COVID-19 and the Healthy Minds Program for Educators

Depression Clinical Trial

— CAHMP-ED  

Official title:

COVID-19 and the Healthy Minds Program for Educators

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04426318
• Other study ID #: 2020-0533
• Secondary ID: A171600EDUC/COUN
• Status: Completed
• Phase: N/A
• Start date: June 14, 2020
• Est. completion date: January 12, 2021

Study information

• Verified date: March 2023
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 698
• Est. completion date: January 12, 2021
• Est. primary completion date: January 12, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Depression
• Psychological Distress
• Psychological Stress
• Stress, Psychological
• Well-being

Intervention

Behavioral:
• Healthy Minds Program Foundations Training
The 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. The program is unique in several ways. First, all program elements are introduced with a summary of the scientific evidence supporting its constituent elements (e.g., Awareness and well-being). Second, 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.

Locations

Country	Name	City	State
United States	University of Wisconsin	Madison	Wisconsin

Sponsors (4)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	Center for Healthy Minds, Chan Zuckerberg Initiative, Healthy Minds Innovations

Country where clinical trial is conducted

United States, 

References & Publications (2)

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 2 — View Citation

Hirshberg MJ, Davidson RJ, and Goldberg SB. Educators Are Not Alright: Mental Health During COVID-19. Educational Researcher 52, no. 1 (January 2023): 48-52. https://doi.org/10.3102/0013189X221142595.

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Slope Across Time on Practice Quality and Mood Items	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).	Every other day when participant completes a practice (up to 4 weeks)
Other	Digital Working Alliance	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.	After weeks 1, 2, and 3 during the intervention, 4 weeks (post intervention), 16 weeks (3 months post-intervention) - Intervention group only
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	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, after weeks 1, 2, and 3 of the intervention, 4 weeks (post intervention), 16 weeks (3 months post-intervention)
Secondary	Change From Baseline on the Five Facet Mindfulness Questionnaire Act With Awareness Subscale	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, after weeks 1, 2, and 3 of the intervention, 4 weeks (post intervention), 16 weeks (3 months post-intervention)
Secondary	Change From Baseline on the Drexel Defusion Scale (DDS)	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, after weeks 1, 2, and 3 of the intervention, 4 weeks (post intervention), 16 weeks (3 months post-intervention)
Secondary	Change From Baseline on the Meaning in Life Questionnaire	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, after weeks 1, 2, and 3 of the intervention, 4 weeks (post intervention), 16 weeks (3 months post-intervention)
Secondary	Change From Baseline on the NIH Toolbox Loneliness Scale	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.	baseline, after weeks 1, 2, and 3 of the intervention, 4 weeks (post intervention), 16 weeks (3 months post-intervention)
Secondary	Conway COVID Questionnaire Subscale Scores	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.	baseline
Secondary	Conway COVID Questionnaire Subscale Scores	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.	4 weeks (post intervention)
Secondary	Conway COVID Questionnaire Subscale Scores	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.	16 weeks (3 months post-intervention)
Secondary	Self-Compassion Scale Short Form Score	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, 4 weeks (post intervention), 16 weeks (3 months post-intervention)
Secondary	Change From Baseline on the Perseverative Thought Questionnaire	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, 4 weeks (post intervention), 16 weeks (3 months post-intervention)
Secondary	Change From Baseline on the World Health Organization 5-item (WHO-5) Well-being Scale	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, 4 weeks (post intervention), 16 weeks (3 months post-intervention)
Secondary	Change From Baseline on the Neutral Face Rating Task	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 both prosocial construal and bias range from 1 to 7, with higher scores representing greater prosocial construal and bias favoring white faces (negative scores on the bias measure indicate bias for liking black faces more than white faces).	baseline, 4 weeks (post intervention), 16 weeks (3 months post-intervention)
Secondary	Change From Baseline on the Growth Mindset Scale for Well-Being	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).	baseline, 4 weeks (post intervention)