Biofeedback-aided Intervention for Self-regulation
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- State/Trait Anxiety Scale
研究概览
简要总结
The investigators propose a randomized controlled trial (RCT) to investigate the feasibility and efficacy of non-intrusive biofeedback devices that can be worn throughout the day in providing therapeutic cues to college students suffering from chronic anxiety. The biofeedback device detects physiological stress indices in real time (e.g., changes in breathing rate) and provides feedback (e.g., through minor vibration or text messages) serving as a cue to the wearer to recall therapeutic steps at exactly those moments they need to exert cognitive control. Students will be randomized in a 1) experimental group with biofeedback device and 2) experimental group without biofeedback device. Experimental groups will undergo an intervention that will strengthening cognitive control through mindfulness-based relaxation techniques. Outcome measures will include a multi-method approach collecting questionnaire, behavioral, and psycho-physiological indices of anxiety and self-control. The proposed study is innovative and has the potential to lead to more effective and cost-efficient types of intervention applications in the future.
详细描述
Fourty participants will be tested in approximately 2 groups of 20 each. After individual first lab visits, participants in each cohort will be randomized into two groups: two experimental groups. The experimental group will subsequently attend a group-based relaxation treatment based on mindfulness meditation principles. After this intervention, one of the experimental groups will use the biofeedback device in the next two weeks, whereas the other experimental group will not. Both the biofeedback and No-Biofeedback group will receive texts on a daily basis.
During the lab session, participants will sign informed consent and fill out questionnaires. Questionnaires used will be:
- Difficulties in Emotion Regulation Scale
- State-Trait Anxiety Inventory
- Perceived Stress Scale
- Patient Health Questionnaire
- Sleep Scale from the Medical Outcomes Study
- and a constructed questionnaire about social support ( family & friends)
After that, participants are being hooked up to the ECG and Psychophysiological measures for a Stroop task (identify color of the word). The design will utilize a 1 min congruent task, followed by a 2 minute relaxation period, then a 1 min in-congruent task, followed up a 2 min relaxation period, then another 1 min congruent task, followed by a final 2 minute relaxation period. After that, participants will be deceived to think they will have to give a speech task in front of 5 evaluators. We will, however, inform participants of technical difficulties, resulting in our inability to follow through with the task, then again give the 2 minutes to regulate their physiology. Lab sessions, including set-up, should take about 45 minutes. After the testing section, all physiological measures will be removed and RAs will review meditation/ relaxation strategies with the participant. This relaxation training session will take about thirty minutes. After that, the biofeedback group will be given the biofeedback device as well as instruction on how to pair the device with their phone. After that, participants are free to leave.
The same lab procedures are being followed for the second lab visit after, approximately, two weeks without the relaxation session.
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •students,
- •self-reported chronic anxiety
排除标准
- •Attention Deficit Hyperactive Disorder
- •no major psychiatric disorder ( depression/anxiety okay)
研究组 & 干预措施
Experimental 1
Wearable biofeedback device + Relaxation Training
干预措施: Wearable biofeedback (Device)
Experimental 1
Wearable biofeedback device + Relaxation Training
干预措施: Relaxation Treatment (Behavioral)
Experimental 2
Relaxation Training only
干预措施: Relaxation Treatment (Behavioral)
结局指标
主要结局
State/Trait Anxiety Scale
时间窗: 2 weeks
State Trait Anxiety Index (STAI); Spielberger, Gorsuch, Lushene, Vagg, \& Jacobs, 1983
Heart Rate
时间窗: 2 weeks
Using Biopac
Perceived Stress Scale
时间窗: 2 weeks
Perceived Stress Scale; Cohen, Kamarack, \& Mermelstein, 1983
Respiratory Sinus Arrithmiya
时间窗: 2 weeks
Using Biopac
Difficulties in Emotion Regulation Scale
时间窗: 2 weeks
Difficulties in Emotion Regulation (DERS); Gratz \& Roemer, 2004
Heart Rate Reactivity
时间窗: 2 weeks
Using Biopac
次要结局
未报告次要终点
研究者
Steven Woltering
Assistant Professor
Texas A&M University