Trial Outcomes & Findings for Behavior, Biology and Well-Being Study (NCT NCT05183867)
NCT ID: NCT05183867
Last Updated: 2025-09-09
Results Overview
The PHQ-8 is an 8-item questionnaire where participants report how often in the past 2 weeks they were bothered by specific problems. It is scored on a 4-point Likert scale where 0 = not at all to 3 = nearly every day. The total possible range of scores is 0-24 where higher scores indicate more depressive symptoms.
COMPLETED
NA
1157 participants
Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up
2025-09-09
Participant Flow
Participant milestones
| Measure |
Healthy Minds Program (HMP) App
Participants will receive access to the 4-week HMP Foundations module. The HMP app is a meditation-based smartphone app designed to promote and protect psychological well-being through sustainable skills training. The program is grounded in constituents of psychological well-being identified in empirical literature. HMP provides core content, with instruction administered through a curriculum of guided practices. HMP is based on research on eudaimonic well-being (e.g., environmental mastery, purpose) and brain-based skills that underlie these qualities (e.g., regulation of attention, mental flexibility). The full HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose. At post-treatment, participants will be given access to additional HMP content to support their continued practice.
Healthy Minds Program: HMP is a 4-week mobile health (mHealth) meditation training program.
|
Psychoeducation App
Participants will receive access to the 4-week HMP Foundations module with guided meditation practices removed. The active control will include only the didactic content included in HMP without the guided meditation practices.
Healthy Minds Program: HMP is a 4-week mobile health (mHealth) meditation training program.
|
Usual Care
Participants will receive access to HMP at the end of the study and will be encouraged to continue with their usual care.
|
|---|---|---|---|
|
Overall Study
STARTED
|
462
|
463
|
232
|
|
Overall Study
COMPLETED
|
459
|
461
|
232
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
0
|
Reasons for withdrawal
| Measure |
Healthy Minds Program (HMP) App
Participants will receive access to the 4-week HMP Foundations module. The HMP app is a meditation-based smartphone app designed to promote and protect psychological well-being through sustainable skills training. The program is grounded in constituents of psychological well-being identified in empirical literature. HMP provides core content, with instruction administered through a curriculum of guided practices. HMP is based on research on eudaimonic well-being (e.g., environmental mastery, purpose) and brain-based skills that underlie these qualities (e.g., regulation of attention, mental flexibility). The full HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose. At post-treatment, participants will be given access to additional HMP content to support their continued practice.
Healthy Minds Program: HMP is a 4-week mobile health (mHealth) meditation training program.
|
Psychoeducation App
Participants will receive access to the 4-week HMP Foundations module with guided meditation practices removed. The active control will include only the didactic content included in HMP without the guided meditation practices.
Healthy Minds Program: HMP is a 4-week mobile health (mHealth) meditation training program.
|
Usual Care
Participants will receive access to HMP at the end of the study and will be encouraged to continue with their usual care.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
2
|
0
|
Baseline Characteristics
Behavior, Biology and Well-Being Study
Baseline characteristics by cohort
| Measure |
Healthy Minds Program (HMP) App
n=462 Participants
Participants will receive access to the 4-week HMP Foundations module. The HMP app is a meditation-based smartphone app designed to promote and protect psychological well-being through sustainable skills training. The program is grounded in constituents of psychological well-being identified in empirical literature. HMP provides core content, with instruction administered through a curriculum of guided practices. HMP is based on research on eudaimonic well-being (e.g., environmental mastery, purpose) and brain-based skills that underlie these qualities (e.g., regulation of attention, mental flexibility). The full HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose. At post-treatment, participants will be given access to additional HMP content to support their continued practice.
Healthy Minds Program: HMP is a 4-week mobile health (mHealth) meditation training program.
|
Psychoeducation App
n=463 Participants
Participants will receive access to the 4-week HMP Foundations module with guided meditation practices removed. The active control will include only the didactic content included in HMP without the guided meditation practices.
Healthy Minds Program: HMP is a 4-week mobile health (mHealth) meditation training program.
|
Usual Care
n=232 Participants
Participants will receive access to HMP at the end of the study and will be encouraged to continue with their usual care.
|
Total
n=1157 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
38.34 years
STANDARD_DEVIATION 11.84 • n=5 Participants
|
39.02 years
STANDARD_DEVIATION 12.18 • n=7 Participants
|
38.72 years
STANDARD_DEVIATION 12.64 • n=5 Participants
|
38.69 years
STANDARD_DEVIATION 12.13 • n=4 Participants
|
|
Sex/Gender, Customized
Man
|
93 Participants
n=5 Participants
|
103 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
245 Participants
n=4 Participants
|
|
Sex/Gender, Customized
Woman
|
355 Participants
n=5 Participants
|
342 Participants
n=7 Participants
|
173 Participants
n=5 Participants
|
870 Participants
n=4 Participants
|
|
Sex/Gender, Customized
Other
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Sex/Gender, Customized
Unknown or Not Reported
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
48 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
112 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
400 Participants
n=5 Participants
|
406 Participants
n=7 Participants
|
198 Participants
n=5 Participants
|
1004 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
14 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
41 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
26 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
62 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
36 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
103 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
341 Participants
n=5 Participants
|
357 Participants
n=7 Participants
|
176 Participants
n=5 Participants
|
874 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
45 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
82 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
12 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
462 participants
n=5 Participants
|
463 participants
n=7 Participants
|
232 participants
n=5 Participants
|
1157 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-upPopulation: Some participants did not provide data at all time points.
The PHQ-8 is an 8-item questionnaire where participants report how often in the past 2 weeks they were bothered by specific problems. It is scored on a 4-point Likert scale where 0 = not at all to 3 = nearly every day. The total possible range of scores is 0-24 where higher scores indicate more depressive symptoms.
Outcome measures
| Measure |
Healthy Minds Program (HMP) App
n=462 Participants
Participants will receive full access to the 4-week HMP Foundations module. The full HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose. At post-treatment, participants will be given access to additional HMP content to support their continued practice.
Healthy Minds Program: HMP is a 4-week mobile health (mHealth) meditation training program.
|
Psychoeducation App
n=463 Participants
Participants will receive access to the 4-week HMP Foundations module with guided meditation practices removed. The active control will include only the didactic content included in HMP without the guided meditation practices.
Healthy Minds Program: HMP is a 4-week mobile health (mHealth) meditation training program.
|
Usual Care
n=232 Participants
Participants will receive access to HMP at the end of the study and will be encouraged to continue with their usual care.
|
|---|---|---|---|
|
Depression Symptoms Measured by Patient Health Questionnaire - 8 (PHQ-8) Score
Week 2
|
8.37 score on a scale
Standard Deviation 4.75
|
8.28 score on a scale
Standard Deviation 4.6
|
9.03 score on a scale
Standard Deviation 5.22
|
|
Depression Symptoms Measured by Patient Health Questionnaire - 8 (PHQ-8) Score
baseline
|
10.06 score on a scale
Standard Deviation 4.85
|
9.85 score on a scale
Standard Deviation 4.68
|
9.79 score on a scale
Standard Deviation 4.75
|
|
Depression Symptoms Measured by Patient Health Questionnaire - 8 (PHQ-8) Score
Week 1
|
9.17 score on a scale
Standard Deviation 4.72
|
8.8 score on a scale
Standard Deviation 4.71
|
9.45 score on a scale
Standard Deviation 5.11
|
|
Depression Symptoms Measured by Patient Health Questionnaire - 8 (PHQ-8) Score
Week 3
|
7.88 score on a scale
Standard Deviation 4.9
|
8.01 score on a scale
Standard Deviation 4.84
|
9.21 score on a scale
Standard Deviation 4.93
|
|
Depression Symptoms Measured by Patient Health Questionnaire - 8 (PHQ-8) Score
Week 4
|
7.21 score on a scale
Standard Deviation 4.8
|
7.39 score on a scale
Standard Deviation 4.8
|
8.86 score on a scale
Standard Deviation 5.11
|
|
Depression Symptoms Measured by Patient Health Questionnaire - 8 (PHQ-8) Score
3-month follow-up
|
6.67 score on a scale
Standard Deviation 4.6
|
6.93 score on a scale
Standard Deviation 4.92
|
8.46 score on a scale
Standard Deviation 5.09
|
SECONDARY outcome
Timeframe: Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-upPopulation: Some participants did not provide data at all time points.
The GAD-7 is a 7-item questionnaire where participants report how often in the past 2 weeks they were bothered by specific problems. It is scored on a 4-point Likert scale where 0 = not at all to 3 = nearly every day. The total possible range of scores is 0-21 where higher scores indicate more anxious symptoms.
Outcome measures
| Measure |
Healthy Minds Program (HMP) App
n=462 Participants
Participants will receive full access to the 4-week HMP Foundations module. The full HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose. At post-treatment, participants will be given access to additional HMP content to support their continued practice.
Healthy Minds Program: HMP is a 4-week mobile health (mHealth) meditation training program.
|
Psychoeducation App
n=463 Participants
Participants will receive access to the 4-week HMP Foundations module with guided meditation practices removed. The active control will include only the didactic content included in HMP without the guided meditation practices.
Healthy Minds Program: HMP is a 4-week mobile health (mHealth) meditation training program.
|
Usual Care
n=232 Participants
Participants will receive access to HMP at the end of the study and will be encouraged to continue with their usual care.
|
|---|---|---|---|
|
Anxiety Symptoms Measured by Generalized Anxiety Disorder - 7 (GAD-7) Score
baseline
|
8.94 score on a scale
Standard Deviation 4.95
|
8.67 score on a scale
Standard Deviation 4.97
|
8.37 score on a scale
Standard Deviation 4.97
|
|
Anxiety Symptoms Measured by Generalized Anxiety Disorder - 7 (GAD-7) Score
Week 1
|
8.58 score on a scale
Standard Deviation 4.88
|
8.13 score on a scale
Standard Deviation 4.97
|
8.04 score on a scale
Standard Deviation 5.27
|
|
Anxiety Symptoms Measured by Generalized Anxiety Disorder - 7 (GAD-7) Score
Week 2
|
7.66 score on a scale
Standard Deviation 4.66
|
7.46 score on a scale
Standard Deviation 4.88
|
7.68 score on a scale
Standard Deviation 5.04
|
|
Anxiety Symptoms Measured by Generalized Anxiety Disorder - 7 (GAD-7) Score
Week 3
|
7.21 score on a scale
Standard Deviation 4.6
|
7.15 score on a scale
Standard Deviation 4.71
|
7.59 score on a scale
Standard Deviation 5.16
|
|
Anxiety Symptoms Measured by Generalized Anxiety Disorder - 7 (GAD-7) Score
Week 4
|
6.39 score on a scale
Standard Deviation 4.55
|
6.46 score on a scale
Standard Deviation 4.6
|
7.28 score on a scale
Standard Deviation 5.19
|
|
Anxiety Symptoms Measured by Generalized Anxiety Disorder - 7 (GAD-7) Score
3-month follow-up
|
6.1 score on a scale
Standard Deviation 4.63
|
6.22 score on a scale
Standard Deviation 4.75
|
7.08 score on a scale
Standard Deviation 5.09
|
SECONDARY outcome
Timeframe: Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-upPopulation: Some participants did not provide data at all time points.
The PROMIS Sleep Disturbance scale is a computer-adaptive measure where participants report how often in the past 7 days they had various sleep-related experiences (e.g., "my sleep was restful"). It is scored on a 5-point Likert scale where 1 = not at all to 5 = very much. It provides total scores as T-scores (mean = 50, standard deviation (SD) = 10) where higher scores indicate more sleep disturbance.
Outcome measures
| Measure |
Healthy Minds Program (HMP) App
n=462 Participants
Participants will receive full access to the 4-week HMP Foundations module. The full HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose. At post-treatment, participants will be given access to additional HMP content to support their continued practice.
Healthy Minds Program: HMP is a 4-week mobile health (mHealth) meditation training program.
|
Psychoeducation App
n=463 Participants
Participants will receive access to the 4-week HMP Foundations module with guided meditation practices removed. The active control will include only the didactic content included in HMP without the guided meditation practices.
