N/A
N=666
COVID-19 and the Healthy Minds Program for Educators
Anxiety · Depression · Psychological Stress · Psychological Distress · Well-being
Bottom Line
View on ClinicalTrials.gov: NCT04426318 ↗Enrolled (actual)
666
Serious AEs
0.0%
Results posted
Feb 2022
Primary outcome: Primary: 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 — 0.00; 0.00; -0.29; -0.10 z-score
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Healthy Minds Program Foundations Training (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Wisconsin, Madison
- Primary completion
- Jan 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
0.00; 0.00; -0.29; -0.10; -0.40; -0.10 | — |
| SECONDARY Change From Baseline on the Five Facet Mindfulness Questionnaire Act With Awareness Subscale |
24.80; 24.56; 24.19; 25.57; 25.71; 25.69 | — |
| SECONDARY Change From Baseline on the Drexel Defusion Scale (DDS) |
24.83; 24.45; 27.14; 26.26; 28.45; 26.96 | — |
| SECONDARY Change From Baseline on the Meaning in Life Questionnaire |
26.20; 25.81; 26.83; 26.02; 27.15; 25.85 | — |
| SECONDARY Change From Baseline on the NIH Toolbox Loneliness Scale |
2.53; 2.58; 2.34; 2.49; 2.16; 2.38 | — |
| SECONDARY Conway COVID Questionnaire Subscale Scores |
2.91; 3.01; 3.50; 3.67; 4.45; 4.56 | — |
| SECONDARY Conway COVID Questionnaire Subscale Scores |
2.91; 3.01; 3.50; 3.67; 4.45; 4.56 | — |
| SECONDARY Conway COVID Questionnaire Subscale Scores |
2.91; 3.01; 3.50; 3.67; 4.45; 4.56 | — |
| SECONDARY Self-Compassion Scale Short Form Score |
35.7; 35.2; 40.1; 36.4; 40.3; 38.0 | — |
| SECONDARY Change From Baseline on the Perseverative Thought Questionnaire |
29.89; 29.62; 24.75; 28.19; 23.47; 25.91 | — |
| SECONDARY Change From Baseline on the World Health Organization 5-item (WHO-5) Well-being Scale |
12.76; 12.47; 15.07; 12.83; 14.07; 12.59 | — |
| SECONDARY Change From Baseline on the Neutral Face Rating Task: Prosocial Construal |
4.46; 4.44; 4.42; 4.27; 4.44; 4.37 | — |
| SECONDARY Change From Baseline on the Neutral Face Rating Task: Race Bias |
-0.57; -0.50; -0.54; -0.55; -0.51; -0.46 | — |
| SECONDARY Change From Baseline on the Growth Mindset Scale for Well-Being |
5.00; 4.94; 5.18; 4.87 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Ages 18 years old and up
- Employees of a K-12 school district in Wisconsin
- Smartphone or device that can download apps from Google Play or the iTunes app store
Exclusion Criteria
- Individuals under 18 years old
- Significant meditation experience:
- Meditation retreat experience (meditation retreat or yoga/body practice retreat with significant meditation component),
- Regular meditation practice weekly for over 1 year OR daily practice within the previous 6 months; or
- Previous use of the HMP app.
- Patient-Reported Outcomes Measurement Information System (PROMIS) depression score > 70
Data sourced from ClinicalTrials.gov (NCT04426318). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.