An interventional study of 4-week MBAT and 2-week MBAT in Psychological Stress, Anxiety and Post Traumatic Stress Disorder, sponsored by University of Miami. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-09-18.
Sponsored by University of Miami · Not applicable, Interventional, and Basic science
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Among 290 studies in Stress, Psychological with a site in United States — 31 open to participants now, 47 under way, 1 of them phase 3. Stress, Psychological · United States.
Among the 290 studies in Stress, Psychological with a site in United States, this one is the 92nd largest by enrollment of the 262 interventional ones that give a count, is one of 19 that started in 2017, is one of 240 with no phase, and was the 93rd registered.
848 studies on the registry are indexed under Stress, Psychological; 139 are open to participants now.
Browse Stress, Psychological studies →31 of the 290 studies in Stress, Psychological with a site in United States are open now. Recruiting first, the newest first:
Rachel Yehuda · Sites in United States
Ages 18+
University of Pennsylvania · Sites in United States
Ages 21–60 · Healthy volunteers
University of Florida · Sites in United States
Ages 30–55 · Healthy volunteers
University of Arizona · Sites in United States
Ages 65+ · Healthy volunteers
Efforia, Inc · Sites in United States
Ages 18+ · Healthy volunteers
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 75 Stress, Psychological studies recruiting now, 34 (45%) set no upper age limit and 37 (49%) stop at 75 or younger; 14 take children under 18; 49 take healthy volunteers.
This study: 18 Years to 65 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
290 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 8 · Phase 2 11 · Phase 3 3 · Phase 4 3
First in 1997; this study’s year is marked. 19 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 120 is above the median of 84 across 692 interventional studies indexed under Stress, Psychological.
Median enrollment 84 across the 262 interventional studies, 138 across the 28 observational. Of the 225 that completed or were terminated, 58 (26%) have results posted.
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13 of 290 have an industry lead sponsor. The 10 most frequent:
University of Miami is the lead sponsor of 842 studies on the registry; 166 are open to participants now.
Of its 115 completed or terminated interventional studies of FDA-regulated products, 97 (84%) have results posted.
University of Miami has 4 studies filed under Stress, Psychological — fewer than ten, so there is no comparison to draw.
19 of the studies in Stress, Psychological with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05552053Phase 3Cedars-Sinai Medical CenterResources, Inspiration, Support and Empowerment (RISE) for Black Pregnant Women | 2026-12-31 |
| NCT07718646Oklahoma State UniversityMobile Health Coping Intervention for Mothers Experiencing Food Insecurity | 2026-11 |
| NCT06989593Sarah SchlegelBreaking Silence Through Story: A Narrative Medicine Intervention for Parents of Children With Urogenital Conditions | 2026-11 |
| NCT04317482University of ArkansasThe Human Stress Response in a Simulated ED Setting | 2026-12 |
| NCT07029165University of Massachusetts, BostonKidney Blood Flow During Exercise in Older African American Adults | 2026-12 |
Add all 19 to your calendar (.ics) → With an account.
Among the 290 studies in Stress, Psychological with a site in United States, from their registry updates:
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This project aims to contextualize delivery of mindfulness training to U.S. Army personnel, evaluate its effectiveness on measures of executive functions and psychological well-being, and determine best practices for its delivery.
Background: An individual's success in the U.S. Army relies on many factors including the integrity of executive functions (EFs). EFs comprise a complex, multi-faceted brain system necessary to pay attention, overcome habitual and automatic behaviors, regulate mood, and ensure that current behavior is in line with short and long-term goals.Yet, protracted periods of high uncertainty, high demands, and high stress can lead to decreases in the efficiency and availability of EFs. Given the high demands and psychological vulnerabilities that U.S. Army personnel may face, it is critical to provide them with training programs to protect against degradation of EFs (particularly attention and working memory) over high-stress, high-demand intervals. Prior research on mindfulness training (MT) in civilians and military servicemembers showed that MT can effectively protect against degradation in attention and working memory and benefit psychological well-being over high-demand intervals.
