A majority of the >1 million people who require life support in an intensive care unit (ICU) now survive. As survival has improved however, growing numbers suffer not only from subsequent physical disability, but also persistent symptoms of depression, anxiety, and post-traumatic stress disorder (PTSD). Few interventions address ICU survivors' psychological distress. Fewer still address the physical, geographical, and logistical barriers to receiving post-discharge support that medically ill populations encounter. Consequently, this population suffers with an unmet need of great public health importance. Mindfulness is an adaptable self-regulation practice that alleviates psychological distress symptoms using a variety of meditative techniques, typically taught face-to face over months. As an extension of standard mindfulness practices, we developed a telephone-/web-delivered mobile mindfulness-based training (mMBT) system informed by ICU survivors' input that could address medically ill patients' delivery barriers. Our recent pilot study demonstrated early support for mMBT's feasibility and acceptability, now with enhanced content and electronic patient-reported outcomes capability. Our early work on mMBT, while promising, identified key knowledge gaps in population targeting, plausible ranges of psychological distress estimates relevant to study design, and assurance of acceptability that must be addressed before a definitive clinical trial is conducted. Therefore, we propose a 2-year pilot study targeting NCCAM PAR-14-182 in which 70 ICU survivors are randomized to 6 weekly telephone sessions of either mMBT or an education control.
Our specific aims will use quantitative and qualitative methods to: (1) evaluate mMBT feasibility, acceptability, and usability as well as (2) better estimate mMBT's effect on psychological distress symptoms. In an exploratory aim, we will explore the impact of self-directed mMBT in a 20-person uncontrolled study informed by Aims 1 & 2. Innovative elements of our proposal include a using ICU survivors as a model for studying medically ill patients with barriers to care, a mobile health delivery system, focus on common barriers to post- discharge therapy, amenability to wide dissemination, and exploration of potentially paradigm-shifting automated stepped therapy-elements that could improve access to mind-body therapies and enhance the feasibility of large-scale mind-body clinical trials involving serious illness. Overall, this R34 project is necessary and sufficient to inform a future RCT that could advance the field of critical care with a personalizable therapy that empowers patients to participate in their own recovery.
Each year over 1 million people develop critical illness and need life support. Over half of these patients suffer from serious symptoms of depression, anxiety, and PTSD for over 1 year after hospital discharge. However, very little research has been done on how to improve this serious problem. This proposal aims to determine if a promising mindfulness meditation training program provided by telephone and the internet is a helpful research direction for addressing this group's persistent, disabling distress.
