Medical Policy

Wearable devices for stress relief are typically worn on the wrist, waist, skin, or clothes to aid wearers in identifying stressful triggers. Stress relief wearables often include biofeedback to help wearers learn to modify their physiologic response and may contain a therapeutic intervention, such as a calming vibration, activated by device-detected physiologic stressful stimuli or devices for audio-visual entrainment (AVE).

Note: Some benefit plans may exclude coverage of consumer wearable devices (such as a smart phone, smart watch, or other personal tracking devices), including any software or applications. Over-the-counter (OTC) applications are generally excluded from benefit plan coverage.

Investigational and Not Medically Necessary:

Wearable devices for management, monitoring or prevention of stress and stress-related conditions are considered investigational and not medically necessary for all indications.

Published research to date on the reliability and efficacy of wearable devices for stress relief largely consists of case-series and cohort studies.

In 2017, Betti and colleagues conducted a study to develop and test the ability of a wearable physiological sensors system, based on electrocardiogram (ECG), electrodermal activity (EDA) and electroencephalogram (EEG), to detect stress and to assess whether related physiological changes in signals were associated with changes in salivary cortisol levels (a validated, reliable, and objective biomarker of stress). A total of 15 healthy participants (mean age 40.8 years), wore a set of 3 commercial sensors (Shimmer Sensor and MindWave Mobile EEG headset) to record physiological signs during application of Maastricht Acute Stress Test. Salivary samples were collected throughout the different phases of the test. Correlation analysis showed that the observed changes in physiological features were consistently associated with levels of salivary cortisol (R2=0.714). The clinical utility of these sensors and their impact on meaningful clinical outcomes remains to be established.

In 2017, Azevedo and colleagues published results of an investigation of whether the use of the Doppel wristband device could alleviate physiological arousal and anxiety during the anticipation of a presentation. A total of 52 study participants were randomized into two groups in a single-blind fashion (both wearing the device on their wrist which they were told monitored blood pressure). For the intervention group only (n=25), the device emitted a slow heartbeat-like vibration. Spontaneous fluctuations in skin conductance (NS-SCRs) analyses were used to measure autonomic arousal for 5 minutes while participants were instructed to prepare a speech in 5 minutes which they would then have to present for 3-4 minutes to study investigators. The presentation requirement was fabricated but all participants, except 1, believed they would have to present. At baseline, both groups demonstrated comparable levels of objective arousal (NS-SCRs analysis) and objective anxiety, participants in the active Doppel arm showed a significantly smaller increase in arousal relative to the control group during the assigned task (period of ‘anticipation’) (t[1, 50]=2.24; p=0.029,). Similarly, at the end of the speech preparation (5 minutes later), the active Doppel arm demonstrated a significantly smaller increase in their subjective anxiety measures compared to the control group (t[1, 50]=2.79, p=0.007). There was no significant difference in average heart rate between the groups during or after the task. The underlying mechanism through which Doppel may elicit an effect on skin conductance, or subjective measures of anxiety, is not understood.

In 2019, Can and colleagues collected physiological data over 9 days from 21 participants of an algorithmic programming contest. The event included lectures, contests and free time. By using heart rate activity, skin conductance and accelerometer data, study investigators were able to successfully discriminate contest programming stress, an increased cognitive load (during lecture) and down-time activities by using machine learning methods. This feasibility study suggests that further study is warranted to determine the clinical utility of such measurement tools in identifying and managing stress.

In 2020, Han and colleagues published data from wearable systems that provide objective daily stress measurements based on three physiological measurements obtained using ECG, photoplethysmogram (PPG) (detects blood volume changes in the microvascular bed of tissue) and galvanic skin response (GSR) using Shimmer3 ECG, Shimmer3 GSRþ, and Empatica E4 wearable sensors. Controlled stress assessments were conducted on 17 participants via laboratory-based stress tests consisting of several tasks designed to induce short-term stress. In a smaller subset of participants, investigators also collected physiological data during everyday life along with self-reported stress levels every 30 minutes (n=3). Study results demonstrated 94.55% accuracy in the generalized model for stress detection. This feasibility study with a limited number of participants suggests measurement of physiological signals may reliably predict periods of stress. The clinical utility and efficacy of such data remains to be established.