Healthy Minds Program: HMP is a 4-week mobile health (mHealth) meditation training program.
|
Usual Care
n=232 Participants
Participants will receive access to HMP at the end of the study and will be encouraged to continue with their usual care.
|
|---|---|---|---|
|
Sleep Disturbance Measured by Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Score
baseline
|
57.73 T-score
Standard Deviation 8.03
|
56.94 T-score
Standard Deviation 8.16
|
56.9 T-score
Standard Deviation 8.41
|
|
Sleep Disturbance Measured by Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Score
Week 1
|
56.26 T-score
Standard Deviation 8.35
|
55.91 T-score
Standard Deviation 8.31
|
57.12 T-score
Standard Deviation 8.67
|
|
Sleep Disturbance Measured by Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Score
Week 2
|
55.78 T-score
Standard Deviation 8.93
|
55.48 T-score
Standard Deviation 8.04
|
55.65 T-score
Standard Deviation 9.19
|
|
Sleep Disturbance Measured by Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Score
Week 3
|
55.14 T-score
Standard Deviation 9.24
|
54.8 T-score
Standard Deviation 8.96
|
56.53 T-score
Standard Deviation 8.95
|
|
Sleep Disturbance Measured by Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Score
Week 4
|
54.23 T-score
Standard Deviation 9.06
|
54.17 T-score
Standard Deviation 8.76
|
55.81 T-score
Standard Deviation 9.23
|
|
Sleep Disturbance Measured by Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Score
3-month follow-up
|
53.61 T-score
Standard Deviation 9.1
|
53.51 T-score
Standard Deviation 9.29
|
55.76 T-score
Standard Deviation 9.31
|
SECONDARY outcome
Timeframe: Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-upPopulation: Some participants did not provide data at all time-points
The Flourishing Index is a 10-item questionnaire where participants report their general level of flourishing (e.g., well-being, health, etc.). It is scored on a 0 to 10-point scale, with anchors varying across items. The total score ranges from 0 to 100 with higher scores indicating higher flourishing.
Outcome measures
| Measure |
Healthy Minds Program (HMP) App
n=462 Participants
Participants will receive full access to the 4-week HMP Foundations module. The full HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose. At post-treatment, participants will be given access to additional HMP content to support their continued practice.
Healthy Minds Program: HMP is a 4-week mobile health (mHealth) meditation training program.
|
Psychoeducation App
n=463 Participants
Participants will receive access to the 4-week HMP Foundations module with guided meditation practices removed. The active control will include only the didactic content included in HMP without the guided meditation practices.
Healthy Minds Program: HMP is a 4-week mobile health (mHealth) meditation training program.
|
Usual Care
n=232 Participants
Participants will receive access to HMP at the end of the study and will be encouraged to continue with their usual care.
|
|---|---|---|---|
|
Flourishing Measured by the Flourishing Index Score
baseline
|
56.26 score on a scale
Standard Deviation 15.33
|
56.55 score on a scale
Standard Deviation 16.05
|
56.63 score on a scale
Standard Deviation 15.22
|
|
Flourishing Measured by the Flourishing Index Score
Week 1
|
57.19 score on a scale
Standard Deviation 15.69
|
57.52 score on a scale
Standard Deviation 15.83
|
57.22 score on a scale
Standard Deviation 14.9
|
|
Flourishing Measured by the Flourishing Index Score
Week 2
|
60.11 score on a scale
Standard Deviation 15.58
|
59.92 score on a scale
Standard Deviation 15.85
|
58.18 score on a scale
Standard Deviation 16.38
|
|
Flourishing Measured by the Flourishing Index Score
Week 3
|
62.45 score on a scale
Standard Deviation 15.95
|
60.87 score on a scale
Standard Deviation 15.77
|
58.30 score on a scale
Standard Deviation 15.80
|
|
Flourishing Measured by the Flourishing Index Score
Week 4
|
64.53 score on a scale
Standard Deviation 16.54
|
63.52 score on a scale
Standard Deviation 16.42
|
59.29 score on a scale
Standard Deviation 16.43
|
|
Flourishing Measured by the Flourishing Index Score
3-month follow-up
|
66.00 score on a scale
Standard Deviation 16.58
|
64.62 score on a scale
Standard Deviation 16.76
|
60.99 score on a scale
Standard Deviation 15.43
|
SECONDARY outcome
Timeframe: Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-upPopulation: Some participants did not provide data at all time points.
The Five Facet Mindfulness Questionnaire Acting with Awareness Subscale is a 8-item subscale where participants report on their general ability to focus. It is scored on a 5-point Likert scale where 1 = never or very rarely true to 5 = very often or always true. The total possible range of scores is 8-40 where higher scores indicate a greater ability to focus.
Outcome measures
| Measure |
Healthy Minds Program (HMP) App
n=462 Participants
Participants will receive full access to the 4-week HMP Foundations module. The full HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose. At post-treatment, participants will be given access to additional HMP content to support their continued practice.
Healthy Minds Program: HMP is a 4-week mobile health (mHealth) meditation training program.
|
Psychoeducation App
n=463 Participants
Participants will receive access to the 4-week HMP Foundations module with guided meditation practices removed. The active control will include only the didactic content included in HMP without the guided meditation practices.
Healthy Minds Program: HMP is a 4-week mobile health (mHealth) meditation training program.
|
Usual Care
n=232 Participants
Participants will receive access to HMP at the end of the study and will be encouraged to continue with their usual care.
|
|---|---|---|---|
|
Awareness Measured by Five Facet Mindfulness Questionnaire Acting With Awareness Subscale Score
baseline
|
24.11 score on a scale
Standard Deviation 6.13
|
24.41 score on a scale
Standard Deviation 6.32
|
23.95 score on a scale
Standard Deviation 6.57
|
|
Awareness Measured by Five Facet Mindfulness Questionnaire Acting With Awareness Subscale Score
Week 1
|
23.61 score on a scale
Standard Deviation 6.88
|
24.26 score on a scale
Standard Deviation 6.91
|
24.27 score on a scale
Standard Deviation 7.35
|
|
Awareness Measured by Five Facet Mindfulness Questionnaire Acting With Awareness Subscale Score
Week 2
|
24.55 score on a scale
Standard Deviation 7.1
|
25.02 score on a scale
Standard Deviation 7.02
|
24.63 score on a scale
Standard Deviation 7.29
|
|
Awareness Measured by Five Facet Mindfulness Questionnaire Acting With Awareness Subscale Score
Week 3
|
25.68 score on a scale
Standard Deviation 7.28
|
25.95 score on a scale
Standard Deviation 7.4
|
24.74 score on a scale
Standard Deviation 7.65
|
|
Awareness Measured by Five Facet Mindfulness Questionnaire Acting With Awareness Subscale Score
Week 4
|
25.89 score on a scale
Standard Deviation 6.74
|
26.03 score on a scale
Standard Deviation 6.83
|
24.68 score on a scale
Standard Deviation 6.92
|
|
Awareness Measured by Five Facet Mindfulness Questionnaire Acting With Awareness Subscale Score
3-month follow-up
|
26.09 score on a scale
Standard Deviation 6.78
|
26.18 score on a scale
Standard Deviation 6.32
|
24.75 score on a scale
Standard Deviation 6.75
|
SECONDARY outcome
Timeframe: Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-upPopulation: Some participants did not provide data at all time points.
The NIH Toolbox Loneliness is a 5-item questionnaire where participants report how often in the past week they have felt loneliness. It is scored on a 5-point Likert scale where 1 = never to 5 = always. The total possible range of scores is 5-25 where higher scores indicate a greater sense of loneliness.
Outcome measures
| Measure |
Healthy Minds Program (HMP) App
n=462 Participants
Participants will receive full access to the 4-week HMP Foundations module. The full HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose. At post-treatment, participants will be given access to additional HMP content to support their continued practice.
Healthy Minds Program: HMP is a 4-week mobile health (mHealth) meditation training program.
|
Psychoeducation App
n=463 Participants
Participants will receive access to the 4-week HMP Foundations module with guided meditation practices removed. The active control will include only the didactic content included in HMP without the guided meditation practices.
Healthy Minds Program: HMP is a 4-week mobile health (mHealth) meditation training program.
|
Usual Care
n=232 Participants
Participants will receive access to HMP at the end of the study and will be encouraged to continue with their usual care.
|
|---|---|---|---|
|
Connection Measured by NIH Toolbox Loneliness Score
baseline
|
15.1 score on a scale
Standard Deviation 4.85
|
14.74 score on a scale
Standard Deviation 4.63
|
15.13 score on a scale
Standard Deviation 4.66
|
|
Connection Measured by NIH Toolbox Loneliness Score
Week 1
|
14.33 score on a scale
Standard Deviation 5.11
|
13.97 score on a scale
Standard Deviation 4.82
|
14.57 score on a scale
Standard Deviation 4.81
|
|
Connection Measured by NIH Toolbox Loneliness Score
Week 2
|
13.52 score on a scale
Standard Deviation 5.14
|
13.24 score on a scale
Standard Deviation 4.64
|
13.86 score on a scale
Standard Deviation 4.98
|
|
Connection Measured by NIH Toolbox Loneliness Score
Week 3
|
13.05 score on a scale
Standard Deviation 5.28
|
13.00 score on a scale
Standard Deviation 4.79
|
14.21 score on a scale
Standard Deviation 4.85
|
|
Connection Measured by NIH Toolbox Loneliness Score
Week 4
|
12.54 score on a scale
Standard Deviation 5.30
|
12.41 score on a scale
Standard Deviation 4.74
|
14.16 score on a scale
Standard Deviation 4.73
|
|
Connection Measured by NIH Toolbox Loneliness Score
3-month follow-up
|
12.31 score on a scale
Standard Deviation 5.11
|
12.82 score on a scale
Standard Deviation 4.96
|
14.10 score on a scale
Standard Deviation 4.81
|
SECONDARY outcome
Timeframe: Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-upPopulation: Some participants did not provide data at all time points.
The Decentering subscale of the Experience Questionnaire is an 11-item questionnaire where participants report on their ability to decenter from their experience. It is scored on a 5-point Likert scale where 1 = never to 5 = all the time. The total possible range of scores is 11-55 where higher scores indicate a greater ability to decenter from experience.
Outcome measures
| Measure |
Healthy Minds Program (HMP) App
n=462 Participants
Participants will receive full access to the 4-week HMP Foundations module. The full HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose. At post-treatment, participants will be given access to additional HMP content to support their continued practice.
Healthy Minds Program: HMP is a 4-week mobile health (mHealth) meditation training program.
|
Psychoeducation App
n=463 Participants
Participants will receive access to the 4-week HMP Foundations module with guided meditation practices removed. The active control will include only the didactic content included in HMP without the guided meditation practices.
Healthy Minds Program: HMP is a 4-week mobile health (mHealth) meditation training program.
|
Usual Care
n=232 Participants
Participants will receive access to HMP at the end of the study and will be encouraged to continue with their usual care.
|
|---|---|---|---|
|
Decentering Measured by Decentering Subscale of Experiencing Questionnaire Scale Score
baseline
|
33.12 score on a scale
Standard Deviation 6.65
|
33.22 score on a scale
Standard Deviation 6.95
|
33.51 score on a scale
Standard Deviation 7.40
|
|
Decentering Measured by Decentering Subscale of Experiencing Questionnaire Scale Score
Week 1
|
34.15 score on a scale
Standard Deviation 6.31
|
33.92 score on a scale
Standard Deviation 6.42
|
33.99 score on a scale
Standard Deviation 6.94
|
|
Decentering Measured by Decentering Subscale of Experiencing Questionnaire Scale Score
Week 2
|
36.49 score on a scale
Standard Deviation 6.14
|
35.74 score on a scale
Standard Deviation 6.40
|
34.43 score on a scale
Standard Deviation 6.70
|
|
Decentering Measured by Decentering Subscale of Experiencing Questionnaire Scale Score
Week 3
|
37.46 score on a scale
Standard Deviation 6.46
|
36.69 score on a scale
Standard Deviation 6.67
|
34.74 score on a scale
Standard Deviation 6.65
|
|
Decentering Measured by Decentering Subscale of Experiencing Questionnaire Scale Score
Week 4
|
39.05 score on a scale
Standard Deviation 6.98
|
37.94 score on a scale
Standard Deviation 7.17
|
34.67 score on a scale
Standard Deviation 6.96
|
|
Decentering Measured by Decentering Subscale of Experiencing Questionnaire Scale Score
3-month follow-up
|
39.26 score on a scale
Standard Deviation 7.37
|
38.37 score on a scale
Standard Deviation 7.42
|
35.55 score on a scale
Standard Deviation 7.04
|
SECONDARY outcome
Timeframe: Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-upPopulation: Some participants did not provide data at all time points.
The PROMIS / NIH Toolbox Meaning and Purpose is a computer-adaptive measure where participants report how much meaning and purpose they experience in life (e.g., "I understand my life's meaning"). It is scored on a 5-point Likert scale where 1 = strongly disagree to 5 = strongly agree. It provides total scores as T-scores (mean = 50, SD = 10) where higher scores indicate more meaning and purpose in life.
Outcome measures
| Measure |
Healthy Minds Program (HMP) App
n=462 Participants
Participants will receive full access to the 4-week HMP Foundations module. The full HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose. At post-treatment, participants will be given access to additional HMP content to support their continued practice.
