18 and older, any sex, with Anxiety or Depression. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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 ScalePrimary· baseline, after weeks 1, 2, and 3 of the intervention, 4 weeks (post intervention), 16 weeks (3 months post-intervention)
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.
Baseline
Group
Value
95% CI
Healthy Minds Program Foundations Training
0.00
± 0.88
Wait-list Control
0.00
± 0.91
Week 1
Group
Value
95% CI
Healthy Minds Program Foundations Training
-0.29
± 0.89
Wait-list Control
-0.10
± 0.95
Week 2
Group
Value
95% CI
Healthy Minds Program Foundations Training
-0.40
± 0.85
Wait-list Control
-0.10
± 1.01
Week 3
Group
Value
95% CI
Healthy Minds Program Foundations Training
-0.55
± 0.88
Wait-list Control
-0.14
± 1.02
Week 4
Group
Value
95% CI
Healthy Minds Program Foundations Training
-0.67
± 0.89
Wait-list Control
-0.20
± 1.03
Week 16
Group
Value
95% CI
Healthy Minds Program Foundations Training
-0.55
± 0.87
Wait-list Control
-0.24
± 1.00
Change From Baseline on the Five Facet Mindfulness Questionnaire Act With Awareness SubscaleSecondary· baseline, after weeks 1, 2, and 3 of the intervention, 4 weeks (post intervention), 16 weeks (3 months post-intervention)
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.
baseline
Group
Value
95% CI
Healthy Minds Program Foundations Training
24.80
± 5.93
Wait-list Control
24.56
± 6.12
Week 1
Group
Value
95% CI
Healthy Minds Program Foundations Training
24.19
± 5.62
Wait-list Control
25.57
± 6.15
Week 2
Group
Value
95% CI
Healthy Minds Program Foundations Training
25.71
± 5.47
Wait-list Control
25.69
± 6.44
Week 3
Group
Value
95% CI
Healthy Minds Program Foundations Training
26.45
± 5.61
Wait-list Control
26.15
± 6.21
Week 4
Group
Value
95% CI
Healthy Minds Program Foundations Training
27.12
± 5.67
Wait-list Control
26.12
± 6.76
Week 16
Group
Value
95% CI
Healthy Minds Program Foundations Training
27.1
± 5.32
Wait-list Control
26.02
± 6.36
Change From Baseline on the Drexel Defusion Scale (DDS)Secondary· baseline, after weeks 1, 2, and 3 of the intervention, 4 weeks (post intervention), 16 weeks (3 months post-intervention)
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.
baseline
Group
Value
95% CI
Healthy Minds Program Foundations Training
24.83
± 7.89
Wait-list Control
24.45
± 8.23
Week 1
Group
Value
95% CI
Healthy Minds Program Foundations Training
27.14
± 8.72
Wait-list Control
26.26
± 8.31
Week 2
Group
Value
95% CI
Healthy Minds Program Foundations Training
28.45
± 8.42
Wait-list Control
26.96
± 8.73
Week 3
Group
Value
95% CI
Healthy Minds Program Foundations Training
29.61
± 8.73
Wait-list Control
27.52
± 9.07
Week 4
Group
Value
95% CI
Healthy Minds Program Foundations Training
31.43
± 8.54
Wait-list Control
27.92
± 8.63
Week 16
Group
Value
95% CI
Healthy Minds Program Foundations Training
30.93
± 8.69
Wait-list Control
28.23
± 8.57
Change From Baseline on the Meaning in Life QuestionnaireSecondary· baseline, after weeks 1, 2, and 3 of the intervention, 4 weeks (post intervention), 16 weeks (3 months post-intervention)
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.
baseline
Group
Value
95% CI
Healthy Minds Program Foundations Training
26.20
± 5.44
Wait-list Control
25.81
± 5.46
Week 1
Group
Value
95% CI
Healthy Minds Program Foundations Training
26.83
± 5.13
Wait-list Control
26.02
± 5.38
Week 2
Group
Value
95% CI
Healthy Minds Program Foundations Training
27.15
± 5.14
Wait-list Control
25.85
± 5.68
Week 3
Group
Value
95% CI
Healthy Minds Program Foundations Training
27.62
± 4.92
Wait-list Control
26.13
± 5.83
Week 4
Group
Value
95% CI
Healthy Minds Program Foundations Training
27.85
± 5.35
Wait-list Control
26.02
± 6.07
Week 16
Group
Value
95% CI
Healthy Minds Program Foundations Training
27.91
± 5.14
Wait-list Control
26.29
± 5.87
Change From Baseline on the NIH Toolbox Loneliness ScaleSecondary· baseline, after weeks 1, 2, and 3 of the intervention, 4 weeks (post intervention), 16 weeks (3 months post-intervention)
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.
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.
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.
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.
