Cognitive ChangeNCT04576832
Mindfulness Training for Senior Leaders
A study testing Mindfulness-Based Attention Training (MBAT) web-course in people with Cognitive Change, run by University of Miami at 1 site in United States.
Trial summary
The overarching goal of the project is to investigate if a mindfulness-based attention training (MBAT) program contextualized for Military Senior Leaders (SLs) might benefit SLs in three key domains: (1) cognitive abilities, (2) psychological well-being and self-reported physical health, and (3) strategic leadership… 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?
- Mindfulness-Based Attention Training (MBAT) web-course
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Nov 2022to 20 Apr 2023
- 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
- Individuals who are willing and able to consent to participate in the study.
- Individuals who participated in the courses provided by the Army War College (AWC).
Who cannot join
- 1. Individuals who have been hospitalized for psychological/mental health issues within the last month
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mindfulness Training for U.S. Army Senior Leaders
The overarching goal of the project is to investigate if a mindfulness-based attention training (MBAT) program contextualized for Military Senior Leaders (SLs) might benefit SLs in three key domains: (1) cognitive abilities, (2) psychological well-being and self-reported physical health, and (3) strategic leadership skills and ability. The MBAT-SL program will be tested by the training cohorts and compared to the wait-list control cohorts who will receive the training after a no-training interval.
- Conditions
- Cognitive Change
- Being tested
- Mindfulness-Based Attention Training (MBAT) web-course
- Keywords
- mindfulness training, psychological health
- 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.
Mindfulness-Based Attention Training (MBAT) web-courseBehavioural
Pre-recorded weekly sessions for 4 weeks. Each session will consist of approximately 2 hours of video content per week and weekly mindfulness exercises. This video will include MBAT program lectures, pre-recorded testimony from military leaders, and teaching materials. The course will also include 15-min daily mindfulness practice drills.
| Study group | Role | What they receive |
|---|---|---|
| Group A (MT group) | Experimental | Participants will receive 4 weeks of mindfulness training during the first training interval between the first (T1) and second (T2) assessment sessions. Receives: Behavioral: Mindfulness-Based Attention Training (MBAT) web-course |
| Group B (Wait-list group) | Active comparator | Participants will not receive 4 weeks of mindfulness training during the first training interval; they will receive 4 weeks of mindfulness training during the second training interval between the second (T2) and third (T3) assessment sessions. Receives: Behavioral: Mindfulness-Based Attention Training (MBAT) web-course |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Sustained attention to response task (SART) score
The SART involves pressing a button to frequently presented non-target trials (numbers 1, 2, 4, 5, 6, 7, 8, and 9) and withholding the button press to the infrequent target trials (number 3). The participants can have a total score between 0 and 100% with a higher score indicating better sustained attention.
Measured: Baseline (T1) to post-4-week training interval (T2).
Secondary outcomes (6)
Change in 5FMQ scores
Five-Facet Mindfulness Questionnaire (5FMQ) is used to assess the five major aspects of mindfulness. The present study will use the 15-item short version. The scores range from 15 to 75, with higher scores indicating greater levels of mindfulness in different aspects of one's life.
Measured: Baseline (T1) to post-4-week training interval (T2).
Change in Decentering score
Decentering consists of 11 items measuring various thoughts and experiences, and the tendency to distance from those. The decentering score ranges from 1 to 55, with a higher score indicating a high level of decentering.
Measured: Baseline (T1) to post-4-week training interval (T2).
Change in PANAS positive affect score
Positive and Negative Affect Scale (PANAS) is a widely used self-reported measure of positive and negative affect. The present study will use a short version with a 5-item positive subscale. The score ranges from 5 to 25 with a higher score indicating a higher positive mood.
Measured: Baseline (T1) to post-4-week training interval (T2).
Change in PANAS negative affect score
Positive and Negative Affect Scale (PANAS) is a widely used self-reported measure of positive and negative affect. The present study will use a short version with a 5-item negative subscale. The score ranges from 5 to 25 with a higher score indicating a higher negative mood.
Measured: Baseline (T1) to post-4-week training interval (T2).
Change in PSS score
Perceived Stress Scale (PSS) is a questionnaire measuring the degree to which situations in one's life are viewed as stressful within the past month. The present study will use the 4-item short version, with the total score ranging from 0 to 16, with a higher score indicating a higher level of perceived stress.
Measured: Baseline (T1) to post-4-week training interval (T2).
