NCT06300554

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 21, 2024

Completed
16 days until next milestone

First Posted

Study publicly available on registry

March 8, 2024

Completed
5 months until next milestone

Study Start

First participant enrolled

August 1, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 22, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 22, 2024

Completed
Last Updated

October 29, 2024

Status Verified

October 1, 2024

Enrollment Period

3 months

First QC Date

February 21, 2024

Last Update Submit

October 28, 2024

Conditions

Outcome Measures

Primary Outcomes (6)

  • System Usability Scale Score

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

    post-test (up to 4 weeks)

  • Acceptability of Intervention Measure (AIM)

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

    post-test (up to 4 weeks)

  • Intervention Appropriateness Measure (IAM)

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

    post-test (up to 4 weeks)

  • Feasibility of Intervention Measure (FIM)

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

    post-test (up to 4 weeks)

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

    post-test (up to 4 weeks)

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

    post-test (up to 4 weeks)

Secondary Outcomes (8)

  • Change in Perceived Stress Score

    baseline and post-test (up to 4 weeks)

  • Change in WHO-5 Well-Being Score

    baseline and post-test (up to 4 weeks)

  • Change in PROMIS Depression Score

    baseline and post-test (up to 4 weeks)

  • Change in PROMIS Anxiety Score

    baseline and post-test (up to 4 weeks)

  • Change in Meaning of Life Questionnaire - Presence Subscale Score

    baseline and post-test (up to 4 weeks)

  • +3 more secondary outcomes

Other Outcomes (2)

  • HMP App Usage: Reasons for not downloading the HMP App

    post-test (up to 4 weeks)

  • HMP App Usage: Reasons for not opening the HMP App

    post-test (up to 4 weeks)

Study Arms (1)

Participants from the 10th Mountain Division

EXPERIMENTAL
Device: Healthy Minds Program App

Interventions

freely available well-being app

Participants from the 10th Mountain Division

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Active duty military at the 10th Mountain Division

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53705, United States

Location

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Study Officials

  • Simon Goldberg, PhD

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 21, 2024

First Posted

March 8, 2024

Study Start

August 1, 2024

Primary Completion

October 22, 2024

Study Completion

October 22, 2024

Last Updated

October 29, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations