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Completed

NCT Number: NCT06300554

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.

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Key information

Conditions

Well-Being, Psychological Behavior Personal Satisfaction Psychological Well-Being

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Wisconsin

Madison, Wisconsin, 53705, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Active duty military at the 10th Mountain Division

Exclusion criteria

  • N/A

Treatment and study plan

Healthy Minds Program App

Device

freely available well-being app

Primary outcomes

  1. System Usability Scale Score

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

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

  2. Acceptability of Intervention Measure (AIM)

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

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

  3. Intervention Appropriateness Measure (IAM)

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

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

  4. Feasibility of Intervention Measure (FIM)

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

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

  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

    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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

Other outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Mar 8, 2024
Registry last updated
Oct 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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