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Mindfulness Intervention for Dysautonomia

N/A

Recruiting

Led By Jeffrey J. Hsu, MD, PhD

Research Sponsored by University of California, Los Angeles

Eligibility Criteria Checklist

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

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline / pre intervention(1-2 weeks prior to intervention), post intervention (1-2 weeks post intervention completion); 4 weeks post intervention

Awards & highlights

Study Summary

This trial will explore if mindfulness can help people with COVID-19 symptoms over a 6-week course.

Eligible Conditions

COVID-19
Dysautonomia

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline / pre intervention(1-2 weeks prior to intervention), post intervention (1-2 weeks post intervention completion); 4 weeks post intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline / pre intervention(1-2 weeks prior to intervention), post intervention (1-2 weeks post intervention completion); 4 weeks post intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline / pre intervention(1-2 weeks prior to intervention), post intervention (1-2 weeks post intervention completion); 4 weeks post intervention for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change from baseline in Active Stand Test of hemodynamic symptom parameters, exercise tolerance.

Change from baseline in mean score in Health-Related Quality of Life (QOL) SF-20

Change from baseline in the composite autonomic symptom score COMPASS-31 for autonomic symptoms

+1 more

Secondary outcome measures

Change from baseline in mean scores of CD-RISC 10 - Connor Davidson Resilience Scale.

Fatigue

Change from baseline in mean scores of GAD7- Generalized Anxiety Disorder

+5 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Mindfulness InterventionExperimental Treatment1 Intervention

All participants will attend a virtual 6-week course entitled Mindful Awareness Practices (MAPs) created, hosted and led by expert facilitators from the Mindful Awareness Research Center at UCLA. Participants will learn Mindful concepts and a variety of Mindfulness practices. This intervention will consist of a mix of lecture, practice, group feedback, and discussion regarding mindfulness. Mindfulness is the mental state achieved by focusing one's awareness on the present while acknowledging and accepting any feelings, thoughts, or bodily sensations. MAPs classes meets weekly for two hours per week for six weeks. Participants are encouraged to complete some daily meditation practice starting at five minutes a day and working up to 20 minutes daily by the end of the course.

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Who is running the clinical trial?

University of California, Los AngelesLead Sponsor

1,530 Previous Clinical Trials

10,278,172 Total Patients Enrolled

1 Trials studying Dysautonomia

75 Patients Enrolled for Dysautonomia

Jeffrey J. Hsu, MD, PhDPrincipal InvestigatorUniversity of California, Los Angeles

Frequently Asked Questions

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

Is access to this medical investigation restricted to persons aged 55 and over?

"The age range of the desired participants for this trial is 18 years or older to 54 years old."

Answered by AI

What criteria must an individual meet to be eligible for this research?

"To be eligible for this research, applicants must have dysautonomia and fall between 18-54 years of age. Approximately 30 participants are being accepted into the trial."

Answered by AI

Is recruitment still underway for this experimental project?

"Yes, the information on clinicaltrials.gov verifies that this medical trial is currently recruiting participants. It was first posted to the website on February 1st 2023 and recently revised on January 20th 23rd. The study requires 30 individuals at a single location."

Answered by AI

How many participants are enrolled in this trial?

"Indeed, according to clinicaltrials.gov, this medical study is soliciting participants as of now. It was initially posted on February 1st 2023 and has been recently updated on January 20th 2023. 30 individuals are sought from a single research institution."

Answered by AI

What are the ultimate objectives of this research endeavor?

"The primary objective of the study, which will be evaluated over a pre-intervention and post-intervention timeline, is to assess changes in hemodynamic symptom parameters and exercise tolerance. Secondary outcomes include assessing Perceived Stress Scale (PSS) scores as well as Impact of Event Scale -Revised (IES-R) ratings that measure event related distress levels. Lastly, Fatigue Symptom Inventory (FSI) evaluations are used to gain insight into how fatigue affects quality of life."

Answered by AI

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COMPASS 31: A Refined and Abbreviated Composite Autonomic Symptom Score

Sletten, David M., Guillermo A. Suarez, Phillip A. Low, Jay Mandrekar, and Wolfgang Singer. 2012. “COMPASS 31: A Refined and Abbreviated Composite Autonomic Symptom Score”. Mayo Clinic Proceedings. Elsevier BV. doi:10.1016/j.mayocp.2012.10.013.

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