Trials Today

The Advancing Dynamic And Personalized Training Study

Purpose

This study aims to enhance the Healthy Minds Program (HMP) app by developing and testing a personalized, data-driven approach to optimize long-term well-being. 1100 participants will be enrolled and on study for up to 4 months (4 week intervention plus 3 month follow-up).

Condition

Well-Being, Psychological

Eligibility

Eligible Ages: Over 18 Years
Eligible Sex: All
Accepts Healthy Volunteers: Yes

Inclusion Criteria

Elevated symptoms of depression (PHQ-9 greater than or equal to 5) - proficiency in English - access to a smartphone and internet - ability to receive text messages

Exclusion Criteria

Prior experience with meditation - Prior use of the Healthy Minds Program app - History of psychosis or mania - Plans to travel in the next six weeks - Suicidal ideation or thoughts of self-harm indicated by PHQ-9 item 9 and BDI item 9 - Failure to select the correct code word mentioned in the welcome video - Not a US citizen - Non-permanent resident

Study Design

Phase: N/A
Study Type: Interventional
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description: Participants are randomized to six different binary conditions. The investigators plan to collapse the groups for analysis, for example, combining participants with or without the introduction videos, regardless of their other assigned conditions.
Primary Purpose: Other
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
Experimental Introduction Video to HMP app	All participants are randomized to this condition (Yes or No)	Other: Healthy Minds Program (HMP) app All participants will complete baseline surveys, weekly questionnaires (for 4 weeks) through the HMP app intervention, and will be surveyed again at 3-months post-intervention. Participants are randomized to each of the following binary conditions. 1. Introduction video for the app (yes / no) 2. Introduction video for the training modules (yes / no) 3. Module order based on ACIP score (highest-first / lowest-first) 4. Practice-nudging text messages (yes / no) 5. Microsupport messages during the intervention period (yes / no) 6. Microsupport messages during the follow-up period (yes / no Other names: HMP app
Experimental Introduction Video to Training Modules	All participants are randomized to this condition (Yes or No)	Other: Healthy Minds Program (HMP) app All participants will complete baseline surveys, weekly questionnaires (for 4 weeks) through the HMP app intervention, and will be surveyed again at 3-months post-intervention. Participants are randomized to each of the following binary conditions. 1. Introduction video for the app (yes / no) 2. Introduction video for the training modules (yes / no) 3. Module order based on ACIP score (highest-first / lowest-first) 4. Practice-nudging text messages (yes / no) 5. Microsupport messages during the intervention period (yes / no) 6. Microsupport messages during the follow-up period (yes / no Other names: HMP app
Experimental Module Order based on ACIP Score	All participants are randomized to this condition (Highest score first or Lowest score first)	Other: Healthy Minds Program (HMP) app All participants will complete baseline surveys, weekly questionnaires (for 4 weeks) through the HMP app intervention, and will be surveyed again at 3-months post-intervention. Participants are randomized to each of the following binary conditions. 1. Introduction video for the app (yes / no) 2. Introduction video for the training modules (yes / no) 3. Module order based on ACIP score (highest-first / lowest-first) 4. Practice-nudging text messages (yes / no) 5. Microsupport messages during the intervention period (yes / no) 6. Microsupport messages during the follow-up period (yes / no Other names: HMP app
Experimental Practice-Nudging Test Messages	All participants are randomized to this condition (Yes or No)	Other: Healthy Minds Program (HMP) app All participants will complete baseline surveys, weekly questionnaires (for 4 weeks) through the HMP app intervention, and will be surveyed again at 3-months post-intervention. Participants are randomized to each of the following binary conditions. 1. Introduction video for the app (yes / no) 2. Introduction video for the training modules (yes / no) 3. Module order based on ACIP score (highest-first / lowest-first) 4. Practice-nudging text messages (yes / no) 5. Microsupport messages during the intervention period (yes / no) 6. Microsupport messages during the follow-up period (yes / no Other names: HMP app
Experimental Microsupport Messages During Intervention	All participants are randomized to this condition (Yes or No)	Other: Healthy Minds Program (HMP) app All participants will complete baseline surveys, weekly questionnaires (for 4 weeks) through the HMP app intervention, and will be surveyed again at 3-months post-intervention. Participants are randomized to each of the following binary conditions. 1. Introduction video for the app (yes / no) 2. Introduction video for the training modules (yes / no) 3. Module order based on ACIP score (highest-first / lowest-first) 4. Practice-nudging text messages (yes / no) 5. Microsupport messages during the intervention period (yes / no) 6. Microsupport messages during the follow-up period (yes / no Other names: HMP app
Experimental Microsupport Messages During Follow-Up	All participants are randomized to this condition (Yes or No)	Other: Healthy Minds Program (HMP) app All participants will complete baseline surveys, weekly questionnaires (for 4 weeks) through the HMP app intervention, and will be surveyed again at 3-months post-intervention. Participants are randomized to each of the following binary conditions. 1. Introduction video for the app (yes / no) 2. Introduction video for the training modules (yes / no) 3. Module order based on ACIP score (highest-first / lowest-first) 4. Practice-nudging text messages (yes / no) 5. Microsupport messages during the intervention period (yes / no) 6. Microsupport messages during the follow-up period (yes / no Other names: HMP app

Recruiting Locations

Center for Healthy Minds
Madison 5261457, Wisconsin 5279468 53703

Contact:
Wendy Lau
608-890-3073
wendy.lau@wisc.edu

More Details

NCT ID: NCT07051330
Status: Recruiting
Sponsor: University of Wisconsin, Madison

Study Contact

Simon Goldberg, PhD
(608) 265-8986
sbgoldberg@wisc.edu

Detailed Description

Participants will be randomly assigned to various training conditions that vary across six factors. Each of the six factors is binary ("yes" vs. "no"), and for each factor there is a 50 percent probability of assignment to either level. 1. Introduction video for the app (yes / no) 2. Introduction video for the training modules (yes / no) 3. Module order based on ACIP score (highest-first / lowest-first) 4. Practice-nudging text messages (yes / no) 5. Microsupport messages during the intervention period (yes / no) 6. Microsupport messages during the follow-up period (yes / no) Participants will take surveys at baseline, weekly through the 4-week intervention, and 3-month follow-up.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.