Clinical trial NCT04426318: COVID-19 and the Healthy Minds Program for Educators
Official title: COVID-19 and the Healthy Minds Program for Educators
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Depression
Psychological Stress
Psychological Distress
Well-being
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: Chan Zuckerberg Initiative
name: Healthy Minds Innovations
name: Center for Healthy Minds
First posted: 2020-06-11
Enrollment: 698
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Random parallel assignment
Primary purpose: TREATMENT

Brief 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:

  1. Meditation retreat experience (meditation retreat or yoga/body practice retreat with significant meditation component),
  2. Regular meditation practice weekly for over 1 year OR daily practice within the previous 6 months; or
  3. Previous use of the HMP app.
* Patient-Reported Outcomes Measurement Information System (PROMIS) depression score \> 70

Primary outcomes:
measure: 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
timeFrame: baseline, after weeks 1, 2, and 3 of the intervention, 4 weeks (post intervention), 16 weeks (3 months post-intervention)
Secondary outcomes:
measure: Change From Baseline on the Five Facet Mindfulness Questionnaire Act With Awareness Subscale
timeFrame: baseline, after weeks 1, 2, and 3 of the intervention, 4 weeks (post intervention), 16 weeks (3 months post-intervention)
measure: Change From Baseline on the Drexel Defusion Scale (DDS)
timeFrame: baseline, after weeks 1, 2, and 3 of the intervention, 4 weeks (post intervention), 16 weeks (3 months post-intervention)
measure: Change From Baseline on the Meaning in Life Questionnaire
timeFrame: baseline, after weeks 1, 2, and 3 of the intervention, 4 weeks (post intervention), 16 weeks (3 months post-intervention)
measure: Change From Baseline on the NIH Toolbox Loneliness Scale
timeFrame: baseline, after weeks 1, 2, and 3 of the intervention, 4 weeks (post intervention), 16 weeks (3 months post-intervention)
measure: Conway COVID Questionnaire Subscale Scores
timeFrame: baseline
measure: Conway COVID Questionnaire Subscale Scores
timeFrame: 4 weeks (post intervention)
measure: Conway COVID Questionnaire Subscale Scores
timeFrame: 16 weeks (3 months post-intervention)
measure: Self-Compassion Scale Short Form Score
timeFrame: baseline, 4 weeks (post intervention), 16 weeks (3 months post-intervention)
measure: Change From Baseline on the Perseverative Thought Questionnaire
timeFrame: baseline, 4 weeks (post intervention), 16 weeks (3 months post-intervention)
measure: Change From Baseline on the World Health Organization 5-item (WHO-5) Well-being Scale
timeFrame: baseline, 4 weeks (post intervention), 16 weeks (3 months post-intervention)
measure: Change From Baseline on the Neutral Face Rating Task: Prosocial Construal
timeFrame: baseline, 4 weeks (post intervention), 16 weeks (3 months post-intervention)
measure: Change From Baseline on the Neutral Face Rating Task: Race Bias
timeFrame: baseline, 4 weeks (post intervention), 16 weeks (3 months post-intervention)
measure: Change From Baseline on the Growth Mindset Scale for Well-Being
timeFrame: baseline, 4 weeks (post intervention)
Other outcomes:
measure: Slope Across Time on Practice Quality and Mood Items
timeFrame: Every other day when participant completes a practice (up to 4 weeks)
measure: Digital Working Alliance
timeFrame: After weeks 1, 2, and 3 during the intervention, 4 weeks (post intervention), 16 weeks (3 months post-intervention) - Intervention group only
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
References:
citation: Goldberg SB, Baldwin SA, Riordan KM, Torous J, Dahl CJ, Davidson RJ, Hirshberg MJ. Alliance With an Unguided Smartphone App: Validation of the Digital Working Alliance Inventory. Assessment. 2022 Sep;29(6):1331-1345. doi: 10.1177/10731911211015310. Epub 2021 May 18.
citation: Hirshberg MJ, Davidson RJ, Goldberg SB. Educators Are Not Alright: Mental Health During COVID-19. Educ Res. 2023 Jan;52(1):48-52. doi: 10.3102/0013189X221142595.
citation: Webb CA, Hirshberg MJ, Davidson RJ, Goldberg SB. Personalized Prediction of Response to Smartphone-Delivered Meditation Training: Randomized Controlled Trial. J Med Internet Res. 2022 Nov 8;24(11):e41566. doi: 10.2196/41566.