mindfulness-Based Cognitive Therapy |
| ID | Term |
|---|---|
| D064866 | Mindfulness |
| D015928 | Cognitive Behavioral Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
Not provided
Not provided
| OTHER |
| Genetic Alliance | OTHER |
| COPD Foundation | OTHER |
| The Duchenne Registry | OTHER |
| University of California, San Francisco | OTHER |
| Children's Hospital Medical Center, Cincinnati | OTHER |
| Hugo W. Moser Research Institute at Kennedy Krieger, Inc. | OTHER |
| Accelerated Cure Project for Multiple Sclerosis | OTHER |
| Mayo Clinic | OTHER |
| Phelan-McDermid Syndrome Foundation | OTHER |
| Immune Deficiency Foundation | OTHER |
| Brigham and Women's Hospital | OTHER |
| University of Pennsylvania | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
| Brief Mindfulness | Behavioral | 3 sessions of online mindfulness therapy |
|
| 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. | Baseline to 8 Weeks, Baseline to 20 Weeks |
| Estimated Weekly Change on Patient Reported Outcomes Measurement Information System (PROMIS): Emotional Distress-Anxiety Short Form | The PROMIS: Emotional Distress-Anxiety Short Form is a 4-item questionnaire that measures self-reported fear, anxious misery, hyperarousal, and somatic symptoms related to arousal in the past seven days. Scores range 4-20, with higher scores representing more severe anxiety symptoms. Change = estimated average weekly change during time frame. | Baseline to 8 Weeks, Baseline to 20 Weeks |
| Estimated Weekly Change on Patient Reported Outcomes Measurement Information System (PROMIS): Ability to Participate in Social Roles and Activities Short Form | The PROMIS: Ability to Participate in Social Roles and Activities Short Form is a 4-item questionnaire that measures the perceived ability to perform one's everyday social roles and activities. Scores range 4-20 with higher scores representing fewer limitations (greater abilities). Change = estimated average weekly change during time frame. | Baseline to 8 Weeks, Baseline to 20 Weeks |
| Estimated Weekly Change on Five Facet Mindfulness Questionnaire (FFMQ) Abbreviated | The FFMQ is a 39-item questionnaire that examines five aspects of mindfulness: observing, describing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience. Only the questions related to non-judging of inner experience and non-reactivity were administered (15 items total). The total score on these 15 items was used (range: 15-75). Higher scores represent greater mindfulness. Change = estimated average weekly change during time frame. | Baseline to 8 Weeks, Baseline to 20 Weeks |
The WHO-5 is a 5-item questionnaire that assesses well-being over the prior two weeks. Scores range 0-100 with higher scores reflecting greater well-being. The PSS is a 10-item questionnaire that evaluates an individual's experiences of stress in the previous month. Scores range 0-40, with higher scores representing greater perceived stress. |
| Baseline to 8 Weeks, Baseline to 20 Weeks |
| 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. | Baseline to 8 Weeks, Baseline to 20 Weeks |
| 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. | Baseline to 8 Weeks, Baseline to 20 Weeks |
| 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). | Baseline to 8 Weeks, Baseline to 20 Weeks |
| 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. | Baseline to 8 Weeks, Baseline to 20 Weeks |
3 sessions of online mindfulness therapy
Brief Mindfulness: 3 sessions of online mindfulness therapy
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Sex Assigned at Birth | Count of Participants | Participants |
|
| Sex/Gender, Customized | Gender Identity | Count of Participants | Participants |
|
| Sex/Gender, Customized | Sexual Orientation | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Race/Origin | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Ethnicity | Count of Participants | Participants |
|
| World Health Organization-5 Well-Being Index | This 5-item questionnaire assesses well-being over the prior two weeks. Scores range 0-100 with higher scores reflecting greater well-being. | Mean | Standard Deviation | units on a scale |
|
| Five Facet Mindfulness Questionnaire | This 39-item questionnaire 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. | Mean | Standard Deviation | units on a scale |
|
| Perceived Stress Scale | This 10-item questionnaire evaluates an individual's experiences of stress in the previous month. Scores range 0-40, with higher scores representing greater perceived stress. | Mean | Standard Deviation | units on a scale |
