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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04210076
Other study ID # 20191047
Secondary ID W81XWH1920064
Status Completed
Phase N/A
First received
Last updated
Start date May 10, 2021
Est. completion date April 12, 2022

Study information

Verified date August 2022
Source University of Miami
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to look at how mindfulness training may influence how the participant thinks, feels, and acts.


Recruitment information / eligibility

Status Completed
Enrollment 356
Est. completion date April 12, 2022
Est. primary completion date April 7, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Individuals who are between 18 and 65 years of age - Individuals who are fluent English speakers - Individuals who are active-duty service members - Men and women of all races and ethnicities Exclusion Criteria: - Individuals who have a medical or neurological condition that might interfere with performance on the task in the study (e.g., epilepsy) - Individuals with a history of hospitalization for psychological/mental health issues within the last 6 months.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
MBAT-T
The MBAT-Team program builds on the basic 4-week, 8-hour MBAT-Soldier program. In addition to the basic program, MBAT-Team includes exercises promoting the cultivation of attention and emotion regulation in the service of effective team interactions (e.g., mindful communication and listening; monitoring and attention to the activities and emotional states of others, and additional practices to promote collective mindfulness).
MBAT-I
The MBAT-Individual program is based on the basic 4-week, 8-hour MBAT-Soldier curriculum.

Locations

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

Sponsors (2)

Lead Sponsor Collaborator
University of Miami United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Change in Accuracy on Cognitive and Marksmanship Drills Marksmanship will be measured with drills involving synthetic rifles to interact with stimuli in an augmented reality environment. Accuracy in the drills will be scored from 0% to 100%, with a higher score indicating better performance. Baseline (testing session 1) to week 5 (testing session 2)
Other Change in Reaction Time on Cognitive and Marksmanship Drills Marksmanship will be measured with drills involving synthetic rifles to interact with stimuli in an augmented reality environment. Reaction time will be measured in milliseconds, with lower values indicating faster responses. Baseline (testing session 1) to week 5 (testing session 2)
Primary Change in Attentional Performance Attentional Performance as measured by the Sustained Attention Response Task (SART).This task uses a continuous performance paradigm involving button presses to frequently presented non-targets (numbers 1, 2, 4, 5, 6, 7, 8, and 9) but requires the participants to withhold their motor response to the infrequent target (number 3). Withholding responses only to infrequent targets encourages a pre-potent response and mind wandering. Real-time subjective experience of mind wandering during SART is assessed through experience-sampling probes randomly presented throughout the task. Baseline (testing session 1) to week 5 (testing session 2)
Primary Change in Working Memory Performance Working Memory Performance as measured by the Working memory task with Affective Distracters. In this task, participants are presented with a memory array that they are to encode and hold in memory during a delay interval. During the delay, emotionally negative or neutral scene images are presented. Baseline (testing session 1) to week 5 (testing session 2)
Secondary Change in Cohesion Cohesion as measured by 3 items adapted from a questionnaire developed by Podsakoff and MacKenzie. Scale items are rated on a scale from 1 to 5 (1 = strongly disagree, 5 = strongly agree), according to how much participants agree with each item. Baseline (testing session 1) to week 5 (testing session 2)
Secondary Change in Team Situation Monitoring Team Situation Monitoring is measured by 7-item subscale of the Teamwork Perception Questionnaire, which assesses individuals' shared perceptions of group-level team skills and behavior. The scale consists of a list of items that are rated on a scale from 1 to 5 (1 = strongly disagree, 5 = strongly agree), according to how much participants agree with each item. Baseline (testing session 1) to week 5 (testing session 2)
Secondary Change in Workgroup Emotional Intelligence Workgroup Emotional Intelligence as measured by the Workgroup Emotional Intelligence Profile, which is a 16-item measure of emotional intelligence abilities that manifest as behaviors in work teams. The scale consists of a list of items that are rated on a scale from 1 to 7 (1 = strongly disagree, 7 = strongly agree), according to how much participants agree with each item. This measure reflects an individual's judgment of their ability to monitor and manage their own emotions and the emotions of the members of their squad. Baseline (testing session 1) to week 5 (testing session 2)
Secondary Change in Team Mindfulness Team Mindfulness as measured by the Team Mindfulness Scale, which is a 10-item scale measuring the individual's experience of their team interactions as mindful. The total score ranges from 1 to 5, with a higher score indicating an individual's perception of the team's attitudes and experiences as marked by greater mindfulness. Baseline (testing session 1) to week 5 (testing session 2)
Secondary Change in Mindfulness Mindfulness as measured by the short version of the Five-Facet Mindfulness Questionnaire, which is a 15-item scale. The total score ranges from 15 to 75, with a higher score indicating greater levels of mindfulness in different aspects of one's life. Baseline (testing session 1) to week 5 (testing session 2)
Secondary Change in Decentering Decentering as measured by the decentering sub-scale of the Experience Questionnaire, which is an 11-item scale measuring various thoughts and experiences, and the tendency to distance from those. The total score ranges from 1 to 55, with a higher score indicating higher levels of decentering. Baseline (testing session 1) to week 5 (testing session 2)
Secondary Change in Psychological Health Psychological health as measured by the Patient Health Questionnaire, which is a 4-item scale measuring depression and anxiety. The total score ranges from 0 to 12, with higher scores indicating a higher level of depression and anxiety. Baseline (testing session 1) to week 5 (testing session 2)
Secondary Change in Positive Affect Positive affect as measured by the short version of the Positive and Negative Affect Schedule (PANAS-10), a 5-item scale measuring the frequency of experiences of positive affect. The total score ranges from 5 to 25, with a higher score indicating a higher positive mood. Baseline (testing session 1) to week 5 (testing session 2)
Secondary Change in Negative Affect Negative affect as measured by the short version of the Positive and Negative Affect Schedule (PANAS-10), a 5-item scale measuring the frequency of experiences of negative affect. The total score ranges from 5 to 25, with a higher score indicating a higher negative mood. Baseline (testing session 1) to week 5 (testing session 2)
Secondary Change in Perceived Stress Perceived Stress as measured by the short version of the Perceived Stress Scale, which is a 4-item scale measuring the degree to which situations in one's life are viewed as stressful. The total score ranges from 0 to 16, with a higher score indicating higher levels of perceived stress. Baseline (testing session 1) to week 5 (testing session 2)
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