Human and Digital Support Study

Not Applicable

Completed

• Conditions: Anxiety; Depression

• Registration Number: NCT06244043
• Lead Sponsor: University of Wisconsin, Madison

Brief Summary

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.

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 Timeline

• Study First Submitted: 2024-01-29
• Study First Submitted QC: 2024-01-29
• Study First Posted: 2024-02-06
• Study Start: 2024-03-07
• Primary Completion: 2024-06-02
• Study Completion: 2024-06-02
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-15
• Last Update Posted: 2024-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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