Mindfulness Based Stress Reduction for Aggression

Phase-Based Estimates
1
Effectiveness
1
Safety
VA Connecticut Healthcare System West Haven Campus, West Haven, CT, West Haven, CT
Aggression+1 More
Mindfulness Based Stress Reduction - Behavioral
Eligibility
18+
All Sexes
Eligible conditions
Aggression

Study Summary

This study is evaluating whether a mindfulness intervention may help reduce anger and aggressive behavior in veterans with post-traumatic stress disorder.

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Eligible Conditions

  • Aggression
  • Anger

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Mindfulness Based Stress Reduction will improve 3 primary outcomes and 2 secondary outcomes in patients with Aggression. Measurement will happen over the course of within 4 weeks following the completion of either of the two treatments.

Week 6
aggression
anger
Week 4
heart rate
provoked aggression
skin-conductance levels

Trial Safety

Side Effects for

Mindfulness Based Stress Reduction
muscle soreness
2%
sleep disruption
0%
This histogram enumerates side effects from a completed 2013 Phase 4 trial (NCT01033851) in the Mindfulness Based Stress Reduction ARM group. Side effects include: muscle soreness with 2%, sleep disruption with 0%.

Trial Design

2 Treatment Groups

Trauma Recovery Education Class
Mindfulness Based Stress Reduction

This trial requires 60 total participants across 2 different treatment groups

This trial involves 2 different treatments. Mindfulness Based Stress Reduction is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Mindfulness Based Stress Reduction
Behavioral
Mindfulness Based Stress Reduction (MBSR) is a group-based intervention in which participants are taught different mindfulness meditation practices, including body scan (focusing attention to different areas of the body in sequence), sitting meditation (focusing attention to one's breathing), and Hatha yoga postures (focusing attention to different body sensations during gentle stretching). Participants also are taught how to practice mindfulness while engaging in ordinary activities including walking, standing, and eating. MBSR consists of 8, two-hour weekly sessions and will be delivered in group format. MBSR groups will be delivered virtually.
Trauma Recovery Education Class
Behavioral
Trauma Recovery Education Class (TREC): TREC is a group based treatment that focuses on providing information on PTSD and traumatic reactions. TREC provides psycho-education to Veterans on PTSD, including common reactions to trauma and the role of avoidance, common problems associated with PTSD, as well as common barriers to care (e.g., stigma, maladaptive beliefs, fear). Additional content focuses on problem identification and goal setting, discussion of current problems and life issues, and treatment planning. TREC consists of 8, one-hour weekly sessions. TREC groups will be delivered virtually.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mindfulness Based Stress Reduction
2012
Completed Phase 4
~3160

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, after 3 weeks of treatment, within 4 weeks following the completion of either of the two treatments, after 6 weeks of treatment, 3-month follow up
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly baseline, after 3 weeks of treatment, within 4 weeks following the completion of either of the two treatments, after 6 weeks of treatment, 3-month follow up for reporting.

Closest Location

VA Connecticut Healthcare System West Haven Campus, West Haven, CT - West Haven, CT

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 2 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Participants must have been diagnosed with PTSD by a mental health professional according to the DSM-V diagnostic criteria. show original
Participants must also indicate any difficulties they are currently experiencing with anger and aggression. show original

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is aggression?

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Aggressive behavior includes actions and emotions characterized by intense, uncontrollable motivation to inflict physical or mental harm on other persons, the intention to cause harm to one's self, and an overall propensity to strike out aggressively toward persons and situations perceived as threats. For children with ADHD, such a behavior may be less understood and less effectively treated. This article provides an overview of this important and challenging behavioral challenge for clinicians, and suggestions for dealing with it in children and young people with ADHD.

Unverified Answer

What are common treatments for aggression?

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The treatments that have been found to be most effective for treating aggression are antidepressant medication, cognitive behavioral therapy and behavioral activation. Some studies indicate that behavioral activation may be as effective as medication. Aggressive behavior as comorbid with anxiety disorder is associated with poor treatment outcome. Future research should examine the feasibility and effectiveness of new treatments for treating aggression.

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Can aggression be cured?

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Considering that patients and their caregivers alike have a number of needs in their lives, therapies that aim to address aggression need to be tailored in order to effectively address the needs of both parties.

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How many people get aggression a year in the United States?

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Nearly 90 million Americans experience at least one aspect of aggression a year. Aggression is more prevalent among Hispanics than in non-Hispanic whites and black Americans.

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What are the signs of aggression?

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Among individuals who are medically stable, an increased frequency of the PIA may be an indication of the presence of aggression that requires further exploration.

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What causes aggression?

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In a recent study, findings show that aggression is a result of multiple factors, ranging from a genetic one to ones that are largely internal, thus more related to personality traits. Among the factors associated with aggression are the environment, such as psychological, economic, and cultural factors. One of the factors that are especially important in aggression is a person's personality; it is the main variable that determines the behavior. If there is a high level of aggressiveness from a person that has a hard time in a society, there will be an increase in aggression. In the future, studies and new tools that assess personality are needed to determine the causes and prediction of aggressive behavior in the same manner that is now done with psychological traits.

Unverified Answer

Have there been other clinical trials involving mindfulness based stress reduction?

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Data from a recent study suggest that MCBT can reduce both physical and psychological symptoms of anxiety and depression that would likely benefit people at all clinical levels of distress, and thus that the use of MCBT might be a useful treatment for anxiety and depression in general, particularly because it is more accessible, free of adverse pharmacodynamic effects and has a potentially broad therapeutic indication.

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Is mindfulness based stress reduction safe for people?

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In this first prospective study of MBSR in Australia, one in every 40 participants experienced acute adverse events that were not associated with either MBSR therapy or baseline characteristics of the participants. Serious adverse events were reported only rarely. MBSR was acceptable to participants and therapists, and the intervention appears to be safe.

Unverified Answer

Does mindfulness based stress reduction improve quality of life for those with aggression?

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MBSR is an effective method that has positive effects on mental health and quality of life in the short term for those with aggressive behaviours, independent of symptoms of psychopathology. In a recent study, findings have implications for interventions to address the association between mental disorders and quality of life.

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Who should consider clinical trials for aggression?

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It is possible for clinicians to make clinical decisions about participation in the first Phase II trial they read about. Inadequate consideration and referral to trials may lead to poor outcomes in patients. Thus, all patients and families should be informed that clinical studies are available for aggressive treatment.

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What is the primary cause of aggression?

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In a recent study, findings provide empirical support for aggression arising from a complex set of factors including early life trauma; stress, anxiety, and depression; coping; substance abuse; marital conflict; and adverse experiences in the community or prison. Aggressive behaviors have been studied in relation to personality style, temperament, and the four dimensions of personality personality disorder, as well as in relation to specific types of childhood adversity, but not consistently, and often with very limited numbers. In a recent study, findings show that there is no single personality or temperament profile associated with aggressiveness. They suggest a possible distinction of two broad types of interpersonal aggression. One is characterised by a primary or main motive of punishment-driven aggression, the other by a motive of punishment-driven aggression, and interpersonal conflict.

Unverified Answer

What does mindfulness based stress reduction usually treat?

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Results from a recent paper are the first to link mindfulness practices to measurable reductions in depression amongst patients receiving cognitive behavioural therapy for the treatment of depression and PTSD.

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