Summary

Eligibility
for people ages 18-60 (full criteria)
Location
at UCLA
Dates
study started
completion around
Principal Investigator
by Natacha D. Emerson (ucla)

Description

Summary

Biofeedback is a therapeutic paradigm that teaches patients how to gain awareness and control over previously unrecognized sympathetic changes such as body temperature, blood pressure, and heart rate. We propose to use a six session biofeedback protocol that includes heart-rate variability (HRV) biofeedback, respiration/relaxation training, and body temperature control to treat patients with unaddressed respiratory symptoms (e.g. shortness of breath) who are under the care of pulmonologists and have not responded to traditional biomedical approaches (e.g. inhalers, pulmonary rehab, etc.).

Details

Biofeedback is a therapeutic paradigm that teaches patients how to gain awareness and control over previously unrecognized sympathetic changes such as body temperature, blood pressure, and heart rate. Through a series of mind-body techniques, patients are taught to reduce sympathetic responses, leading to self-regulation over physiological responses that affect somatic sensitivity. The investigators propose to use a six session biofeedback protocol that includes heart-rate variability (HRV) biofeedback, respiration/relaxation training, and body temperature control to treat patients with unaddressed respiratory symptoms (e.g. shortness of breath) who are under the care of pulmonologists and have not responded to traditional biomedical approaches (e.g. inhalers, pulmonary rehab, etc.). The aim of the study is to determine whether patients who complete a six-session biofeedback protocol report a decrease in somatic symptoms, and improvements in self-rated mental health (depression, anxiety, quality of life) after the program and at three-months follow-up. The investigators will also study whether these improvements are also related to reduced healthcare utilization.

The investigators plan to recruit up to 100 participants in the study. Participants who are screened as eligible for biofeedback for their physical ailments or psychological complaints will be asked complete a set of questionnaires before, after, and three months' post-treatment to evaluate the utility of the biofeedback treatment protocol. These questionnaires will be available online and will be completed from home. Participants who are eligible to participate but cannot complete questionnaires from home will be given the option of completing the questionnaires in the office before the first biofeedback session. Participants that cannot be immediately enrolled in the protocol due to scheduling reasons will be asked to complete the questionnaires at recruitment to serve as wait-list controls. They will complete the same consent as other participants. The investigators anticipate that questionnaires will take 30 minutes to complete, totaling about 90 minutes for participants immediately enrolled and 120 minutes for wait-list controls.

Each biofeedback session will take 1 hour each. Session 1 of biofeedback will present the rationale and evidence for the treatment, teach breathing techniques, and introduce the biofeedback sensors for respiration, heart rate and temperature using the Biotrace software. The session will focus on breathing rate practice. Session 2 will introduce heart rate variability (HRV), cover breathing rhythm, and focus on the completion Resonance Frequency Assessment, an exercise to identify a participant's ideal breath rate for sustaining HRV. Session 3 will continue HRV practice using a separate software with video games, Alive. Session 4 will repeat session 3 but with more challenging practice of HRV video games. Session 5 will continue HRV practice in the first software (Biotrace) then will introduce participants to temperature control. Session 6 will repeat Session 5 but with more challenging practice for temperature control. Total time for participation will be approximately seven hours across three to six months.

Keywords

Shortness of Breath/Dyspnea, Dyspnea, Respiratory Signs and Symptoms, Immediate Enrollment

Eligibility

You can join if…

Open to people ages 18-60

  1. participants must be between 18-60
  2. English speaking
  3. must have least one respiratory sx and have received care from a pulmonologist for this sx

You CAN'T join if...

severe psychopathology (e.g., psychosis, active suicidality, moderate to severe intellectual impairment).

Location

  • Natacha Emerson accepting new patients
    Los Angeles California 90095 United States

Lead Scientist at University of California Health

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Los Angeles
ID
NCT05973513
Study Type
Observational
Participants
Expecting 25 study participants
Last Updated