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Trial Outcomes & Findings for COVID-19 and the Healthy Minds Program for Educators (NCT NCT04426318)

NCT ID: NCT04426318

Last Updated: 2024-09-19

Results Overview

Psychological distress will be assessed by aggregating 3 measures: PROMIS anxiety and PROMIS depression, and the NIH Toolbox Perceived Stress Scale. Averages will be z-scored with a mean of 0 and a standard deviation 1. Higher scores indicate increased psychological distress.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

698 participants

Primary outcome timeframe

baseline, after weeks 1, 2, and 3 of the intervention, 4 weeks (post intervention), 16 weeks (3 months post-intervention)

Results posted on

2024-09-19

Participant Flow

8321 Wisconsin school system employees invited, 1136 self-screened for eligibility, 353 ineligible (for prior medication, prior HMP app use, or depression t-score greater than 70), 698 consented, 32 did not complete a pre-test, 666 assigned to an arm.

Participant milestones

Participant milestones
Measure
Healthy Minds Program Foundations Training
Healthy Minds Program (HMP) is a novel, smartphone-based app that provides a series of guided meditation practices on four primary constituents of well-being: Awareness, Connection, Insight, and Purpose. All program elements are introduced with a summary of the scientific evidence supporting its constituent elements (e.g., Awareness and well-being). In addition to standard sitting meditation practices found in many meditation-based behavioral interventions, the HMP offers active practices in which participants can develop the same skills but while embedding practice into activities they already do in their normal daily routine.
Wait-list Control
Participants assigned to the wait-list control will not receive treatment for the intervention and follow-up period. They will be provided access to the HMP Foundations training after completing follow-up testing.
Overall Study
STARTED
346
320
Overall Study
Failed Attention Checks
4
6
Overall Study
Downloaded HMP App
329
0
Overall Study
Completed T2 Assessment
281
280
Overall Study
Completed T3 Assessment
261
274
Overall Study
Completed T4 Assessment
261
275
Overall Study
Completed T5 Assessment
284
293
Overall Study
Completed T6 Assessment
286
293
Overall Study
Final Intent to Treat Sample
344
318
Overall Study
COMPLETED
344
318
Overall Study
NOT COMPLETED
2
2

Reasons for withdrawal

Reasons for withdrawal
Measure
Healthy Minds Program Foundations Training
Healthy Minds Program (HMP) is a novel, smartphone-based app that provides a series of guided meditation practices on four primary constituents of well-being: Awareness, Connection, Insight, and Purpose. All program elements are introduced with a summary of the scientific evidence supporting its constituent elements (e.g., Awareness and well-being). In addition to standard sitting meditation practices found in many meditation-based behavioral interventions, the HMP offers active practices in which participants can develop the same skills but while embedding practice into activities they already do in their normal daily routine.
Wait-list Control
Participants assigned to the wait-list control will not receive treatment for the intervention and follow-up period. They will be provided access to the HMP Foundations training after completing follow-up testing.
Overall Study
failed attention checks and had their data removed from analyses
2
2

Baseline Characteristics

COVID-19 and the Healthy Minds Program for Educators

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Healthy Minds Program Foundations Training
n=344 Participants
Healthy Minds Program (HMP) is a novel, smartphone-based app that provides a series of guided meditation practices on four primary constituents of well-being: Awareness, Connection, Insight, and Purpose. All program elements are introduced with a summary of the scientific evidence supporting its constituent elements (e.g., Awareness and well-being). In addition to standard sitting meditation practices found in many meditation-based behavioral interventions, the HMP offers active practices in which participants can develop the same skills but while embedding practice into activities they already do in their normal daily routine.
Wait-list Control
n=318 Participants
Participants assigned to the wait-list control will not receive treatment for the intervention and follow-up period. They will be provided access to the HMP Foundations training after completing follow-up testing.
Total
n=662 Participants
Total of all reporting groups
Age, Customized
under 20 years
0 Participants
n=99 Participants
1 Participants
n=107 Participants
1 Participants
n=206 Participants
Age, Customized
20-30 years
55 Participants
n=99 Participants
46 Participants
n=107 Participants
101 Participants
n=206 Participants
Age, Customized
30-40 years
105 Participants
n=99 Participants
90 Participants
n=107 Participants
195 Participants
n=206 Participants
Age, Customized
40-50 years
103 Participants
n=99 Participants
93 Participants
n=107 Participants
196 Participants
n=206 Participants
Age, Customized
50-60 years
61 Participants
n=99 Participants
79 Participants
n=107 Participants
140 Participants
n=206 Participants
Age, Customized
over 60 years
20 Participants
n=99 Participants
9 Participants
n=107 Participants
29 Participants
n=206 Participants
Sex/Gender, Customized
Female
302 Participants
n=99 Participants
281 Participants
n=107 Participants
583 Participants
n=206 Participants
Sex/Gender, Customized
Male
42 Participants
n=99 Participants
37 Participants
n=107 Participants
79 Participants
n=206 Participants
Sex/Gender, Customized
Non-Binary
1 Participants
n=99 Participants
0 Participants
n=107 Participants
1 Participants
n=206 Participants
Race/Ethnicity, Customized
American Indian / Alaskan Native
5 Participants
n=99 Participants
4 Participants
n=107 Participants
9 Participants
n=206 Participants
Race/Ethnicity, Customized
Asian / Pacific Islander
9 Participants
n=99 Participants
4 Participants
n=107 Participants
13 Participants
n=206 Participants
Race/Ethnicity, Customized
Black / African American
11 Participants
n=99 Participants
15 Participants
n=107 Participants
26 Participants
n=206 Participants
Race/Ethnicity, Customized
Hispanic / Latino
15 Participants
n=99 Participants
17 Participants
n=107 Participants
32 Participants
n=206 Participants
Race/Ethnicity, Customized
White / Caucasian
315 Participants
n=99 Participants
287 Participants
n=107 Participants
602 Participants
n=206 Participants
Region of Enrollment
United States
344 participants
n=99 Participants
318 participants
n=107 Participants
662 participants
n=206 Participants
Highest Level of Education
less than 7 years formal education
1 Participants
n=99 Participants
2 Participants
n=107 Participants
3 Participants
n=206 Participants
Highest Level of Education
Graduated High School
10 Participants
n=99 Participants
6 Participants
n=107 Participants
16 Participants
n=206 Participants
Highest Level of Education
Some College
24 Participants
n=99 Participants
27 Participants
n=107 Participants
51 Participants
n=206 Participants
Highest Level of Education
Graduated College
100 Participants
n=99 Participants
103 Participants
n=107 Participants
203 Participants
n=206 Participants
Highest Level of Education
Advanced Degree
208 Participants
n=99 Participants
178 Participants
n=107 Participants
386 Participants
n=206 Participants
Highest Level of Education
NA
1 Participants
n=99 Participants
2 Participants
n=107 Participants
3 Participants
n=206 Participants
Household Income
Less than $20,000
8 Participants
n=99 Participants
9 Participants
n=107 Participants
17 Participants
n=206 Participants
Household Income
$20,000 - $40,000
22 Participants
n=99 Participants
19 Participants
n=107 Participants
41 Participants
n=206 Participants
Household Income
$40,000 - $70,000
80 Participants
n=99 Participants
82 Participants
n=107 Participants
162 Participants
n=206 Participants
Household Income
$70,000 - $100,000
87 Participants
n=99 Participants
74 Participants
n=107 Participants
161 Participants
n=206 Participants
Household Income
$100,000 - $200,000
135 Participants
n=99 Participants
121 Participants
n=107 Participants
256 Participants
n=206 Participants
Household Income
greater than $200,000
9 Participants
n=99 Participants
12 Participants
n=107 Participants
21 Participants
n=206 Participants
Household Income
Unknown
3 Participants
n=99 Participants
1 Participants
n=107 Participants
4 Participants
n=206 Participants
Employment Category
Classroom Teacher
144 Participants
n=99 Participants
134 Participants
n=107 Participants
278 Participants
n=206 Participants
Employment Category
Classroom Support
47 Participants
n=99 Participants
44 Participants
n=107 Participants
91 Participants
n=206 Participants
Employment Category
Special Education Teacher
29 Participants
n=99 Participants
31 Participants
n=107 Participants
60 Participants
n=206 Participants
Employment Category
School Support
38 Participants
n=99 Participants
35 Participants
n=107 Participants
73 Participants
n=206 Participants
Employment Category
School Administrator
8 Participants
n=99 Participants
4 Participants
n=107 Participants
12 Participants
n=206 Participants
Employment Category
System Staff
20 Participants
n=99 Participants
27 Participants
n=107 Participants
47 Participants
n=206 Participants
Employment Category
Other / Unknown
58 Participants
n=99 Participants
43 Participants
n=107 Participants
101 Participants
n=206 Participants

