Innovations in Biofeedback and Its Use in Mental Health
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Beck Anxiety Inventory
研究概览
简要总结
This study investigates the use of new technologies in "biofeedback gaming" and their potential for use as a treatment for stress and anxiety. Biofeedback training is typically accomplished through devices that measure heartrate variability (HRV), galvanic skin response (GSR), or electroencephalogram (EEG). Typically, the use of this equipment requires a practitioner with specialized training in reading and interpreting HRV, GSR, and/or EEG. However, recent advances in technology have made biofeedback devices more readily available to the general public, and some commercial devices are now being sold. This study investigates the utility of these commercial devices with a mild clinical population. In this study, participants use two tools for biofeedback training, one is called "The Pip," described in Group C, below, and another is a computer game called Nevermind, described in Groups A and B, below. These are compared against a control group (group D), which is standard relaxation training without biofeedback.
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
- Double (Participant, Investigator)
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Biofeedback plus gaming (Nevermind)
- Group A is a biofeedback plus gaming group. Participants in this group play a horror videogame called Nevermind, while also wearing a chest strap heart rate monitor. The object of the videogame is to assist a patient by entering his/her mind and helping him/her work through some trauma memories. The way the game works is that the more anxious players are, the faster their heart beats, and the faster the heart beats, the harder and scarier the game gets. Thus, in order for one to do well in the game, he or she has to learn how to control the heartbeat and stress through relaxation. A therapist will help people in this group to learn relaxation techniques to help calm their body and finish the game.
干预措施: Biofeedback plus gaming (Nevermind) (Device)
Gaming only
- Group B is a gaming only group. Like Group A, participants in this group play a Nevermind, but this time they do not wear a heart rate monitor. A therapist will still be present to help people in this group to learn relaxation techniques to help calm themselves during game play, but in this case the game does not change based on heart rate.
干预措施: Gaming only (Behavioral)
Biofeedback only (The Pip)
- Group C is a biofeedback only group. In Group C, participants use a device called The Pip that measures Galvanic Skin Response. The Pip interacts with a few basic apps used in this study to teach relaxation. In one app, players control flying dragons. The more relaxed players are (as measured by GSR), the higher and faster their dragon flies. In another app, players control the changing of seasons. The more relaxed players are, the faster they can make seasons change from winter to spring. In another app, players can watch a simple graph of their stress over a period of time. Participants can learn to decrease stress by learning to make the line on the graph go down. In Group C, a therapist will also be present with participants to help them learn techniques to reduce stress.
干预措施: Biofeedback only (The Pip) (Device)
Relaxation training only
- Group D is a relaxation training only group. In Group D, participants receive relaxation training from a trained therapist. Participants in this group learn and practice with their therapist different techniques to help them relax and reduce stress.
干预措施: Relaxation training (Behavioral)
结局指标
主要结局
Beck Anxiety Inventory
时间窗: Baseline, post-treatment change in outcome 4 days after session 8, and follow-up change in outcome 6-weeks after session 8.
21-item symptom checklist. Total score will be used as outcome. Total score ranges from 0-63, with higher scores indicating more anxiety.
Anxiety Disorders Interview Schedule - 5 (ADIS-5)
时间窗: Baseline, post-treatment change in outcome 4 days after session 8, and follow-up change in outcome 6-weeks after session 8.
Diagnostic interview for anxiety disorders
COPE
时间窗: Baseline, post-treatment change in outcome 4 days after session 8, and follow-up change in outcome 6-weeks after session 8.
60-item measure assessing a broad range of coping responses. There are 15 subscales, each representing a different coping skill and each ranging in score from 4-16, with higher scores indicating more frequent usage of each of the 15 measured coping skills.
Perceived Stress Scale
时间窗: Baseline, post-treatment change in outcome 4 days after session 8, and follow-up change in outcome 6-weeks after session 8.
10-item measure of perceived stress. Total score used as primary outcomes. Total scores range from 0-40 with higher scores indicating higher levels of perceived stress.
次要结局
- Functional outcome (sleep)(Baseline, post-treatment change in outcome 4 days after session 8, and follow-up change in outcome 6-weeks after session 8.)
研究者
Jason Steadman
Assistant Professor of Psychology
East Tennessee State University