Development and Clinical Evaluation of an mHealth Application for Stress Management

Abstract

A large number of individuals experience mental health disorders, with cognitive behavioral therapy (CBT) emerging as a standard practice for reduction in psychiatric symptoms, including stress, anger, anxiety, and depression. However, CBT is associated with significant patient dropout and lacks the means to provide objective data regarding a patient’s experience and symptoms between sessions. Emerging wearables and mobile health (mHealth) applications represent an approach that may provide objective data to the patient and provider between CBT sessions. Here, we describe the development of a classifier of real-time physiological stress in a healthy population (n = 35) and apply it in a controlled clinical evaluation for armed forces veterans undergoing CBT for stress and anger management (n = 16). Using cardiovascular and electrodermal inputs from a wearable device, the classifier was able to detect physiological stress in a non-clinical sample with accuracy greater than 90%. In a small clinical sample, patients who used the classifier and an associated mHealth application were less likely to discontinue therapy (p = 0.016, d = 1.34) and significantly improved on measures of stress (p = 0.032, d = 1.61), anxiety (p = 0.050, d = 1.26), and anger (p = 0.046, d = 1.41) compared to controls undergoing CBT alone. Given the large number of individuals that experience mental health disorders and the unmet need for treatment, especially in developing nations, such mHealth approaches have the potential to provide or augment treatment at low cost in the absence of in-person care.

Three Questions to Consider Before Applying Ecological Momentary Interventions (EMI) in Psychiatry

“…Currently, the efficacy of EMI applications is mostly evaluated based on patients' self-reports and thus not different from the evaluation of classical face-to-face therapies. In most cases, questionnaires or reports on mental health outcomes are filled in prior to and after the intervention (e.g., 27,28), sometimes with additional follow-up assessments (e.g., 19,29). While selfreports are necessary to gain insights into the subjective perception and evaluation of symptoms, they are potentially confounded by biases (30).…”

“…A small-sampled clinical EMI study on stress and anger management in veterans (27) used mobile cardiovascular and electrodermal measurements to indicate physiological stress. Both the control group (n = 6) and the experimental group (n = 10) received standard CBT for 8 to 10 weeks.…”

Examination of the Impact of Condensed Biofeedback Training on Acute Stress Responses

“…Briefly, baseline HR and EDA were used to normalize real-time HR and EDA data. Normalized data was then subjected to a 2-feature linear model classifier which audibly alerted the participant when ANS stress was observed [43]. Salivary cortisol indicative of HPA stress response was measured by standard ELISA (Salimetrics, Carlsbad CA intra-assay CV = 4.5%, inter-assay CV = 5.8%).…”

Device telemonitoring may observe emotional status - psychological impact of arrhythmic episodes alert.

“…There is evidence for telemonitoring of cardiac implantable electronic devices (CIED) to improve the prognosis in patients with CIED, and remote multiparameter monitoring based on defibrillation devices has become a class II b recommendation in those subjects (2,3) . Telemedicine has also been shown to be helpful to manage psychological status in chronic diseases, and internet-mediated interventions are believed to be effective for depression and anxiety (1,4,5) . Mental disorders related to life with an implantable cardioverter-defibrillator (ICD) are a known and common problem (3) .…”

“…Telemedicine and e-health constitute a modern and quickly developing approach to health care provision (1) . There is evidence for telemonitoring of cardiac implantable electronic devices (CIED) to improve the prognosis in patients with CIED, and remote multiparameter monitoring based on defibrillation devices has become a class II b recommendation in those subjects (2,3) .…”