ResilienceTTTNCT03250156
Investigating Train the Trainer Delivery of Mindfulness-based Training
A study testing MBAT with proctored practice and MBAT with non-proctored practice in people with Resilience and Stress, run by University of Miami at 2 sites in United States.
Trial summary
This project aims to evaluate the effectiveness of mindfulness training (MT) on cognitive and psychological factors when incorporated to the duty-day schedule of servicemembers (via proctored mindfulness practice). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Resilience, Stress
- What is being tested?
- MBAT with proctored practice and MBAT with non-proctored practice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 2 sitesUnited States
- Study dates
- 25 Jul 2017to 5 Oct 2017
- 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
- English-speaking
- Active duty military
- Able to understand and provide signed informed consent
Who cannot join
- Non-controlled severe medical disease that might interfere with the performance of the study.
- Any other condition the investigator might deem problematic for the inclusion of the volunteer in a trial of this nature will also be considered.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Miami
Coral Gables, Florida, 33146
Ft. Drum
Fort Drum, New York, 13602
About this study
Official title: Investigating Train the Trainer Delivery of Mindfulness-based Training- Ft. Drum Soldiers
This project aims to evaluate the effectiveness of mindfulness training (MT) on cognitive and psychological factors when incorporated to the duty-day schedule of servicemembers (via proctored mindfulness practice). Based on prior literature, it can be hypothesized that the benefits of MT on measures of attention, working memory, and psychological well-being will be greater for servicemembers who engage in proctored mindfulness practice and receive duty-day support compared to servicemembers who practice independently, on their own time, with no structured duty day support.
Read the detailed description
Background: Prior research on mindfulness training (MT) in military servicemembers showed that MT can effectively protect against degradation in attention and working memory over high-demand intervals. The benefits of MT in servicemembers were also linked to greater engagement in mindfulness practice. These prior MT programs delivered their training via a direct delivery approach, which involved a mindfulness training expert (TE) providing training to an end-user (e.g., military servicemembers). While successful, these programs are poorly suited for rapid, large-scale dissemination because these programs require direct training from a mindfulness training expert to an end-user and a considerable amount of time dedicated to training. To overcome these issues, the principal investigator together with a mindfulness expert developed a mindfulness training program contextualized for the U.S. Army, known as MBAT (Mindfulness-Based Attention Training), that is amenable to the train-the-train delivery approach and can provide rapid, large-scale dissemination to thousands of individuals. Specifically, Master Resilience Trainer - Performance Expert specialists (PEs), who have extensive experience working with soldiers but no mindfulness experience, were trained to deliver the MBAT course.
Problem: While training PEs to deliver MBAT complies with the U.S. Army time constraints, it remains unclear what is the best way to incorporate daily mindfulness practice into the duty schedule of servicemembers, which has a pivotal contribution to the protection against decline over high-demand intervals.
Project Goal: The aim of the present study is to investigate the impact of proctored vs. non-proctored practice of MBAT delivered by a PE to servicemembers. To investigate this issue, a trained PE will deliver MBAT to two groups of soldiers who will differ in the amount of duty-day support received to complete out-of-class mindfulness exercises. One group will be assigned proctored practice incorporated in the daily physical training (PT) and another group will be assigned non-proctored practice during which participants will perform the exercise independently, on their own.
- Conditions
- Resilience, Stress
- Being tested
- MBAT with proctored practice, MBAT with non-proctored practice
- Keywords
- Mindfulness, Attention, Working Memory, Psychological Well-Being, Proctored Practice
- 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 with proctored practiceBehavioural
The training program is known as Mindfulness-Based Attention Training, or MBAT. The MBAT program is based on the principles of Mindfulness-Based Stress Reduction, but contextualized for military personnel using themes relevant to military life. The training content is comprised four central themes: concentration, body awareness, open monitoring, and compassion. Participants will have proctored practice and complete the assigned, out-of-class mindfulness exercises during the duty day as party of their physical training.