PRIMARY outcome

Timeframe: baseline, after weeks 1, 2, and 3 of the intervention, 4 weeks (post intervention), 16 weeks (3 months post-intervention)

Population: not all participants returned surveys for each time point

Psychological distress will be assessed by aggregating 3 measures: PROMIS anxiety and PROMIS depression, and the NIH Toolbox Perceived Stress Scale. Averages will be z-scored with a mean of 0 and a standard deviation 1. Higher scores indicate increased psychological distress.

Outcome measures

Outcome measures
Measure
Healthy Minds Program Foundations Training
n=344 Participants
Healthy Minds Program (HMP) is a novel, smartphone-based app that provides a series of guided meditation practices on four primary constituents of well-being: Awareness, Connection, Insight, and Purpose. All program elements are introduced with a summary of the scientific evidence supporting its constituent elements (e.g., Awareness and well-being). In addition to standard sitting meditation practices found in many meditation-based behavioral interventions, the HMP offers active practices in which participants can develop the same skills but while embedding practice into activities they already do in their normal daily routine.
Wait-list Control
n=318 Participants
Participants assigned to the wait-list control will not receive treatment for the intervention and follow-up period. They will be provided access to the HMP Foundations training after completing follow-up testing.
Change From Baseline on an Aggregate Measure of Psychological Distress That Averages the Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety and Depressive Measures and the NIH Perceived Stress Scale
Baseline
0.00 z-score
Standard Deviation 0.88
0.00 z-score
Standard Deviation 0.91
Change From Baseline on an Aggregate Measure of Psychological Distress That Averages the Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety and Depressive Measures and the NIH Perceived Stress Scale
Week 2
-0.40 z-score
Standard Deviation 0.85
-0.10 z-score
Standard Deviation 1.01
Change From Baseline on an Aggregate Measure of Psychological Distress That Averages the Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety and Depressive Measures and the NIH Perceived Stress Scale
Week 3
-0.55 z-score
Standard Deviation 0.88
-0.14 z-score
Standard Deviation 1.02
Change From Baseline on an Aggregate Measure of Psychological Distress That Averages the Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety and Depressive Measures and the NIH Perceived Stress Scale
Week 1
-0.29 z-score
Standard Deviation 0.89
-0.10 z-score
Standard Deviation 0.95
Change From Baseline on an Aggregate Measure of Psychological Distress That Averages the Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety and Depressive Measures and the NIH Perceived Stress Scale
Week 4
-0.67 z-score
Standard Deviation 0.89
-0.20 z-score
Standard Deviation 1.03
Change From Baseline on an Aggregate Measure of Psychological Distress That Averages the Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety and Depressive Measures and the NIH Perceived Stress Scale
Week 16
-0.55 z-score
Standard Deviation 0.87
-0.24 z-score
Standard Deviation 1.00

SECONDARY outcome

Timeframe: baseline, after weeks 1, 2, and 3 of the intervention, 4 weeks (post intervention), 16 weeks (3 months post-intervention)

Population: not all participants returned surveys for each time point

A measure of acting with mindful awareness. The total possible range in scores is 8-40, with higher scores indicating greater levels of this facet of mindfulness.

Outcome measures

Outcome measures
Measure
Healthy Minds Program Foundations Training
n=344 Participants
Healthy Minds Program (HMP) is a novel, smartphone-based app that provides a series of guided meditation practices on four primary constituents of well-being: Awareness, Connection, Insight, and Purpose. All program elements are introduced with a summary of the scientific evidence supporting its constituent elements (e.g., Awareness and well-being). In addition to standard sitting meditation practices found in many meditation-based behavioral interventions, the HMP offers active practices in which participants can develop the same skills but while embedding practice into activities they already do in their normal daily routine.
Wait-list Control
n=318 Participants
Participants assigned to the wait-list control will not receive treatment for the intervention and follow-up period. They will be provided access to the HMP Foundations training after completing follow-up testing.
Change From Baseline on the Five Facet Mindfulness Questionnaire Act With Awareness Subscale
baseline
24.80 score on a scale
Standard Deviation 5.93
24.56 score on a scale
Standard Deviation 6.12
Change From Baseline on the Five Facet Mindfulness Questionnaire Act With Awareness Subscale
Week 1
24.19 score on a scale
Standard Deviation 5.62
25.57 score on a scale
Standard Deviation 6.15
Change From Baseline on the Five Facet Mindfulness Questionnaire Act With Awareness Subscale
Week 2
25.71 score on a scale
Standard Deviation 5.47
25.69 score on a scale
Standard Deviation 6.44
Change From Baseline on the Five Facet Mindfulness Questionnaire Act With Awareness Subscale
Week 3
26.45 score on a scale
Standard Deviation 5.61
26.15 score on a scale
Standard Deviation 6.21
Change From Baseline on the Five Facet Mindfulness Questionnaire Act With Awareness Subscale
Week 4
27.12 score on a scale
Standard Deviation 5.67
26.12 score on a scale
Standard Deviation 6.76
Change From Baseline on the Five Facet Mindfulness Questionnaire Act With Awareness Subscale
Week 16
27.1 score on a scale
Standard Deviation 5.32
26.02 score on a scale
Standard Deviation 6.36

SECONDARY outcome

Timeframe: baseline, after weeks 1, 2, and 3 of the intervention, 4 weeks (post intervention), 16 weeks (3 months post-intervention)

Population: not all participants returned surveys for each time point

Psychological distancing (i.e., defusion) will be assessed with the 10-item Drexel Defusion Scale (DDS). The total possible range in scores is 0-50, with higher scores indicating greater levels of psychological distancing.

