Cognitive ChangeNCT04703296
Mindfulness Training in Special Operations Forces (SOF) Candidates
A study testing MBAT course in people with Cognitive Change, run by University of Miami at 1 site in United States.
Trial summary
The overarching goal of this study is to develop, deliver, and investigate the utility and feasibility of train-the-trainer delivery of mindfulness training (MT) in support of improved readiness (across cognitive, affective, and social domains of the human dimension) and improve retention of candidates in the SOF… 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 course
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 245 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Mar 2022to 9 Jan 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.
- Men and women of all races and ethnicities.
- Individuals who are willing and able to consent to participate in the study.
- Individuals who are attending Special Warfare Center and School (SWCS).
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 overarching goal of this study is to develop, deliver, and investigate the utility and feasibility of train-the-trainer delivery of mindfulness training (MT) in support of improved readiness (across cognitive, affective, and social domains of the human dimension) and improve retention of candidates in the SOF qualification pipeline at the U.S. Army John F. Kennedy Special Warfare Center and School (referred to as SWCS).
- Conditions
- Cognitive Change
- Being tested
- MBAT course
- Keywords
- Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MBAT courseBehavioural
The MBAT will involve:
(i) 4 weekly 1.5-hour course sessions. The sessions will provide guided exercises, didactic information, and discussions to promote greater mindfulness.
(ii) Daily mindfulness practice that will be facilitated by the Measuring Mindfulness App (MMA) and/or instructor-delivered mindfulness practices. The daily mindfulness practice will require about 15 minutes to complete.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness training (MT) group | Experimental | Receives 4 weeks of mindfulness training followed by a testing session. Receives: Behavioral: MBAT course |
| No-training control (NTC) group | No intervention | Receives 4 weeks of no mindfulness training followed by a testing session. |
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). SART has a range of scores from 0 to 1 with a higher score indicating better accuracy of completing the task.
Measured: Baseline (week 1) to week 6 (after 4-week training interval)
Change in Working Memory Performance
Working Memory Performance as measured by the Working Memory Task with Affective Distracters (WMDA). WMDA has a range of scores from 0 to 100%, with higher scores indicating better accuracy on the task.
Measured: Baseline (week 1) to week 6 (after 4-week training interval)
Change in Cognitive Failures
Cognitive Failures will be measured by the Cognitive Failures Questionnaire (CFQ). CFQ has total score ranging from 0 to 100, with a higher score indicating more cognitive failures.
Measured: Baseline (week 1) to week 6 (after 4-week training interval)
Secondary outcomes (6)
Change in Positive Affect
Positive Affect will be measured by the Positive and Negative Affect Schedule (PANAS-10). The PANAS Positive has a range of scores from 5 to 25, with higher score indicating higher positive mood.
Measured: Baseline (week 1) to week 6 (after 4-week training interval)
Change in Negative Affect
Negative Affect will be measured by the Positive and Negative Affect Schedule (PANAS-10). The PANAS Negative has a range of scores from 5 to 25, with higher score indicating higher negative mood.
Measured: Baseline (week 1) to week 6 (after 4-week training interval)
Change in Perceived Stress
The short version of the Perceived Stress Scale (PSS) will be used assess perceived stress. The 4-item PSS has a range of scores from 0 to 16, with higher score indicating higher level of perceived stress.
Measured: Baseline (week 1) to week 6 (after 4-week training interval)
Change in Psychological Health
Patient Health Questionnaire (PHQ-4) will be used to assess depression and anxiety. PHQ-4 has a range of scores from 0 to 12, with higher scores indicating higher level of depression and anxiety.
Measured: Baseline (week 1) to week 6 (after 4-week training interval)
Change in Decentering
EQ Decentering is an 11-item sub-scale 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 high level of decentering.