Problem: While being successful, prior MT programs required a considerable amount of time dedicated to training (e.g., 24-hour training) and it is challenging to integrate these long programs into the busy schedule of the U.S. Army personnel. To accommodate the time constraints, the principal investigator together with a mindfulness expert developed a short-form mindfulness training program contextualized for the U.S. Army; the program consists of 8-hour training and is known as MBAT, Mindfulness-Based Attention Training.
Project Goal: The present study aims to investigate the best practices for delivery of a short-form mindfulness training to U.S. Army Cohorts. Specifically, the present study will examine the best delivery structure for the MBAT by comparing MBAT course delivered in 2 weeks vs. 4 weeks.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will engage in Mindfulness-Based Attention Training (MBAT) in 4, 2-hour training classes over 4 weeks.
Behavioral: 4-week MBAT
Participants will engage in Mindfulness-Based Attention Training (MBAT) in 4, 2-hour training classes over 2 weeks.
Behavioral: 2-week MBAT
Participants will receive no intervention but will be tested before and after a no-training interval.
The training 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 of four central themes: concentration, body awareness, open monitoring, and compassion. This content will be delivered in 4, 2-hour sessions over 4 weeks. Participants will be assigned homework mindfulness practice during the interval of course delivery as well as for the few weeks following the end of the course.
The training 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 of four central themes: concentration, body awareness, open monitoring, and compassion. This content will be delivered in 4, 2-hour sessions over 2 weeks. Participants will be assigned homework mindfulness practice during the interval of course delivery as well as for the few weeks following the end of the course.
Change in Sustained Attention to Response Task (SART)
The SART is used to assess attentional performance and 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 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.
Time frame: Change from the pre-intervention baseline (testing 1) to the long-term post-intervention (testing 3), which is an average of 8 weeks from the baseline.
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 and the neutral images are non-combat scenes.
Time frame: Change from the pre-intervention baseline (testing 1) to the long-term post-intervention (testing 3), which is an average of 8 weeks from the baseline.
Change in Patient Health Questionnaire depression scale (PHQ)
PHQ is used as a valid diagnostic and severity measure for depressive disorders.
Time frame: Change from the pre-intervention baseline (testing 1) to the immediate post-intervention (testing 2; either 2 weeks or 4 weeks according to the group) and the long-term post-intervention (testing 3), which is an average of 8 weeks from the baseline.
Change in Generalized Anxiety Disorder assessment (GAD-7)
GAD is used as a screening tool and severity measure for generalized anxiety disorder.
Time frame: Change from the pre-intervention baseline (testing 1) to the immediate post-intervention (testing 2; either 2 weeks or 4 weeks according to the group) and the long-term post-intervention (testing 3), which is an average of 8 weeks from the baseline.
Change in PTSD Checklist_Military (PCLM)
PCLM assesses the symptoms of Post-Traumatic Stress Disorder in military personnel.
Time frame: Change from the pre-intervention baseline (testing 1) to the immediate post-intervention (testing 2; either 2 weeks or 4 weeks according to the group) and the long-term post-intervention (testing 3), which is an average of 8 weeks from the baseline.
Change in the Pittsburgh Sleep Quality Index (PSQI)
PSQI assesses sleep quality and disturbances in seven "component" scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction.
Time frame: Change from the pre-intervention baseline (testing 1) to the immediate post-intervention (testing 2; either 2 weeks or 4 weeks according to the group) and the long-term post-intervention (testing 3), which is an average of 8 weeks from the baseline.
Change in Alcohol Use Disorders Identification Test-Consumption (AUDIT-C)
AUDIT-C allows to identify people who are hazardous drinkers or have active alcohol use disorders.
Time frame: Change from the pre-intervention baseline (testing 1) to the immediate post-intervention (testing 2; either 2 weeks or 4 weeks according to the group) and the long-term post-intervention (testing 3), which is an average of 8 weeks from the baseline.
Change in Brief Resilience Scale (BRS)
BRS assesses the ability to bounce back or recover from stress.