Healthy Minds Program: HMP is a 4-week mobile health (mHealth) meditation training program.
|
Psychoeducation App
n=463 Participants
Participants will receive access to the 4-week HMP Foundations module with guided meditation practices removed. The active control will include only the didactic content included in HMP without the guided meditation practices.
Healthy Minds Program: HMP is a 4-week mobile health (mHealth) meditation training program.
|
Usual Care
n=232 Participants
Participants will receive access to HMP at the end of the study and will be encouraged to continue with their usual care.
|
|---|---|---|---|
|
Meaning in Life Measured by NIH Toolbox Meaning and Purpose Score
baseline
|
43.44 T-score
Standard Deviation 9.89
|
43.09 T-score
Standard Deviation 9.78
|
43.33 T-score
Standard Deviation 9.76
|
|
Meaning in Life Measured by NIH Toolbox Meaning and Purpose Score
Week 1
|
42.89 T-score
Standard Deviation 9.64
|
42.59 T-score
Standard Deviation 9.74
|
41.58 T-score
Standard Deviation 9.67
|
|
Meaning in Life Measured by NIH Toolbox Meaning and Purpose Score
Week 2
|
44.07 T-score
Standard Deviation 9.89
|
43.66 T-score
Standard Deviation 9.96
|
41.71 T-score
Standard Deviation 11.03
|
|
Meaning in Life Measured by NIH Toolbox Meaning and Purpose Score
Week 3
|
44.98 T-score
Standard Deviation 10.25
|
44.27 T-score
Standard Deviation 10.47
|
41.96 T-score
Standard Deviation 10.61
|
|
Meaning in Life Measured by NIH Toolbox Meaning and Purpose Score
Week 4
|
46.86 T-score
Standard Deviation 11.07
|
45.74 T-score
Standard Deviation 10.63
|
42.88 T-score
Standard Deviation 10.47
|
|
Meaning in Life Measured by NIH Toolbox Meaning and Purpose Score
3-month follow-up
|
47.64 T-score
Standard Deviation 10.93
|
46.19 T-score
Standard Deviation 10.69
|
44.21 T-score
Standard Deviation 10.60
|
SECONDARY outcome
Timeframe: Baseline, week 4 (of intervention period), and 3 month follow-upPopulation: Some participants did not provide data at all time points.
The single-item PROMIS Pain Intensity scale is a 1-item scale where participants report on their pain intensity in the past 7 days. It is scored on an 11-point Likert-scale where 0 = no pain and 10 = worst pain imaginable. Scores range from 0 to 10, with higher scores indicating higher pain intensity
Outcome measures
| Measure |
Healthy Minds Program (HMP) App
n=462 Participants
Participants will receive full access to the 4-week HMP Foundations module. The full HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose. At post-treatment, participants will be given access to additional HMP content to support their continued practice.
Healthy Minds Program: HMP is a 4-week mobile health (mHealth) meditation training program.
|
Psychoeducation App
n=463 Participants
Participants will receive access to the 4-week HMP Foundations module with guided meditation practices removed. The active control will include only the didactic content included in HMP without the guided meditation practices.
Healthy Minds Program: HMP is a 4-week mobile health (mHealth) meditation training program.
|
Usual Care
n=232 Participants
Participants will receive access to HMP at the end of the study and will be encouraged to continue with their usual care.
|
|---|---|---|---|
|
Pain Intensity Measured by PROMIS Pain Intensity Score
baseline
|
3.22 score on a scale
Standard Deviation 2.54
|
3.33 score on a scale
Standard Deviation 2.53
|
3.42 score on a scale
Standard Deviation 2.59
|
|
Pain Intensity Measured by PROMIS Pain Intensity Score
Week 4
|
2.98 score on a scale
Standard Deviation 2.6
|
3.12 score on a scale
Standard Deviation 2.57
|
3.5 score on a scale
Standard Deviation 2.81
|
|
Pain Intensity Measured by PROMIS Pain Intensity Score
3-month follow-up
|
3.11 score on a scale
Standard Deviation 2.63
|
3.07 score on a scale
Standard Deviation 2.59
|
3.39 score on a scale
Standard Deviation 2.73
|
SECONDARY outcome
Timeframe: Baseline, week 4 (of intervention period), and 3 month follow-upPopulation: Some participants did not provide data at all time points.
The PROMIS Pain Interference scale is a computer-adaptive measure where participants report how often in the past 7 days they had pain-related interference in their life (e.g., "how much did pain interfere with your enjoyment of life"). It is scored on a 5-point Likert scale where 1 = not at all to 5 = very much. It provides total scores as T-scores (mean = 50, SD = 10) where higher scores indicate more pain interference.
Outcome measures
| Measure |
Healthy Minds Program (HMP) App
n=462 Participants
Participants will receive full access to the 4-week HMP Foundations module. The full HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose. At post-treatment, participants will be given access to additional HMP content to support their continued practice.
Healthy Minds Program: HMP is a 4-week mobile health (mHealth) meditation training program.
|
Psychoeducation App
n=463 Participants
Participants will receive access to the 4-week HMP Foundations module with guided meditation practices removed. The active control will include only the didactic content included in HMP without the guided meditation practices.
Healthy Minds Program: HMP is a 4-week mobile health (mHealth) meditation training program.
|
Usual Care
n=232 Participants
Participants will receive access to HMP at the end of the study and will be encouraged to continue with their usual care.
|
|---|---|---|---|
|
Pain Interference Measured by PROMIS Pain Inference Scale Score
baseline
|
52.94 T-score
Standard Deviation 10.27
|
53.6 T-score
Standard Deviation 10.17
|
53.57 T-score
Standard Deviation 10.51
|
|
Pain Interference Measured by PROMIS Pain Inference Scale Score
Week 4
|
51.65 T-score
Standard Deviation 10.55
|
51.66 T-score
Standard Deviation 9.81
|
53.16 T-score
Standard Deviation 10.91
|
|
Pain Interference Measured by PROMIS Pain Inference Scale Score
3-month follow-up
|
52.21 T-score
Standard Deviation 10.65
|
52.13 T-score
Standard Deviation 10.17
|
52.96 T-score
Standard Deviation 11.06
|
SECONDARY outcome
Timeframe: Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-upPopulation: Some participants did not provide data at all time points.
The Five Facet Mindfulness Questionnaire Nonjudgment Subscale is a 8-item subscale where participants report on their nonjudgment of experience in daily life. It is scored on a 5-point Likert scale where 1 = never or very rarely true to 5 = very often or always true. The total possible range of scores is 8-40 where higher scores indicate a greater nonjudgment of experience.
Outcome measures
| Measure |
Healthy Minds Program (HMP) App
n=462 Participants
Participants will receive full access to the 4-week HMP Foundations module. The full HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose. At post-treatment, participants will be given access to additional HMP content to support their continued practice.
Healthy Minds Program: HMP is a 4-week mobile health (mHealth) meditation training program.
|
Psychoeducation App
n=463 Participants
Participants will receive access to the 4-week HMP Foundations module with guided meditation practices removed. The active control will include only the didactic content included in HMP without the guided meditation practices.
Healthy Minds Program: HMP is a 4-week mobile health (mHealth) meditation training program.
|
Usual Care
n=232 Participants
Participants will receive access to HMP at the end of the study and will be encouraged to continue with their usual care.
|
|---|---|---|---|
|
Nonjudgment Measured by Five Facet Mindfulness Questionnaire Nonjudgment Subscale Score
Week 1
|
26.24 score on a scale
Standard Deviation 7.45
|
26.32 score on a scale
Standard Deviation 7.47
|
25.84 score on a scale
Standard Deviation 7.80
|
|
Nonjudgment Measured by Five Facet Mindfulness Questionnaire Nonjudgment Subscale Score
Week 2
|
27.98 score on a scale
Standard Deviation 7.46
|
27.46 score on a scale
Standard Deviation 7.55
|
26.88 score on a scale
Standard Deviation 7.67
|
|
Nonjudgment Measured by Five Facet Mindfulness Questionnaire Nonjudgment Subscale Score
3-month follow-up
|
28.89 score on a scale
Standard Deviation 6.77
|
27.83 score on a scale
Standard Deviation 6.95
|
26.12 score on a scale
Standard Deviation 7.42
|
|
Nonjudgment Measured by Five Facet Mindfulness Questionnaire Nonjudgment Subscale Score
baseline
|
24.62 score on a scale
Standard Deviation 7.05
|
24.35 score on a scale
Standard Deviation 6.88
|
23.92 score on a scale
Standard Deviation 6.89
|
|
Nonjudgment Measured by Five Facet Mindfulness Questionnaire Nonjudgment Subscale Score
Week 3
|
29.53 score on a scale
Standard Deviation 7.50
|
28.57 score on a scale
Standard Deviation 7.68
|
26.99 score on a scale
Standard Deviation 7.97
|
|
Nonjudgment Measured by Five Facet Mindfulness Questionnaire Nonjudgment Subscale Score
Week 4
|
28.93 score on a scale
Standard Deviation 6.86
|
28.16 score on a scale
Standard Deviation 6.90
|
26.35 score on a scale
Standard Deviation 7.62
|
SECONDARY outcome
Timeframe: Baseline, week 4, and 3 month follow upPopulation: Some participants did not provide data at all time points.
The Climate Change Anxiety Scale is a 13-item scale where participants report their anxiety regarding climate change (e.g., "I have nightmares about climate change"). It is scored on a 5-point Likert scale where 1 = "never" to 5 = "almost always." Total scores range from 13 to 65 where higher scores indicate greater climate change anxiety.
Outcome measures
| Measure |
Healthy Minds Program (HMP) App
n=462 Participants
Participants will receive full access to the 4-week HMP Foundations module. The full HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose. At post-treatment, participants will be given access to additional HMP content to support their continued practice.
Healthy Minds Program: HMP is a 4-week mobile health (mHealth) meditation training program.
|
Psychoeducation App
n=463 Participants
Participants will receive access to the 4-week HMP Foundations module with guided meditation practices removed. The active control will include only the didactic content included in HMP without the guided meditation practices.
Healthy Minds Program: HMP is a 4-week mobile health (mHealth) meditation training program.
|
Usual Care
n=232 Participants
Participants will receive access to HMP at the end of the study and will be encouraged to continue with their usual care.
|
|---|---|---|---|
|
Climate Change Anxiety Scale
baseline
|
21.17 score on a scale
Standard Deviation 7.02
|
20.98 score on a scale
Standard Deviation 7.54
|
21.22 score on a scale
Standard Deviation 7.91
|
|
Climate Change Anxiety Scale
Week 4
|
20.79 score on a scale
Standard Deviation 6.95
|
20.67 score on a scale
Standard Deviation 7.51
|
21.01 score on a scale
Standard Deviation 8.18
|
|
Climate Change Anxiety Scale
3-month follow-up
|
20.5 score on a scale
Standard Deviation 6.68
|
20.34 score on a scale
Standard Deviation 7.74
|
20.18 score on a scale
Standard Deviation 8.33
|
SECONDARY outcome
Timeframe: Baseline, week 4, and 3 month follow upPopulation: Some participants did not provide data at all time points.
The Wellbeing Growth Mindset scale is a 3-item scale where participants report whether they believe wellbeing is malleable (e.g., "Your well-being is something about you that you can't change very much."). It is scored on a 6-point Likert scale where 1 = "strongly disagree" to 6 = "strongly agree." Total scores range from 3 to 18 where higher scores indicate greater wellbeing growth mindset.
Outcome measures
| Measure |
Healthy Minds Program (HMP) App
n=462 Participants
Participants will receive full access to the 4-week HMP Foundations module. The full HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose. At post-treatment, participants will be given access to additional HMP content to support their continued practice.
Healthy Minds Program: HMP is a 4-week mobile health (mHealth) meditation training program.
|
Psychoeducation App
n=463 Participants
Participants will receive access to the 4-week HMP Foundations module with guided meditation practices removed. The active control will include only the didactic content included in HMP without the guided meditation practices.
Healthy Minds Program: HMP is a 4-week mobile health (mHealth) meditation training program.
|
Usual Care
n=232 Participants
Participants will receive access to HMP at the end of the study and will be encouraged to continue with their usual care.
|
|---|---|---|---|
|
Wellbeing Growth Mindset
baseline
|
14.27 score on a scale
Standard Deviation 2.83
|
14.07 score on a scale
Standard Deviation 2.89
|
13.88 score on a scale
Standard Deviation 3.17
|
|
Wellbeing Growth Mindset
Week 4
|
14.61 score on a scale
Standard Deviation 2.90
|
14.46 score on a scale
Standard Deviation 2.70
|
13.50 score on a scale
Standard Deviation 3.23
|
|
Wellbeing Growth Mindset
3-month follow-up
|
14.31 score on a scale
Standard Deviation 2.93
|
14.04 score on a scale
Standard Deviation 3.10
|
13.54 score on a scale
Standard Deviation 3.12
|
SECONDARY outcome
Timeframe: Baseline, week 4, and 3 month follow upPopulation: Some participants did not provide data at all time points.
