ClinicalTrials.gg
CompletedNCT06300554Updated Oct 29, 2024

10th Mountain Healthy Minds Program App Study

An interventional study of Healthy Minds Program App in Well-Being, Psychological, sponsored by University of Wisconsin, Madison. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-29.

Sponsored by University of Wisconsin, Madison · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of the study is to evaluate the acceptability, feasibility, and preliminary effects of the Healthy Minds Program (HMP) App in approximately 150 active duty military members.

Read the detailed description

Participants will be informed about the study during regularly scheduled activities. They will be informed that enrolling in the study is voluntary.

Participants will complete a 10-15 minute battery of questionnaires at baseline and post-test. In between these assessments, they will be asked to download and use the Healthy Minds Program app for 4 weeks. Post-test assessment will occur following the 4-week intervention period.

02

Conditions studied

  • Well-Being, Psychological
03

In context

Psychological Well-Being

1,049 studies on the registry are indexed under Psychological Well-Being; 509 are open to participants now.

This study's enrollment of 30 is below the median of 113 across 888 interventional studies indexed under Psychological Well-Being.

Browse Psychological Well-Being studies →

Lead sponsor

University of Wisconsin, Madison is the lead sponsor of 1,182 studies on the registry; 180 are open to participants now.

Of its 156 completed or terminated interventional studies of FDA-regulated products, 118 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Active duty military at the 10th Mountain Division

Exclusion criteria

Exclusion Criteria:

  • N/A
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    Participants from the 10th Mountain Division

    Device: Healthy Minds Program App

Interventions

  • DeviceHealthy Minds Program App

    freely available well-being app

06

What researchers measure

Primary outcomes

  1. System Usability Scale Score

    Scored from 1 to 5 where higher scores indicate increased usability.

    Time frame: post-test (up to 4 weeks)

  2. Acceptability of Intervention Measure (AIM)

    Scored from 1 to 5 where higher scores indicate increased acceptability.

    Time frame: post-test (up to 4 weeks)

  3. Intervention Appropriateness Measure (IAM)

    Scored from 1 to 5 where higher scores indicate increased appropriateness.

    Time frame: post-test (up to 4 weeks)

  4. Feasibility of Intervention Measure (FIM)

    Scored from 1 to 5 where higher scores indicate increased feasibility.

    Time frame: post-test (up to 4 weeks)

  5. HMP App Usage: Did you use the Healthy Minds Program App (Yes or No)

    Time frame: post-test (up to 4 weeks)

  6. HMP App Usage: Did you download the Healthy Minds Program App (Yes or No)

    Time frame: post-test (up to 4 weeks)

Secondary outcomes

  1. Change in Perceived Stress Score

    A measure of perceived stress in the past week scored from 0 to 4 where higher numbers indicate higher stress.

    Time frame: baseline and post-test (up to 4 weeks)

  2. Change in WHO-5 Well-Being Score

    A measure of well-being in the past week scored from 1 to 6 where higher numbers indicate greater well-being.

    Time frame: baseline and post-test (up to 4 weeks)

  3. Change in PROMIS Depression Score

    A measure of feelings of depression scored from 1 to 5 where higher numbers indicate increased feelings of depression.

    Time frame: baseline and post-test (up to 4 weeks)

  4. Change in PROMIS Anxiety Score

    A measure of feelings of anxiety scored from 1 to 5 where higher numbers indicate increased feelings of anxiety.

    Time frame: baseline and post-test (up to 4 weeks)

  5. Change in Meaning of Life Questionnaire - Presence Subscale Score

    Scored from 1 to 7 where higher scores indicate greater sense of meaning and purpose.

    Time frame: baseline and post-test (up to 4 weeks)

  6. Change in NIH Toolbox Loneliness Score

    A measure of loneliness scored from 1 to 5 where higher scores indicate increased loneliness.

    Time frame: baseline and post-test (up to 4 weeks)

  7. Change in Suicide Cognitions Scale Score

    A 16-item survey scored from 0-4 for a total range of scores from 0-64. Higher scores indicate increased suicidal cognition.

    Time frame: baseline and post-test (up to 4 weeks)

  8. HMP App Usage: How many times did you use the HMP App

    Tally of participant usage from 1 time, less than once per week, about once per week, more than once per week, about daily.

    Time frame: post-test (up to 4 weeks)

Other outcomes

  1. HMP App Usage: Reasons for not downloading the HMP App

    Tally of participant reasons, including not interested, not relevant, worried about data security, did not have time, or other.

    Time frame: post-test (up to 4 weeks)

  2. HMP App Usage: Reasons for not opening the HMP App

    Tally of participant reasons, including not interested, not relevant, worried about data security, did not have time, or other.

    Time frame: post-test (up to 4 weeks)

07

Study locations

1 site
  • University of Wisconsin
    Madison, Wisconsin 53705, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 29, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06300554
Responsible party
Sponsor
First posted
Mar 8, 2024
Start date
Aug 1, 2024
Primary completion
Oct 22, 2024
Completion
Oct 22, 2024
Last update
Oct 29, 2024

Study contacts

Simon Goldberg, PhD
principal investigator · University of Wisconsin, Madison

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.

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