Time frame: Change from the pre-intervention baseline (testing 1) to the immediate post-intervention (testing 2; either 2 weeks or 4 weeks according to the group) and the long-term post-intervention (testing 3), which is an average of 8 weeks from the baseline.
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.
Time frame: Change from the pre-intervention baseline (testing 1) to the immediate post-intervention (testing 2; either 2 weeks or 4 weeks according to the group) and the long-term post-intervention (testing 3), which is an average of 8 weeks from the baseline.
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.
Time frame: Change from the pre-intervention baseline (testing 1) to the immediate post-intervention (testing 2; either 2 weeks or 4 weeks according to the group) and the long-term post-intervention (testing 3), which is an average of 8 weeks from the baseline.
Change in Adult Decision-Making Competence scale (Sunk Costs questionnaire)
Sunk Costs assesses resistance to framing, recognizing social norms, under/overconfidence, applying decision rules, risk perception, resistance to sunk costs, and path independence. A variant of this measure assessing resistance to sunk costs in a military context may be used.
Time frame: Change from the pre-intervention baseline (testing 1) to the long-term post-intervention (testing 3), which is an average of 8 weeks from the baseline.
Change in Cognitive Failures Questionnaire (CFQ)
CFQ assesses the frequency of committing minor, everyday mistakes.
Time frame: Change from the pre-intervention baseline (testing 1) to the immediate post-intervention (testing 2; either 2 weeks or 4 weeks according to the group) and the long-term post-intervention (testing 3), which is an average of 8 weeks from the baseline.
Change in Five-Facet Mindfulness Questionnaire (5FMQ)
5FMQ assesses five major measures of mindfulness, including non-judgment of experience, non-reactivity to inner experience, observing emotions, acting with awareness, and describing feelings in words.
Time frame: Change from the pre-intervention baseline (testing 1) to the long-term post-intervention (testing 3), which is an average of 8 weeks from the baseline.
Change in Emotion Regulation Questionnaire (ERQ)
ERQ assesses individual differences in two emotion regulation strategies: expressive suppression and cognitive reappraisal.
Time frame: Change from the pre-intervention baseline (testing 1) to the long-term post-intervention (testing 3), which is an average of 8 weeks from the baseline.
Change in Combat Experiences Scale (CES)
CES assesses how many different experiences someone had while deployed and in combat.
Time frame: Change from the pre-intervention baseline (testing 1) to the long-term post-intervention (testing 3), which is an average of 8 weeks from the baseline.
Change in Rumination and Response Scale (RRS)
RRS assesses two aspects of rumination: brooding and reflective pondering
Time frame: Change from the pre-intervention baseline (testing 1) to the long-term post-intervention (testing 3), which is an average of 8 weeks from the baseline.
Change in Self-Compassion Questionnaire (SCQ)
SCQ assesses various facets of self-compassion
Time frame: Change from the pre-intervention baseline (testing 1) to the long-term post-intervention (testing 3), which is an average of 8 weeks from the baseline.
Change in Mind Wandering Questionnaire (MWQ)
MWQ assesses common experiences related to distraction and mind-wandering.
Time frame: Change from the pre-intervention baseline (testing 1) to the long-term post-intervention (testing 3), which is an average of 8 weeks from the baseline.
Practice logs
Practice logs will be used to keep track of participants daily mindfulness practice.
Time frame: Participants will complete paper practice logs tracking their daily practice (i.e., minutes) from the beginning of the MBAT through study completion (testing 3), which is an average of 8 weeks after beginning of the intervention.
Motivation
Five questions regarding motivation to complete the testing session
Time frame: Participants answer the motivation questions during the long-term post-intervention (testing 3) testing session, which is an average of 8 weeks from the baseline.
Plan to share: No
Ran from Oct 2017 to primary completion in Mar 2018, 5 months.
Of 459 non-industry interventional studies with no phase under Stress, Psychological, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 26. This study's 5 months is below that.
Counting every sponsor, half of 472 studies reached it within 13 months; a quarter within 5 and three quarters within 26.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.
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