Open Trial of Biofeedback for Respiratory Symptoms

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.).

Study Overview

• Status: Not yet recruiting
• Conditions: Shortness of Breath/Dyspnea

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 25

Contacts and Locations

• Study Contact: Name: Natacha D Emerson, PhD; Phone Number: 310-794-8416; Email: ndemerson@mednet.ucla.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

(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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Immediate Enrollment; We propose to study whether patients who complete a clinical six-session biofeedback protocol will demonstrate improvements in mental and physical health.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in score on the PHQ-9	Improvement in self-rated depressive sx on the PHQ-9	After six week protocol and 3 months after six week protcol
Change in score on the GAD-7	Improvement in self-rated anxiety sx on the GAD-7	After six week protocol and 3 months after six week protcol
Change in score on the SF-36	Improvement in self-rated QOL on the SF-36	After six week protocol and 3 months after six week protcol
Change in score on the PHQ-15	Improvement in self-rated physical symptoms on the PHQ-15	After six week protocol and 3 months after six week protcol
Change in score on the PSQI	Improvement in self-rated sleep quality and duration on the PSQI	After six week protocol and 3 months after six week protcol
Change in score on the St George's Respiratory Questionnaire (SGRQ)	Improvement in self-rated respiratory sx on the SGRQ	After six week protocol and 3 months after six week protcol

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in healthcare utilization	Reduced healthcare utilization: Fewer medical visits and use of prescription and OTC meds in last month	After six week protocol and 3 months after six week protcol

Collaborators and Investigators

• Sponsor: University of California, Los Angeles

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2023
• Primary Completion (Estimated): July 31, 2025
• Study Completion (Estimated): July 31, 2026

Study Registration Dates

• First Submitted: July 17, 2023
• First Submitted That Met QC Criteria: July 31, 2023
• First Posted (Actual): August 3, 2023

Study Record Updates

• Last Update Posted (Actual): August 3, 2023
• Last Update Submitted That Met QC Criteria: July 31, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Dyspnea; Signs and Symptoms, Respiratory
• Other Study ID Numbers: 21-000741-B

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No