MBAT with non-proctored practiceBehavioural
The training program is known as Mindfulness-Based Attention Training, or MBAT. The MBAT program is based on the principles of Mindfulness-Based Stress Reduction, but contextualized for military personnel using themes relevant to military life. The training content is comprised four central themes: concentration, body awareness, open monitoring, and compassion.Participants will not have proctored practice and will complete the assigned, out-of-class mindfulness exercises on their own.
| Study group | Role | What they receive |
|---|---|---|
| MBAT with proctored practice | Experimental | Participants will engage in Mindfulness Based Attention Training (MBAT) in 4, 2-hour training classes with 1 class per week. Participants in the proctored practice group will complete assigned, out of class mindfulness exercises during the duty day - for example, as part of their daily physical training (e.g., mindful cooldown, final 15 minutes of PT is spent engaging in a mindfulness exercise using a guided recording). Receives: Behavioral: MBAT with proctored practice |
| MBAT with non-proctored practice | Active comparator | Participants will engage in Mindfulness Based Attention Training (MBAT) in 4, 2-hour training classes with 1 class per week. Participants in the non-proctored practice group will complete assigned, out of class mindfulness exercises on their own time with no structured duty day support. Receives: Behavioral: MBAT with non-proctored practice |
| No Training Control | No intervention | This group will receive no intervention. |
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)
The SART is used to assess attentional performance and self-reported mind wandering (i.e., off-task thinking which is typically self-generated and compromises the performance of the task at hand). The 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 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: Participants will complete the SART at three time points: Pre-intervention baseline (T1), post-intervention up to 2 weeks after the end of the 4-week training (T2), and follow-up up to two months after the end of the training (T3).
Change in Working Memory Task with Affective Distraction (WMDA)
The WMDA is used to assess the ability to hold information in working memory while overcoming emotional reactivity and distraction. Specifically, participants are presented with a memory item that they need to memorize and hold in memory during a delay interval. During the delay, emotionally negative or neutral scene images are presented. The negative images are combat scenes from Iraq or Afghanistan (Morey et al., 2009) and the neutral images are non-combat scenes.
Measured: Participants will complete the WMDA at three time points: Pre-intervention baseline (T1), post-intervention up to 2 weeks after the end of the 4-week training (T2), and follow-up up to two months after the end of the training (T3).
Secondary outcomes (2)
Change in Positive and Negative Affect Scale (PANAS)
PANAS assesses positive and negative affect. It consists of a list of descriptors of positive (e.g., 'interested', 'enthusiastic') and negative (e.g., 'irritable', 'upset') affects. Items are rated on a 5-point scale (1 = very slightly or not at all, 5 = extremely), according to how participants feel. The Positive Affect scale reflects the extent to which a person feels enthusiastic, active, and alert; the Negative Affect scale reflects unpleasant mood states, such as anger, disgust, and fear.
Measured: Pre-intervention baseline (T1), post-intervention up to 2 weeks after the end of the 4-week training (T2), and follow-up up to two months after the end of the training (T3).
Change in Perceived Stress Scale (PSS)
PSS assesses the degree to which situations in one's life are viewed as stressful within the past month. Individual items assess feelings of stress, nervousness, irritation at life's hassles, and perceptions of one's own coping and control over a situation.
Measured: Pre-intervention baseline (T1), post-intervention up to 2 weeks after the end of the 4-week training (T2), and follow-up up to two months after the end of the training (T3).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2017
- Study start25 Jul 2017
- Primary completion5 Oct 2017
- Study completion5 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for ResilienceStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- We aim to recruit three groups. Two groups will receive mindfulness training (MBAT) but will differ in their level of duty day support to engage in daily assigned mindfulness exercises. The Proctored group (n = 45) will receive mindfulness training and complete assigned exercises during the duty day, integrated into their daily physical training. The Non-Proctored group (n = 45) will receive identical mindfulness training, but complete their assigned exercises on their own time. These participants will not receive additional duty day support for their practice. A third group will receive no training and serve as a control group (No-Training Control, n = 45). The design relies on group randomization at the level of individual platoons. This is due to the military requirement that organic unit structure is maintained during testing and course session scheduling. The number of participants is based on prior research (Jha et al., 2017).
- Masking
- None (open label)
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- Fort Drum, United States Department of Defense
- Responsible party
- Principal investigator, Amishi Jha, University of Miami
- Investigators
- Amishi P Jha, Ph.D, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03250156
- Sponsor's protocol ID
- 20120450
- Acronym
- TTT
- Status last verified
- Sep 2018
- First submitted
- 25 Jul 2017
- Last updated
- 18 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jha, AP, Morrison, AB, Parker, SC, & Stanley, EA. Practice is protective: Mindfulness training promotes cognitive resilience in high-stress cohorts. Mindfulness. 2016; 7(1), 1-13. doi: 10.1007/s12671-015-0465-9.
Jha AP, Morrison AB, Dainer-Best J, Parker S, Rostrup N, Stanley EA. Minds "at attention": mindfulness training curbs attentional lapses in military cohorts. PLoS One. 2015 Feb 11;10(2):e0116889. doi: 10.1371/journal.pone.0116889. eCollection 2015.
