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临床试验/NCT05120648
NCT05120648已完成不适用

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

University of California, Los Angeles1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2021年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
1
主要终点
Change in depression score on the PHQ-9

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
15 Years 至 60 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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.).

排除标准

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

结局指标

主要结局

Change in depression score on the PHQ-9

时间窗: 3 months and 6 months

Improvement in self-rated depressive sx on the PHQ-9

Change in quality of life (QOL)

时间窗: 3 months and 6 months

Improvement in self-rated QOL on the SF-36

Improved sleep

时间窗: 3 months and 6 months

Improved sleep and reduced insomnia on the PSQI

Reduced physical symptoms

时间窗: 3 months and 6 months

Improvement in self-rated physical symptoms on the PHQ-15

Reduced health anxiety

时间窗: 3 months and 6 months

Reduced scores on the self-reported Health Anxiety Inventory

Change in anxiety

时间窗: 3 months and 6 months

Improvement in self-rated anxiety sx on the GAD-7

Improved self-efficacy

时间窗: 3 months and 6 months

Improvement in self-rated self-efficacy on the Self-efficacy for Managing Chronic Disease 6-item Scale

次要结局

  • Reduced healthcare utilization(3 months and 6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Natacha D. Emerson

Assistant Clinical Professor

University of California, Los Angeles

研究点 (1)

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