Feasibility of using a biofeedback device in mindfulness training - a pilot randomized controlled trial.
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BACKGROUND: Stress can negatively impact an individual's health and well-being and high levels of stress are noted to exist among college students today. While traditional treatment methods are plagued with stigma and transfer problems, newly developed wearable biofeedback devices may offer unexplored possibilities. Although these products are becoming commonplace and inexpensive, scientific evidence of the effectiveness of these products is scarce and their feasibility within research contexts are relatively unexplored. Conversely, companies are not required, and possibly reluctant, to release information on the efficacy of these products against their claims. Thus, in the present pilot, we assess the feasibility of using a real-time respiratory-based biofeedback device in preparation for a larger study. Our main aims were to assess device-adherence and collaboration with the company that develops and sells the device. METHOD: Data were collected from 39 college students who self-identified as experiencing chronic stress at a Southwestern university in the USA. Students were randomized into either a mindfulness-only control group without a biofeedback device (n = 21), or an experimental group with biofeedback device (n = 18). Both groups received mindfulness meditation training. Pre-test and post-test procedures were conducted 2 weeks apart. Further, both participant compliance and company compliance were assessed and collaboration with the company was evaluated. RESULTS: Participant device-adherence as well as the company's collaboration necessary for a full-scale study was determined to be low. This may also have affected our results which showed a strong main effect for time for all outcome variables, suggesting all groups showed improvement in their levels of stress after the intervention period. No group by time effects were identified, however, indicating no added benefit of the biofeedback device. CONCLUSIONS: Our findings suggest feasibility of future studies requires full collaboration and detailed and agreed upon data sharing procedures with the biofeedback company. The particular device under investigation added no value to the intervention outcomes and it was not feasible to continue a larger-scale study. Further, as the technology sector is innovating faster than it can validate products, we urge for open science collaborations between public and private sectors to properly develop evidence-based regulations that can withstand technological innovation while maintaining product quality, safety, and effectiveness. TRIAL REGISTRATION: NCT02837016 . Registered 19 July 2016.