Outcome measures

Outcome measures
Measure
Healthy Minds Program Foundations Training
n=344 Participants
Healthy Minds Program (HMP) is a novel, smartphone-based app that provides a series of guided meditation practices on four primary constituents of well-being: Awareness, Connection, Insight, and Purpose. All program elements are introduced with a summary of the scientific evidence supporting its constituent elements (e.g., Awareness and well-being). In addition to standard sitting meditation practices found in many meditation-based behavioral interventions, the HMP offers active practices in which participants can develop the same skills but while embedding practice into activities they already do in their normal daily routine.
Wait-list Control
n=318 Participants
Participants assigned to the wait-list control will not receive treatment for the intervention and follow-up period. They will be provided access to the HMP Foundations training after completing follow-up testing.
Change From Baseline on the Drexel Defusion Scale (DDS)
Week 3
29.61 score on a scale
Standard Deviation 8.73
27.52 score on a scale
Standard Deviation 9.07
Change From Baseline on the Drexel Defusion Scale (DDS)
Week 16
30.93 score on a scale
Standard Deviation 8.69
28.23 score on a scale
Standard Deviation 8.57
Change From Baseline on the Drexel Defusion Scale (DDS)
baseline
24.83 score on a scale
Standard Deviation 7.89
24.45 score on a scale
Standard Deviation 8.23
Change From Baseline on the Drexel Defusion Scale (DDS)
Week 1
27.14 score on a scale
Standard Deviation 8.72
26.26 score on a scale
Standard Deviation 8.31
Change From Baseline on the Drexel Defusion Scale (DDS)
Week 2
28.45 score on a scale
Standard Deviation 8.42
26.96 score on a scale
Standard Deviation 8.73
Change From Baseline on the Drexel Defusion Scale (DDS)
Week 4
31.43 score on a scale
Standard Deviation 8.54
27.92 score on a scale
Standard Deviation 8.63

SECONDARY outcome

Timeframe: baseline, after weeks 1, 2, and 3 of the intervention, 4 weeks (post intervention), 16 weeks (3 months post-intervention)

Population: not all participants returned surveys for each time point

The Meaning in Life Questionnaire Presence subscale will be used to measure perceptions of meaning and purpose in life. The total possible range in scores is 5 - 35 with higher scores indicating greater levels of meaning.

Outcome measures

Outcome measures
Measure
Healthy Minds Program Foundations Training
n=344 Participants
Healthy Minds Program (HMP) is a novel, smartphone-based app that provides a series of guided meditation practices on four primary constituents of well-being: Awareness, Connection, Insight, and Purpose. All program elements are introduced with a summary of the scientific evidence supporting its constituent elements (e.g., Awareness and well-being). In addition to standard sitting meditation practices found in many meditation-based behavioral interventions, the HMP offers active practices in which participants can develop the same skills but while embedding practice into activities they already do in their normal daily routine.
Wait-list Control
n=318 Participants
Participants assigned to the wait-list control will not receive treatment for the intervention and follow-up period. They will be provided access to the HMP Foundations training after completing follow-up testing.
Change From Baseline on the Meaning in Life Questionnaire
baseline
26.20 score on a scale
Standard Deviation 5.44
25.81 score on a scale
Standard Deviation 5.46
Change From Baseline on the Meaning in Life Questionnaire
Week 1
26.83 score on a scale
Standard Deviation 5.13
26.02 score on a scale
Standard Deviation 5.38
Change From Baseline on the Meaning in Life Questionnaire
Week 2
27.15 score on a scale
Standard Deviation 5.14
25.85 score on a scale
Standard Deviation 5.68
Change From Baseline on the Meaning in Life Questionnaire
Week 3
27.62 score on a scale
Standard Deviation 4.92
26.13 score on a scale
Standard Deviation 5.83
Change From Baseline on the Meaning in Life Questionnaire
Week 4
27.85 score on a scale
Standard Deviation 5.35
26.02 score on a scale
Standard Deviation 6.07
Change From Baseline on the Meaning in Life Questionnaire
Week 16
27.91 score on a scale
Standard Deviation 5.14
26.29 score on a scale
Standard Deviation 5.87

SECONDARY outcome

Timeframe: baseline, after weeks 1, 2, and 3 of the intervention, 4 weeks (post intervention), 16 weeks (3 months post-intervention)

Population: not all participants returned surveys for each time point

A measure of loneliness (i.e, lack of social connectedness). The total possible range in scores is 1-5, representing the average across all items; higher scores indicate greater levels of loneliness.

Outcome measures

Outcome measures
Measure
Healthy Minds Program Foundations Training
n=344 Participants
Healthy Minds Program (HMP) is a novel, smartphone-based app that provides a series of guided meditation practices on four primary constituents of well-being: Awareness, Connection, Insight, and Purpose. All program elements are introduced with a summary of the scientific evidence supporting its constituent elements (e.g., Awareness and well-being). In addition to standard sitting meditation practices found in many meditation-based behavioral interventions, the HMP offers active practices in which participants can develop the same skills but while embedding practice into activities they already do in their normal daily routine.
Wait-list Control
n=318 Participants
Participants assigned to the wait-list control will not receive treatment for the intervention and follow-up period. They will be provided access to the HMP Foundations training after completing follow-up testing.
Change From Baseline on the NIH Toolbox Loneliness Scale
Week 4
2.07 score on a scale
Standard Deviation 0.71
2.33 score on a scale
Standard Deviation 0.81
Change From Baseline on the NIH Toolbox Loneliness Scale
Week 16
2.13 score on a scale
Standard Deviation 0.75
2.38 score on a scale
Standard Deviation 0.82
Change From Baseline on the NIH Toolbox Loneliness Scale
baseline
2.53 score on a scale
Standard Deviation 0.77
2.58 score on a scale
Standard Deviation 0.77
Change From Baseline on the NIH Toolbox Loneliness Scale
Week 1
2.34 score on a scale
Standard Deviation 0.75
2.49 score on a scale
Standard Deviation 0.74
Change From Baseline on the NIH Toolbox Loneliness Scale
Week 2
2.16 score on a scale
Standard Deviation 0.72
2.38 score on a scale
Standard Deviation 0.72
Change From Baseline on the NIH Toolbox Loneliness Scale
Week 3
2.02 score on a scale
Standard Deviation 0.68
2.37 score on a scale
Standard Deviation 0.75

SECONDARY outcome

Timeframe: baseline

Population: not all participants returned surveys for each time point

The Conway COVID Questionnaire is a new, 16-tem measure of coronavirus related distress and related experiences. Subscales include: perceived threat, financial scale, resource scale, psychological scale, symptoms scale, proximity to others scale, and news scale. Ratings from 1 to 7 with 1 = "not true of me at all" and 7 = "very true of me" with higher scores representing greater perceived threat. Mean for each subscale reported.

Outcome measures

Outcome measures
Measure
Healthy Minds Program Foundations Training
n=342 Participants
Healthy Minds Program (HMP) is a novel, smartphone-based app that provides a series of guided meditation practices on four primary constituents of well-being: Awareness, Connection, Insight, and Purpose. All program elements are introduced with a summary of the scientific evidence supporting its constituent elements (e.g., Awareness and well-being). In addition to standard sitting meditation practices found in many meditation-based behavioral interventions, the HMP offers active practices in which participants can develop the same skills but while embedding practice into activities they already do in their normal daily routine.
Wait-list Control
n=315 Participants
Participants assigned to the wait-list control will not receive treatment for the intervention and follow-up period. They will be provided access to the HMP Foundations training after completing follow-up testing.
Conway COVID Questionnaire Subscale Scores
Threat Subscale
5.05 score on a scale
Standard Deviation 1.35
5.03 score on a scale
Standard Deviation 1.30
Conway COVID Questionnaire Subscale Scores
Financial Subscale
3.09 score on a scale
Standard Deviation 2.08
3.00 score on a scale
Standard Deviation 2.02
Conway COVID Questionnaire Subscale Scores
Proximity Subscale
3.16 score on a scale
Standard Deviation 1.70
2.99 score on a scale
Standard Deviation 1.66
Conway COVID Questionnaire Subscale Scores
News Subscale
4.03 score on a scale
Standard Deviation 1.65
4.10 score on a scale
Standard Deviation 1.55
Conway COVID Questionnaire Subscale Scores
Psychological Subscale
4.45 score on a scale
Standard Deviation 1.45
4.39 score on a scale
Standard Deviation 1.44
Conway COVID Questionnaire Subscale Scores
Resource Subscale
2.13 score on a scale
Standard Deviation 1.85
2.00 score on a scale
Standard Deviation 1.28
Conway COVID Questionnaire Subscale Scores
Symptoms Subscale
1.65 score on a scale
Standard Deviation 1.10
1.70 score on a scale
Standard Deviation 1.17

SECONDARY outcome

Timeframe: 4 weeks (post intervention)

Population: not all participants returned surveys for each time point

The Conway COVID Questionnaire is a new, 16-tem measure of coronavirus related distress and related experiences. Subscales include: perceived threat, financial scale, resource scale, psychological scale, symptoms scale, proximity to others scale, and news scale. Ratings from 1 to 7 with 1 = "not true of me at all" and 7 = "very true of me" with higher scores representing greater perceived threat. Mean for each subscale reported.

