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Completed

NCT Number: NCT04589195

Measuring Mindfulness Application

The purpose of the research study is to learn more about how ROTC cadets may engage with mindfulness training program content that is delivered through a smartphone or website application. Mindfulness training program content includes mindfulness practices that foster attention and awareness.

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Key information

Conditions

Cognitive Change Behavior Personal Satisfaction Psychological Well-Being

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami

Coral Gables, Florida, 33146, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Individuals who are between 18 and 64 years of age.
  • Individuals who are fluent English speakers.
  • Individuals who have access to either an Apple or Android smart phone and a desktop or laptop computer, are able to adequately and independently use both devices, and have Internet connection.
  • Individuals who are willing and able to consent to participate in the study.
  • Individuals who are in the South Florida ROTC program.

Exclusion criteria

1.Individuals with an active and untreated mental condition (e.g., Bipolar disorder, Major Depression) and/or hospitalization for psychological/mental health issues within the last month.

Treatment and study plan

Mindfulness Training

Behavioral

The intervention includes four weeks of MT application use, accessed via phone or computer, consisting of 15-minute daily mindfulness practices 5 days a week.

Primary outcomes

  1. Change in Positive Affect

    Time frame: Baseline to Week 5

    Positive affect will be measured with the 10-item version of the Positive and Negative Affect Schedule (PANAS-10). The PANAS positive sub-scale has 5 items and a range of scores from 5 to 25, with a higher score indicating a higher positive mood.

  2. Change in Negative Affect

    Time frame: Baseline to Week 5

    Negative affect will be measured with the 10-item version of the Positive and Negative Affect Schedule (PANAS-10). The PANAS negative sub-scale has 5 items and a range of scores from 5 to 25, with a higher score indicating a higher negative mood.

  3. Change in Perceived Stress

    Time frame: Baseline to Week 5

    Perceived Stress will be measured with the Perceived Stress Scale (PSS). PSS has a range of scores from 0 to 40, with a higher score indicates a higher level of perceived stress.

Secondary outcomes

  1. Change in Sustained Attention Response Task (SART) scores

    Time frame: Baseline to Week 5

    The SART involves pressing a button to frequently presented non-target trials and withholding the button press to the infrequent target trials. The participants can have a total score between 0 and 100%, with a higher score indicating butter sustained attention.

  2. Change in Cognitive Failures

    Time frame: Baseline to Week 5

    Cognitive Failures will be measured with the Cognitive Failures Questionnaire (CFQ). CFQ has a range of scores from 0 to 100, with a higher score indicating more cognitive failures.

Other outcomes

  1. Change in Psychological Health

    Time frame: Baseline to Week 5

    Patient Health Questionnaire (PHQ4) will be used to assess depression and anxiety. PHQ has a range of scores from 0 to 12, with a higher score indicating higher level of depression and anxiety.

  2. Change in Mindfulness

    Time frame: Baseline to Week 5

    Mindfulness will be measured with the short 15-item version of the Five-Facet Mindfulness Questionnaire (FFMQ-15). FFMQ-15 has a range of scores from 15 to 75, with a higher score indicating a greater level of mindfulness.

  3. Change in Decentering

    Time frame: Baseline to Week 5

    Decentering will be measured with the decentering scale from the Experience Questionnaire (EQ-D). EQ-D has a range of scores from 11 to 55, with a higher score indicating a greater level of decentering.

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Official study title

Measurement of an Application - Based Delivery of Mindfulness Training Program Content

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Oct 19, 2020
Registry last updated
Jan 14, 2022

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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