The HM Index is a 17-item questionnaire assessing qualities trained in the HMP app (awareness, connection, insight, purpose). It is scored on a 0- to 4-point Likert scale where 0 = a low amount (e.g., never, not at all, none of the time) and 4 = a higher amount (e.g., always, to the highest degree, all of the time) of a particular quality. Total scores for the Awareness subscale is 0 to 16 where higher scores indicate more awareness.
Outcome measures
| Measure |
Healthy Minds Program (HMP) App
n=462 Participants
Participants will receive full access to the 4-week HMP Foundations module. The full HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose. At post-treatment, participants will be given access to additional HMP content to support their continued practice.
Healthy Minds Program: HMP is a 4-week mobile health (mHealth) meditation training program.
|
Psychoeducation App
n=463 Participants
Participants will receive access to the 4-week HMP Foundations module with guided meditation practices removed. The active control will include only the didactic content included in HMP without the guided meditation practices.
Healthy Minds Program: HMP is a 4-week mobile health (mHealth) meditation training program.
|
Usual Care
n=232 Participants
Participants will receive access to HMP at the end of the study and will be encouraged to continue with their usual care.
|
|---|---|---|---|
|
Healthy Minds Index (HM Index) - Awareness
baseline
|
9.13 score on a scale
Standard Deviation 2.72
|
9.11 score on a scale
Standard Deviation 2.8
|
9.01 score on a scale
Standard Deviation 2.86
|
|
Healthy Minds Index (HM Index) - Awareness
Week 4
|
9.55 score on a scale
Standard Deviation 2.75
|
9.33 score on a scale
Standard Deviation 2.94
|
8.72 score on a scale
Standard Deviation 2.91
|
|
Healthy Minds Index (HM Index) - Awareness
3-month follow-up
|
9.72 score on a scale
Standard Deviation 2.78
|
9.5 score on a scale
Standard Deviation 2.88
|
8.89 score on a scale
Standard Deviation 2.76
|
SECONDARY outcome
Timeframe: Baseline, week 4, and 3 month follow upPopulation: Some participants did not provide data at all time points.
The HM Index is a 17-item questionnaire assessing qualities trained in the HMP app (awareness, connection, insight, purpose). It is scored on a 0- to 4-point Likert scale where 0 = a low amount (e.g., never, not at all, none of the time) and 4 = a higher amount (e.g., always, to the highest degree, all of the time) of a particular quality. Total scores for the Connection subscale range from 0 to 24, where higher scores indicate more connection.
Outcome measures
| Measure |
Healthy Minds Program (HMP) App
n=462 Participants
Participants will receive full access to the 4-week HMP Foundations module. The full HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose. At post-treatment, participants will be given access to additional HMP content to support their continued practice.
Healthy Minds Program: HMP is a 4-week mobile health (mHealth) meditation training program.
|
Psychoeducation App
n=463 Participants
Participants will receive access to the 4-week HMP Foundations module with guided meditation practices removed. The active control will include only the didactic content included in HMP without the guided meditation practices.
Healthy Minds Program: HMP is a 4-week mobile health (mHealth) meditation training program.
|
Usual Care
n=232 Participants
Participants will receive access to HMP at the end of the study and will be encouraged to continue with their usual care.
|
|---|---|---|---|
|
Healthy Minds Index (HM Index) - Connection
Week 4
|
16.03 score on a scale
Standard Deviation 4.03
|
16.16 score on a scale
Standard Deviation 3.86
|
15.16 score on a scale
Standard Deviation 3.72
|
|
Healthy Minds Index (HM Index) - Connection
3-month follow-up
|
15.88 score on a scale
Standard Deviation 4.02
|
16.03 score on a scale
Standard Deviation 3.81
|
15.08 score on a scale
Standard Deviation 3.94
|
|
Healthy Minds Index (HM Index) - Connection
baseline
|
15.67 score on a scale
Standard Deviation 3.79
|
15.65 score on a scale
Standard Deviation 3.49
|
15.64 score on a scale
Standard Deviation 3.64
|
SECONDARY outcome
Timeframe: Baseline, week 4, and 3 month follow upPopulation: Some participants did not provide data at all time points.
The HM Index is a 17-item questionnaire assessing qualities trained in the HMP app (awareness, connection, insight, purpose). It is scored on a 0- to 4-point Likert scale where 0 = a low amount (e.g., never, not at all, none of the time) and 4 = a higher amount (e.g., always, to the highest degree, all of the time) of a particular quality. Total scores for the Insight subscale range from 0 to 12, where higher scores indicate more insight.
Outcome measures
| Measure |
Healthy Minds Program (HMP) App
n=462 Participants
Participants will receive full access to the 4-week HMP Foundations module. The full HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose. At post-treatment, participants will be given access to additional HMP content to support their continued practice.
Healthy Minds Program: HMP is a 4-week mobile health (mHealth) meditation training program.
|
Psychoeducation App
n=463 Participants
Participants will receive access to the 4-week HMP Foundations module with guided meditation practices removed. The active control will include only the didactic content included in HMP without the guided meditation practices.
Healthy Minds Program: HMP is a 4-week mobile health (mHealth) meditation training program.
|
Usual Care
n=232 Participants
Participants will receive access to HMP at the end of the study and will be encouraged to continue with their usual care.
|
|---|---|---|---|
|
Healthy Minds Index (HM Index) - Insight
3-month follow-up
|
6.86 score on a scale
Standard Deviation 2.34
|
6.89 score on a scale
Standard Deviation 2.23
|
6.08 score on a scale
Standard Deviation 2.26
|
|
Healthy Minds Index (HM Index) - Insight
baseline
|
5.79 score on a scale
Standard Deviation 2.3
|
5.76 score on a scale
Standard Deviation 2.44
|
6.03 score on a scale
Standard Deviation 2.24
|
|
Healthy Minds Index (HM Index) - Insight
Week 4
|
6.78 score on a scale
Standard Deviation 2.31
|
6.71 score on a scale
Standard Deviation 2.29
|
6.07 score on a scale
Standard Deviation 2.16
|
SECONDARY outcome
Timeframe: Baseline, week 4, and 3 month follow upPopulation: Some participants did not provide data at all time points.
The HM Index is a 17-item questionnaire assessing qualities trained in the HMP app (awareness, connection, insight, purpose). It is scored on a 0- to 4-point Likert scale where 0 = a low amount (e.g., never, not at all, none of the time) and 4 = a higher amount (e.g., always, to the highest degree, all of the time) of a particular quality. Total scores for the Purpose subscale range from 0 to 16, where higher scores indicate more purpose.
Outcome measures
| Measure |
Healthy Minds Program (HMP) App
n=462 Participants
Participants will receive full access to the 4-week HMP Foundations module. The full HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose. At post-treatment, participants will be given access to additional HMP content to support their continued practice.
Healthy Minds Program: HMP is a 4-week mobile health (mHealth) meditation training program.
|
Psychoeducation App
n=463 Participants
Participants will receive access to the 4-week HMP Foundations module with guided meditation practices removed. The active control will include only the didactic content included in HMP without the guided meditation practices.
Healthy Minds Program: HMP is a 4-week mobile health (mHealth) meditation training program.
|
Usual Care
n=232 Participants
Participants will receive access to HMP at the end of the study and will be encouraged to continue with their usual care.
|
|---|---|---|---|
|
Healthy Minds Index (HM Index) - Purpose
baseline
|
9.07 score on a scale
Standard Deviation 3.57
|
8.8 score on a scale
Standard Deviation 3.71
|
9.22 score on a scale
Standard Deviation 3.61
|
|
Healthy Minds Index (HM Index) - Purpose
Week 4
|
10.19 score on a scale
Standard Deviation 3.47
|
10.05 score on a scale
Standard Deviation 3.56
|
8.95 score on a scale
Standard Deviation 3.61
|
|
Healthy Minds Index (HM Index) - Purpose
3-month follow-up
|
10.48 score on a scale
Standard Deviation 3.34
|
10.16 score on a scale
Standard Deviation 3.56
|
9.43 score on a scale
Standard Deviation 3.95
|
SECONDARY outcome
Timeframe: Baseline, week 4, and 3 month follow upPopulation: Some participants did not provide data at all time points.
The Life Orientation Test - Revised is a 6-item scale where participants report their level of optimism (e.g., "In uncertain times, I usually expect the best"). It is scored on a 5-point Likert scale where 0 = "strongly disagree" to 4 = "strongly agree." Total scores range from 0 to 24 where higher scores indicate greater optimism.
Outcome measures
| Measure |
Healthy Minds Program (HMP) App
n=462 Participants
Participants will receive full access to the 4-week HMP Foundations module. The full HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose. At post-treatment, participants will be given access to additional HMP content to support their continued practice.
Healthy Minds Program: HMP is a 4-week mobile health (mHealth) meditation training program.
|
Psychoeducation App
n=463 Participants
Participants will receive access to the 4-week HMP Foundations module with guided meditation practices removed. The active control will include only the didactic content included in HMP without the guided meditation practices.
Healthy Minds Program: HMP is a 4-week mobile health (mHealth) meditation training program.
|
Usual Care
n=232 Participants
Participants will receive access to HMP at the end of the study and will be encouraged to continue with their usual care.
|
|---|---|---|---|
|
Life Orientation Test - Revised
Week 4
|
13.42 score on a scale
Standard Deviation 5.02
|
13.01 score on a scale
Standard Deviation 4.73
|
12.23 score on a scale
Standard Deviation 4.98
|
|
Life Orientation Test - Revised
baseline
|
11.78 score on a scale
Standard Deviation 4.97
|
11.71 score on a scale
Standard Deviation 4.72
|
11.77 score on a scale
Standard Deviation 5.21
|
|
Life Orientation Test - Revised
3-month follow-up
|
13.73 score on a scale
Standard Deviation 5.13
|
13.17 score on a scale
Standard Deviation 4.83
|
12.22 score on a scale
Standard Deviation 5.32
|
SECONDARY outcome
Timeframe: Baseline, week 4, and 3 month follow upPopulation: Some participants did not provide data at all time points.
The Perceived Stress Scale is a 10-item scale where participants report their level of perceived stress (e.g., "In the last month, how often have you felt nervous and 'stressed'?"). It is scored on a 5-point Likert scale where 0 = "never" to 4 = "very often." Total scores range from 0 to 40 where higher scores indicate greater perceived stress.
Outcome measures
| Measure |
Healthy Minds Program (HMP) App
n=462 Participants
Participants will receive full access to the 4-week HMP Foundations module. The full HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose. At post-treatment, participants will be given access to additional HMP content to support their continued practice.
Healthy Minds Program: HMP is a 4-week mobile health (mHealth) meditation training program.
|
Psychoeducation App
n=463 Participants
Participants will receive access to the 4-week HMP Foundations module with guided meditation practices removed. The active control will include only the didactic content included in HMP without the guided meditation practices.
Healthy Minds Program: HMP is a 4-week mobile health (mHealth) meditation training program.
|
Usual Care
n=232 Participants
Participants will receive access to HMP at the end of the study and will be encouraged to continue with their usual care.
|
|---|---|---|---|
|
Perceived Stress Scale
baseline
|
29.7 score on a scale
Standard Deviation 6.77
|
29.51 score on a scale
Standard Deviation 6.29
|
29.72 score on a scale
Standard Deviation 6.64
|
|
Perceived Stress Scale
Week 4
|
26.46 score on a scale
Standard Deviation 6.82
|
26.90 score on a scale
Standard Deviation 6.54
|
29.17 score on a scale
Standard Deviation 6.54
|
|
Perceived Stress Scale
3-month follow-up
|
25.70 score on a scale
Standard Deviation 7.37
|
26.03 score on a scale
Standard Deviation 7.10
|
28.45 score on a scale
Standard Deviation 7.11
|
SECONDARY outcome
Timeframe: Baseline, week 4, and 3 month follow upPopulation: Some participants did not provide data at all time points.
The Perseverative Thinking Questionnaire is a 15-item scale where participants report their level of repetitive negative thinking (e.g., "My thoughts repeat themselves"). It is scored on a 5-point Likert scale where 0 = "never" to 4 = "almost always." Total scores range from 0 to 60 where higher scores indicate greater perseverative thinking.
