Measuring Mindfulness Application

Cognitive Change Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04589195
• Other study ID #: 20201140
• Status: Completed
• Phase: N/A
• Start date: October 11, 2021
• Est. completion date: December 26, 2021

Study information

• Verified date: January 2022
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: December 26, 2021
• Est. primary completion date: November 29, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Change

Intervention

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.

Locations

Country	Name	City	State
United States	University of Miami	Coral Gables	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Primary	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
Primary	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
Primary	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	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
Secondary	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