10th Mountain Healthy Minds Program App Study

October 28, 2024 updated by: University of Wisconsin, Madison
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
System Usability Scale Score
Time Frame: post-test (up to 4 weeks)
Scored from 1 to 5 where higher scores indicate increased usability.
post-test (up to 4 weeks)
Acceptability of Intervention Measure (AIM)
Time Frame: post-test (up to 4 weeks)
Scored from 1 to 5 where higher scores indicate increased acceptability.
post-test (up to 4 weeks)
Intervention Appropriateness Measure (IAM)
Time Frame: post-test (up to 4 weeks)
Scored from 1 to 5 where higher scores indicate increased appropriateness.
post-test (up to 4 weeks)
Feasibility of Intervention Measure (FIM)
Time Frame: post-test (up to 4 weeks)
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)
Time Frame: post-test (up to 4 weeks)
post-test (up to 4 weeks)
HMP App Usage: Did you download the Healthy Minds Program App (Yes or No)
Time Frame: post-test (up to 4 weeks)
post-test (up to 4 weeks)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Perceived Stress Score
Time Frame: baseline and post-test (up to 4 weeks)
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
Time Frame: baseline and post-test (up to 4 weeks)
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
Time Frame: baseline and post-test (up to 4 weeks)
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
Time Frame: baseline and post-test (up to 4 weeks)
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
Time Frame: baseline and post-test (up to 4 weeks)
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
Time Frame: baseline and post-test (up to 4 weeks)
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
Time Frame: baseline and post-test (up to 4 weeks)
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
Time Frame: post-test (up to 4 weeks)
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
HMP App Usage: Reasons for not downloading the HMP App
Time Frame: post-test (up to 4 weeks)
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
Time Frame: post-test (up to 4 weeks)
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Wisconsin, Madison

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Simon Goldberg, PhD, University of Wisconsin, Madison

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 22, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 22, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 21, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 7, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 8, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 29, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 28, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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