Cognitive ChangeNCT04210076
Mindfulness Training for Small Teams
A study testing MBAT-T and MBAT-I in people with Cognitive Change, run by University of Miami at 1 site in United States.
Trial summary
The purpose of this study is to look at how mindfulness training may influence how the participant thinks, feels, and acts. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Change
- What is being tested?
- MBAT-T and MBAT-I
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 356 participants
- Where
- 1 siteUnited States
- Study dates
- 10 May 2021to 12 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to look at how mindfulness training may influence how the participant thinks, feels, and acts.
- Conditions
- Cognitive Change
- Being tested
- MBAT-T, MBAT-I
- Keywords
- attentional performance, psychological well-being, operational performance
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MBAT-TBehavioural
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-IBehavioural
The MBAT-Individual program is based on the basic 4-week, 8-hour MBAT-Soldier curriculum.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness-Based Attention Training for Teams (MBAT-T) | Experimental | 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. Receives: Behavioral: MBAT-T |
| Mindfulness-Based Attention Training for Individuals (MBAT-I) | Active comparator | 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. Receives: Behavioral: MBAT-I |
| No-training | No intervention | Teams will not engage in any mindfulness training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (testing session 1) to week 5 (testing session 2)
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.
Measured: Baseline (testing session 1) to week 5 (testing session 2)
Secondary outcomes (10)
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.
Measured: Baseline (testing session 1) to week 5 (testing session 2)
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.
Measured: Baseline (testing session 1) to week 5 (testing session 2)
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.
Measured: Baseline (testing session 1) to week 5 (testing session 2)
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.
Measured: Baseline (testing session 1) to week 5 (testing session 2)
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.
Measured: Baseline (testing session 1) to week 5 (testing session 2)
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.
Measured: Baseline (testing session 1) to week 5 (testing session 2)
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.
Measured: Baseline (testing session 1) to week 5 (testing session 2)
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.
Measured: Baseline (testing session 1) to week 5 (testing session 2)
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.
Measured: Baseline (testing session 1) to week 5 (testing session 2)
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.
Measured: Baseline (testing session 1) to week 5 (testing session 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2019
- Study start10 May 2021
- Primary completion7 Apr 2022
- Study completion12 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cognitive ChangeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 356 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Principal investigator, Amishi Jha, University of Miami
- Investigators
- Amishi P Jha, PhD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04210076
- Sponsor's protocol ID
- 20191047
- Other IDs
- W81XWH1920064
- Status last verified
- Aug 2022
- First submitted
- 20 Dec 2019
- Last updated
- 1 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zanesco AP, Denkova E, Barry J, Jha AP. Mind wandering is associated with worsening attentional vigilance. J Exp Psychol Hum Percept Perform. 2024 Nov;50(11):1049-1066. doi: 10.1037/xhp0001233. Epub 2024 Aug 22.
PubMed 39172363
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness Training for Small Teams
- ClinicalTrials.gov ID
- NCT04210076
- Acronym / sponsor ID
- 20191047
- Conditions
- Cognitive Change
- Keywords
- attentional performance, psychological well-being, operational performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 356 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- 10 May 2021 (actual)
- Primary completion
- 7 Apr 2022 (actual)
- Study completion
- 12 Apr 2022 (actual)
- First posted
- 24 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to look at how mindfulness training may influence how the participant thinks, feels, and acts.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-Based Attention Training for Teams (MBAT-T) | Experimental | Behavioral: MBAT-TTeams 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. |
| Mindfulness-Based Attention Training for Individuals (MBAT-I) | Active comparator | Behavioral: MBAT-IIndividuals 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. |
| No-training | No intervention | –Teams will not engage in any mindfulness training |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MBAT-TThe 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). | Behavioural | Mindfulness-Based Attention Training for Teams (MBAT-T) |
| MBAT-IThe MBAT-Individual program is based on the basic 4-week, 8-hour MBAT-Soldier curriculum. | Behavioural | Mindfulness-Based Attention Training for Individuals (MBAT-I) |
Primary outcome
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.
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.
10 secondary outcomes
Change in Cohesion
Time frame: 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)
Change in Workgroup Emotional Intelligence
Time frame: 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)
Change in Mindfulness
Time frame: 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)
Change in Psychological Health
Time frame: 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)
Change in Negative Affect
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2022.
- Derived from this study: PubMed 39172363Zanesco AP, Denkova E, Barry J, Jha AP. Mind wandering is associated with worsening attentional vigilance. J Exp Psychol Hum Percept Perform. 2024 Nov;50(11):1049-1066. doi: 10.1037/xhp0001233. Epub 2024 Aug 22.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amishi P Jha, PhD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MBAT-T and MBAT-I in people with Cognitive Change, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Attentional Performance (time frame: Baseline (testing session 1) to week 5 (testing session 2)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04210076, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2022.