|
| PROMIS Emotional Distress - Anxiety Short Form (Adult, 4-Item) | This 4-item questionnaire 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. | Mean | Standard Deviation | units on a scale |
|
| PROMIS Emotional Distress - Depression Short Form (Adult, v. 8a) | This 8-item questionnaire measured perceived depressive symptoms over the past week. Scores range 8-40, with higher scores representing more severe depressive symptoms. | Mean | Standard Deviation | units on a scale |
|
| PROMIS: Ability to Participate in Social Roles and Activities Short Form (Adult, 4-item) | This 4-item questionnaire 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). | Mean | Standard Deviation | units on a scale |
|
3 sessions of online mindfulness therapy
Brief Mindfulness: 3 sessions of online mindfulness therapy
|
|
|
| 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. | Posted | Mean | 95% Confidence Interval | estimated weekly change in scale score | Baseline to 8 Weeks, Baseline to 20 Weeks |
|
|
|
|
| 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. | Posted | Mean | 95% Confidence Interval | estimated weekly change in scale score | Baseline to 8 Weeks, Baseline to 20 Weeks |
|
|
|
|
| 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. | Posted | Mean | 95% Confidence Interval | estimated weekly change in scale score | Baseline to 8 Weeks, Baseline to 20 Weeks |
|
|
|
|
| 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. | Posted | Mean | 95% Confidence Interval | estimated weekly change in scale score | Baseline to 8 Weeks, Baseline to 20 Weeks |
|
|
|
|
| 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. | Posted | Mean | 95% Confidence Interval | estimated weekly change in scale score | Baseline to 8 Weeks, Baseline to 20 Weeks |
|
|
|
|
| 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. | Posted | Mean | 95% Confidence Interval | estimated weekly change in WHO-5 score | Baseline to 8 Weeks, Baseline to 20 Weeks |
|
|
|
|
| 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. | Posted | Median | 95% Confidence Interval | estimated weekly change in WHO-5 score | Baseline to 8 Weeks, Baseline to 20 Weeks |
|
|
|
|
| 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. | Posted | Mean | 95% Confidence Interval | estimated weekly change in WHO-5 score | Baseline to 8 Weeks, Baseline to 20 Weeks |
|
|
|
|
| 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. | Posted | Mean | 95% Confidence Interval | estimated weekly change in WHO-5 score | Baseline to 8 Weeks, Baseline to 20 Weeks |
|
|
|
|
| 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). | Posted | Mean | 95% Confidence Interval | estimated weekly change in WHO-5 score | Baseline to 8 Weeks, Baseline to 20 Weeks |
|
|
|
|
| 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. | Posted | Mean | 95% Confidence Interval | estimated weekly change in WHO-5 score | Baseline to 8 Weeks, Baseline to 20 Weeks |
|
|
|
|
| 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. | Posted | Mean | 95% Confidence Interval | estimated weekly change in WHO-5 score | Baseline to 8 Weeks, Baseline to 20 Weeks |
|
|
|
|
| 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. | Posted | Mean | 95% Confidence Interval | estimated weekly change in WHO-5 score | Baseline to 8 Weeks, Baseline to 20 Weeks |
|
|
|
|
| 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. | Posted | Mean | 95% Confidence Interval | estimated weekly change in WHO-5 score | Baseline to 8 Weeks, Baseline to 20 Weeks |
|
|
|
|
| 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. | Posted | Mean | 95% Confidence Interval | estimated weekly change in WHO-5 score | Baseline to 8 Weeks, Baseline to 20 Weeks |
|
|
|
|
| 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. | Posted | Mean | 95% Confidence Interval | estimated weekly change in WHO-5 score | Baseline to 8 Weeks, Baseline to 20 Weeks |
|
|
|
|
| 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. | Posted | Mean | 95% Confidence Interval | estimated weekly change in WHO-5 score | Baseline to 8 Weeks, Baseline to 20 Weeks |
|
|
|
|
| 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. | Posted | Mean | 95% Confidence Interval | estimated weekly change in WHO-5 score | Baseline to 8 Weeks, Baseline to 20 Weeks |
|
|
|
|
| 0 |
| 2,220 |
| 30 |
| 2,220 |
| 33 |
| 2,220 |