In 2021, Yamane and colleagues published results of a randomized trial in which 28 individuals were randomized to use of the Breathe app or non-Breathe app group. Study investigators used heart rate variability (HRV) as an objective outcome in addition to anxiety questionnaires. Both groups were assigned identical relaxing tasks for 10 minutes, including listening to calming music and completion of an anxiety questionnaire. The groups were then given differing tasks to perform over a 10-minute period in preparation for a speech. The Breathe app group completed 2, 5-minute breathe cycles following guidance provided by the app which also transmitted vibrations to the wrist. The control group was asked to listen to an explanation of the study for 10 minutes just prior to speaking in an effort to inhibit them from performing alternative relaxing techniques. Participants were given instructions on how to deliver their speech which was to be recorded and judged, then 10 minutes to prepare and 5 minutes to present. Following the speech, another anxiety questionnaire was administered. The study validated via both the subjective and objective measurements that the task significantly increased participants’ stress. The effect of the Breathe app on participants’ objective and subjective measures during speech delivery were compared and significant differences were found across many measures. While objective measurement showed a significant difference in heart rate (p=0.02), subjective measurements were similar between the two study arms. Further study is warranted.

In 2021, Hickey and colleagues conducted a systematic review which included 21 studies with the aim of critically appraising the most recent smart devices and wearable technologies used to identify depression, anxiety, and stress, as well as critique the physiological processes used to enable their detection. The included articles that assessed stress and anxiety unanimously used heart rate variability (HRV) parameters for detection of anxiety and stress; stress was better detected by HRV and EGG together. The systematic review concluded that average heart rate used by many commercially available smart devices is not as accurate in the detection of stress and anxiety compared with HRV and electrodermal activity.

In 2021, Giorgi and colleagues studied the reliability and capability of two consumer wearable devices (Empatica E4 and Muse 2) in discriminating specific mental states compared to laboratory equipment. Electrooculographic (EOG) (used to investigate eye movements), EDA and PPG signals were acquired from a group of 17 volunteers who were exposed to a variety of scenarios designed to induce different levels of mental workload, stress, and emotional states. The results demonstrated that the parameters computed by the consumer wearable and laboratory sensors were positively and significantly correlated to one another. The impact of these findings on the clinical utility of the devices warrants further investigation.

In 2021, Nguyen and colleagues conducted a randomized controlled trial (RCT) involving 28 children diagnosed with autism spectrum disorder (ASD) to assess whether a wearable, real-time device called the Anxiety Meter improved wearers ability to detect symptoms related to anxiety prompting faster initiation of relaxation techniques (i.e., diaphragmatic breathing). Study participants were taught how to use diaphragmatic breathing over the course of three visits, on the fourth and final visit participants were randomized to receive feedback via the wearable device or not. All participants were prompted to initiate the relaxation technique if they detected stress. The study reported that feedback from the device was associated with increased likelihood of initiating deep breathing in response to anxiety. Study limitations include the small sample size and single visit measurement to assess the efficacy of the intervention. Study authors concluded that a real-time, anxiety symptom detecting wearable device is feasible for improving anxiety management techniques in ASD. Further research is warranted.

In 2022, Lui and colleagues sought to characterize physiological monitoring capabilities of the Apple Watch and the potential implications for behavioral health treatment. A total of 19 validation or comparison studies were identified, most demonstrated that the Apple Watch could measure heart rate reasonably well, but errors in accuracy increased with movement. Heart rate variability measurements were able to detect mild stress. The Apple Watch was reported to overestimate energy expenditure but provided the most reliable results relative to comparative devices. None of the studies examined sought to validate the efficacy of the Sleep app feature though the accelerometer’s ability to detect sleep disturbances was promising. The review authors concluded, that “...a lack of methodologically robust and replicated evidence of user benefit … and concerns about personal health information remain key factors that must be addressed to enable broader uptake.”