PubMed 25671579Jha AP, Stanley EA, Kiyonaga A, Wong L, Gelfand L. Examining the protective effects of mindfulness training on working memory capacity and affective experience. Emotion. 2010 Feb;10(1):54-64. doi: 10.1037/a0018438.
PubMed 20141302Jha AP, Witkin JE, Morrison AB, Rostrup N, Stanley E. Short-Form Mindfulness Training Protects Against Working Memory Degradation over High-Demand Intervals. Journal of Cognitive Enhancement 2017 1(2): 154-171. doi:10.1007/s41465-017-0035-2.
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Train the Trainer Delivery of Mindfulness-based Training- Ft. Drum Soldiers
- ClinicalTrials.gov ID
- NCT03250156
- Acronym / sponsor ID
- TTT / 20120450
- Conditions
- Resilience, Stress
- Keywords
- Mindfulness, Attention, Working Memory, Psychological Well-Being, Proctored Practice
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- Fort Drum, United States Department of Defense
- Study start
- 25 Jul 2017 (actual)
- Primary completion
- 5 Oct 2017 (actual)
- Study completion
- 5 Oct 2017 (actual)
- First posted
- 15 Aug 2017 (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.
This project aims to evaluate the effectiveness of mindfulness training (MT) on cognitive and psychological factors when incorporated to the duty-day schedule of servicemembers (via proctored mindfulness practice). Based on prior literature, it can be hypothesized that the benefits of MT on measures of attention, working memory, and psychological well-being will be greater for servicemembers who engage in proctored mindfulness practice and receive duty-day support compared to servicemembers who practice independently, on their own time, with no structured duty day support.
Detailed description
Background: Prior research on mindfulness training (MT) in military servicemembers showed that MT can effectively protect against degradation in attention and working memory over high-demand intervals. The benefits of MT in servicemembers were also linked to greater engagement in mindfulness practice. These prior MT programs delivered their training via a direct delivery approach, which involved a mindfulness training expert (TE) providing training to an end-user (e.g., military servicemembers). While successful, these programs are poorly suited for rapid, large-scale dissemination because these programs require direct training from a mindfulness training expert to an end-user and a considerable amount of time dedicated to training. To overcome these issues, the principal investigator together with a mindfulness expert developed a mindfulness training program contextualized for the U.S. Army, known as MBAT (Mindfulness-Based Attention Training), that is amenable to the train-the-train delivery approach and can provide rapid, large-scale dissemination to thousands of individuals. Specifically, Master Resilience Trainer - Performance Expert specialists (PEs), who have extensive experience working with soldiers but no mindfulness experience, were trained to deliver the MBAT course.
Problem: While training PEs to deliver MBAT complies with the U.S. Army time constraints, it remains unclear what is the best way to incorporate daily mindfulness practice into the duty schedule of servicemembers, which has a pivotal contribution to the protection against decline over high-demand intervals.
Project Goal: The aim of the present study is to investigate the impact of proctored vs. non-proctored practice of MBAT delivered by a PE to servicemembers. To investigate this issue, a trained PE will deliver MBAT to two groups of soldiers who will differ in the amount of duty-day support received to complete out-of-class mindfulness exercises. One group will be assigned proctored practice incorporated in the daily physical training (PT) and another group will be assigned non-proctored practice during which participants will perform the exercise independently, on their own.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- We aim to recruit three groups. Two groups will receive mindfulness training (MBAT) but will differ in their level of duty day support to engage in daily assigned mindfulness exercises. The Proctored group (n = 45) will receive mindfulness training and complete assigned exercises during the duty day, integrated into their daily physical training. The Non-Proctored group (n = 45) will receive identical mindfulness training, but complete their assigned exercises on their own time. These participants will not receive additional duty day support for their practice. A third group will receive no training and serve as a control group (No-Training Control, n = 45). The design relies on group randomization at the level of individual platoons. This is due to the military requirement that organic unit structure is maintained during testing and course session scheduling. The number of participants is based on prior research (Jha et al., 2017).
| Arm | Type | Receives |
|---|---|---|
| MBAT with proctored practice | Experimental | Behavioral: MBAT with proctored practiceParticipants will engage in Mindfulness Based Attention Training (MBAT) in 4, 2-hour training classes with 1 class per week. Participants in the proctored practice group will complete assigned, out of class mindfulness exercises during the duty day - for example, as part of their daily physical training (e.g., mindful cooldown, final 15 minutes of PT is spent engaging in a mindfulness exercise using a guided recording). |
| MBAT with non-proctored practice | Active comparator | Behavioral: MBAT with non-proctored practiceParticipants will engage in Mindfulness Based Attention Training (MBAT) in 4, 2-hour training classes with 1 class per week. Participants in the non-proctored practice group will complete assigned, out of class mindfulness exercises on their own time with no structured duty day support. |
| No Training Control | No intervention | –This group will receive no intervention. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- English-speaking
- Active duty military
- Able to understand and provide signed informed consent
Key exclusion criteria (2 listed)
- Non-controlled severe medical disease that might interfere with the performance of the study.