| EG001 | Brief Mindfulness | 3 sessions of online mindfulness therapy Brief Mindfulness: 3 sessions of online mindfulness therapy | 0 | 2,192 | 31 | 2,192 | 41 | 2,192 |
| Gastrointestinal Issue | Gastrointestinal disorders | Systematic Assessment |
|
| Undefined Health Issue | General disorders | Systematic Assessment |
|
| Immune System Issue | Immune system disorders | Systematic Assessment |
|
| Infection | Infections and infestations | Systematic Assessment |
|
| Musculoskeletal or Connective Tissue Issue | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Nervous System Issue | Nervous system disorders | Systematic Assessment |
|
| Psychiatric Issue | Psychiatric disorders | Systematic Assessment |
|
| Renal Issue | Renal and urinary disorders | Systematic Assessment |
|
| Respiratory Issue/Flu | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Negative Life Event | Social circumstances | Systematic Assessment |
|
| Surgical or Medical Procedure | Surgical and medical procedures | Systematic Assessment |
|
| Blood/Lymphatic Issue | Blood and lymphatic system disorders | Systematic Assessment |
|
| Endocrine Issue | Endocrine disorders | Systematic Assessment |
|
| Gastrointestinal Issue | Gastrointestinal disorders | Systematic Assessment |
|
| Undefined Health Issue | General disorders | Systematic Assessment |
|
| Injury or Procedural Complication | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Musculoskeletal or Connective Tissue Issue | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Nervous System Issue | Nervous system disorders | Systematic Assessment |
|
| Medication Side-Effect | Product Issues | Systematic Assessment |
|
| Psychiatric Issue | Psychiatric disorders | Systematic Assessment |
|
| Renal Issue | Renal and urinary disorders | Systematic Assessment |
|
| Respiratory Issue/Flu | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Skin Condition | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Negative Life Event | Social circumstances | Systematic Assessment |
|
| Surgical or Medical Procedure | Surgical and medical procedures | Systematic Assessment |
|
| Vascular Issue | Vascular disorders | Systematic Assessment |
|
| Blood or Lymphatic Issue | Blood and lymphatic system disorders | Systematic Assessment |
|
| Vision/Eye Issue | Eye disorders | Systematic Assessment |
|
| Immune System Issue | Immune system disorders | Systematic Assessment |
|
| Injury or Procedural Complication | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Reproductive Issue | Reproductive system and breast disorders | Systematic Assessment |
|
Not provided
Not provided
| D004191 |
| Behavioral Disciplines and Activities |
| 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. | Mixed Models Analysis | df = 1018 | .394 | A two-sided significance level of .05 was used. | Difference in Slopes | 0.01 | 2-Sided | 95 | -0.01 | 0.03 | Slope estimate = difference in slopes between conditions (Mindfulness Light vs. Mindfulness-Based Cognitive Therapy) during time frame. | Superiority |
| Superiority |
| 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. | Mixed Models Analysis | df = 1159 | <.001 | A two-sided significance level of .05 was used. | Difference in Slopes | 0.05 | 2-Sided | 95 | 0.02 | 0.08 | Slope estimate = difference in slopes between conditions (Mindfulness Light vs. Mindfulness-Based Cognitive Therapy) during time frame. | Superiority |
| Superiority |
| 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. | Mixed Models Analysis | df = 1171 | .048 | A two-sided significance level of .05 was used. | Difference in Slopes | 0.02 | 2-Sided | 95 | 0.00 | 0.03 | Slope estimate = difference in slopes between conditions (Mindfulness Light vs. Mindfulness-Based Cognitive Therapy) during time frame. | Superiority |
| Superiority |
| 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. | Mixed Models Analysis | df = 1179 | .446 | A two-sided significance level of .05 was used. | Difference in Slopes | 0.01 | 2-Sided | 95 | -0.01 | 0.03 | Slope estimate = difference in slopes between conditions (Mindfulness Light vs. Mindfulness-Based Cognitive Therapy) during time frame. | Superiority |
| 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. | Mixed Models Analysis | df = 1067 | .033 | A two-sided significance level of .05 was used. | Difference in Slopes | -0.06 | 2-Sided | 95 | -0.11 | -0.01 | Slope estimate = difference in slopes between conditions (Mindfulness Light vs. Mindfulness-Based Cognitive Therapy) during time frame. | Superiority |