Change in PHQ4 scores
Patient Health Questionnaire 4 items (PHQ4) is an ultra-brief 4-item measure of depression and anxiety in the general population with the total score ranging from 0 to 12. Higher score indicates higher level of anxiety and depression.
Measured: Baseline (T1) to post-4-week training interval (T2).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2020
- Study start10 Nov 2022
- Primary completion20 Apr 2023
- Study completion20 Apr 2023
Why it stopped: Due to an enrollment strategy change
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 91 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 Jha, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04576832
- Sponsor's protocol ID
- 20201075
- Other IDs
- W911QY-17-C-0101
- Status last verified
- Jun 2024
- First submitted
- 30 Sep 2020
- Last updated
- 28 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness Training for U.S. Army Senior Leaders
- ClinicalTrials.gov ID
- NCT04576832
- Acronym / sponsor ID
- 20201075
- Conditions
- Cognitive Change
- Keywords
- mindfulness training, psychological health
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to an enrollment strategy change
- Enrolment
- 91 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- 10 Nov 2022 (actual)
- Primary completion
- 20 Apr 2023 (actual)
- Study completion
- 20 Apr 2023 (actual)
- First posted
- 6 Oct 2020 (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 overarching goal of the project is to investigate if a mindfulness-based attention training (MBAT) program contextualized for Military Senior Leaders (SLs) might benefit SLs in three key domains: (1) cognitive abilities, (2) psychological well-being and self-reported physical health, and (3) strategic leadership skills and ability. The MBAT-SL program will be tested by the training cohorts and compared to the wait-list control cohorts who will receive the training after a no-training interval.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (MT group) | Experimental | Behavioral: Mindfulness-Based Attention Training (MBAT) web-courseParticipants will receive 4 weeks of mindfulness training during the first training interval between the first (T1) and second (T2) assessment sessions. |
| Group B (Wait-list group) | Active comparator | Behavioral: Mindfulness-Based Attention Training (MBAT) web-courseParticipants will not receive 4 weeks of mindfulness training during the first training interval; they will receive 4 weeks of mindfulness training during the second training interval between the second (T2) and third (T3) assessment sessions. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Individuals who are between 18 and 65 years of age.
- Individuals who are fluent English speakers.
- Individuals who are active-duty service members
- Individuals who are willing and able to consent to participate in the study.
- Individuals who participated in the courses provided by the Army War College (AWC).
Key exclusion criteria (1 listed)
- 1. Individuals who have been hospitalized for psychological/mental health issues within the last month
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 |
|---|---|---|
| Mindfulness-Based Attention Training (MBAT) web-coursePre-recorded weekly sessions for 4 weeks. Each session will consist of approximately 2 hours of video content per week and weekly mindfulness exercises. This video will include MBAT program lectures, pre-recorded testimony from military leaders, and teaching materials. The course will also include 15-min daily mindfulness practice drills. | Behavioural | Group A (MT group), Group B (Wait-list group) |
Primary outcome
Change in Sustained attention to response task (SART) score
Time frame: Baseline (T1) to post-4-week training interval (T2).
The SART involves pressing a button to frequently presented non-target trials (numbers 1, 2, 4, 5, 6, 7, 8, and 9) and withholding the button press to the infrequent target trials (number 3). The participants can have a total score between 0 and 100% with a higher score indicating better sustained attention.
6 secondary outcomes
Change in 5FMQ scores
Time frame: Baseline (T1) to post-4-week training interval (T2).
Change in Decentering score
Time frame: Baseline (T1) to post-4-week training interval (T2).
Change in PANAS positive affect score
Time frame: Baseline (T1) to post-4-week training interval (T2).
Change in PANAS negative affect score
Time frame: Baseline (T1) to post-4-week training interval (T2).
Change in PSS score
Time frame: Baseline (T1) to post-4-week training interval (T2).
Change in PHQ4 scores
Time frame: Baseline (T1) to post-4-week training interval (T2).
Results and safety
The study was stopped early (reason given: Due to an enrollment strategy change). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2024.
- 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 Jha 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 Mindfulness-Based Attention Training (MBAT) web-course 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 5 inclusion and 1 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: stopped early, as of the sponsor's last update on 28 Jun 2024. 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 was stopped early (reason given: Due to an enrollment strategy change). Results are not available in the source record.
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 Sustained attention to response task (SART) score (time frame: Baseline (T1) to post-4-week training interval (T2).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jun 2024.