Outcome measures
| Measure |
Healthy Minds Program (HMP) App
n=462 Participants
Participants will receive full access to the 4-week HMP Foundations module. The full HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose. At post-treatment, participants will be given access to additional HMP content to support their continued practice.
Healthy Minds Program: HMP is a 4-week mobile health (mHealth) meditation training program.
|
Psychoeducation App
n=463 Participants
Participants will receive access to the 4-week HMP Foundations module with guided meditation practices removed. The active control will include only the didactic content included in HMP without the guided meditation practices.
Healthy Minds Program: HMP is a 4-week mobile health (mHealth) meditation training program.
|
Usual Care
n=232 Participants
Participants will receive access to HMP at the end of the study and will be encouraged to continue with their usual care.
|
|---|---|---|---|
|
Perseverative Thinking Questionnaire
baseline
|
32.02 score on a scale
Standard Deviation 11.34
|
31.14 score on a scale
Standard Deviation 11.56
|
31.56 score on a scale
Standard Deviation 11.83
|
|
Perseverative Thinking Questionnaire
4 week
|
26.94 score on a scale
Standard Deviation 11.90
|
27.08 score on a scale
Standard Deviation 11.59
|
30.69 score on a scale
Standard Deviation 11.93
|
|
Perseverative Thinking Questionnaire
3-month follow-up
|
25.39 score on a scale
Standard Deviation 12.40
|
26.48 score on a scale
Standard Deviation 12.03
|
29.28 score on a scale
Standard Deviation 12.55
|
SECONDARY outcome
Timeframe: Baseline, week 4, and 3 month follow upPopulation: Some participants did not provide data at all time points.
The Satisfaction with Life Scale is a 5-item scale where participants report their level of satisfaction with life (e.g., "In most ways my life is close to ideal"). It is scored on a 7-point Likert scale where 1 = "strongly disagree" to 7 = "strongly agree." Total scores range from 5 to 35 where higher scores indicate greater satisfaction with life.
Outcome measures
| Measure |
Healthy Minds Program (HMP) App
n=462 Participants
Participants will receive full access to the 4-week HMP Foundations module. The full HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose. At post-treatment, participants will be given access to additional HMP content to support their continued practice.
Healthy Minds Program: HMP is a 4-week mobile health (mHealth) meditation training program.
|
Psychoeducation App
n=463 Participants
Participants will receive access to the 4-week HMP Foundations module with guided meditation practices removed. The active control will include only the didactic content included in HMP without the guided meditation practices.
Healthy Minds Program: HMP is a 4-week mobile health (mHealth) meditation training program.
|
Usual Care
n=232 Participants
Participants will receive access to HMP at the end of the study and will be encouraged to continue with their usual care.
|
|---|---|---|---|
|
Satisfaction With Life Scale
baseline
|
17.25 score on a scale
Standard Deviation 7.30
|
17.27 score on a scale
Standard Deviation 7.24
|
17.08 score on a scale
Standard Deviation 7.22
|
|
Satisfaction With Life Scale
Week 4
|
19.62 score on a scale
Standard Deviation 7.72
|
19.40 score on a scale
Standard Deviation 7.37
|
17.51 score on a scale
Standard Deviation 7.47
|
|
Satisfaction With Life Scale
3-month follow-up
|
20.33 score on a scale
Standard Deviation 7.81
|
19.94 score on a scale
Standard Deviation 7.61
|
18.04 score on a scale
Standard Deviation 7.42
|
SECONDARY outcome
Timeframe: Baseline, week 4, and 3 month follow upPopulation: Some participants did not provide data at all time points.
The Subjective Happiness Scale is a 4-item scale where participants report their level of subjective happiness (e.g., "In general, I consider myself \[not a very happy person, a very happy person\]"). It is scored on a 7-point Likert scale where 1 = less happy to 7 = more happy. Total scores range from 4 to 28 where higher scores indicate greater subjective happiness.
Outcome measures
| Measure |
Healthy Minds Program (HMP) App
n=462 Participants
Participants will receive full access to the 4-week HMP Foundations module. The full HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose. At post-treatment, participants will be given access to additional HMP content to support their continued practice.
Healthy Minds Program: HMP is a 4-week mobile health (mHealth) meditation training program.
|
Psychoeducation App
n=463 Participants
Participants will receive access to the 4-week HMP Foundations module with guided meditation practices removed. The active control will include only the didactic content included in HMP without the guided meditation practices.
Healthy Minds Program: HMP is a 4-week mobile health (mHealth) meditation training program.
|
Usual Care
n=232 Participants
Participants will receive access to HMP at the end of the study and will be encouraged to continue with their usual care.
|
|---|---|---|---|
|
Subjective Happiness Scale
baseline
|
16.45 score on a scale
Standard Deviation 4.96
|
16.53 score on a scale
Standard Deviation 5.25
|
16.29 score on a scale
Standard Deviation 4.93
|
|
Subjective Happiness Scale
Week 4
|
17.91 score on a scale
Standard Deviation 5.14
|
17.36 score on a scale
Standard Deviation 5.24
|
16.35 score on a scale
Standard Deviation 4.94
|
|
Subjective Happiness Scale
3-month follow-up
|
18.20 score on a scale
Standard Deviation 5.31
|
17.77 score on a scale
Standard Deviation 5.54
|
16.62 score on a scale
Standard Deviation 4.93
|
SECONDARY outcome
Timeframe: Baseline, week 4, and 3 month follow upPopulation: Some participants did not provide data at all time points.
The PRIUSS-3 is a 3-item scale where participants report their level of problematic internet use. It is scored on a 4-point Likert scale where 0 = never to 4 = very often. Total scores range from 0 to 12, where higher scores indicate more problematic internet use.
Outcome measures
| Measure |
Healthy Minds Program (HMP) App
n=462 Participants
Participants will receive full access to the 4-week HMP Foundations module. The full HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose. At post-treatment, participants will be given access to additional HMP content to support their continued practice.
Healthy Minds Program: HMP is a 4-week mobile health (mHealth) meditation training program.
|
Psychoeducation App
n=463 Participants
Participants will receive access to the 4-week HMP Foundations module with guided meditation practices removed. The active control will include only the didactic content included in HMP without the guided meditation practices.
Healthy Minds Program: HMP is a 4-week mobile health (mHealth) meditation training program.
|
Usual Care
n=232 Participants
Participants will receive access to HMP at the end of the study and will be encouraged to continue with their usual care.
|
|---|---|---|---|
|
Problematic and Risky Internet Use Screening Scale (PRIUSS-3)
baseline
|
4.79 score on a scale
Standard Deviation 2.68
|
4.45 score on a scale
Standard Deviation 2.74
|
4.42 score on a scale
Standard Deviation 2.87
|
|
Problematic and Risky Internet Use Screening Scale (PRIUSS-3)
Week 4
|
3.96 score on a scale
Standard Deviation 2.83
|
3.97 score on a scale
Standard Deviation 2.76
|
4.94 score on a scale
Standard Deviation 3.15
|
|
Problematic and Risky Internet Use Screening Scale (PRIUSS-3)
3-month follow-up
|
3.81 score on a scale
Standard Deviation 2.75
|
3.63 score on a scale
Standard Deviation 2.61
|
4.50 score on a scale
Standard Deviation 2.82
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 3 month follow-upPopulation: Data not provided or evaluable from all participants at all time points
Dried blood spot samples will be used to measure two inflammatory cytokines (C-reactive protein (CRP) and interleukin-6 (IL-6)). Additionally mRNA assays will be used to detect and quantify inflammatory gene expression detect and monitor cellular immune responses. Analyses will focus on transcripts from \~200 genes known to be involved in the regulation of inflammation, and will consider key transcripts (e.g., IL-1beta, TNF-alpha) as well as summary measures reflecting the activity of transcriptional networks that coordinate inflammation (NF-kB, AP-1).
Outcome measures
| Measure |
Healthy Minds Program (HMP) App
n=462 Participants
Participants will receive full access to the 4-week HMP Foundations module. The full HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose. At post-treatment, participants will be given access to additional HMP content to support their continued practice.
Healthy Minds Program: HMP is a 4-week mobile health (mHealth) meditation training program.
|
Psychoeducation App
n=463 Participants
Participants will receive access to the 4-week HMP Foundations module with guided meditation practices removed. The active control will include only the didactic content included in HMP without the guided meditation practices.
Healthy Minds Program: HMP is a 4-week mobile health (mHealth) meditation training program.
|
Usual Care
n=232 Participants
Participants will receive access to HMP at the end of the study and will be encouraged to continue with their usual care.
|
|---|---|---|---|
|
Inflammatory Biomarkers: C-reactive Protein (CRP)
baseline
|
2.34 mg/L
Standard Deviation 3.99
|
2.68 mg/L
Standard Deviation 4.16
|
2.67 mg/L
Standard Deviation 2.43
|
|
Inflammatory Biomarkers: C-reactive Protein (CRP)
3-month follow-up
|
2.56 mg/L
Standard Deviation 4.17
|
2.89 mg/L
Standard Deviation 4.55
|
2.60 mg/L
Standard Deviation 4.05
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 3 month follow-upPopulation: Data not provided or evaluable from all participants at all time points
Dried blood spot samples will be used to measure two inflammatory cytokines (C-reactive protein (CRP) and interleukin-6 (IL-6)). Additionally mRNA assays will be used to detect and quantify inflammatory gene expression detect and monitor cellular immune responses. Analyses will focus on transcripts from \~200 genes known to be involved in the regulation of inflammation, and will consider key transcripts (e.g., IL-1beta, TNF-alpha) as well as summary measures reflecting the activity of transcriptional networks that coordinate inflammation (NF-kB, AP-1).
Outcome measures
| Measure |
Healthy Minds Program (HMP) App
n=462 Participants
Participants will receive full access to the 4-week HMP Foundations module. The full HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose. At post-treatment, participants will be given access to additional HMP content to support their continued practice.
Healthy Minds Program: HMP is a 4-week mobile health (mHealth) meditation training program.
|
Psychoeducation App
n=463 Participants
Participants will receive access to the 4-week HMP Foundations module with guided meditation practices removed. The active control will include only the didactic content included in HMP without the guided meditation practices.
Healthy Minds Program: HMP is a 4-week mobile health (mHealth) meditation training program.
|
Usual Care
n=232 Participants
Participants will receive access to HMP at the end of the study and will be encouraged to continue with their usual care.
|
|---|---|---|---|
|
Inflammatory Biomarkers: TNF-Alpha, IL-6, Il-10
TNF-Alpha at baseline
|
2.12 pg/mL
Standard Deviation 7.08
|
1.69 pg/mL
Standard Deviation 0.85
|
1.75 pg/mL
Standard Deviation 0.79
|
|
Inflammatory Biomarkers: TNF-Alpha, IL-6, Il-10
TNF-Alpha at 3-month follow-up
|
1.83 pg/mL
Standard Deviation 3.71
|
1.62 pg/mL
Standard Deviation 0.83
|
2.02 pg/mL
Standard Deviation 3.11
|
|
Inflammatory Biomarkers: TNF-Alpha, IL-6, Il-10
IL-6 at baseline
|
0.81 pg/mL
Standard Deviation 6.94
|
0.33 pg/mL
Standard Deviation 0.36
|
0.36 pg/mL
Standard Deviation 0.48
|
|
Inflammatory Biomarkers: TNF-Alpha, IL-6, Il-10
IL-6 at 3-month follow-up
|
0.81 pg/mL
Standard Deviation 5.18
|
0.37 pg/mL
Standard Deviation 0.68
|
0.73 pg/mL
Standard Deviation 2.95
|
|
Inflammatory Biomarkers: TNF-Alpha, IL-6, Il-10
IL-10 at baseline
|
0.12 pg/mL
Standard Deviation 0.19
|
0.13 pg/mL
Standard Deviation 0.23
|
0.36 pg/mL
Standard Deviation 2.76
|
|
Inflammatory Biomarkers: TNF-Alpha, IL-6, Il-10
IL-10 at 3-month follow-up
|
0.13 pg/mL
Standard Deviation 0.20
|
0.14 pg/mL
Standard Deviation 0.25
|
0.37 pg/mL
Standard Deviation 2.81
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 3 month follow-upPopulation: Some participants did not provide data at all time-points.
Genetic analyses of the microbiome of the fecal sample (microorganism DNA, not that of the person) will be performed. Reported here are the observed (total number of distinct taxa) and calculated (Chao1 = N + S2 / (2 D), where N is the number of observed OTUs (Operational Taxonomic Units), S is the number of singleton OTUs, and D is the number of doublet OTUs) number of species represented in the sample. Chao1 is a species richness calculator that accounts for rare species.
Outcome measures
| Measure |
Healthy Minds Program (HMP) App
n=462 Participants
Participants will receive full access to the 4-week HMP Foundations module. The full HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose. At post-treatment, participants will be given access to additional HMP content to support their continued practice.
Healthy Minds Program: HMP is a 4-week mobile health (mHealth) meditation training program.
|
Psychoeducation App
n=463 Participants
Participants will receive access to the 4-week HMP Foundations module with guided meditation practices removed. The active control will include only the didactic content included in HMP without the guided meditation practices.
Healthy Minds Program: HMP is a 4-week mobile health (mHealth) meditation training program.
|
Usual Care
n=232 Participants
Participants will receive access to HMP at the end of the study and will be encouraged to continue with their usual care.
|
|---|---|---|---|
|
Microbiome Alpha Diversity: Species Richness
Observed at baseline
|
308.78 species
Standard Deviation 122.78
|
300.80 species
Standard Deviation 117.87
|
312.68 species
Standard Deviation 114.24
|
|
Microbiome Alpha Diversity: Species Richness
Calculated at baseline
|
309.89 species
Standard Deviation 123.30
|
301.88 species
Standard Deviation 118.55
|
313.87 species
Standard Deviation 114.89
|
|
Microbiome Alpha Diversity: Species Richness
Calculated at 3-month follow-up
|
304.58 species
Standard Deviation 120.94
|
301.97 species
Standard Deviation 117.57
|
312.64 species
Standard Deviation 115.77
|
|
Microbiome Alpha Diversity: Species Richness
Observed at 3-month follow-up
|
303.48 species
Standard Deviation 120.49
|
300.88 species
Standard Deviation 116.95
|
311.52 species
Standard Deviation 115.26
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 3 month follow-upPopulation: Some participants did not provide data at all time-points.
Genetic analyses of the microbiome of the fecal sample (microorganism DNA, not that of the person) will be performed. Shannon Diversity Index quantifies both the richness and the evenness of a community. It takes into account the number of taxa (richness) and their relative abundances (evenness). A higher Shannon index value indicates greater diversity, with both a high number of taxa and more even distribution of abundances among them. It is often used to assess the balance between species in a community. Typically ranges from 0-5 with higher numbers indicating increasing species diversity.
Outcome measures
| Measure |
Healthy Minds Program (HMP) App
n=462 Participants
Participants will receive full access to the 4-week HMP Foundations module. The full HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose. At post-treatment, participants will be given access to additional HMP content to support their continued practice.
Healthy Minds Program: HMP is a 4-week mobile health (mHealth) meditation training program.
|
Psychoeducation App
n=463 Participants
Participants will receive access to the 4-week HMP Foundations module with guided meditation practices removed. The active control will include only the didactic content included in HMP without the guided meditation practices.
Healthy Minds Program: HMP is a 4-week mobile health (mHealth) meditation training program.
|
Usual Care
n=232 Participants
Participants will receive access to HMP at the end of the study and will be encouraged to continue with their usual care.
|
|---|---|---|---|
|
Microbiome Alpha Diversity: Shannon Diversity Index (H')
baseline
|
4.20 H' index
Standard Deviation 0.56
|
4.19 H' index
Standard Deviation 0.54
|
4.23 H' index
Standard Deviation 0.52
|
|
Microbiome Alpha Diversity: Shannon Diversity Index (H')
3-month follow-up
|
4.19 H' index
Standard Deviation 0.61
|
4.20 H' index
Standard Deviation 0.51
|
4.24 H' index
Standard Deviation 0.53
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 3 month follow-upPopulation: Some participants did not provide data at all time-points.
Genetic analyses of the microbiome of the fecal sample (microorganism DNA, not that of the person) will be performed. Simpson is the probability that any two microbes are the same species, ranging from 0-1. Inverse Simpson (1 / Simpson) considers both richness and evenness. It places greater weight on the more abundant taxa. A higher inverse Simpson index suggests a more even distribution of taxa, with fewer dominant species. The inverse Simpson index is sensitive to the presence of dominant species and may emphasize diversity loss when one or a few species dominate the community.
Outcome measures
| Measure |
Healthy Minds Program (HMP) App
n=462 Participants
Participants will receive full access to the 4-week HMP Foundations module. The full HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose. At post-treatment, participants will be given access to additional HMP content to support their continued practice.
Healthy Minds Program: HMP is a 4-week mobile health (mHealth) meditation training program.
|
Psychoeducation App
n=463 Participants
Participants will receive access to the 4-week HMP Foundations module with guided meditation practices removed. The active control will include only the didactic content included in HMP without the guided meditation practices.
Healthy Minds Program: HMP is a 4-week mobile health (mHealth) meditation training program.
|
Usual Care
n=232 Participants
Participants will receive access to HMP at the end of the study and will be encouraged to continue with their usual care.
|
|---|---|---|---|
|
Microbiome Alpha Diversity: Inverse Simpson (1/D)
baseline
|
42.62 1/D index
Standard Deviation 45.06
|
42.54 1/D index
Standard Deviation 45.04
|
43.41 1/D index
Standard Deviation 44.28
|
|
Microbiome Alpha Diversity: Inverse Simpson (1/D)
3-month follow-up
|
43.59 1/D index
Standard Deviation 46.13
|
42.21 1/D index
Standard Deviation 44.66
|
44.43 1/D index
Standard Deviation 46.58
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 3 month follow-upPopulation: Some participants did not provide data at all time-points.
Genetic analyses of the microbiome of the fecal sample (microorganism DNA, not that of the person) will be performed. Pielou Evenness Index measures how evenly the individuals are distributed across the taxa in a sample. It is calculated by dividing the Shannon diversity index by the maximum possible value of the Shannon index (which occurs when all taxa are equally abundant). The Pielou index ranges from 0 (no evenness, where one species dominates) to 1 (perfect evenness, where all species are equally abundant).
Outcome measures
| Measure |
Healthy Minds Program (HMP) App
n=462 Participants
Participants will receive full access to the 4-week HMP Foundations module. The full HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose. At post-treatment, participants will be given access to additional HMP content to support their continued practice.
Healthy Minds Program: HMP is a 4-week mobile health (mHealth) meditation training program.
|
Psychoeducation App
n=463 Participants
Participants will receive access to the 4-week HMP Foundations module with guided meditation practices removed. The active control will include only the didactic content included in HMP without the guided meditation practices.
Healthy Minds Program: HMP is a 4-week mobile health (mHealth) meditation training program.
|
Usual Care
n=232 Participants
Participants will receive access to HMP at the end of the study and will be encouraged to continue with their usual care.
|
|---|---|---|---|
|
Microbiome Alpha Diversity: Pielou Evenness Index (J)
baseline
|
0.74 J index
Standard Deviation 0.07
|
0.74 J index
Standard Deviation 0.06
|
0.74 J index
Standard Deviation 0.07
|
|
Microbiome Alpha Diversity: Pielou Evenness Index (J)
3-month follow-up
|
0.74 J index
Standard Deviation 0.08
|
0.75 J index
Standard Deviation 0.06
|
0.75 J index
Standard Deviation 0.07
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 3 month follow-upPopulation: Some participants did not provide data at all time-points.
Genetic analyses of the microbiome of the fecal sample (microorganism DNA, not that of the person) will be performed. Simpson's Dominance Index measures the probability that two randomly selected individuals from a community belong to the same species (or taxon). It ranges from 0 to 1, where 0 indicates perfect diversity (no dominance of a single species) and values closer to 1 indicate that one or a few species dominate the community. A lower Simpson's dominance score suggests a more diverse community, while a higher score indicates a community dominated by a few taxa.
Outcome measures
| Measure |
Healthy Minds Program (HMP) App
n=462 Participants
Participants will receive full access to the 4-week HMP Foundations module. The full HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose. At post-treatment, participants will be given access to additional HMP content to support their continued practice.
Healthy Minds Program: HMP is a 4-week mobile health (mHealth) meditation training program.
|
Psychoeducation App
n=463 Participants
Participants will receive access to the 4-week HMP Foundations module with guided meditation practices removed. The active control will include only the didactic content included in HMP without the guided meditation practices.
Healthy Minds Program: HMP is a 4-week mobile health (mHealth) meditation training program.
|
Usual Care
n=232 Participants
Participants will receive access to HMP at the end of the study and will be encouraged to continue with their usual care.
|
|---|---|---|---|
|
Microbiome Alpha Diversity: Simpson's Dominance Index (D)
baseline
|
0.04 D index
Standard Deviation 0.03
|
0.04 D index
Standard Deviation 0.02
|
0.03 D index
Standard Deviation 0.02
|
|
Microbiome Alpha Diversity: Simpson's Dominance Index (D)
3-month follow-up
|
0.04 D index
Standard Deviation 0.05
|
0.03 D index
Standard Deviation 0.02
|
0.03 D index
Standard Deviation 0.02
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-upPopulation: Some participants did not provide data at all time-points.
Participants provide video recordings of their face while responding to a prompt watching brief videos of positive valence (e.g., baby giggling). Data are reported in Action Unit 6 (AU6) of Facial Action Coding System (FACS). FACS is an anatomically-based system for describing facial movement, breaking facial expressions into individual muscle movements called Action Units (AUs). The scores indicate the intensity of cheek movement (0-100), higher movements indicate more intense movement.
Outcome measures
| Measure |
Healthy Minds Program (HMP) App
n=462 Participants
Participants will receive full access to the 4-week HMP Foundations module. The full HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose. At post-treatment, participants will be given access to additional HMP content to support their continued practice.
Healthy Minds Program: HMP is a 4-week mobile health (mHealth) meditation training program.
|
Psychoeducation App
n=463 Participants
Participants will receive access to the 4-week HMP Foundations module with guided meditation practices removed. The active control will include only the didactic content included in HMP without the guided meditation practices.
Healthy Minds Program: HMP is a 4-week mobile health (mHealth) meditation training program.
|
Usual Care
n=232 Participants
Participants will receive access to HMP at the end of the study and will be encouraged to continue with their usual care.
|
|---|---|---|---|
|
Facial Behavior: Cheek Raise Score
Week 3
|
10.15 score on a scale
Standard Deviation 12.35
|
10.28 score on a scale
Standard Deviation 13.73
|
8.29 score on a scale
Standard Deviation 12.43
|
|
Facial Behavior: Cheek Raise Score
baseline
|
11.92 score on a scale
Standard Deviation 15.40
|
12.43 score on a scale
Standard Deviation 15.97
|
10.06 score on a scale
Standard Deviation 12.86
|
|
Facial Behavior: Cheek Raise Score
Week 1
|
9.91 score on a scale
Standard Deviation 12.61
|
10.05 score on a scale
Standard Deviation 13.39
|
8.55 score on a scale
Standard Deviation 11.23
|
|
Facial Behavior: Cheek Raise Score
Week 4
|
10.40 score on a scale
Standard Deviation 12.27
|
11.16 score on a scale
Standard Deviation 14.54
|
8.58 score on a scale
Standard Deviation 10.12
|
|
Facial Behavior: Cheek Raise Score
Week 2
|
9.77 score on a scale
Standard Deviation 12.25
|
10.64 score on a scale
Standard Deviation 12.42
|
7.43 score on a scale
Standard Deviation 10.60
|
|
Facial Behavior: Cheek Raise Score
3-month follow-up
|
11.57 score on a scale
Standard Deviation 13.99
|
10.55 score on a scale
Standard Deviation 14.88
|
8.60 score on a scale
Standard Deviation 12.84
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, week 4 (of intervention period), and 3 month follow-upPopulation: Some participants did not provide data at all time-points.
Meditation training has the capacity to normalize the overgeneralized inflexible cognition endemic to depression, which is hypothesized to relate to alterations in the hippocampal-dependent process of pattern separation. The investigators will use a pattern separation task to evaluate hippocampal function. The Lure Discrimination Task (LDI) is the difference between the probability of giving a "Similar" response to the lure items (similar to target items) minus the probability of giving a "Similar" response to the foils (unrelated to target items). Larger differences indicate increased discrimination.
Outcome measures
| Measure |
Healthy Minds Program (HMP) App
n=462 Participants
Participants will receive full access to the 4-week HMP Foundations module. The full HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose. At post-treatment, participants will be given access to additional HMP content to support their continued practice.
Healthy Minds Program: HMP is a 4-week mobile health (mHealth) meditation training program.
|
Psychoeducation App
n=463 Participants
Participants will receive access to the 4-week HMP Foundations module with guided meditation practices removed. The active control will include only the didactic content included in HMP without the guided meditation practices.