Outcome measures

Outcome measures
Measure
Healthy Minds Program Foundations Training
n=280 Participants
Healthy Minds Program (HMP) is a novel, smartphone-based app that provides a series of guided meditation practices on four primary constituents of well-being: Awareness, Connection, Insight, and Purpose. All program elements are introduced with a summary of the scientific evidence supporting its constituent elements (e.g., Awareness and well-being). In addition to standard sitting meditation practices found in many meditation-based behavioral interventions, the HMP offers active practices in which participants can develop the same skills but while embedding practice into activities they already do in their normal daily routine.
Wait-list Control
n=289 Participants
Participants assigned to the wait-list control will not receive treatment for the intervention and follow-up period. They will be provided access to the HMP Foundations training after completing follow-up testing.
Conway COVID Questionnaire Subscale Scores
Financial Subscale
3.10 score on a scale
Standard Deviation 2.08
2.93 score on a scale
Standard Deviation 2.02
Conway COVID Questionnaire Subscale Scores
News Subscale
3.67 score on a scale
Standard Deviation 1.55
3.66 score on a scale
Standard Deviation 1.53
Conway COVID Questionnaire Subscale Scores
Proximity Subscale
3.36 score on a scale
Standard Deviation 1.67
3.41 score on a scale
Standard Deviation 1.73
Conway COVID Questionnaire Subscale Scores
Psychological Subscale
3.96 score on a scale
Standard Deviation 1.55
4.13 score on a scale
Standard Deviation 1.54
Conway COVID Questionnaire Subscale Scores
Resource Subscale
1.85 score on a scale
Standard Deviation 1.17
1.97 score on a scale
Standard Deviation 1.34
Conway COVID Questionnaire Subscale Scores
Symptoms Subscale
1.57 score on a scale
Standard Deviation 1.06
1.82 score on a scale
Standard Deviation 1.24
Conway COVID Questionnaire Subscale Scores
Threat Subscale
4.64 score on a scale
Standard Deviation 1.38
4.74 score on a scale
Standard Deviation 1.39

SECONDARY outcome

Timeframe: 16 weeks (3 months post-intervention)

Population: not all participants returned surveys for each time point

The Conway COVID Questionnaire is a new, 16-tem measure of coronavirus related distress and related experiences. Subscales include: perceived threat, financial scale, resource scale, psychological scale, symptoms scale, proximity to others scale, and news scale. Ratings from 1 to 7 with 1 = "not true of me at all" and 7 = "very true of me" with higher scores representing greater perceived threat. Mean for each subscale reported.

Outcome measures

Outcome measures
Measure
Healthy Minds Program Foundations Training
n=280 Participants
Healthy Minds Program (HMP) is a novel, smartphone-based app that provides a series of guided meditation practices on four primary constituents of well-being: Awareness, Connection, Insight, and Purpose. All program elements are introduced with a summary of the scientific evidence supporting its constituent elements (e.g., Awareness and well-being). In addition to standard sitting meditation practices found in many meditation-based behavioral interventions, the HMP offers active practices in which participants can develop the same skills but while embedding practice into activities they already do in their normal daily routine.
Wait-list Control
n=289 Participants
Participants assigned to the wait-list control will not receive treatment for the intervention and follow-up period. They will be provided access to the HMP Foundations training after completing follow-up testing.
Conway COVID Questionnaire Subscale Scores
News Subscale
3.50 score on a scale
Standard Deviation 1.58
3.67 score on a scale
Standard Deviation 1.49
Conway COVID Questionnaire Subscale Scores
Financial Subscale
2.91 score on a scale
Standard Deviation 1.97
3.01 score on a scale
Standard Deviation 2.07
Conway COVID Questionnaire Subscale Scores
Proximity Subscale
4.45 score on a scale
Standard Deviation 1.63
4.56 score on a scale
Standard Deviation 1.60
Conway COVID Questionnaire Subscale Scores
Psychological Subscale
3.98 score on a scale
Standard Deviation 1.46
4.18 score on a scale
Standard Deviation 1.58
Conway COVID Questionnaire Subscale Scores
Resource Subscale
1.81 score on a scale
Standard Deviation 1.20
1.90 score on a scale
Standard Deviation 1.27
Conway COVID Questionnaire Subscale Scores
Symptoms Subscale
1.89 score on a scale
Standard Deviation 1.38
2.13 score on a scale
Standard Deviation 1.48
Conway COVID Questionnaire Subscale Scores
Threat Subscale
4.81 score on a scale
Standard Deviation 1.36
4.90 score on a scale
Standard Deviation 1.33

SECONDARY outcome

Timeframe: baseline, 4 weeks (post intervention), 16 weeks (3 months post-intervention)

Population: not all participants returned surveys for each time point

The Self-Compassion Scale Short Form will be used to measure self-compassion. The total possible range in scores is 12-60, with higher scores indicating greater levels of self-compassion.

Outcome measures

Outcome measures
Measure
Healthy Minds Program Foundations Training
n=344 Participants
Healthy Minds Program (HMP) is a novel, smartphone-based app that provides a series of guided meditation practices on four primary constituents of well-being: Awareness, Connection, Insight, and Purpose. All program elements are introduced with a summary of the scientific evidence supporting its constituent elements (e.g., Awareness and well-being). In addition to standard sitting meditation practices found in many meditation-based behavioral interventions, the HMP offers active practices in which participants can develop the same skills but while embedding practice into activities they already do in their normal daily routine.
Wait-list Control
n=318 Participants
Participants assigned to the wait-list control will not receive treatment for the intervention and follow-up period. They will be provided access to the HMP Foundations training after completing follow-up testing.
Self-Compassion Scale Short Form Score
baseline
35.7 score on a scale
Standard Deviation 8.25
35.2 score on a scale
Standard Deviation 8.42
Self-Compassion Scale Short Form Score
Week 4
40.1 score on a scale
Standard Deviation 8.75
36.4 score on a scale
Standard Deviation 9.36
Self-Compassion Scale Short Form Score
Week 16
40.3 score on a scale
Standard Deviation 7.62
38.0 score on a scale
Standard Deviation 9.28

SECONDARY outcome

Timeframe: baseline, 4 weeks (post intervention), 16 weeks (3 months post-intervention)

Population: not all participants returned surveys for each time point

Negative ruminative thinking will be measured with the Perseverative Thought Questionnaire. The total possible range in scores is 0-60, with higher scores indicating greater levels negative ruminative thinking.

