Biofeedback Treatment of Anxiety Associated With Chronic Spinal Cord Injury
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change in Depression Anxiety Stress Scale-21 (DASS-21) scores
研究概览
简要总结
The purpose of this research is to test the feasibility of an intervention using biofeedback to treat stress and anxiety among individuals with tetraplegia.
The expected duration of participation in this study is about 5 hours over the course of about 5 weeks. Participants will be randomly assigned to either a biofeedback training intervention or a control group. After completing questionnaires, participants will undergo physiological monitoring for the purpose of measuring heart rate and breathing. Those assigned to the biofeedback group will undergo 20 minutes of physiological monitoring while also participating in biofeedback training twice a week for 4 weeks (8 sessions) from home. Those assigned to the control group will undergo 20 minutes of physiological monitoring twice a week for 4 weeks (8 sessions) from home, but will not receive biofeedback training. Each session is expected to last 30 minutes to allow for completion of questionnaires over the the phone prior to and following each training session.
It is hypothesized that the biofeedback intervention will demonstrate high feasibility and compared to those in the control group, participants who receive the biofeedback intervention will attain greater pre-post reductions in both physiological and self-reported stress.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 65
- •Diagnosis of tetraplegia with residual sensory or motor impairments
- •Discharged from inpatient rehabilitation and living in the community
- •Access to high-speed internet at home
- •Willingness to download the videoconferencing software Zoom
- •Access to a mobile phone and willingness to download HRV software
排除标准
- •Does not speak English
- •Scores less than 37 on the STAI
- •Unable to travel to Craig for an initial assessment
- •History of participating in biofeedback training
- •Requires mechanical ventilation
- •Dependent on diaphragm pacer for respiration
- •Currently in treatment for anxiety (e.g., pharmacologic or psychotherapeutic)
- •Associated medical condition for which biofeedback is contraindicated (e.g., psychosis, pacemaker, or other implantable electric device)
- •Currently hospitalized for medical/rehabilitation treatment
- •Unable to commit to the four-week intervention
结局指标
主要结局
Change in Depression Anxiety Stress Scale-21 (DASS-21) scores
时间窗: Baseline (week 0) and Session #8 (week 4)
The Depression Anxiety Stress Scale-21 (DASS-21) is a self report instrument designed to measure core symptoms of depression, anxiety, and stress. Each of the three DASS-21 scales contains seven items, divided into subscales with similar content. Scores for depression, anxiety, and stress are calculated by summing the scores for the relevant items. Items are rated on a scale from 0 (did not apply to me at all) to 3 (applied to me very much or most of time), with higher scores indicating more depression, anxiety, and stress.
Change in physiological stress
时间窗: Session #1 (week 1) and Session #8 (week 4)
Average LF (ms2)
Change in Subjective Units of Distress Scale (SUDS) scores
时间窗: Baseline (week 0) and Session #8 (week 4)
The Subjective Units of Distress Scale (SUDS) is a single-item self report instrument designed to measure the intensity of feelings and other internal experiences such as anxiety, anger, agitation, stress, or other painful feelings. A scale of 0 to 100 will be used to measure the subjective intensity of disturbance or distress experienced by the participant. A higher score indicates greater distress.
次要结局
- State Trait Anxiety Inventory (STAI)(After intervention sessions #1-8 (weeks 1 through 4))
- Symptom list(After intervention session #1 (week 1), before and after intervention sessions #2-8 (weeks 1 through 4))
研究者
Kimberley R Monden
Senior Principal Investigator
University of Minnesota