10th Mountain Healthy Minds Program App Study

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.

Study Overview

• Status: Completed
• Conditions: Well-Being, Psychological
• Intervention / Treatment: Device: Healthy Minds Program App

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53705
      • University of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Active duty military at the 10th Mountain Division

Exclusion Criteria:

• N/A

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Participants from the 10th Mountain Division	Device: Healthy Minds Program App; freely available well-being app

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	baseline and post-test (up to 4 weeks)
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.	baseline and post-test (up to 4 weeks)
Change in PROMIS Depression Score	A measure of feelings of depression scored from 1 to 5 where higher numbers indicate increased feelings of depression.	baseline and post-test (up to 4 weeks)
Change in PROMIS Anxiety Score	A measure of feelings of anxiety scored from 1 to 5 where higher numbers indicate increased feelings of anxiety.	baseline and post-test (up to 4 weeks)
Change in Meaning of Life Questionnaire - Presence Subscale Score	Scored from 1 to 7 where higher scores indicate greater sense of meaning and purpose.	baseline and post-test (up to 4 weeks)
Change in NIH Toolbox Loneliness Score	A measure of loneliness scored from 1 to 5 where higher scores indicate increased loneliness.	baseline and post-test (up to 4 weeks)
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.	baseline and post-test (up to 4 weeks)
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.	post-test (up to 4 weeks)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	post-test (up to 4 weeks)
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.	post-test (up to 4 weeks)

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Investigators: Principal Investigator: Simon Goldberg, PhD, University of Wisconsin, Madison

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2024
• Primary Completion (Actual): October 22, 2024
• Study Completion (Actual): October 22, 2024

Study Registration Dates

• First Submitted: February 21, 2024
• First Submitted That Met QC Criteria: March 7, 2024
• First Posted (Actual): March 8, 2024

Study Record Updates

• Last Update Posted (Actual): October 29, 2024
• Last Update Submitted That Met QC Criteria: October 28, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 2023-1653; A171600 (Other Identifier: UW Madison); Version 1/26/2024 (Other Identifier: UW Madison)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No