Innovations in Biofeedback and Its Use in Mental Health
- Conditions
- Biofeedback, PsychologyAnxiety
- Registration Number
- NCT03618121
- Lead Sponsor
- East Tennessee State University
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Beck Anxiety Inventory 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) 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 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 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.
- Secondary Outcome Measures
Name Time Method 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. Subject report of average hours of sleep per night