Financial Subscale
Group
Value
95% CI
Healthy Minds Program Foundations Training
2.91
± 1.97
Wait-list Control
3.01
± 2.07
News Subscale
Group
Value
95% CI
Healthy Minds Program Foundations Training
3.50
± 1.58
Wait-list Control
3.67
± 1.49
Proximity Subscale
Group
Value
95% CI
Healthy Minds Program Foundations Training
4.45
± 1.63
Wait-list Control
4.56
± 1.60
Psychological Subscale
Group
Value
95% CI
Healthy Minds Program Foundations Training
3.98
± 1.46
Wait-list Control
4.18
± 1.58
Resource Subscale
Group
Value
95% CI
Healthy Minds Program Foundations Training
1.81
± 1.20
Wait-list Control
1.90
± 1.27
Symptoms Subscale
Group
Value
95% CI
Healthy Minds Program Foundations Training
1.89
± 1.38
Wait-list Control
2.13
± 1.48
Threat Subscale
Group
Value
95% CI
Healthy Minds Program Foundations Training
4.81
± 1.36
Wait-list Control
4.90
± 1.33
Self-Compassion Scale Short Form ScoreSecondary· baseline, 4 weeks (post intervention), 16 weeks (3 months post-intervention)
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.
baseline
Group
Value
95% CI
Healthy Minds Program Foundations Training
35.7
± 8.25
Wait-list Control
35.2
± 8.42
Week 4
Group
Value
95% CI
Healthy Minds Program Foundations Training
40.1
± 8.75
Wait-list Control
36.4
± 9.36
Week 16
Group
Value
95% CI
Healthy Minds Program Foundations Training
40.3
± 7.62
Wait-list Control
38.0
± 9.28
Change From Baseline on the Perseverative Thought QuestionnaireSecondary· baseline, 4 weeks (post intervention), 16 weeks (3 months post-intervention)
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.
baseline
Group
Value
95% CI
Healthy Minds Program Foundations Training
29.89
± 10.43
Wait-list Control
29.62
± 11.29
Week 4
Group
Value
95% CI
Healthy Minds Program Foundations Training
24.75
± 10.71
Wait-list Control
28.19
± 12.37
Week 16
Group
Value
95% CI
Healthy Minds Program Foundations Training
23.47
± 10.74
Wait-list Control
25.91
± 12.19
Change From Baseline on the World Health Organization 5-item (WHO-5) Well-being ScaleSecondary· baseline, 4 weeks (post intervention), 16 weeks (3 months post-intervention)
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.
baseline
Group
Value
95% CI
Healthy Minds Program Foundations Training
12.76
± 4.71
Wait-list Control
12.47
± 4.33
Week 4
Group
Value
95% CI
Healthy Minds Program Foundations Training
15.07
± 4.33
Wait-list Control
12.83
± 4.84
Week 16
Group
Value
95% CI
Healthy Minds Program Foundations Training
14.07
± 4.64
Wait-list Control
12.59
± 4.74
Change From Baseline on the Neutral Face Rating Task: Prosocial ConstrualSecondary· baseline, 4 weeks (post intervention), 16 weeks (3 months post-intervention)
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.
baseline
Group
Value
95% CI
Healthy Minds Program Foundations Training
4.46
± 0.60
Wait-list Control
4.44
± 0.68
4 weeks
Group
Value
95% CI
Healthy Minds Program Foundations Training
4.42
± 0.65
Wait-list Control
4.27
± 0.59
16 weeks
Group
Value
95% CI
Healthy Minds Program Foundations Training
4.44
± 0.63
Wait-list Control
4.37
± 0.60
Adverse events — posted to ClinicalTrials.gov
Time frame: up to 16 weeks.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This study is a randomized controlled trial (RCT) of the four-week Healthy Minds Program (HMP) app Foundations training in employees of a mid-size urban school district in the United States during the summer of 2020, in the midst of the novel coronavirus pandemic. A 3-month follow-up in the fall of 2020 will also be conducted.
Participants will be recruited via email and mailed postcards, and will first complete an online screen. Eligible participants will then enter a waiting zone for between 2-days and 2-weeks before they are sent the online pre-test. Upon completion of the pre-test, participants will be assigned to condition via a simple random number generator. If assigned to the intervention (i.e., the Healthy Minds Program App), participants will receive instructions and support in downloading and activating the app. Every 7-days over the 4-week intervention period participants in both conditions will complete the same set of measures. A full battery of measures will be administered a second time post-test, following the 4-week intervention period. Three-months after post-test, a follow-up assessment will be conducted.
The investigators predict that participants assigned to the intervention will demonstrate significantly reduced psychological distress after the intervention, and these decreases will persist at the 3-month follow-up. Further, it is hypothesized that baseline participant characteristics and early experience of the intervention will predict treatment adherence, study drop-out and outcomes, and that treatment engagement will moderate outcomes.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Wisconsin, Madison
Last refreshed: 19 September 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04426318.