Outcome measures

Outcome measures
Measure
Healthy Minds Program Foundations Training
n=344 Participants
Healthy Minds Program (HMP) is a novel, smartphone-based app that provides a series of guided meditation practices on four primary constituents of well-being: Awareness, Connection, Insight, and Purpose. All program elements are introduced with a summary of the scientific evidence supporting its constituent elements (e.g., Awareness and well-being). In addition to standard sitting meditation practices found in many meditation-based behavioral interventions, the HMP offers active practices in which participants can develop the same skills but while embedding practice into activities they already do in their normal daily routine.
Wait-list Control
n=318 Participants
Participants assigned to the wait-list control will not receive treatment for the intervention and follow-up period. They will be provided access to the HMP Foundations training after completing follow-up testing.
Change From Baseline on the Perseverative Thought Questionnaire
baseline
29.89 score on a scale
Standard Deviation 10.43
29.62 score on a scale
Standard Deviation 11.29
Change From Baseline on the Perseverative Thought Questionnaire
Week 4
24.75 score on a scale
Standard Deviation 10.71
28.19 score on a scale
Standard Deviation 12.37
Change From Baseline on the Perseverative Thought Questionnaire
Week 16
23.47 score on a scale
Standard Deviation 10.74
25.91 score on a scale
Standard Deviation 12.19

SECONDARY outcome

Timeframe: baseline, 4 weeks (post intervention), 16 weeks (3 months post-intervention)

Population: not all participants returned surveys for each time point

Well-being will be measured using the WHO-5. The total possible range in scores is 0-25, with higher scores indicating greater levels of well-being.

Outcome measures

Outcome measures
Measure
Healthy Minds Program Foundations Training
n=344 Participants
Healthy Minds Program (HMP) is a novel, smartphone-based app that provides a series of guided meditation practices on four primary constituents of well-being: Awareness, Connection, Insight, and Purpose. All program elements are introduced with a summary of the scientific evidence supporting its constituent elements (e.g., Awareness and well-being). In addition to standard sitting meditation practices found in many meditation-based behavioral interventions, the HMP offers active practices in which participants can develop the same skills but while embedding practice into activities they already do in their normal daily routine.
Wait-list Control
n=318 Participants
Participants assigned to the wait-list control will not receive treatment for the intervention and follow-up period. They will be provided access to the HMP Foundations training after completing follow-up testing.
Change From Baseline on the World Health Organization 5-item (WHO-5) Well-being Scale
baseline
12.76 score on a scale
Standard Deviation 4.71
12.47 score on a scale
Standard Deviation 4.33
Change From Baseline on the World Health Organization 5-item (WHO-5) Well-being Scale
Week 4
15.07 score on a scale
Standard Deviation 4.33
12.83 score on a scale
Standard Deviation 4.84
Change From Baseline on the World Health Organization 5-item (WHO-5) Well-being Scale
Week 16
14.07 score on a scale
Standard Deviation 4.64
12.59 score on a scale
Standard Deviation 4.74

SECONDARY outcome

Timeframe: baseline, 4 weeks (post intervention), 16 weeks (3 months post-intervention)

Population: not all participants returned surveys for each time point

The Neutral Face Rating task is a novel measure of prosocial construal (average likability ratings) and race bias (average liking of white faces minus the average liking of black faces). Total score for prosocial construal is from 1 to 7, with higher scores representing greater prosocial construal.

Outcome measures

Outcome measures
Measure
Healthy Minds Program Foundations Training
n=344 Participants
Healthy Minds Program (HMP) is a novel, smartphone-based app that provides a series of guided meditation practices on four primary constituents of well-being: Awareness, Connection, Insight, and Purpose. All program elements are introduced with a summary of the scientific evidence supporting its constituent elements (e.g., Awareness and well-being). In addition to standard sitting meditation practices found in many meditation-based behavioral interventions, the HMP offers active practices in which participants can develop the same skills but while embedding practice into activities they already do in their normal daily routine.
Wait-list Control
n=318 Participants
Participants assigned to the wait-list control will not receive treatment for the intervention and follow-up period. They will be provided access to the HMP Foundations training after completing follow-up testing.
Change From Baseline on the Neutral Face Rating Task: Prosocial Construal
16 weeks
4.44 score on a scale
Standard Deviation 0.63
4.37 score on a scale
Standard Deviation 0.60
Change From Baseline on the Neutral Face Rating Task: Prosocial Construal
baseline
4.46 score on a scale
Standard Deviation 0.60
4.44 score on a scale
Standard Deviation 0.68
Change From Baseline on the Neutral Face Rating Task: Prosocial Construal
4 weeks
4.42 score on a scale
Standard Deviation 0.65
4.27 score on a scale
Standard Deviation 0.59

SECONDARY outcome

Timeframe: baseline, 4 weeks (post intervention), 16 weeks (3 months post-intervention)

Population: not all participants returned surveys for each time point

The Neutral Face Rating task is a novel measure of prosocial construal (average likability ratings) and race bias (average liking of white faces minus the average liking of black faces). Total score for race bias range from -6 to 6, with higher scores representing greater bias favoring white faces (negative scores on the bias measure indicate bias for liking black faces more than white faces).

Outcome measures

Outcome measures
Measure
Healthy Minds Program Foundations Training
n=344 Participants
Healthy Minds Program (HMP) is a novel, smartphone-based app that provides a series of guided meditation practices on four primary constituents of well-being: Awareness, Connection, Insight, and Purpose. All program elements are introduced with a summary of the scientific evidence supporting its constituent elements (e.g., Awareness and well-being). In addition to standard sitting meditation practices found in many meditation-based behavioral interventions, the HMP offers active practices in which participants can develop the same skills but while embedding practice into activities they already do in their normal daily routine.
Wait-list Control
n=318 Participants
Participants assigned to the wait-list control will not receive treatment for the intervention and follow-up period. They will be provided access to the HMP Foundations training after completing follow-up testing.
Change From Baseline on the Neutral Face Rating Task: Race Bias
baseline
-0.57 score on a scale
Standard Deviation 0.67
-0.50 score on a scale
Standard Deviation 0.68
Change From Baseline on the Neutral Face Rating Task: Race Bias
4 weeks
-0.54 score on a scale
Standard Deviation 0.68
-0.55 score on a scale
Standard Deviation 0.73
Change From Baseline on the Neutral Face Rating Task: Race Bias
16 weeks
-0.51 score on a scale
Standard Deviation 0.69
-0.46 score on a scale
Standard Deviation 0.67

SECONDARY outcome

Timeframe: baseline, 4 weeks (post intervention)

Population: not all participants returned surveys for each time point

A measure of fixed versus incremental mindset regarding well-being. The average across items for a possible range in scores from 1-6 will be measured, with higher scores indicating greater levels of incremental views on well-being (i.e., it can be learned).

Outcome measures

Outcome measures
Measure
Healthy Minds Program Foundations Training
n=342 Participants
Healthy Minds Program (HMP) is a novel, smartphone-based app that provides a series of guided meditation practices on four primary constituents of well-being: Awareness, Connection, Insight, and Purpose. All program elements are introduced with a summary of the scientific evidence supporting its constituent elements (e.g., Awareness and well-being). In addition to standard sitting meditation practices found in many meditation-based behavioral interventions, the HMP offers active practices in which participants can develop the same skills but while embedding practice into activities they already do in their normal daily routine.
Wait-list Control
n=314 Participants
Participants assigned to the wait-list control will not receive treatment for the intervention and follow-up period. They will be provided access to the HMP Foundations training after completing follow-up testing.
Change From Baseline on the Growth Mindset Scale for Well-Being
baseline
5.00 score on a scale
Standard Deviation 0.83
4.94 score on a scale
Standard Deviation 0.85
Change From Baseline on the Growth Mindset Scale for Well-Being
4 weeks
5.18 score on a scale
Standard Deviation 0.81
4.87 score on a scale
Standard Deviation 0.87

OTHER_PRE_SPECIFIED outcome

Timeframe: Every other day when participant completes a practice (up to 4 weeks)

4-tems following each app-based practice for treatment participants that ask about perceive quality of the practice, (1 poor, 9 very good), and mood (1 poor, 5 good).

