What side effects are associated with this type of intervention?

Mindfulness-Based Attention Training (MBAT) and similar mindfulness practices are generally well-tolerated with minimal side effects. Commonly reported side effects include temporary discomfort during meditation, such as increased anxiety or emotional distress, particularly in individuals with a history of trauma. Other potential side effects may include fatigue, headaches, or difficulty concentrating during initial practice sessions. Overall, these side effects are typically mild and transient, with many individuals experiencing significant benefits in cognitive function, psychological well-being, and stress reduction over time.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of cognitive impairment, particularly in Alzheimer's disease. These include cholinesterase inhibitors like donepezil, rivastigmine, and galantamine, which work by increasing levels of acetylcholine in the brain to help improve memory and cognition. Another approved drug is memantine, an NMDA receptor antagonist that helps regulate glutamate activity to protect against neuronal damage. While these pharmacological treatments focus on biochemical pathways, non-pharmacological interventions such as cognitive behavioral therapy and mindfulness-based stress reduction have also shown promise in enhancing cognitive abilities and psychological well-being, though they are not FDA-approved treatments. These approaches align with the goals of mindfulness-based attention training, which aims to improve cognitive function and overall mental health through structured mindfulness practices.

What other types of research exist?

Promising novel alternatives to Mindfulness-Based Attention Training for cognitive impairment patients include: 1) Transcranial Magnetic Stimulation (TMS), which has shown improvements in language performance and cognitive functions; 2) Transcranial Direct Current Stimulation (tDCS), which has been effective in improving aphasia and cognitive abilities; 3) Cognitive Behavioral Therapy for Insomnia (CBT-I), which enhances sleep-related quality of life and psychological well-being; and 4) Multidisciplinary rehabilitation programs, which combine physical, occupational, and speech therapies to improve overall cognitive and motor functions.

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Mindfulness Training for Cognitive Improvement

N/A

Waitlist Available

Led By Amishi Jha

Research Sponsored by University of Miami

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Individuals who are between 18 and 65 years of age.

Individuals who are between 18 and 65 years of age

Timeline

Screening 3 weeks

Treatment Varies

Follow Up post-4-week training interval 1 (t2) and post-4-week training interval 2 (t3).

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a mindfulness training program designed for Military Senior Leaders. The program aims to improve their thinking skills, mental and physical health, and leadership abilities. Participants will practice focusing their attention and being more aware of the present moment.

Who is the study for?

This trial is for active-duty service members aged 18-65 who have taken courses at the Army War College. Participants must be fluent in English and able to consent. Those hospitalized for mental health issues within the last month cannot join.

What is being tested?

The study examines a Mindfulness-Based Attention Training (MBAT) web-course tailored for Military Senior Leaders, assessing its impact on cognitive abilities, psychological/physical well-being, and leadership skills compared to a wait-list control group.

What are the potential side effects?

Since this intervention involves mindfulness training rather than medication or medical procedures, significant side effects are not anticipated. However, participants may experience emotional discomfort during self-reflection exercises.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 18 and 65 years old.

Select...

I am between 18 and 65 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ post-4-week training interval 1 (t2) and post-4-week training interval 2 (t3).

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~post-4-week training interval 1 (t2) and post-4-week training interval 2 (t3).

This trial's timeline: 3 weeks for screening, Varies for treatment, and post-4-week training interval 1 (t2) and post-4-week training interval 2 (t3). for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Sustained attention to response task (SART) score

Secondary study objectives

Change in 5FMQ scores

Change in Decentering score

Change in PANAS negative affect score

+3 more

Other study objectives

Mindfulness

Change in Anger score

Change in Leadership Questionnaire

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Group A (MT group)Experimental Treatment1 Intervention

Participants will receive 4 weeks of mindfulness training during the first training interval between the first (T1) and second (T2) assessment sessions.

Group II: Group B (Wait-list group)Active Control1 Intervention

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.

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for cognitive impairment, such as Mindfulness-Based Attention Training (MBAT), Cognitive Behavioral Therapy (CBT), and other mindfulness practices, work by enhancing cognitive abilities, reducing stress, and improving psychological well-being. MBAT, for instance, focuses on training attention and mindfulness, which can lead to better cognitive function and emotional regulation. CBT helps by restructuring negative thought patterns and behaviors, thereby improving mental health and cognitive performance. These treatments are crucial for cognitive impairment patients as they address both cognitive deficits and associated psychological issues, leading to improved quality of life and functional abilities.