| Baseline to 8 Weeks: Age 65 |
|
| Baseline to 20 Weeks: Age 45 |
|
| Baseline to 20 Weeks: Age 55 |
|
| Baseline to 20 Weeks: Age 65 |
|
| 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. | Mixed Models Analysis | .275 | Reported p-value is for estimated weekly change in WHO-5 score by treatment by moderator interaction. | Superiority |
| Baseline to Week 8: PSS = 22 |
|
| Baseline to Week 20: PSS = 18 |
|
| Baseline to Week 20: PSS = 20 |
|
| Baseline to Week 20: PSS = 22 |
|
| 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. | Mixed Models Analysis | .341 | Reported p-value is for estimated weekly change in WHO-5 score by treatment by moderator interaction. | Superiority |
| Baseline to Week 8: PROMIS: EDD = 20 |
|
| Baseline to Week 20: PROMIS: EDD = 10 |
|
| Baseline to Week 20: PROMIS: EDD = 15 |
|
| Baseline to Week 20: PROMIS: EDD = 20 |
|
| 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. | Mixed Models Analysis | .319 | Reported p-value is for estimated weekly change in WHO-5 score by treatment by moderator interaction. | Superiority |
| Baseline to 8 Weeks: PROMIS: EDA = 15 |
|
| Baseline to 20 Weeks: PROMIS: EDA = 5 |
|
| Baseline to 20 Weeks: PROMIS: EDA = 10 |
|
| Baseline to 20 Weeks: PROMIS: EDA = 15 |
|
| 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. | Mixed Models Analysis | .890 | Reported p-value is for estimated weekly change in WHO-5 score by treatment by moderator interaction. | Superiority |
| Baseline to 8 Weeks: PROMIS: APRA = 15 |
|
| Baseline to 20 Weeks: PROMIS: APRA = 5 |
|
| Baseline to 20 Weeks: PROMIS: APRA = 10 |
|
| Baseline to 20 Weeks: PROMIS: APRA = 15 |
|
| 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. | Mixed Models Analysis | .733 | Reported p-value is for estimated weekly change in WHO-5 score by treatment by moderator interaction. | Superiority |
| Baseline to 8 Weeks: FFMQ = 60 |
|
| Baseline to 20 Weeks: FFMQ = 40 |
|
| Baseline to 20 Weeks: FFMQ = 50 |
|
| Baseline to 20 Weeks: FFMQ = 60 |
|
| 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. | Mixed Models Analysis | .666 | Reported p-value is for estimated weekly change in WHO-5 score by treatment by moderator interaction. | Superiority |
| Baseline to 20 Weeks: Psychiatric Illness |
|
| Baseline to 20 Weeks: No Psychiatric Illness |
|
| 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. | Mixed Models Analysis | .361 | Reported p-value is for estimated weekly change in WHO-5 score by treatment by moderator interaction. | Superiority |
| Baseline to 20 Weeks: Medical Problems |
|
| Baseline to 20 Weeks: No Medical Problems |
|
| 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. | Mixed Models Analysis | .396 | Reported p-value is for estimated weekly change in WHO-5 score by treatment by moderator interaction. | Superiority |
| Baseline to 8 Weeks: 100% |
|
| Baseline to 20 Weeks: 0% |
|
| Baseline to 20 Weeks: 33% |
|
| Baseline to 20 Weeks: 100% |
|
| 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. | Mixed Models Analysis | .291 | Reported p-value is for estimated weekly change in WHO-5 score by treatment by moderator interaction. | Superiority |
| Baseline to 8 Weeks: > College |
|
| Baseline to 20 Weeks: High School or Less |
|
| Baseline to 20 Weeks: 2 or 4-Year College |
|
| Baseline to 20 Weeks: > College |
|
| 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. | Mixed Models Analysis | .333 | Reported p-value is for estimated weekly change in WHO-5 score by treatment by moderator interaction. | Superiority |
| Baseline to 20 Weeks: White |
|
| Baseline to 20 Weeks: Non-White |
|
| 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. | Mixed Models Analysis | .885 | Reported p-value is for estimated weekly change in WHO-5 score by treatment by moderator interaction. | Superiority |
| Baseline to 8 Weeks: Other |
|
| Baseline to 20 Weeks: Male |
|
| Baseline to 20 Weeks: Female |
|
| Baseline to 20 Weeks: Other |
|
| 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. | Mixed Models Analysis | .266 | Reported p-value is for estimated weekly change in WHO-5 score by treatment by moderator interaction. | Superiority |
| Baseline to 8 Weeks: Other |
|
| Baseline to 20 Weeks: Hispanic |
|
| Baseline to 20 Weeks: Non-Hispanic |
|
| Baseline to 20 Weeks: Other |
|
| 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. | Mixed Models Analysis | .307 | Reported p-value is for estimated weekly change in WHO-5 score by treatment by moderator interaction. | Superiority |