An interventional study of MBAT with proctored practice and MBAT with non-proctored practice in Resilience and Stress, sponsored by University of Miami. Completed at 2 sites 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 654 studies in Psychological Well-Being with a site in United States — 188 open to participants now, 239 under way, 1 of them phase 3. Psychological Well-Being · United States.
Among the 654 studies in Psychological Well-Being with a site in United States, this one is the 262nd largest by enrollment of the 572 interventional ones that give a count, is one of 17 that started in 2017, is one of 514 with no phase, and was the 153rd registered.
2,195 studies on the registry are indexed under Psychological Well-Being; 728 are open to participants now.
Browse Psychological Well-Being studies →188 of the 654 studies in Psychological Well-Being with a site in United States are open now. Recruiting first, the newest first:
Columbia University · Sites in United States
Ages 12–80
Chestnut Health Systems · Sites in United States
Ages 18+ · Healthy volunteers
University of Massachusetts, Worcester · Sites in United States
Ages 18+
Beth Israel Deaconess Medical Center · Sites in United States
Ages 18–40 · Healthy volunteers
University of South Carolina · Sites in United States
Ages 18+ · Women only
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 401 Psychological Well-Being studies recruiting now, 218 (54%) set no upper age limit and 157 (39%) stop at 75 or younger; 120 take children under 18; 204 take healthy volunteers.
This study: 18 Years to 65 Years · all sexes · healthy volunteers too.
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654 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 20 · Phase 2 29 · Phase 3 10 · Phase 4 6
First in 1996; this study’s year is marked. 17 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 128 is above the median of 110 across 1,798 interventional studies indexed under Psychological Well-Being.
Median enrollment 116 across the 572 interventional studies, 500 across the 81 observational. Of the 383 that completed or were terminated, 120 (31%) have results posted.
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53 of 654 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 8 studies filed under Psychological Well-Being — fewer than ten, so there is no comparison to draw.
99 of the studies in Psychological Well-Being with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07011459Tulane UniversityThe Cooking for Health Optimization and Disease Prevention (CHOP) Trial | 2026-11 |
| NCT07718646Oklahoma State UniversityMobile Health Coping Intervention for Mothers Experiencing Food Insecurity | 2026-11 |
| NCT06915259University of PennsylvaniaDoula Model of Care | 2026-11 |
| NCT04833829Emory UniversityCross-disciplinary HIV Integrated Mental Health Support Intervention | 2026-11 |
| NCT06989593Sarah SchlegelBreaking Silence Through Story: A Narrative Medicine Intervention for Parents of Children With Urogenital Conditions | 2026-11 |
Add all 99 to your calendar (.ics) → With an account.
Among the 654 studies in Psychological Well-Being with a site in United States, from their registry updates:
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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.
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.
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 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).
Behavioral: MBAT with proctored practice
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.
Behavioral: MBAT with non-proctored practice
This group will receive no intervention.
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.
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.
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.
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).
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.
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).
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: 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.
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 Connor-Davidson Resilience Score (CD-RISC)
CD-RISC assesses an individual's tendency to cope with change and pressure in a productive way.
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 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: 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 Combat Experiences Scale (CES)
CES assesses combat experiences in the military context.
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 PTSD Checklist_Military (PCLM)
PCLM assesses the symptoms of Post-Traumatic Stress Disorder in military personnel
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 The Pittsburgh Sleep Quality Index (PSQI)
A self-rated questionnaire which assesses sleep quality and disturbances in seven "component" scores: subjective sleep quality, sleep latency, sleep duration, habitual PSQI assesses sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction.
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 Interpersonal Reactivity Index (IRI)
The empathic concern subscale of the IRI is a 7-item measure used to gauge feelings of empathy towards others.
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 Self-Compassion Scale (SCQ)
A 26-item measure used to measure aspects of self-compassion.
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 Obsessive Compulsion Index (OCI-R)
An 18-item scale used to assess symptoms of Obsessive-Compulsive Disorder.
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 Center for Epidemiological Studies Depression Scale (CES-D)
This 20-item scale measures the major components of depressive symptomatology in the general population (i.e., nonpsychiatric persons older than 18).
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 Alcohol Use Disorders Identification Test-Consumption (AUDIT-C)
An alcohol screen that identifies people who are hazardous drinkers or have active alcohol use disorders.
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).
Plan to share: No
Ran from Jul 2017 to primary completion in Oct 2017, 2 months.
Of 1,261 non-industry interventional studies with no phase under Psychological Well-Being, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 34. This study's 2 months is below that.
Counting every sponsor, half of 1,304 studies reached it within 16 months; a quarter within 7 and three quarters within 34.
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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