Effects of Biofeedback on Somatic Symptoms

Effects of Biofeedback on Somatic Symptoms, Psychological Adjustment and Health Status of UCLA Patients

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 UCLA patients with chronic medical conditions (e.g. pulmonary, neurology) and somatic symptoms (pain, psychosomatic non-epileptic seizures, panic attacks, long-COVID symptoms). 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.

Study Overview

• Status: Completed
• Conditions: Somatic Symptom
• Intervention / Treatment: Behavioral: Biofeedback

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 UCLA patients with chronic medical conditions (e.g. pulmonary, neurology) and somatic symptoms (pain, psychosomatic non-epileptic seizures, panic attacks, long-COVID symptoms). 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 (Actual): 20

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • UCLA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 60 years (Child, Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

(1) participants must be between 15-60; (2) English speaking; (3) minor participants must have one parent consent to research and treatment; (4) participants must have at least one qualifying somatic complaint (seizure-like spells, pain, nausea) or have psychosocial distress related to the management of their medical conditions (comorbid panic attacks, low mood, etc.).

Description

Inclusion Criteria:

• between 15-60 years of age
• English speaking
• minor participants must have one parent consent to research and treatment
• must have at least one qualifying somatic complaint (seizure-like spells, pain, nausea) or have psychosocial distress related to the management of their medical conditions (comorbid panic attacks, low mood, etc.).

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

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Immediate enrollment	Behavioral: Biofeedback; We propose to study whether patients who complete a clinical six-session biofeedback protocol will demonstrate improvements in mental and physical health.
Wait-list controls	Behavioral: Biofeedback; 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 depression score on the PHQ-9	Improvement in self-rated depressive sx on the PHQ-9	3 months and 6 months
Change in anxiety	Improvement in self-rated anxiety sx on the GAD-7	3 months and 6 months
Reduced physical symptoms	Improvement in self-rated physical symptoms on the PHQ-15	3 months and 6 months
Improved self-efficacy	Improvement in self-rated self-efficacy on the Self-efficacy for Managing Chronic Disease 6-item Scale	3 months and 6 months
Reduced health anxiety	Reduced scores on the self-reported Health Anxiety Inventory	3 months and 6 months
Improved sleep	Improved sleep and reduced insomnia on the PSQI	3 months and 6 months
Change in quality of life (QOL)	Improvement in self-rated QOL on the SF-36	3 months and 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduced healthcare utilization	Fewer medical visits, hospitalizations, ER visits and use of prescription medications by self-report	3 months and 6 months

Collaborators and Investigators

• Sponsor: University of California, Los Angeles

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Actual): September 1, 2024
• Study Completion (Actual): September 1, 2024

Study Registration Dates

• First Submitted: September 13, 2021
• First Submitted That Met QC Criteria: November 3, 2021
• First Posted (Actual): November 15, 2021

Study Record Updates

• Last Update Posted (Actual): October 3, 2024
• Last Update Submitted That Met QC Criteria: October 2, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Medically Unexplained Symptoms
• Other Study ID Numbers: 21-000741

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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