Healthy Minds Program: HMP is a 4-week mobile health (mHealth) meditation training program.
|
Usual Care
n=232 Participants
Participants will receive access to HMP at the end of the study and will be encouraged to continue with their usual care.
|
|---|---|---|---|
|
Lure Discrimination Task (LDI)
baseline
|
0.44 Lure Discrimination Index
Standard Deviation 0.20
|
0.42 Lure Discrimination Index
Standard Deviation 0.21
|
0.41 Lure Discrimination Index
Standard Deviation 0.21
|
|
Lure Discrimination Task (LDI)
Week 4
|
0.47 Lure Discrimination Index
Standard Deviation 0.21
|
0.45 Lure Discrimination Index
Standard Deviation 0.22
|
0.44 Lure Discrimination Index
Standard Deviation 0.21
|
|
Lure Discrimination Task (LDI)
3-month follow-up
|
0.48 Lure Discrimination Index
Standard Deviation 0.20
|
0.46 Lure Discrimination Index
Standard Deviation 0.22
|
0.46 Lure Discrimination Index
Standard Deviation 0.22
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-upPopulation: Some participants did not provide data at all time-points.
Participants provide recordings of their voice while responding to a prompt that asks to share information about their day. These recordings provide the opportunity to explore indicators of self-referent, inflexible, \& over-generalized thinking within natural language. Reported here is the "I" self-referential word frequency.
Outcome measures
| Measure |
Healthy Minds Program (HMP) App
n=462 Participants
Participants will receive full access to the 4-week HMP Foundations module. The full HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose. At post-treatment, participants will be given access to additional HMP content to support their continued practice.
Healthy Minds Program: HMP is a 4-week mobile health (mHealth) meditation training program.
|
Psychoeducation App
n=463 Participants
Participants will receive access to the 4-week HMP Foundations module with guided meditation practices removed. The active control will include only the didactic content included in HMP without the guided meditation practices.
Healthy Minds Program: HMP is a 4-week mobile health (mHealth) meditation training program.
|
Usual Care
n=232 Participants
Participants will receive access to HMP at the end of the study and will be encouraged to continue with their usual care.
|
|---|---|---|---|
|
Self-Referential Pronoun Use
Baseline
|
8.75 percent self referential words used
Standard Deviation 3.20
|
8.63 percent self referential words used
Standard Deviation 3.43
|
8.47 percent self referential words used
Standard Deviation 3.46
|
|
Self-Referential Pronoun Use
Week 3
|
8.47 percent self referential words used
Standard Deviation 3.59
|
8.57 percent self referential words used
Standard Deviation 3.18
|
9.01 percent self referential words used
Standard Deviation 3.31
|
|
Self-Referential Pronoun Use
Week 4
|
8.07 percent self referential words used
Standard Deviation 3.28
|
8.28 percent self referential words used
Standard Deviation 3.46
|
8.81 percent self referential words used
Standard Deviation 3.41
|
|
Self-Referential Pronoun Use
3-month follow-up
|
8.44 percent self referential words used
Standard Deviation 3.48
|
8.28 percent self referential words used
Standard Deviation 3.32
|
8.67 percent self referential words used
Standard Deviation 3.35
|
|
Self-Referential Pronoun Use
Week 1
|
8.52 percent self referential words used
Standard Deviation 3.46
|
8.42 percent self referential words used
Standard Deviation 3.48
|
8.75 percent self referential words used
Standard Deviation 2.95
|
|
Self-Referential Pronoun Use
Week 2
|
8.48 percent self referential words used
Standard Deviation 3.35
|
8.08 percent self referential words used
Standard Deviation 3.24
|
8.23 percent self referential words used
Standard Deviation 3.42
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-upPopulation: Some participants did not provide data at all time points.
Participants provide recordings of their voice while responding to a prompt that asks to share information about their day. These recordings provide the opportunity to explore negative affect word use. Data are reported in percentage (0-100) where higher numbers indicate more intense negative sentiment.
Outcome measures
| Measure |
Healthy Minds Program (HMP) App
n=462 Participants
Participants will receive full access to the 4-week HMP Foundations module. The full HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose. At post-treatment, participants will be given access to additional HMP content to support their continued practice.
Healthy Minds Program: HMP is a 4-week mobile health (mHealth) meditation training program.
|
Psychoeducation App
n=463 Participants
Participants will receive access to the 4-week HMP Foundations module with guided meditation practices removed. The active control will include only the didactic content included in HMP without the guided meditation practices.
Healthy Minds Program: HMP is a 4-week mobile health (mHealth) meditation training program.
|
Usual Care
n=232 Participants
Participants will receive access to HMP at the end of the study and will be encouraged to continue with their usual care.
|
|---|---|---|---|
|
Negative Affect Word Use: Negative Sentiment
baseline
|
2.94 percent negative words used
Standard Deviation 1.95
|
3.02 percent negative words used
Standard Deviation 1.97
|
2.87 percent negative words used
Standard Deviation 2.03
|
|
Negative Affect Word Use: Negative Sentiment
Week 1
|
2.79 percent negative words used
Standard Deviation 1.88
|
2.90 percent negative words used
Standard Deviation 2.05
|
2.86 percent negative words used
Standard Deviation 1.89
|
|
Negative Affect Word Use: Negative Sentiment
Week 2
|
2.76 percent negative words used
Standard Deviation 1.84
|
2.82 percent negative words used
Standard Deviation 1.89
|
2.72 percent negative words used
Standard Deviation 1.90
|
|
Negative Affect Word Use: Negative Sentiment
Week 3
|
2.53 percent negative words used
Standard Deviation 1.86
|
2.76 percent negative words used
Standard Deviation 1.87
|
3.06 percent negative words used
Standard Deviation 2.03
|
|
Negative Affect Word Use: Negative Sentiment
Week 4
|
2.51 percent negative words used
Standard Deviation 1.81
|
2.48 percent negative words used
Standard Deviation 1.79
|
2.77 percent negative words used
Standard Deviation 2.07
|
|
Negative Affect Word Use: Negative Sentiment
3-month follow-up
|
2.72 percent negative words used
Standard Deviation 1.98
|
2.70 percent negative words used
Standard Deviation 1.90
|
2.89 percent negative words used
Standard Deviation 2.10
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-upPopulation: Some participants did not provide data at all time points.
Participants provide recordings of their voice while responding to a prompt that asks to share information about their day. These recordings provide the opportunity to explore negative affect word use. Data are reported in percentage (0-100) where higher numbers indicate greater positive sentiment.
Outcome measures
| Measure |
Healthy Minds Program (HMP) App
n=462 Participants
Participants will receive full access to the 4-week HMP Foundations module. The full HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose. At post-treatment, participants will be given access to additional HMP content to support their continued practice.
Healthy Minds Program: HMP is a 4-week mobile health (mHealth) meditation training program.
|
Psychoeducation App
n=463 Participants
Participants will receive access to the 4-week HMP Foundations module with guided meditation practices removed. The active control will include only the didactic content included in HMP without the guided meditation practices.
Healthy Minds Program: HMP is a 4-week mobile health (mHealth) meditation training program.
|
Usual Care
n=232 Participants
Participants will receive access to HMP at the end of the study and will be encouraged to continue with their usual care.
|
|---|---|---|---|
|
Negative Affect Word Use: Positive Sentiment
Week 1
|
3.38 percent positive sentiment
Standard Deviation 2.21
|
3.21 percent positive sentiment
Standard Deviation 2.18
|
3.33 percent positive sentiment
Standard Deviation 2.34
|
|
Negative Affect Word Use: Positive Sentiment
Week 4
|
3.68 percent positive sentiment
Standard Deviation 2.32
|
3.73 percent positive sentiment
Standard Deviation 2.26
|
3.47 percent positive sentiment
Standard Deviation 2.34
|
|
Negative Affect Word Use: Positive Sentiment
baseline
|
3.12 percent positive sentiment
Standard Deviation 2.12
|
3.26 percent positive sentiment
Standard Deviation 2.23
|
3.32 percent positive sentiment
Standard Deviation 2.19
|
|
Negative Affect Word Use: Positive Sentiment
Week 2
|
3.29 percent positive sentiment
Standard Deviation 2.02
|
3.48 percent positive sentiment
Standard Deviation 2.26
|
3.41 percent positive sentiment
Standard Deviation 2.19
|
|
Negative Affect Word Use: Positive Sentiment
Week 3
|
3.52 percent positive sentiment
Standard Deviation 2.16
|
3.39 percent positive sentiment
Standard Deviation 2.10
|
3.20 percent positive sentiment
Standard Deviation 2.22
|
|
Negative Affect Word Use: Positive Sentiment
3-month follow-up
|
3.45 percent positive sentiment
Standard Deviation 2.27
|
3.40 percent positive sentiment
Standard Deviation 2.19
|
3.55 percent positive sentiment
Standard Deviation 2.59
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3-month follow-upPopulation: The usual care arm was not surveyed for this measure per protocol.
The Treatment Expectancies is a 6-item scale assessing how much participants believed the training program was helpful to them. Items assess how participants think (e.g., "At this point, how logical does the program offered to you seem?") and feel (e.g., "At this point, how much do you really feel that the program helped you to reduce your stress symptoms?"). Items are scored on either a 9-point Likert scale (e.g., 1 = "not at all logical" to 9 = "very logical") or on a percentage ("At the end of the program, how much improvement in your symptoms do you really feel occurred?", 0% to 100%). Higher scores reflect higher treatment expectancies.
Outcome measures
| Measure |
Healthy Minds Program (HMP) App
n=395 Participants
Participants will receive full access to the 4-week HMP Foundations module. The full HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose. At post-treatment, participants will be given access to additional HMP content to support their continued practice.
Healthy Minds Program: HMP is a 4-week mobile health (mHealth) meditation training program.
|
Psychoeducation App
n=387 Participants
Participants will receive access to the 4-week HMP Foundations module with guided meditation practices removed. The active control will include only the didactic content included in HMP without the guided meditation practices.
Healthy Minds Program: HMP is a 4-week mobile health (mHealth) meditation training program.
|
Usual Care
Participants will receive access to HMP at the end of the study and will be encouraged to continue with their usual care.
|
|---|---|---|---|
|
Treatment Expectancies
|
35.07 score on a scale
Standard Deviation 11.28
|
32.13 score on a scale
Standard Deviation 11.98
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 1, Week 2, Week 3, Week 4, 3-month follow-upPopulation: Some participants did not provide data at all time-points.
The PHQ-8 is an 8-item questionnaire where participants report how often in the past 2 weeks they were bothered by specific problems. Increase in scores indicates increase is depression symptoms.
Outcome measures
| Measure |
Healthy Minds Program (HMP) App
n=462 Participants
Participants will receive full access to the 4-week HMP Foundations module. The full HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose. At post-treatment, participants will be given access to additional HMP content to support their continued practice.
Healthy Minds Program: HMP is a 4-week mobile health (mHealth) meditation training program.
|
Psychoeducation App
n=463 Participants
Participants will receive access to the 4-week HMP Foundations module with guided meditation practices removed. The active control will include only the didactic content included in HMP without the guided meditation practices.
Healthy Minds Program: HMP is a 4-week mobile health (mHealth) meditation training program.
|
Usual Care
n=232 Participants
Participants will receive access to HMP at the end of the study and will be encouraged to continue with their usual care.
|
|---|---|---|---|
|
Number of Participants With PHQ-8 Scores That Increased by 5 Points or More Compared to Baseline
Overall (any time point)
|
78 Participants
|
64 Participants
|
44 Participants
|
|
Number of Participants With PHQ-8 Scores That Increased by 5 Points or More Compared to Baseline
Week 1
|
28 Participants
|
27 Participants
|
15 Participants
|
|
Number of Participants With PHQ-8 Scores That Increased by 5 Points or More Compared to Baseline
Week 2
|
27 Participants
|
25 Participants
|
11 Participants
|
|
Number of Participants With PHQ-8 Scores That Increased by 5 Points or More Compared to Baseline
Week 3
|
30 Participants
|
21 Participants
|
14 Participants
|
|
Number of Participants With PHQ-8 Scores That Increased by 5 Points or More Compared to Baseline
Week 4
|
24 Participants
|
21 Participants
|
14 Participants
|
|
Number of Participants With PHQ-8 Scores That Increased by 5 Points or More Compared to Baseline
3-month follow-up
|
20 Participants
|
20 Participants
|
17 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: week 1, week 2, week 3, week 4, and 3-month follow-upPopulation: Some participants did not provide data at all time points. The usual care arm was not surveyed for this measure per protocol.
The Digital Working Alliance Inventory is a 6-item scale where participants report their working alliance with the HMP app (e.g., "The HMP app supports me to overcome challenges"). It is scored on a 7-point Likert scale where 1 = "strongly disagree" to 7 = "strongly agree." Total scores range from 6 to 42 where higher scores indicate greater working alliance.
