Measuring Mindfulness Application

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

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.

Study Overview

• Status: Completed
• Conditions: Cognitive Change
• Intervention / Treatment: Behavioral: Mindfulness Training

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Coral Gables, Florida, United States, 33146
      • University of Miami

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Individuals who are between 18 and 64 years of age.
2. Individuals who are fluent English speakers.
3. 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.
4. Individuals who are willing and able to consent to participate in the study.
5. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Mindfulness Training (MT) Group; Participants will receive four weeks of MT.	Behavioral: Mindfulness Training; 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.
ACTIVE_COMPARATOR: Wait List MT Group; Participants will receive four weeks of MT training after a five week washout period.	Behavioral: Mindfulness Training; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Positive Affect	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.	Baseline to Week 5
Change in Negative Affect	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.	Baseline to Week 5
Change in Perceived Stress	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.	Baseline to Week 5

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Sustained Attention Response Task (SART) scores	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.	Baseline to Week 5
Change in Cognitive Failures	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.	Baseline to Week 5

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Psychological Health	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.	Baseline to Week 5
Change in Mindfulness	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.	Baseline to Week 5
Change in Decentering	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.	Baseline to Week 5

Collaborators and Investigators

• Sponsor: University of Miami
• Investigators: Principal Investigator: Amishi Jha, PhD, University of Miami

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 11, 2021
• Primary Completion (ACTUAL): November 29, 2021
• Study Completion (ACTUAL): December 26, 2021

Study Registration Dates

• First Submitted: October 9, 2020
• First Submitted That Met QC Criteria: October 9, 2020
• First Posted (ACTUAL): October 19, 2020

Study Record Updates

• Last Update Posted (ACTUAL): January 14, 2022
• Last Update Submitted That Met QC Criteria: January 12, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Cognitive Training; Mindfulness Training; Psychological Health
• Other Study ID Numbers: 20201140

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