Effects of Biofeedback on Somatic Symptoms

NCT05120648 | Completed

• 1 other identifier: 21-000741
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Somatic Symptom

Outcome Measures

Primary Outcomes (7)

• 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 quality of life (QOL)

  Improvement in self-rated QOL on the SF-36

  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

Secondary Outcomes (1)

• Reduced healthcare utilization

  3 months and 6 months

Study Arms (2)

Immediate enrollment

Behavioral: Biofeedback

Wait-list controls

Behavioral: Biofeedback

Interventions

Biofeedback BEHAVIORAL

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

Immediate enrollment; Wait-list controls

Eligibility Criteria

• Age: 15 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.).

You may qualify if:

• 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.).

You may not qualify if:

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

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

UCLA

Los Angeles, California, 90095, United States

Location

Related Publications (1)

• Emerson ND, Lavretsky H, Pittman WQ, Viswanathan N, Siddarth P. An open trial of biofeedback for long COVID. J Psychosom Res. 2024 Apr;179:111625. doi: 10.1016/j.jpsychores.2024.111625. Epub 2024 Feb 23.

  PMID: 38458016 DERIVED

MeSH Terms

Conditions

Medically Unexplained Symptoms

Interventions

Biofeedback, Psychology

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Feedback, Psychological

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Clinical Professor

Study Record Dates

• First Submitted: September 13, 2021
• First Posted: November 15, 2021
• Study Start: September 1, 2021
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: October 3, 2024

Record last verified: 2024-10

Locations

US (1)