Measuring Mindfulness Application

• ClinicalTrials.gov Identifier: NCT04589195
• Recruitment Status: Completed
• First Posted: October 19, 2020
• Last Update Posted: January 14, 2022
• Sponsor: University of Miami
• Information provided by (Responsible Party): Amishi Jha, University of Miami

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Cognitive Change	Behavioral: Mindfulness Training	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 44 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Measurement of an Application - Based Delivery of Mindfulness Training Program Content
• Actual Study Start Date: October 11, 2021
• Actual Primary Completion Date: November 29, 2021
• Actual Study Completion Date: December 26, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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 Outcome Measures:

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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 64 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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.

Contacts and Locations

Locations

United States, Florida

University of Miami

Coral Gables, Florida, United States, 33146

Sponsors and Collaborators

University of Miami

Investigators

• Principal Investigator: Amishi Jha, PhD; University of Miami

More Information

• Responsible Party: Amishi Jha, Professor, University of Miami
• ClinicalTrials.gov Identifier: NCT04589195
• Other Study ID Numbers: 20201140
• First Posted: October 19, 2020
• Last Update Posted: January 14, 2022
• Last Verified: January 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Amishi Jha, University of Miami:

Mindfulness Training; Cognitive Training; Psychological Health