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: After weeks 1, 2, and 3 during the intervention, 4 weeks (post intervention), 16 weeks (3 months post-intervention) - Intervention group only

A measure of working alliance in a digital environment that will be averaged across all items for a score range from 1 to 7, with higher scores reflecting higher levels of alliance.

Outcome measures

Outcome data not reported

Adverse Events

Healthy Minds Program Foundations Training

Serious events: 0 serious events
Other events: 344 other events
Deaths: 0 deaths

Wait-list Control

Serious events: 0 serious events
Other events: 318 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Healthy Minds Program Foundations Training
n=344 participants at risk
Healthy Minds Program (HMP) is a novel, smartphone-based app that provides a series of guided meditation practices on four primary constituents of well-being: Awareness, Connection, Insight, and Purpose. All program elements are introduced with a summary of the scientific evidence supporting its constituent elements (e.g., Awareness and well-being). In addition to standard sitting meditation practices found in many meditation-based behavioral interventions, the HMP offers active practices in which participants can develop the same skills but while embedding practice into activities they already do in their normal daily routine.
Wait-list Control
n=318 participants at risk
Participants assigned to the wait-list control will not receive treatment for the intervention and follow-up period. They will be provided access to the HMP Foundations training after completing follow-up testing.
Nervous system disorders
None to Slight Depression at Baseline
50.9%
175/344 • up to 16 weeks
Anxiety and depression scores were characterized separately at T1 (baseline), T5 (4 weeks), and T6 (16 weeks) based on normative none-to-slight, mild, moderate, and severe symptoms from PROMIS anxiety and PROMIS depression scores (i.e., T-score \<55, 55≥ \<60, 60≥ \<70, and ≥70; Pilkonis et al., 2011).
50.3%
160/318 • up to 16 weeks
Anxiety and depression scores were characterized separately at T1 (baseline), T5 (4 weeks), and T6 (16 weeks) based on normative none-to-slight, mild, moderate, and severe symptoms from PROMIS anxiety and PROMIS depression scores (i.e., T-score \<55, 55≥ \<60, 60≥ \<70, and ≥70; Pilkonis et al., 2011).
Nervous system disorders
Mild Depression at Baseline
23.3%
80/344 • up to 16 weeks
Anxiety and depression scores were characterized separately at T1 (baseline), T5 (4 weeks), and T6 (16 weeks) based on normative none-to-slight, mild, moderate, and severe symptoms from PROMIS anxiety and PROMIS depression scores (i.e., T-score \<55, 55≥ \<60, 60≥ \<70, and ≥70; Pilkonis et al., 2011).
20.4%
65/318 • up to 16 weeks
Anxiety and depression scores were characterized separately at T1 (baseline), T5 (4 weeks), and T6 (16 weeks) based on normative none-to-slight, mild, moderate, and severe symptoms from PROMIS anxiety and PROMIS depression scores (i.e., T-score \<55, 55≥ \<60, 60≥ \<70, and ≥70; Pilkonis et al., 2011).
Nervous system disorders
Moderate Depression at Baseline
25.3%
87/344 • up to 16 weeks
Anxiety and depression scores were characterized separately at T1 (baseline), T5 (4 weeks), and T6 (16 weeks) based on normative none-to-slight, mild, moderate, and severe symptoms from PROMIS anxiety and PROMIS depression scores (i.e., T-score \<55, 55≥ \<60, 60≥ \<70, and ≥70; Pilkonis et al., 2011).
27.4%
87/318 • up to 16 weeks
Anxiety and depression scores were characterized separately at T1 (baseline), T5 (4 weeks), and T6 (16 weeks) based on normative none-to-slight, mild, moderate, and severe symptoms from PROMIS anxiety and PROMIS depression scores (i.e., T-score \<55, 55≥ \<60, 60≥ \<70, and ≥70; Pilkonis et al., 2011).
Nervous system disorders
Severe Depression at Baseline
0.29%
1/344 • up to 16 weeks
Anxiety and depression scores were characterized separately at T1 (baseline), T5 (4 weeks), and T6 (16 weeks) based on normative none-to-slight, mild, moderate, and severe symptoms from PROMIS anxiety and PROMIS depression scores (i.e., T-score \<55, 55≥ \<60, 60≥ \<70, and ≥70; Pilkonis et al., 2011).
0.94%
3/318 • up to 16 weeks
Anxiety and depression scores were characterized separately at T1 (baseline), T5 (4 weeks), and T6 (16 weeks) based on normative none-to-slight, mild, moderate, and severe symptoms from PROMIS anxiety and PROMIS depression scores (i.e., T-score \<55, 55≥ \<60, 60≥ \<70, and ≥70; Pilkonis et al., 2011).
Nervous system disorders
None to Slight Depression at 4 weeks
63.4%
218/344 • up to 16 weeks
Anxiety and depression scores were characterized separately at T1 (baseline), T5 (4 weeks), and T6 (16 weeks) based on normative none-to-slight, mild, moderate, and severe symptoms from PROMIS anxiety and PROMIS depression scores (i.e., T-score \<55, 55≥ \<60, 60≥ \<70, and ≥70; Pilkonis et al., 2011).
54.1%
172/318 • up to 16 weeks
Anxiety and depression scores were characterized separately at T1 (baseline), T5 (4 weeks), and T6 (16 weeks) based on normative none-to-slight, mild, moderate, and severe symptoms from PROMIS anxiety and PROMIS depression scores (i.e., T-score \<55, 55≥ \<60, 60≥ \<70, and ≥70; Pilkonis et al., 2011).
Nervous system disorders
Mild Depression at 4 weeks
10.5%
36/344 • up to 16 weeks
Anxiety and depression scores were characterized separately at T1 (baseline), T5 (4 weeks), and T6 (16 weeks) based on normative none-to-slight, mild, moderate, and severe symptoms from PROMIS anxiety and PROMIS depression scores (i.e., T-score \<55, 55≥ \<60, 60≥ \<70, and ≥70; Pilkonis et al., 2011).
16.0%
51/318 • up to 16 weeks
Anxiety and depression scores were characterized separately at T1 (baseline), T5 (4 weeks), and T6 (16 weeks) based on normative none-to-slight, mild, moderate, and severe symptoms from PROMIS anxiety and PROMIS depression scores (i.e., T-score \<55, 55≥ \<60, 60≥ \<70, and ≥70; Pilkonis et al., 2011).
Nervous system disorders
Moderate Depression at 4 weeks
7.3%
25/344 • up to 16 weeks
Anxiety and depression scores were characterized separately at T1 (baseline), T5 (4 weeks), and T6 (16 weeks) based on normative none-to-slight, mild, moderate, and severe symptoms from PROMIS anxiety and PROMIS depression scores (i.e., T-score \<55, 55≥ \<60, 60≥ \<70, and ≥70; Pilkonis et al., 2011).
