Human and Digital Support Study

The overall purpose of this study is to help determine how best to incorporate small amounts of human and digital support into a meditation app. 32 participants will be enrolled and can expect to be on study for up to 4 weeks.

Study Overview

• Status: Completed
• Conditions: Depression; Anxiety
• Intervention / Treatment: Other: Initial Coaching Call; Other: Email Support; Other: Text Messages

Detailed Description

The overall purpose of this study is to help determine the feasibility and acceptability of incorporating small amounts of human and digital support into a meditation app. Ultimately, the investigators hope this work will help to develop digital tools that can reduce symptoms of depression and/or anxiety. The meditation app of interest is the Healthy Minds Program (HMP). The HMP app provides training in four pillars of well-being (Awareness, Connection, Insight, Purpose) through a combination of podcast-style didactic material and guided meditation practices.

Participants will be randomly assigned to receive or not receive an initial coaching call with a team member. Participants will also be randomly assigned to receive or not receive access to email-based support. All participants with receive text messages encouraging them to engage in the practices taught in the app.

Participants will complete a set of questionnaires at baseline and post-test (following the 4-week intervention period). Questionnaires and items will be selected from the set of questionnaires included in this application. The average length of time to complete questionnaires will be within 15 to 30 minutes. Participants will also receive short daily surveys.

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53705
      • Recruiting
      • University of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adults (age ≥18) who have recently downloaded the HMP app

• Elevated symptoms of depression and/or anxiety

  • Patient Health Questionnaire - 9 (PHQ-9) ≥ 5
  • General Anxiety Disorder - 7 (GAD-7) ≥ 5

Exclusion Criteria:

• Current suicidal or self-harm ideation (PHQ-9 item 9 > 0)
• Current or past psychotic disorder
• Current of past bipolar disorder

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Initial Interventional Coaching Call Plus Email Support	Other: Initial Coaching Call; Participant will receive initial coaching call with a team member. This coaching call will either be interventional (i.e., include content intended to prompt their adherence and benefit from the HMP app) or informational (i.e., include content intended to control for the time and attention of attending a coaching session, but not intended to provide specific benefits).; Other: Email Support; Email-based support throughout study period; Other: Text Messages; All participants with receive text messages encouraging them to engage in the practices taught in the app.
Active Comparator: Initial Interventional Coaching Call No Email Support	Other: Initial Coaching Call; Participant will receive initial coaching call with a team member. This coaching call will either be interventional (i.e., include content intended to prompt their adherence and benefit from the HMP app) or informational (i.e., include content intended to control for the time and attention of attending a coaching session, but not intended to provide specific benefits).; Other: Text Messages; All participants with receive text messages encouraging them to engage in the practices taught in the app.
Active Comparator: Initial Informational Coaching Call Plus Email Support	Other: Email Support; Email-based support throughout study period; Other: Text Messages; All participants with receive text messages encouraging them to engage in the practices taught in the app.
Active Comparator: Initial Informational Coaching Call No Email Support	Other: Text Messages; All participants with receive text messages encouraging them to engage in the practices taught in the app.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Study completion rate	Percentage of participants completing pre- and post-test measures	Baseline to 4 weeks (post-intervention)
Daily diary completion rate	Percentage of daily assessments completed	Baseline to 4 weeks (post-intervention)
Acceptability of Intervention Score	12-item survey scored from 1 - 5 where higher scores indicate more acceptability.	4 weeks (post-intervention)
Modified System Usability Scale Score	10-item survey scored from 1-5 where higher scores indicate more usability.	4 weeks (post-intervention)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Attitudes Towards Psychological Online Interventions Score	16-item survey scored from 1 - 5 where higher scores indicate more positive attitude in each of 4 domains: skepticism, confidence, threat, anonymity.	4 weeks (post-intervention)
Determinants of Meditation Practice Inventory Score	12-item survey scored from 1 - 5 where lower scores indicate lower perceived barriers to meditation practice in each of 4 domains; benefit, knowledge, pragmatic, cultural.	baseline (pre-intervention)
Patient Health Questionnaire - 9 (PHQ-9) Score	9-item survey scored from 0-27 where higher scores indicate increased depression.	baseline (pre-intervention), 4 weeks (post-intervention)
PROMIS Meaning and Purpose Score	Computer adaptive survey scored from 1-5 where higher scores indicate higher sense of meaning and purpose.	baseline (pre-intervention), 4 weeks (post-intervention)
Digital Working Alliance Inventory (D-WAI) Score	6-item survey scored from 1-7 where higher scores indicate increased trust in the app in each of three domains: goals, tasks, bond.	4 weeks (post-intervention)
Five Facet Mindfulness Questionnaire (FFMQ): Awareness Score	8-item survey scored from 1-5 where higher scores indicate lower levels of awareness.	baseline (pre-intervention), 4 weeks (post-intervention)
General Anxiety Disorder -7 (GAD-7) Score	7-item survey scored from 0-21 where higher scores indicate increased anxiety.	screening, 4 weeks (post-intervention)
Mindfulness Adherence Questionnaire: Minutes of meditation per week	Minutes of meditation practice completed per week	4 weeks (post-intervention)
Mindfulness Adherence Questionnaire Score	10-item survey scored from 0-6 where higher scores indicate higher quality meditation practice in two domains: formal practice, informal practice.	4 weeks (post-intervention)
Healthy Minds Index Score	17-item survey scored from 0-4 where higher scores indicate healthier attitude in each of 4 domains: awareness, connection, insight, purpose.	baseline (pre-intervention), 4 weeks (post-intervention)
NIH Toolbox: Loneliness Score	5-item survey scored from 1-5 where higher scores indicate increased loneliness.	baseline (pre-intervention), 4 weeks (post-intervention)
Growth Mindset Scale for Well-Being Score	3-item survey scored from 1-6 where higher score lower growth mindset.	baseline (pre-intervention), 4 weeks (post-intervention)
Experiences Questionnaire Decentering Score	11-item survey scored from 1-5 where higher scores indicate higher levels of decentering.	baseline (pre-intervention), 4 weeks (post-intervention)
Daily Diary Assessment Question Scores	9-items administered in the morning scored from 1 (not at all) to 5 (very much) for domain: mindfulness, decentering, connection, purpose, depression, anxiety, stress, rumination, motivation. 11-items administered in the evening scored from 1 (not at all) to 5 (very much) for domain: mindfulness, decentering, connection, purpose, depression, anxiety, happy event, stressor exposure item, rumination, informal practice item, formal practice item.	daily from baseline to post-test (week 4)

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Collaborators: Thrive Foundation
• Investigators: Principal Investigator: Simon Goldberg, PhD, University of Wisconsin, Madison

Study record dates

Study Major Dates

• Study Start (Actual): March 7, 2024
• Primary Completion (Actual): June 2, 2024
• Study Completion (Actual): June 2, 2024

Study Registration Dates

• First Submitted: January 29, 2024
• First Submitted That Met QC Criteria: January 29, 2024
• First Posted (Actual): February 6, 2024

Study Record Updates

• Last Update Posted (Actual): August 19, 2024
• Last Update Submitted That Met QC Criteria: August 15, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: meditation; app; HMP; Healthy Minds Program
• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: 2023-1379; A171600 (Other Identifier: UW Madison); EDUC/COUNSELING PSYCH (Other Identifier: UW Madison)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No