- Any other condition the investigator might deem problematic for the inclusion of the volunteer in a trial of this nature will also be considered.
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 with proctored practiceThe training program is known as Mindfulness-Based Attention Training, or MBAT. The MBAT program is based on the principles of Mindfulness-Based Stress Reduction, but contextualized for military personnel using themes relevant to military life. The training content is comprised four central themes: concentration, body awareness, open monitoring, and compassion. Participants will have proctored practice and complete the assigned, out-of-class mindfulness exercises during the duty day as party of their physical training. | Behavioural | MBAT with proctored practice |
| MBAT with non-proctored practiceThe training program is known as Mindfulness-Based Attention Training, or MBAT. The MBAT program is based on the principles of Mindfulness-Based Stress Reduction, but contextualized for military personnel using themes relevant to military life. The training content is comprised four central themes: concentration, body awareness, open monitoring, and compassion.Participants will not have proctored practice and will complete the assigned, out-of-class mindfulness exercises on their own. | Behavioural | MBAT with non-proctored practice |
Primary outcome
Change in Sustained Attention to Response Task (SART)
Time frame: Participants will complete the SART at three time points: Pre-intervention baseline (T1), post-intervention up to 2 weeks after the end of the 4-week training (T2), and follow-up up to two months after the end of the training (T3).
The SART is used to assess attentional performance and self-reported mind wandering (i.e., off-task thinking which is typically self-generated and compromises the performance of the task at hand). The 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 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 Task with Affective Distraction (WMDA)
Time frame: Participants will complete the WMDA at three time points: Pre-intervention baseline (T1), post-intervention up to 2 weeks after the end of the 4-week training (T2), and follow-up up to two months after the end of the training (T3).
The WMDA is used to assess the ability to hold information in working memory while overcoming emotional reactivity and distraction. Specifically, participants are presented with a memory item that they need to memorize and hold in memory during a delay interval. During the delay, emotionally negative or neutral scene images are presented. The negative images are combat scenes from Iraq or Afghanistan (Morey et al., 2009) and the neutral images are non-combat scenes.
2 secondary outcomes
Change in Positive and Negative Affect Scale (PANAS)
Time frame: Pre-intervention baseline (T1), post-intervention up to 2 weeks after the end of the 4-week training (T2), and follow-up up to two months after the end of the training (T3).
Change in Perceived Stress Scale (PSS)
Time frame: Pre-intervention baseline (T1), post-intervention up to 2 weeks after the end of the 4-week training (T2), and follow-up up to two months after the end of the training (T3).
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 18 Sep 2018.
- BackgroundJha, AP, Morrison, AB, Parker, SC, & Stanley, EA. Practice is protective: Mindfulness training promotes cognitive resilience in high-stress cohorts. Mindfulness. 2016; 7(1), 1-13. doi: 10.1007/s12671-015-0465-9.
- Background: PubMed 25671579Jha AP, Morrison AB, Dainer-Best J, Parker S, Rostrup N, Stanley EA. Minds "at attention": mindfulness training curbs attentional lapses in military cohorts. PLoS One. 2015 Feb 11;10(2):e0116889. doi: 10.1371/journal.pone.0116889. eCollection 2015.
- Background: PubMed 20141302Jha AP, Stanley EA, Kiyonaga A, Wong L, Gelfand L. Examining the protective effects of mindfulness training on working memory capacity and affective experience. Emotion. 2010 Feb;10(1):54-64. doi: 10.1037/a0018438.
- BackgroundJha AP, Witkin JE, Morrison AB, Rostrup N, Stanley E. Short-Form Mindfulness Training Protects Against Working Memory Degradation over High-Demand Intervals. Journal of Cognitive Enhancement 2017 1(2): 154-171. doi:10.1007/s41465-017-0035-2.
- 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, Ph.D principal investigator
University of Miami
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MBAT with proctored practice and MBAT with non-proctored practice in people with Resilience and Stress, run by University of Miami at 2 sites 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 3 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 18 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Sustained Attention to Response Task (SART) (time frame: Participants will complete the SART at three time points: Pre-intervention baseline (T1), post-intervention up to 2 weeks after the end of the 4-week training (T2), and follow-up up to two months after the end of the training (T3).). 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 NCT03250156, which also lists 4 linked publications.
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 18 Sep 2018.