19.2%
61/318 • up to 16 weeks
Anxiety and depression scores were characterized separately at T1 (baseline), T5 (4 weeks), and T6 (16 weeks) based on normative none-to-slight, mild, moderate, and severe symptoms from PROMIS anxiety and PROMIS depression scores (i.e., T-score \<55, 55≥ \<60, 60≥ \<70, and ≥70; Pilkonis et al., 2011).
Nervous system disorders
Severe Depression at 4 weeks
0.29%
1/344 • up to 16 weeks
Anxiety and depression scores were characterized separately at T1 (baseline), T5 (4 weeks), and T6 (16 weeks) based on normative none-to-slight, mild, moderate, and severe symptoms from PROMIS anxiety and PROMIS depression scores (i.e., T-score \<55, 55≥ \<60, 60≥ \<70, and ≥70; Pilkonis et al., 2011).
1.6%
5/318 • up to 16 weeks
Anxiety and depression scores were characterized separately at T1 (baseline), T5 (4 weeks), and T6 (16 weeks) based on normative none-to-slight, mild, moderate, and severe symptoms from PROMIS anxiety and PROMIS depression scores (i.e., T-score \<55, 55≥ \<60, 60≥ \<70, and ≥70; Pilkonis et al., 2011).
Nervous system disorders
None to Slight Depression at 16 weeks
59.6%
205/344 • up to 16 weeks
Anxiety and depression scores were characterized separately at T1 (baseline), T5 (4 weeks), and T6 (16 weeks) based on normative none-to-slight, mild, moderate, and severe symptoms from PROMIS anxiety and PROMIS depression scores (i.e., T-score \<55, 55≥ \<60, 60≥ \<70, and ≥70; Pilkonis et al., 2011).
53.8%
171/318 • up to 16 weeks
Anxiety and depression scores were characterized separately at T1 (baseline), T5 (4 weeks), and T6 (16 weeks) based on normative none-to-slight, mild, moderate, and severe symptoms from PROMIS anxiety and PROMIS depression scores (i.e., T-score \<55, 55≥ \<60, 60≥ \<70, and ≥70; Pilkonis et al., 2011).
Nervous system disorders
Mild Depression at 16 weeks
13.4%
46/344 • up to 16 weeks
Anxiety and depression scores were characterized separately at T1 (baseline), T5 (4 weeks), and T6 (16 weeks) based on normative none-to-slight, mild, moderate, and severe symptoms from PROMIS anxiety and PROMIS depression scores (i.e., T-score \<55, 55≥ \<60, 60≥ \<70, and ≥70; Pilkonis et al., 2011).
17.9%
57/318 • up to 16 weeks
Anxiety and depression scores were characterized separately at T1 (baseline), T5 (4 weeks), and T6 (16 weeks) based on normative none-to-slight, mild, moderate, and severe symptoms from PROMIS anxiety and PROMIS depression scores (i.e., T-score \<55, 55≥ \<60, 60≥ \<70, and ≥70; Pilkonis et al., 2011).
Nervous system disorders
Moderate Depression at 16 weeks
8.7%
30/344 • up to 16 weeks
Anxiety and depression scores were characterized separately at T1 (baseline), T5 (4 weeks), and T6 (16 weeks) based on normative none-to-slight, mild, moderate, and severe symptoms from PROMIS anxiety and PROMIS depression scores (i.e., T-score \<55, 55≥ \<60, 60≥ \<70, and ≥70; Pilkonis et al., 2011).
19.2%
61/318 • up to 16 weeks
Anxiety and depression scores were characterized separately at T1 (baseline), T5 (4 weeks), and T6 (16 weeks) based on normative none-to-slight, mild, moderate, and severe symptoms from PROMIS anxiety and PROMIS depression scores (i.e., T-score \<55, 55≥ \<60, 60≥ \<70, and ≥70; Pilkonis et al., 2011).
Nervous system disorders
Severe Depression at 16 weeks
0.29%
1/344 • up to 16 weeks
Anxiety and depression scores were characterized separately at T1 (baseline), T5 (4 weeks), and T6 (16 weeks) based on normative none-to-slight, mild, moderate, and severe symptoms from PROMIS anxiety and PROMIS depression scores (i.e., T-score \<55, 55≥ \<60, 60≥ \<70, and ≥70; Pilkonis et al., 2011).
0.31%
1/318 • up to 16 weeks
Anxiety and depression scores were characterized separately at T1 (baseline), T5 (4 weeks), and T6 (16 weeks) based on normative none-to-slight, mild, moderate, and severe symptoms from PROMIS anxiety and PROMIS depression scores (i.e., T-score \<55, 55≥ \<60, 60≥ \<70, and ≥70; Pilkonis et al., 2011).
Nervous system disorders
None to Slight Anxiety at Baseline
22.4%
77/344 • up to 16 weeks
Anxiety and depression scores were characterized separately at T1 (baseline), T5 (4 weeks), and T6 (16 weeks) based on normative none-to-slight, mild, moderate, and severe symptoms from PROMIS anxiety and PROMIS depression scores (i.e., T-score \<55, 55≥ \<60, 60≥ \<70, and ≥70; Pilkonis et al., 2011).
21.7%
69/318 • up to 16 weeks
Anxiety and depression scores were characterized separately at T1 (baseline), T5 (4 weeks), and T6 (16 weeks) based on normative none-to-slight, mild, moderate, and severe symptoms from PROMIS anxiety and PROMIS depression scores (i.e., T-score \<55, 55≥ \<60, 60≥ \<70, and ≥70; Pilkonis et al., 2011).
Nervous system disorders
Mild Anxiety at Baseline
28.5%
98/344 • up to 16 weeks
Anxiety and depression scores were characterized separately at T1 (baseline), T5 (4 weeks), and T6 (16 weeks) based on normative none-to-slight, mild, moderate, and severe symptoms from PROMIS anxiety and PROMIS depression scores (i.e., T-score \<55, 55≥ \<60, 60≥ \<70, and ≥70; Pilkonis et al., 2011).
31.1%
99/318 • up to 16 weeks
Anxiety and depression scores were characterized separately at T1 (baseline), T5 (4 weeks), and T6 (16 weeks) based on normative none-to-slight, mild, moderate, and severe symptoms from PROMIS anxiety and PROMIS depression scores (i.e., T-score \<55, 55≥ \<60, 60≥ \<70, and ≥70; Pilkonis et al., 2011).
Nervous system disorders
Moderate Anxiety at Baseline
44.8%
154/344 • up to 16 weeks
Anxiety and depression scores were characterized separately at T1 (baseline), T5 (4 weeks), and T6 (16 weeks) based on normative none-to-slight, mild, moderate, and severe symptoms from PROMIS anxiety and PROMIS depression scores (i.e., T-score \<55, 55≥ \<60, 60≥ \<70, and ≥70; Pilkonis et al., 2011).
40.9%
130/318 • up to 16 weeks
Anxiety and depression scores were characterized separately at T1 (baseline), T5 (4 weeks), and T6 (16 weeks) based on normative none-to-slight, mild, moderate, and severe symptoms from PROMIS anxiety and PROMIS depression scores (i.e., T-score \<55, 55≥ \<60, 60≥ \<70, and ≥70; Pilkonis et al., 2011).
Nervous system disorders
Severe Anxiety at Baseline
4.1%
14/344 • up to 16 weeks
Anxiety and depression scores were characterized separately at T1 (baseline), T5 (4 weeks), and T6 (16 weeks) based on normative none-to-slight, mild, moderate, and severe symptoms from PROMIS anxiety and PROMIS depression scores (i.e., T-score \<55, 55≥ \<60, 60≥ \<70, and ≥70; Pilkonis et al., 2011).
