COVID-19 and the Healthy Minds Program for Educators

NCT04426318 | Completed Results

• 4 other identifiers: 2020-0533A171600EDUC/COUNSELING PSYCHProtocol Approval 10/15/2020
• Study Type: interventional
• Target: 698
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety; Depression; Psychological Stress; Psychological Distress; Well-being

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• Change From Baseline on the Five Facet Mindfulness Questionnaire Act With Awareness Subscale

  baseline, after weeks 1, 2, and 3 of the intervention, 4 weeks (post intervention), 16 weeks (3 months post-intervention)

• Change From Baseline on the Drexel Defusion Scale (DDS)

  baseline, after weeks 1, 2, and 3 of the intervention, 4 weeks (post intervention), 16 weeks (3 months post-intervention)

• Change From Baseline on the Meaning in Life Questionnaire

  baseline, after weeks 1, 2, and 3 of the intervention, 4 weeks (post intervention), 16 weeks (3 months post-intervention)

• Change From Baseline on the NIH Toolbox Loneliness Scale

  baseline, after weeks 1, 2, and 3 of the intervention, 4 weeks (post intervention), 16 weeks (3 months post-intervention)

• Conway COVID Questionnaire Subscale Scores

  baseline

Other Outcomes (2)

• Slope Across Time on Practice Quality and Mood Items

  Every other day when participant completes a practice (up to 4 weeks)

• Digital Working Alliance

  After weeks 1, 2, and 3 during the intervention, 4 weeks (post intervention), 16 weeks (3 months post-intervention) - Intervention group only

Study Arms (2)

Healthy Minds Program Foundations Training

EXPERIMENTAL

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.

Behavioral: Healthy Minds Program Foundations Training

Wait-list control

NO INTERVENTION

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.

Interventions

Healthy Minds Program Foundations Training BEHAVIORAL

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.

Also known as: meditation, mindfulness

Healthy Minds Program Foundations Training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• Chan Zuckerberg Initiative: collaborator
• Healthy Minds Innovations: collaborator
• Center for Healthy Minds: collaborator

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53705, United States

Location

Related Publications (5)

• 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.

  PMID: 34000843 RESULT

• 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.

  PMID: 37379444 RESULT

• Goldberg SB, Bolt DM, Dahl CJ, Davidson RJ, Hirshberg MJ. Does it matter how meditation feels? An experience sampling study. J Consult Clin Psychol. 2024 Aug;92(8):531-541. doi: 10.1037/ccp0000857.

  PMID: 39347788 DERIVED

• Webb CA, Hirshberg MJ, Gonzalez O, Davidson RJ, Goldberg SB. Revealing subgroup-specific mechanisms of change via moderated mediation: A meditation intervention example. J Consult Clin Psychol. 2024 Jan;92(1):44-53. doi: 10.1037/ccp0000842. Epub 2023 Sep 28.

  PMID: 37768631 DERIVED

• 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.

  PMID: 36346668 DERIVED

Related Links

• OSF Registry

MeSH Terms

Conditions

Anxiety Disorders; Depression; Stress, Psychological

Interventions

Meditation; Mindfulness

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Relaxation Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Cognitive Behavioral Therapy

Results Point of Contact

• Title: Matthew Hirshberg
• Organization: Center for Healthy Minds

hirshberg@wisc.edu

608-262-0035

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Random parallel assignment

Study Record Dates

• First Submitted: June 9, 2020
• First Posted: June 11, 2020
• Study Start: June 14, 2020
• Primary Completion: January 12, 2021
• Study Completion: January 12, 2021
• Last Updated: September 19, 2024
• Results First Posted: February 10, 2022

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Data will be de-identified and made publicly available based on the publication of preregistered study hypotheses following peer review.
• Access Criteria: Researcher consent. Any reasonable request will be granted.

Locations

US (1)