The COMParing App Support Strategies Study

NCT07278466 | Recruiting

• 4 other identifiers: 2025-1444Protocol Version 9/26/2025EDUC/COUNSELING PSYCH1R01MH139512-01
• Study Type: interventional
• Target: 688
• Locations: 1 country
• Sites: 1

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. The meditation app used is the Healthy Minds Program (HMP) which provides training in four pillars of well-being (Awareness, Connection, Insight, Purpose) through a combination of podcast-style didactic material and guided meditation practices.

Conditions

Depression, Anxiety

Keywords

HMP app; healthy minds program; Microsupport; meditation

Outcome Measures

Primary Outcomes (1)

• Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS) Score

  The PHQ-ADS is scored by summing responses to its 16 items (combining the PHQ-9 and GAD-7), with scores ranging from 0 to 48, where higher scores indicate greater distress. Each item uses a 0-3 scale (0=Not at all, 3=Nearly every day). Common interpretation is 10 (mild), 20 (moderate), and 30 (severe) distress.

  baseline, week 1, week 2, week 3, week 4, 6-month follow up

Secondary Outcomes (31)

• Patient-Reported Outcomes Measurement Information System (PROMIS) Depression

  baseline, week 1, week 2, week 3, week 4, 6-month follow up

• PROMIS Toolbox Meaning and Purpose Score

  baseline, week 1, week 2, week 3, week 4, 6-month follow up

• NIH Toolbox Loneliness Score

  baseline, week 1, week 2, week 3, week 4, 6-month follow up

• Beck's Depression Inventory (BDI) Item 9 Score

  baseline, week 1, week 2, week 3, week 4, 6-month follow up

• Five Facet Mindfulness Questionnaire (Awareness subscale) Score

  baseline, week 1, week 2, week 3, week 4, 6-month follow up

Study Arms (8)

Coaching

EXPERIMENTAL

Other: Introductory Coaching Session

Coaching with On-Demand email support

EXPERIMENTAL

Other: Introductory Coaching Session; Other: On-Demand Email Support

Coaching and microsupport

EXPERIMENTAL

Other: Introductory Coaching Session; Other: Microsupport

Coaching with On-Demand email support and microsupport

EXPERIMENTAL

Other: Introductory Coaching Session; Other: On-Demand Email Support; Other: Microsupport

No additional support

NO INTERVENTION

On-Demand email support

EXPERIMENTAL

Other: Introductory Information Session; Other: On-Demand Email Support

Microsupport

EXPERIMENTAL

Other: Introductory Information Session; Other: Microsupport

On-Demand email support and microsupport

EXPERIMENTAL

Other: Introductory Information Session; Other: On-Demand Email Support; Other: Microsupport

Interventions

Introductory Coaching Session OTHER

Participant is randomized to receive a 30-minute meditation coaching session

Coaching; Coaching and microsupport; Coaching with On-Demand email support; Coaching with On-Demand email support and microsupport

Introductory Information Session OTHER

Participant is randomized to receive a 30-minute information session

Microsupport; On-Demand email support; On-Demand email support and microsupport

On-Demand Email Support OTHER

email support throughout the 4 week intervention period

Also known as: email

Coaching with On-Demand email support; Coaching with On-Demand email support and microsupport; On-Demand email support; On-Demand email support and microsupport

Microsupport OTHER

Text message microsupport throughout the 4 week intervention period

Also known as: text message

Coaching and microsupport; Coaching with On-Demand email support and microsupport; Microsupport; On-Demand email support and microsupport

Eligibility Criteria

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

You may qualify if:

• Elevated symptoms of depression and/or anxiety (PHQ-9 greater than or equal to 10, GAD-7 greater than or equal to 10)
• Proficiency in English
• Access to a smartphone and internet
• Ability to receive text messages

You may not qualify if:

• Non-US citizen or legal resident (green card holder)
• History of psychosis or mania
• Suicidal ideation or thoughts of self-harm indicated by PHQ9 item 9 and BDI item 9
• Individuals who do not provide the information required for GUID generation
• Previous participation

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Center for Healthy Minds

Madison, Wisconsin, 53703, United States

RECRUITING

Related Links

• Center for Healthy Minds

MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Simon Goldberg, PhD

  UW Madison

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wendy Lau, PhD

CONTACT

608-890-2747; wendy.lau@wisc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2025
• First Posted: December 12, 2025
• Study Start: March 13, 2026
• Primary Completion (Estimated): January 31, 2029
• Study Completion (Estimated): January 31, 2029
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

US (1)