Mindfulness ecological momentary intervention for Anxiety Disorders

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
The Pennsylvania State University, University Park, PA
Anxiety Disorders+1 More
Mindfulness ecological momentary intervention - Device
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a mindfulness based intervention can help individuals with generalized anxiety disorder.

See full description

Eligible Conditions

  • Anxiety Disorders
  • Generalized Anxiety Disorder

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

This trial is evaluating whether Mindfulness ecological momentary intervention will improve 4 primary outcomes, 18 secondary outcomes, and 1 other outcome in patients with Anxiety Disorders. Measurement will happen over the course of Baseline to 6-Week Post-Randomization.

Baseline
Mental health disorder screening measures
Baseline to 14-Day Post-Treatment
Change from Baseline Attentional Control at 14-Day Post-Treatment
Change from Baseline Depression Symptom Severity at 14-Day Post-Treatment
Change from Baseline Empathy at 14-Day Post-Treatment
Change from Baseline Generalized Anxiety Disorder Symptoms at 14-Day Post-Treatment
Change from Baseline Inhibitory Control at 14-Day Post-Treatment
Change from Baseline Interpersonal Reactivity Traits at 14-Day Post-Treatment
Change from Baseline Perseverative Cognitions at 14-Day Post-Treatment
Change from Baseline Set-Shifting at 14-Day Post-Treatment
Change from Baseline Trait Mindfulness at 14-Day Post-Treatment
Change from Baseline Verbal Fluency at 14-Day Post-Treatment
Change from Baseline Working Memory at 14-Day Post-Treatment
Baseline to 6-Week Post-Randomization
Change from Baseline Attentional Control at 6-Week Post-Randomization
Change from Baseline Depression Symptom Severity at 6-Week Post-Randomization
Change from Baseline Empathy at 6-Week Post-Randomization
Change from Baseline Generalized Anxiety Disorder Symptoms at 6-Week Post-Randomization
Change from Baseline Inhibitory Control at 6-Week Post-Randomization
Change from Baseline Interpersonal Reactivity Traits at 6-Week Post-Randomization
Change from Baseline Perseverative Cognitions at 6-Week Post-Randomization
Change from Baseline Set-Shifting at 6-Week Post-Randomization
Change from Baseline Trait Mindfulness at 6-Week Post-Randomization
Change from Baseline Verbal Fluency at 6-Week Post-Randomization
Change from Baseline Working Memory at 6-Week Post-Randomization

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Mindfulness ecological momentary intervention
1 of 2
Self-monitoring placebo
1 of 2
Experimental Treatment
Non-Treatment Group

This trial requires 300 total participants across 2 different treatment groups

This trial involves 2 different treatments. Mindfulness Ecological Momentary Intervention is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are not being studied for commercial purposes.

Mindfulness ecological momentary intervention
Device
The SMP condition was developed to parallel the treatment while eliminating its theorized active therapeutic elements - open monitoring, acceptance, attending to small moments, breathing retraining, continual practice of mindfulness. Therefore, it did not mention anything about mindfulness at all. Instead, SMP participants were instructed to notice their cognitions and emotions and how distress they might be. No instruction on accepting their thoughts and feelings as they are were given.
Self-monitoring placebo
Device
The SMP condition was developed to parallel the treatment while eliminating its theorized active therapeutic elements - open monitoring, acceptance, attending to small moments, breathing retraining, continual practice of mindfulness. Therefore, it did not mention anything about mindfulness at all. Instead, SMP participants were instructed to notice their cognitions and emotions and how distress they might be. No instruction on accepting their thoughts and feelings as they are were given.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline to 14-day post-treatment
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly baseline to 14-day post-treatment for reporting.

Who is running the study

Principal Investigator
M. G. N.
Prof. Michelle G. Newman, Professor of Psychology
Penn State University

Closest Location

The Pennsylvania State University - University Park, PA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 6 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
The person has a high level of anxiety that is not specific to any particular situation or circumstance. show original
I'm a current student at the Pennsylvania State University or a community-dwelling adult who expressed interest to participate in a research study through the PSU StudyFinder portal. show original
I am proficient in English. show original
from the doctor I have expressed interest in seeking medical treatment from the doctor. show original
I am not currently seeing a mental health professional. show original
Able to provide consent is an important part of the sexual assault response protocol show original

Patient Q&A Section

Can anxiety disorders be cured?

"Anxiety disorders are not in principle or in practice curable. However, they can be decreased or resolved, but this is dependent on the individuals involved and the exact circumstances. These circumstances often change over time." - Anonymous Online Contributor

Unverified Answer

What causes anxiety disorders?

