- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04210076
Mindfulness Training for Small Teams
August 29, 2022 updated by: Amishi Jha, University of Miami
The purpose of this study is to look at how mindfulness training may influence how the participant thinks, feels, and acts.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
356
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
-
Coral Gables, Florida, United States, 33146
- University of Miami
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Mindfulness-Based Attention Training for Teams (MBAT-T)
Teams randomized to this group will receive 4, 2-2.5-hour sessions delivered over 4 weeks of mindfulness training and 15 minutes of daily, out-of-class mindfulness exercises, that will be delivered and tracked using a measuring mindfulness application.
|
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).
|
Active Comparator: Mindfulness-Based Attention Training for Individuals (MBAT-I)
Individuals randomized to this group will receive 4, 2-2.5-hour sessions delivered over 4 weeks of mindfulness training and 15 minutes of daily, out-of-class mindfulness exercises, that will be delivered and tracked using a measuring mindfulness application.
|
The MBAT-Individual program is based on the basic 4-week, 8-hour MBAT-Soldier curriculum.
|
No Intervention: No-training
Teams will not engage in any mindfulness training
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Attentional Performance
Time Frame: Baseline (testing session 1) to week 5 (testing session 2)
|
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)
|
Change in Working Memory Performance
Time Frame: Baseline (testing session 1) to week 5 (testing session 2)
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Cohesion
Time Frame: Baseline (testing session 1) to week 5 (testing session 2)
|
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)
|
Change in Team Situation Monitoring
Time Frame: Baseline (testing session 1) to week 5 (testing session 2)
|
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)
|
Change in Workgroup Emotional Intelligence
Time Frame: Baseline (testing session 1) to week 5 (testing session 2)
|
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)
|
Change in Team Mindfulness
Time Frame: Baseline (testing session 1) to week 5 (testing session 2)
|
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)
|
Change in Mindfulness
Time Frame: Baseline (testing session 1) to week 5 (testing session 2)
|
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)
|
Change in Decentering
Time Frame: Baseline (testing session 1) to week 5 (testing session 2)
|
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)
|
Change in Psychological Health
Time Frame: Baseline (testing session 1) to week 5 (testing session 2)
|
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)
|
Change in Positive Affect
Time Frame: Baseline (testing session 1) to week 5 (testing session 2)
|
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)
|
Change in Negative Affect
Time Frame: Baseline (testing session 1) to week 5 (testing session 2)
|
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)
|
Change in Perceived Stress
Time Frame: Baseline (testing session 1) to week 5 (testing session 2)
|
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)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Accuracy on Cognitive and Marksmanship Drills
Time Frame: Baseline (testing session 1) to week 5 (testing session 2)
|
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)
|
Change in Reaction Time on Cognitive and Marksmanship Drills
Time Frame: Baseline (testing session 1) to week 5 (testing session 2)
|
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)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Amishi P Jha, PhD, University of Miami
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 10, 2021
Primary Completion (Actual)
April 7, 2022
Study Completion (Actual)
April 12, 2022
Study Registration Dates
First Submitted
December 20, 2019
First Submitted That Met QC Criteria
December 20, 2019
First Posted (Actual)
December 24, 2019
Study Record Updates
Last Update Posted (Actual)
September 1, 2022
Last Update Submitted That Met QC Criteria
August 29, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- 20191047
- W81XWH1920064 (Other Grant/Funding Number: Department of Defense)
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cognitive Change
-
University Ramon LlullAinhoa Nieto Guisado; Mònica Solana-TramuntUnknownCognitive Change | Proprioception Change | Balance ChangeSpain
-
Applied Science & Performance InstituteRecruitingCognitive Change | Mood Change | Mental ProcessesUnited States
-
National Council of Scientific and Technical Research...CompletedSleep | Cognitive Change | Mood Change | CreativityArgentina
-
Wake Forest UniversityNot yet recruiting
-
Biruni UniversityCompletedCognitive ChangeTurkey
-
University of MemphisCalerie LLCCompletedCognitive ChangeUnited States
-
Oregon Health and Science UniversityCompleted
-
University of MiamiUnited States Department of DefenseCompleted
-
Northumbria UniversityPerfetti van Melle SPACompletedCognitive ChangeUnited Kingdom
-
Universidad de GranadaCompleted
Clinical Trials on MBAT-T
-
University of MiamiCompletedDepression | Anxiety | Cognitive Change | Post Traumatic Stress Disorder | Psychological StressUnited States
-
University of PennsylvaniaAdvanced Medical ElectronicsCompleted
-
University of MiamiUnited States Department of Defense; Fort DrumCompletedStress | ResilienceUnited States
-
University of MiamiUnited States Department of DefenseCompleted
-
University of MiamiUnited States Department of DefenseEnrolling by invitation
-
Walter Reed Army Institute of Research (WRAIR)U.S. Army Medical Research and Development Command; U.S. Army Training and...CompletedPain | Stress | Health, Subjective | Sleep | Anxiety | Depressive Symptoms | Mood | Leadership | Emotion Regulation | Yoga | Mindfulness | Musculoskeletal Injury | Military Operations | Cohesion, SocialUnited States
-
Biotronik SE & Co. KGCompletedHeart Failure | BradycardiaDenmark, Hong Kong, Austria, Germany, Belgium
-
University of California, BerkeleyUniversity of Nevada, Reno; World Bank; L'Office National de Nutrition, MadagascarRecruitingEarly Childhood DevelopmentMadagascar
-
Biotronik SE & Co. KGCompletedVentricular Fibrillation | Ventricular TachycardiaGermany, Czech Republic
-
University of South FloridaNational Cancer Institute (NCI)RecruitingCancer | Obesity, Childhood | SurvivorshipUnited States