Measured: Baseline (week 1) to week 6 (after 4-week training interval)
Change in Mind Wandering
Four Factor Mind Wandering (4FMW) Questionnaire is a 16-item scale that asks participants to indicate how often they experience a situation described in the form of a statement on a 5-point Likert-type scale from never (1) to always (5). 4FMW has a range of scores from 16 to 80, with higher scores indicating greater mind wandering.
Measured: Baseline (week 1) to week 6 (after 4-week training interval)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2021
- Study start16 Mar 2022
- Primary completion7 Dec 2022
- Study completion9 Jan 2023
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.
- More trials run by University of MiamiThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 245 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
- NCT04703296
- Sponsor's protocol ID
- 20201488
- Other IDs
- W81XWH20C0065
- Status last verified
- Jan 2023
- First submitted
- 7 Jan 2021
- Last updated
- 12 Jan 2023
- 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 12 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness Training in Special Operations Forces (SOF) Candidates
- ClinicalTrials.gov ID
- NCT04703296
- Acronym / sponsor ID
- 20201488
- Conditions
- Cognitive Change
- Keywords
- Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 245 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- 16 Mar 2022 (actual)
- Primary completion
- 7 Dec 2022 (actual)
- Study completion
- 9 Jan 2023 (actual)
- First posted
- 11 Jan 2021 (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 this study is to develop, deliver, and investigate the utility and feasibility of train-the-trainer delivery of mindfulness training (MT) in support of improved readiness (across cognitive, affective, and social domains of the human dimension) and improve retention of candidates in the SOF qualification pipeline at the U.S. Army John F. Kennedy Special Warfare Center and School (referred to as SWCS).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness training (MT) group | Experimental | Behavioral: MBAT courseReceives 4 weeks of mindfulness training followed by a testing session. |
| No-training control (NTC) group | No intervention | –Receives 4 weeks of no mindfulness training followed by a testing session. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 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.
- Individuals who are willing and able to consent to participate in the study.
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 courseThe MBAT will involve: (i) 4 weekly 1.5-hour course sessions. The sessions will provide guided exercises, didactic information, and discussions to promote greater mindfulness. (ii) Daily mindfulness practice that will be facilitated by the Measuring Mindfulness App (MMA) and/or instructor-delivered mindfulness practices. The daily mindfulness practice will require about 15 minutes to complete. | Behavioural | Mindfulness training (MT) group |
Primary outcome
Change in Attentional Performance
Time frame: Baseline (week 1) to week 6 (after 4-week training interval)
Attentional Performance as measured by the Sustained Attention Response Task (SART). SART has a range of scores from 0 to 1 with a higher score indicating better accuracy of completing the task.
Change in Working Memory Performance
Time frame: Baseline (week 1) to week 6 (after 4-week training interval)
Working Memory Performance as measured by the Working Memory Task with Affective Distracters (WMDA). WMDA has a range of scores from 0 to 100%, with higher scores indicating better accuracy on the task.
Change in Cognitive Failures
Time frame: Baseline (week 1) to week 6 (after 4-week training interval)
Cognitive Failures will be measured by the Cognitive Failures Questionnaire (CFQ). CFQ has total score ranging from 0 to 100, with a higher score indicating more cognitive failures.
6 secondary outcomes
Change in Positive Affect
Time frame: Baseline (week 1) to week 6 (after 4-week training interval)
Change in Negative Affect
Time frame: Baseline (week 1) to week 6 (after 4-week training interval)
Change in Perceived Stress
Time frame: Baseline (week 1) to week 6 (after 4-week training interval)
Change in Psychological Health
Time frame: Baseline (week 1) to week 6 (after 4-week training interval)
Change in Decentering
Time frame: Baseline (week 1) to week 6 (after 4-week training interval)
Change in Mind Wandering
Time frame: Baseline (week 1) to week 6 (after 4-week training interval)
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 12 Jan 2023.
- 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 MBAT 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 6 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 12 Jan 2023. 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 (week 1) to week 6 (after 4-week training interval)). The study lists 3 primary outcomes in all. 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 12 Jan 2023.