"Anxiety is associated with many factors, which vary considerably among individuals. It can arise from genetic and environmental effects, but most anxiety cases are due to a combination of both. Anxiety is associated with many physical symptoms, but it can also be one of the symptoms that is associated with a disease, such as PTSD. There is no single underlying cause for all types of anxiety.\n" - Anonymous Online Contributor

Unverified Answer

How many people get anxiety disorders a year in the United States?

"About 20 million adults in the United States have some form of anxiety disorder, and 3.5% of these people will be hospitalized due to the condition. Approximately 1 in 20 US children will be hospitalized due to an anxiety disorder." - Anonymous Online Contributor

Unverified Answer

What is anxiety disorders?

"Anxious moods can arise from various causes that vary greatly. For instance, some people can experience anxiety as an adverse reaction to a medical diagnosis or a traumatic event such as a war or natural disaster, whereas others may experience anxiety because of fear or fear of failure or failure, loss or the thought of losing someone or events that have a negative impact on their lives. Anxiety is also commonly associated with feelings of inadequacy, loneliness, boredom, irritability, restlessness and guilt. Many people experiencing anxiety disorders also experience worry, which is a heightened state of anxiety that is associated with the thought of real, or perceived threats to their lives or those in which they have a stake." - Anonymous Online Contributor

Unverified Answer

What are common treatments for anxiety disorders?

"A common treatment for anxiety disorders includes psychotherapy and medications. However, the most common treatment style comes from medication, where anxiolytics, antidepressants, and anticonvulsants are used on their own or in combination. A small number of individuals, about 5%, use alternative forms of treatment, but the data does not indicate a style favored by some for particular cases." - Anonymous Online Contributor

Unverified Answer

What are the signs of anxiety disorders?

"Anxiety disorders are the fourth most common mental health problem and are also associated with a wide variety of physical and psychosocial problems. Identification of these signs will allow for early diagnosis and management, and thereby better outcomes for both mental health and physical health. This article addresses the common clinical signs of anxiety disorders. In addition it draws on current evidence to provide insight into the possible underlying biological and psychosocial mechanisms and signs of anxiety disorders." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating anxiety disorders?

"It has been proposed that the mechanisms that mediate anxiety disorders involve abnormal regulation of the HPA axis, alterations in glutamatergic neurotransmission, and/or abnormalities in the autonomic nervous system. These mechanisms could be targeted using pharmacological agents, cognitive or behavioral treatments, and/or psychotherapeutic interventions." - Anonymous Online Contributor

Unverified Answer

Has mindfulness ecological momentary intervention proven to be more effective than a placebo?

"Ecological momentary interventions have proven to be effective in altering stress, anxiety, and depression. Data from a recent study of this randomized controlled trial suggest that using a mindfulness intervention may have an effective tool to manage physical-behavioral symptoms of depression, anxiety, and stress in relation to the experience of momentary stressful situations." - Anonymous Online Contributor

Unverified Answer

What is the latest research for anxiety disorders?

"Anxiety disorder is the most common mental disorder in the United States, and the rate of incidence is steadily increasing. Most research studies have focused on anxiety disorders in adult populations, but studies are expanding into pediatric and adolescent populations, which might represent a higher-risk group in terms of developing depression or anxiety. In the future, it is important for clinicians to focus attention on the early identification and early intervention of anxiety disorders for those at particularly high risk, particularly for children, adolescents, and even parents because their development can be very affected by early onset of anxiety disorders." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving mindfulness ecological momentary intervention?

"The trial that is included in this paper was one of the early M-EMI trials. A significant limitation of the present study is that it did not compare the results of a M-EMI group to those of a standard clinical psychotherapy group. Further investigation into this M-EMI group may provide insight into therapeutic methods for anxiety disorders. We conclude that empirical studies of M-EMI should be replicated in controlled clinical trials, and that future M-EMI research should be conducted using randomized controlled trials." - Anonymous Online Contributor

Unverified Answer

What does mindfulness ecological momentary intervention usually treat?

"The MIE-N has been developed to be a treatment intervention that was well-accepted by the majority of the women, who, in contrast to the women who completed the MIE, found it enjoyable to participate in and very helpful to them. The women who completed the Mie were then able to integrate their experiences of the treatment into their everyday lives. Results from a recent clinical trial show that the MIE-N is a promising intervention for treatment of women's anxiety. The MIE appears to be an important part of the self-management support package for women with a variety of anxiety disorders. It could be integrated with treatment and other services and provide a real-world'real life' context for treatment, without compromising efficacy." - Anonymous Online Contributor

Unverified Answer

How does mindfulness ecological momentary intervention work?

"The present findings suggest that cognitive-behavioural therapies can be effective in reducing anxiety in highly anxious patients. In addition, they demonstrate some effectiveness of a methodic approach to investigating CBT for anxiety, examining both trait and state anxiety in the intervention group." - Anonymous Online Contributor

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