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COVID-19 and the Healthy Minds Program for Educators (CAHMP-ED)

Primary Purpose

Anxiety, Depression, Psychological Stress

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Healthy Minds Program Foundations Training
Sponsored by
University of Wisconsin, Madison
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Wisconsin

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Healthy Minds Program Foundations Training

Wait-list control

Arm Description

Healthy Minds Program (HMP) Description: The HMP app was developed by Healthy Minds Innovations at the UW Center for Healthy Minds, and is based on the work of Richard Davidson, PhD. HMP is designed to promote and protect psychological well-being through sustainable skills training. The program is grounded in constituents of psychological well-being identified in empirical literature. HMP provides core content, with instruction administered through a curriculum of high-quality guided practices. HMP is based on research on eudaimonic well-being (e.g., environmental mastery, purpose) and brain-based skills that underlie these qualities (e.g., regulation of attention, mental flexibility). HMP has >100 guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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).
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).

Full Information

First Posted
June 9, 2020
Last Updated
March 28, 2023
Sponsor
University of Wisconsin, Madison
Collaborators
Chan Zuckerberg Initiative, Healthy Minds Innovations, Center for Healthy Minds
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1. Study Identification

Unique Protocol Identification Number
NCT04426318
Brief Title
COVID-19 and the Healthy Minds Program for Educators
Acronym
CAHMP-ED
Official Title
COVID-19 and the Healthy Minds Program for Educators
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
June 14, 2020 (Actual)
Primary Completion Date
January 12, 2021 (Actual)
Study Completion Date
January 12, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
Collaborators
Chan Zuckerberg Initiative, Healthy Minds Innovations, Center for Healthy Minds

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Depression, Psychological Stress, Psychological Distress, Well-being

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Random parallel assignment
Masking
Investigator
Masking Description
There is no outcome assessor - all assessments will be conducted online by participants. Investigators will be blind to group assignment during data analysis. Analysis of hypotheses related to baseline characteristics, adherence and dosage cannot be blinded.
Allocation
Randomized
Enrollment
698 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Healthy Minds Program Foundations Training
Arm Type
Experimental
Arm Description
Healthy Minds Program (HMP) Description: The HMP app was developed by Healthy Minds Innovations at the UW Center for Healthy Minds, and is based on the work of Richard Davidson, PhD. HMP is designed to promote and protect psychological well-being through sustainable skills training. The program is grounded in constituents of psychological well-being identified in empirical literature. HMP provides core content, with instruction administered through a curriculum of high-quality guided practices. HMP is based on research on eudaimonic well-being (e.g., environmental mastery, purpose) and brain-based skills that underlie these qualities (e.g., regulation of attention, mental flexibility). HMP has >100 guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose.
Arm Title
Wait-list control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Healthy Minds Program Foundations Training
Other Intervention Name(s)
meditation, mindfulness
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
baseline, after weeks 1, 2, and 3 of the intervention, 4 weeks (post intervention), 16 weeks (3 months post-intervention)
Secondary Outcome Measure Information:
Title
Change From Baseline on the Five Facet Mindfulness Questionnaire Act With Awareness Subscale
Description
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.
Time Frame
baseline, after weeks 1, 2, and 3 of the intervention, 4 weeks (post intervention), 16 weeks (3 months post-intervention)
Title
Change From Baseline on the Drexel Defusion Scale (DDS)
Description
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.
Time Frame
baseline, after weeks 1, 2, and 3 of the intervention, 4 weeks (post intervention), 16 weeks (3 months post-intervention)
Title
Change From Baseline on the Meaning in Life Questionnaire
Description
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.
Time Frame
baseline, after weeks 1, 2, and 3 of the intervention, 4 weeks (post intervention), 16 weeks (3 months post-intervention)
Title
Change From Baseline on the NIH Toolbox Loneliness Scale
Description
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.
Time Frame
baseline, after weeks 1, 2, and 3 of the intervention, 4 weeks (post intervention), 16 weeks (3 months post-intervention)
Title
Conway COVID Questionnaire Subscale Scores
Description
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.
Time Frame
baseline
Title
Conway COVID Questionnaire Subscale Scores
Description
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.
Time Frame
4 weeks (post intervention)
Title
Conway COVID Questionnaire Subscale Scores
Description
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.
Time Frame
16 weeks (3 months post-intervention)
Title
Self-Compassion Scale Short Form Score
Description
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.
Time Frame
baseline, 4 weeks (post intervention), 16 weeks (3 months post-intervention)
Title
Change From Baseline on the Perseverative Thought Questionnaire
Description
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.
Time Frame
baseline, 4 weeks (post intervention), 16 weeks (3 months post-intervention)
Title
Change From Baseline on the World Health Organization 5-item (WHO-5) Well-being Scale
Description
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.
Time Frame
baseline, 4 weeks (post intervention), 16 weeks (3 months post-intervention)
Title
Change From Baseline on the Neutral Face Rating Task
Description
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).
Time Frame
baseline, 4 weeks (post intervention), 16 weeks (3 months post-intervention)
Title
Change From Baseline on the Growth Mindset Scale for Well-Being
Description
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).
Time Frame
baseline, 4 weeks (post intervention)
Other Pre-specified Outcome Measures:
Title
Slope Across Time on Practice Quality and Mood Items
Description
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).
Time Frame
Every other day when participant completes a practice (up to 4 weeks)
Title
Digital Working Alliance
Description
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.
Time Frame
After weeks 1, 2, and 3 during the intervention, 4 weeks (post intervention), 16 weeks (3 months post-intervention) - Intervention group only

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
University of Wisconsin
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data will be de-identified and listed in public data registries (i.e., osf) based on the publication of preregistered study hypotheses on a manuscript by manuscript basis.
IPD Sharing Time Frame
Data will be de-identified and made publicly available based on the publication of preregistered study hypotheses following peer review.
IPD Sharing Access Criteria
Researcher consent. Any reasonable request will be granted.
Citations:
PubMed Identifier
34000843
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.
Results Reference
result
PubMed Identifier
37379444
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.
Results Reference
result
PubMed Identifier
36346668
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.
Results Reference
derived

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COVID-19 and the Healthy Minds Program for Educators

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