Outcome measures
| Measure |
Healthy Minds Program (HMP) App
n=462 Participants
Participants will receive full access to the 4-week HMP Foundations module. The full HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose. At post-treatment, participants will be given access to additional HMP content to support their continued practice.
Healthy Minds Program: HMP is a 4-week mobile health (mHealth) meditation training program.
|
Psychoeducation App
n=463 Participants
Participants will receive access to the 4-week HMP Foundations module with guided meditation practices removed. The active control will include only the didactic content included in HMP without the guided meditation practices.
Healthy Minds Program: HMP is a 4-week mobile health (mHealth) meditation training program.
|
Usual Care
Participants will receive access to HMP at the end of the study and will be encouraged to continue with their usual care.
|
|---|---|---|---|
|
Digital Working Alliance Inventory
Week 1
|
32.04 score on a scale
Standard Deviation 6.35
|
30.65 score on a scale
Standard Deviation 6.29
|
—
|
|
Digital Working Alliance Inventory
Week 2
|
32.67 score on a scale
Standard Deviation 5.84
|
30.89 score on a scale
Standard Deviation 6.89
|
—
|
|
Digital Working Alliance Inventory
Week 3
|
33.37 score on a scale
Standard Deviation 6.55
|
31.79 score on a scale
Standard Deviation 6.9
|
—
|
|
Digital Working Alliance Inventory
Week 4
|
33.72 score on a scale
Standard Deviation 6.75
|
32.25 score on a scale
Standard Deviation 7.27
|
—
|
|
Digital Working Alliance Inventory
3-month follow-up
|
31.94 score on a scale
Standard Deviation 7.51
|
30.89 score on a scale
Standard Deviation 7.53
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, week 4 (of intervention period), and 3 month follow-upPopulation: Some participants did not provide data at all-time points.
The Inclusion of Nature in Self is a single item measure assessing the degree to which someone views nature as a part of their sense of self. Participants indicate which of a series of overlapping circles most closely resembles nature and their self. More overlapping circles indicate greater inclusion of nature in self.
Outcome measures
| Measure |
Healthy Minds Program (HMP) App
n=462 Participants
Participants will receive full access to the 4-week HMP Foundations module. The full HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose. At post-treatment, participants will be given access to additional HMP content to support their continued practice.
Healthy Minds Program: HMP is a 4-week mobile health (mHealth) meditation training program.
|
Psychoeducation App
n=463 Participants
Participants will receive access to the 4-week HMP Foundations module with guided meditation practices removed. The active control will include only the didactic content included in HMP without the guided meditation practices.
Healthy Minds Program: HMP is a 4-week mobile health (mHealth) meditation training program.
|
Usual Care
n=232 Participants
Participants will receive access to HMP at the end of the study and will be encouraged to continue with their usual care.
|
|---|---|---|---|
|
Inclusion of Nature in Self
baseline
|
4.06 overlapping circles
Standard Deviation 1.70
|
4.04 overlapping circles
Standard Deviation 1.73
|
3.89 overlapping circles
Standard Deviation 1.72
|
|
Inclusion of Nature in Self
Week 4
|
4.54 overlapping circles
Standard Deviation 1.65
|
4.26 overlapping circles
Standard Deviation 1.74
|
4.02 overlapping circles
Standard Deviation 1.71
|
|
Inclusion of Nature in Self
3-month follow-up
|
4.41 overlapping circles
Standard Deviation 1.63
|
4.18 overlapping circles
Standard Deviation 1.73
|
3.84 overlapping circles
Standard Deviation 1.71
|
OTHER_PRE_SPECIFIED outcome
Timeframe: week 1, week 2, week 3, week 4, and 3 month follow upPopulation: Some participants did not provide data at all time points. The usual care arm was not surveyed for this measure per protocol.
The Mindfulness Adherence Questionnaire informal practice items are 6-items assessing the application of mindfulness during daily life (e.g., "In your daily life, how much of the time were you practicing being gentle and compassionate toward yourself?"). It is scored on a 7-point Likert scale where 0 = "never" to 6 = "always." Total scores range from 0 to 42 where higher scores indicate greater informal mindfulness practice.
Outcome measures
| Measure |
Healthy Minds Program (HMP) App
n=462 Participants
Participants will receive full access to the 4-week HMP Foundations module. The full HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose. At post-treatment, participants will be given access to additional HMP content to support their continued practice.
Healthy Minds Program: HMP is a 4-week mobile health (mHealth) meditation training program.
|
Psychoeducation App
n=463 Participants
Participants will receive access to the 4-week HMP Foundations module with guided meditation practices removed. The active control will include only the didactic content included in HMP without the guided meditation practices.
Healthy Minds Program: HMP is a 4-week mobile health (mHealth) meditation training program.
|
Usual Care
Participants will receive access to HMP at the end of the study and will be encouraged to continue with their usual care.
|
|---|---|---|---|
|
Mindfulness Adherence Questionnaire
Week 1
|
18.48 score on a scale
Standard Deviation 6.07
|
18.93 score on a scale
Standard Deviation 6.27
|
—
|
|
Mindfulness Adherence Questionnaire
Week 2
|
20.61 score on a scale
Standard Deviation 6.15
|
20.35 score on a scale
Standard Deviation 6.47
|
—
|
|
Mindfulness Adherence Questionnaire
Week 3
|
21.56 score on a scale
Standard Deviation 6.49
|
21.09 score on a scale
Standard Deviation 6.48
|
—
|
|
Mindfulness Adherence Questionnaire
Week 4
|
22.22 score on a scale
Standard Deviation 6.5
|
21.82 score on a scale
Standard Deviation 6.95
|
—
|
|
Mindfulness Adherence Questionnaire
3-month follow-up
|
21.87 score on a scale
Standard Deviation 7.24
|
21.96 score on a scale
Standard Deviation 7.05
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Before and after HMP activities week 1, week 2, week 2, and week 4Population: The usual care arm was not surveyed for this measure per protocol.
Two items assessing positive affect are scored on a 1- to 7-point Likert scale where 1 = not at all and 7 = very much. Data comes from multiple surveys.
Outcome measures
| Measure |
Healthy Minds Program (HMP) App
n=8667 Surveys
Participants will receive full access to the 4-week HMP Foundations module. The full HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose. At post-treatment, participants will be given access to additional HMP content to support their continued practice.
Healthy Minds Program: HMP is a 4-week mobile health (mHealth) meditation training program.
|
Psychoeducation App
n=9269 Surveys
Participants will receive access to the 4-week HMP Foundations module with guided meditation practices removed. The active control will include only the didactic content included in HMP without the guided meditation practices.
Healthy Minds Program: HMP is a 4-week mobile health (mHealth) meditation training program.
|
Usual Care
Participants will receive access to HMP at the end of the study and will be encouraged to continue with their usual care.
|
|---|---|---|---|
|
Change in Pre- and Post-practice Positive Affect
Change from Before and After Intervention Week 1
|
0.54 score on a scale
Standard Deviation 0.99
|
0.35 score on a scale
Standard Deviation 0.90
|
—
|
|
Change in Pre- and Post-practice Positive Affect
Change from Before and After Intervention Week 2
|
0.44 score on a scale
Standard Deviation 0.90
|
0.33 score on a scale
Standard Deviation 0.83
|
—
|
|
Change in Pre- and Post-practice Positive Affect
Change from Before and After Intervention Week 3
|
0.38 score on a scale
Standard Deviation 0.80
|
0.28 score on a scale
Standard Deviation 0.76
|
—
|
|
Change in Pre- and Post-practice Positive Affect
Change from Before and After Intervention Week 4
|
0.36 score on a scale
Standard Deviation 0.85
|
0.24 score on a scale
Standard Deviation 0.78
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Before and after HMP activities week 1, week 2, week 2, and week 4Population: The usual care arm was not surveyed for this measure per protocol.
Two items assessing negative affect are scored on a 1- to 7-point Likert scale where 1 = not at all and 7 = very much. Data comes from multiple surveys.
Outcome measures
| Measure |
Healthy Minds Program (HMP) App
n=8667 Surveys
Participants will receive full access to the 4-week HMP Foundations module. The full HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose. At post-treatment, participants will be given access to additional HMP content to support their continued practice.
Healthy Minds Program: HMP is a 4-week mobile health (mHealth) meditation training program.
|
Psychoeducation App
n=9269 Surveys
Participants will receive access to the 4-week HMP Foundations module with guided meditation practices removed. The active control will include only the didactic content included in HMP without the guided meditation practices.
Healthy Minds Program: HMP is a 4-week mobile health (mHealth) meditation training program.
|
Usual Care
Participants will receive access to HMP at the end of the study and will be encouraged to continue with their usual care.
|
|---|---|---|---|
|
Change in Pre- and Post-practice Negative Affect
Change from Before and After Intervention Week 1
|
-0.51 score on a scale
Standard Deviation 0.92
|
-0.42 score on a scale
Standard Deviation 0.95
|
—
|
|
Change in Pre- and Post-practice Negative Affect
Change from Before and After Intervention Week 2
|
-0.38 score on a scale
Standard Deviation 0.88
|
-0.29 score on a scale
Standard Deviation 0.85
|
—
|
|
Change in Pre- and Post-practice Negative Affect
Change from Before and After Intervention Week 3
|
-0.30 score on a scale
Standard Deviation 0.75
|
-0.29 score on a scale
Standard Deviation 0.79
|
—
|
|
Change in Pre- and Post-practice Negative Affect
Change from Before and After Intervention Week 4
|
-0.33 score on a scale
Standard Deviation 0.82
|
-0.21 score on a scale
Standard Deviation 0.80
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Before and after HMP activities week 1, week 2, week 2, and week 4Population: Data collected only from HMP arm per protocol.
A single item assessing focus during HMP activities is scored on a 1- to 7-point Likert scale where 1 = not at all and 7 = most of the time. Data comes from multiple surveys.
Outcome measures
| Measure |
Healthy Minds Program (HMP) App
n=8663 Surveys
Participants will receive full access to the 4-week HMP Foundations module. The full HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose. At post-treatment, participants will be given access to additional HMP content to support their continued practice.
Healthy Minds Program: HMP is a 4-week mobile health (mHealth) meditation training program.
|
Psychoeducation App
Participants will receive access to the 4-week HMP Foundations module with guided meditation practices removed. The active control will include only the didactic content included in HMP without the guided meditation practices.
Healthy Minds Program: HMP is a 4-week mobile health (mHealth) meditation training program.
|
Usual Care
Participants will receive access to HMP at the end of the study and will be encouraged to continue with their usual care.
|
|---|---|---|---|
|
Change in Post-practice Focus
Week 1
|
5.93 score on a scale
Standard Deviation 1.22
|
—
|
—
|
|
Change in Post-practice Focus
Week 2
|
6.08 score on a scale
Standard Deviation 1.14
|
—
|
—
|
|
Change in Post-practice Focus
Week 3
|
6.08 score on a scale
Standard Deviation 1.23
|
—
|
—
|
|
Change in Post-practice Focus
Week 4
|
6.21 score on a scale
Standard Deviation 1.06
|
—
|
—
|
Adverse Events
Healthy Minds Program (HMP) App
Psychoeducation App
Usual Care
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Healthy Minds Program (HMP) App
n=462 participants at risk
Participants will receive access to the 4-week HMP Foundations module. The HMP app is a meditation-based smartphone app designed to promote and protect psychological well-being through sustainable skills training. The program is grounded in constituents of psychological well-being identified in empirical literature. HMP provides core content, with instruction administered through a curriculum of guided practices. HMP is based on research on eudaimonic well-being (e.g., environmental mastery, purpose) and brain-based skills that underlie these qualities (e.g., regulation of attention, mental flexibility). The full HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose. At post-treatment, participants will be given access to additional HMP content to support their continued practice.
Healthy Minds Program: HMP is a 4-week mobile health (mHealth) meditation training program.
|
Psychoeducation App
n=463 participants at risk
Participants will receive access to the 4-week HMP Foundations module with guided meditation practices removed. The active control will include only the didactic content included in HMP without the guided meditation practices.
Healthy Minds Program: HMP is a 4-week mobile health (mHealth) meditation training program.
|
Usual Care
n=232 participants at risk
Participants will receive access to HMP at the end of the study and will be encouraged to continue with their usual care.
|
|---|---|---|---|
|
Psychiatric disorders
Increased Symptoms of Depression
|
16.9%
78/462 • data collected up to 4 months on study
|
13.8%
64/463 • data collected up to 4 months on study
|
19.0%
44/232 • data collected up to 4 months on study
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place