5.3%
17/318 • up to 16 weeks
Anxiety and depression scores were characterized separately at T1 (baseline), T5 (4 weeks), and T6 (16 weeks) based on normative none-to-slight, mild, moderate, and severe symptoms from PROMIS anxiety and PROMIS depression scores (i.e., T-score \<55, 55≥ \<60, 60≥ \<70, and ≥70; Pilkonis et al., 2011).
Nervous system disorders
None to Slight Anxiety at 4 weeks
38.7%
133/344 • up to 16 weeks
Anxiety and depression scores were characterized separately at T1 (baseline), T5 (4 weeks), and T6 (16 weeks) based on normative none-to-slight, mild, moderate, and severe symptoms from PROMIS anxiety and PROMIS depression scores (i.e., T-score \<55, 55≥ \<60, 60≥ \<70, and ≥70; Pilkonis et al., 2011).
28.6%
91/318 • up to 16 weeks
Anxiety and depression scores were characterized separately at T1 (baseline), T5 (4 weeks), and T6 (16 weeks) based on normative none-to-slight, mild, moderate, and severe symptoms from PROMIS anxiety and PROMIS depression scores (i.e., T-score \<55, 55≥ \<60, 60≥ \<70, and ≥70; Pilkonis et al., 2011).
Nervous system disorders
Mild Anxiety at 4 weeks
21.8%
75/344 • up to 16 weeks
Anxiety and depression scores were characterized separately at T1 (baseline), T5 (4 weeks), and T6 (16 weeks) based on normative none-to-slight, mild, moderate, and severe symptoms from PROMIS anxiety and PROMIS depression scores (i.e., T-score \<55, 55≥ \<60, 60≥ \<70, and ≥70; Pilkonis et al., 2011).
25.2%
80/318 • up to 16 weeks
Anxiety and depression scores were characterized separately at T1 (baseline), T5 (4 weeks), and T6 (16 weeks) based on normative none-to-slight, mild, moderate, and severe symptoms from PROMIS anxiety and PROMIS depression scores (i.e., T-score \<55, 55≥ \<60, 60≥ \<70, and ≥70; Pilkonis et al., 2011).
Nervous system disorders
Moderate Anxiety at 4 weeks
20.1%
69/344 • up to 16 weeks
Anxiety and depression scores were characterized separately at T1 (baseline), T5 (4 weeks), and T6 (16 weeks) based on normative none-to-slight, mild, moderate, and severe symptoms from PROMIS anxiety and PROMIS depression scores (i.e., T-score \<55, 55≥ \<60, 60≥ \<70, and ≥70; Pilkonis et al., 2011).
33.0%
105/318 • up to 16 weeks
Anxiety and depression scores were characterized separately at T1 (baseline), T5 (4 weeks), and T6 (16 weeks) based on normative none-to-slight, mild, moderate, and severe symptoms from PROMIS anxiety and PROMIS depression scores (i.e., T-score \<55, 55≥ \<60, 60≥ \<70, and ≥70; Pilkonis et al., 2011).
Nervous system disorders
Severe Anxiety at 4 weeks
0.87%
3/344 • up to 16 weeks
Anxiety and depression scores were characterized separately at T1 (baseline), T5 (4 weeks), and T6 (16 weeks) based on normative none-to-slight, mild, moderate, and severe symptoms from PROMIS anxiety and PROMIS depression scores (i.e., T-score \<55, 55≥ \<60, 60≥ \<70, and ≥70; Pilkonis et al., 2011).
4.1%
13/318 • up to 16 weeks
Anxiety and depression scores were characterized separately at T1 (baseline), T5 (4 weeks), and T6 (16 weeks) based on normative none-to-slight, mild, moderate, and severe symptoms from PROMIS anxiety and PROMIS depression scores (i.e., T-score \<55, 55≥ \<60, 60≥ \<70, and ≥70; Pilkonis et al., 2011).
Nervous system disorders
None to Slight Anxiety at 16 weeks
32.8%
113/344 • up to 16 weeks
Anxiety and depression scores were characterized separately at T1 (baseline), T5 (4 weeks), and T6 (16 weeks) based on normative none-to-slight, mild, moderate, and severe symptoms from PROMIS anxiety and PROMIS depression scores (i.e., T-score \<55, 55≥ \<60, 60≥ \<70, and ≥70; Pilkonis et al., 2011).
31.4%
100/318 • up to 16 weeks
Anxiety and depression scores were characterized separately at T1 (baseline), T5 (4 weeks), and T6 (16 weeks) based on normative none-to-slight, mild, moderate, and severe symptoms from PROMIS anxiety and PROMIS depression scores (i.e., T-score \<55, 55≥ \<60, 60≥ \<70, and ≥70; Pilkonis et al., 2011).
Nervous system disorders
Mild Anxiety at 16 weeks
25.9%
89/344 • up to 16 weeks
Anxiety and depression scores were characterized separately at T1 (baseline), T5 (4 weeks), and T6 (16 weeks) based on normative none-to-slight, mild, moderate, and severe symptoms from PROMIS anxiety and PROMIS depression scores (i.e., T-score \<55, 55≥ \<60, 60≥ \<70, and ≥70; Pilkonis et al., 2011).
25.2%
80/318 • up to 16 weeks
Anxiety and depression scores were characterized separately at T1 (baseline), T5 (4 weeks), and T6 (16 weeks) based on normative none-to-slight, mild, moderate, and severe symptoms from PROMIS anxiety and PROMIS depression scores (i.e., T-score \<55, 55≥ \<60, 60≥ \<70, and ≥70; Pilkonis et al., 2011).
Nervous system disorders
Moderate Anxiety at 16 weeks
23.0%
79/344 • up to 16 weeks
Anxiety and depression scores were characterized separately at T1 (baseline), T5 (4 weeks), and T6 (16 weeks) based on normative none-to-slight, mild, moderate, and severe symptoms from PROMIS anxiety and PROMIS depression scores (i.e., T-score \<55, 55≥ \<60, 60≥ \<70, and ≥70; Pilkonis et al., 2011).
30.2%
96/318 • up to 16 weeks
Anxiety and depression scores were characterized separately at T1 (baseline), T5 (4 weeks), and T6 (16 weeks) based on normative none-to-slight, mild, moderate, and severe symptoms from PROMIS anxiety and PROMIS depression scores (i.e., T-score \<55, 55≥ \<60, 60≥ \<70, and ≥70; Pilkonis et al., 2011).
Nervous system disorders
Severe Anxiety at 16 weeks
0.29%
1/344 • up to 16 weeks
Anxiety and depression scores were characterized separately at T1 (baseline), T5 (4 weeks), and T6 (16 weeks) based on normative none-to-slight, mild, moderate, and severe symptoms from PROMIS anxiety and PROMIS depression scores (i.e., T-score \<55, 55≥ \<60, 60≥ \<70, and ≥70; Pilkonis et al., 2011).
3.1%
10/318 • up to 16 weeks
Anxiety and depression scores were characterized separately at T1 (baseline), T5 (4 weeks), and T6 (16 weeks) based on normative none-to-slight, mild, moderate, and severe symptoms from PROMIS anxiety and PROMIS depression scores (i.e., T-score \<55, 55≥ \<60, 60≥ \<70, and ≥70; Pilkonis et al., 2011).

Additional Information

Matthew Hirshberg

Center for Healthy Minds

Phone: 608-262-0035

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place