Ignite Creation Date:
2025-12-24 @ 4:26 PM
Ignite Modification Date:
2025-12-24 @ 4:26 PM
Study NCT ID:
NCT07278466
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-12
First Post:
2025-12-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The COMParing App Support Strategies Study
Sponsor:
University of Wisconsin, Madison
Organization:
Study Overview
Official Title:
The COMParing App Support Strategies Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Detailed Description:
Participants will be randomly assigned to various support conditions that vary across three binary factors,
1. Introductory coaching session vs introductory information session
2. On-demand email support (Yes/No)
3. Microsupport messages (Yes/No)
Participants will be screened for eligibility using a web-based screener that assesses inclusion and exclusion criteria. Eligible participants will receive a study overview and will have the option to go through an online consent process. After giving consent, participant will receive a text message to assess their ability to receive text messages and tab on a link embedded in the text message. Those who failed to go through this process will be screened out.
Participants consented will complete a baseline survey consisting of a series of questionnaires and daily check-in assessment sent to their phone. Only those who successfully complete the baseline survey and the first daily check-in survey will advance in the study. Participants will schedule a meeting with our study staff member after completing the baseline survey and first daily check-in survey. They will be assessed through questionnaires at baseline, weekly during the 4-week intervention period, and at 6-month follow-up. They will also complete daily check-in survey twice a day throughout the intervention.
1. Introductory coaching session vs introductory information session
2. On-demand email support (Yes/No)
3. Microsupport messages (Yes/No)
Participants will be screened for eligibility using a web-based screener that assesses inclusion and exclusion criteria. Eligible participants will receive a study overview and will have the option to go through an online consent process. After giving consent, participant will receive a text message to assess their ability to receive text messages and tab on a link embedded in the text message. Those who failed to go through this process will be screened out.
Participants consented will complete a baseline survey consisting of a series of questionnaires and daily check-in assessment sent to their phone. Only those who successfully complete the baseline survey and the first daily check-in survey will advance in the study. Participants will schedule a meeting with our study staff member after completing the baseline survey and first daily check-in survey. They will be assessed through questionnaires at baseline, weekly during the 4-week intervention period, and at 6-month follow-up. They will also complete daily check-in survey twice a day throughout the intervention.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| Protocol Version 9/26/2025 | OTHER | UW Madison | View | |
| EDUC/COUNSELING PSYCH | OTHER | UW Madison | View | |
| 1R01MH139512-01 | NIH | None | https://reporter.nih.gov/quic… | View |