In 2024, Lee and colleagues published results of a randomized, double-blind, RCT designed to evaluate the effectiveness and safety of a neurofeedback wearable device to reduce stress. Enrolled participants (n=38) had a diagnosis of psychological stress with depression or sleep disturbances and were randomly assigned to wearable neurofeedback-assisted meditation (n = 20) or neurofeedback non-assisted meditation (n = 18) for 12 minutes twice a day for 2 weeks. The non-assisted meditation group demonstrated a marginally significant change in Perceived Stress Scale score after the 2-week intervention compared to the control group (6.45 ± 0.95 vs. 3.00 ± 5.54, p=0.037). While depressive mood and sleep improved in each group from baseline, there was no significant difference between the two groups. There were no significant differences between the two groups in objective measures of stress-related physiological parameters, such as stress hormones or qEEG. Subjective measurement of device satisfaction was significantly higher in the intervention group compared to the control group (p=0.008). This study did not demonstrate improvement in objective stress-related physiological measures related to a wearable biofeedback device. Further study is warranted.

Stress is defined as a type of change or stimuli that causes physical, emotional, or psychological strain beyond available resources. Physiologic stress is defined as a body's response to the stimuli or change. While everyone experiences stress to some degree, and stress in and of itself is not inherently bad, chronic stress and the body’s physiologic response to stressful stimuli are associated with a multitude of disease processes.

In 2021, the American Psychological Association reported that 3 out of 4 adults self-identified as experiencing ‘high’ levels of stress in the year prior. Recently, there has been mounting interest in the utility of wearable monitoring devices to assess stress levels and physiologic responses to stressful stimuli, including audio-visual entrainment (AVE), a technique that emits pulses of light and sound with the aim of altering brainwave patterns. It is theorized that tracking and monitoring levels of stress can increase the wearer’s awareness of stressful stimuli as well as provide opportunity for intervention. As such, wearable devices are being explored as a medium for aiding in the development of coping skills to reduce the intensity of physiologic responses with the end-goal of minimizing negative impacts on overall health and quality of life. At this time, research in this area is in early development as manufacturers explore the reliability and efficacy of wearable devices for stress management.

The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

When services are Investigational and Not Medically Necessary:
For the following procedure codes, or when the code describes a procedure indicated in the Position Statement section as investigational and not medically necessary.

Peer Reviewed Publications:

1. T Azevedo R, Bennett N, Bilicki A, et al. The calming effect of a new wearable device during the anticipation of public speech. Sci Rep. 2017; 7(1):2285.
2. Betti S, Lova RM, Rovini E, et al. Evaluation of an integrated system of wearable physiological sensors for stress monitoring in working environments by using biological markers. IEEE Trans Biomed Eng. 2018; 65(8):1748-1758.
3. Can YS, Chalabianloo N, Ekiz D, Ersoy C. Continuous stress detection using wearable sensors in real life: algorithmic programming contest case study. Sensors (Basel). 2019; 19(8):1849.
4. Giorgi A, Ronca V, Vozzi A, et al. Wearable technologies for mental workload, stress, and emotional state assessment during working-like tasks: A comparison with laboratory technologies. Sensors (Basel). 2021; 21(7):2332.
5. Han HJ, Labbaf S, Borelli JL, et al. Objective stress monitoring based on wearable sensors in everyday settings. J Med Eng Technol. 2020; 44(4):177-189.
6. Hickey BA, Chalmers T, Newton P, et al. Smart devices and wearable technologies to detect and monitor mental health conditions and stress: a systematic review. Sensors (Basel). 2021; 21(10):3461.
7. Lee E, Hong JK, Choi H, Yoon IY. Modest effects of neurofeedback-assisted meditation using a wearable device on stress reduction: a randomized, double-blind, and controlled study. J Korean Med Sci. 2024 11; 39(9):e94.
8. Lui GY, Loughnane D, Polley C, et al. The Apple Watch for monitoring mental health-related physiological symptoms: literature review. JMIR Ment Health. 2022; 9(9):e37354.
9. Nguyen J, Cardy RE, Anagnostou E, et al. Examining the effect of a wearable, anxiety detection technology on improving the awareness of anxiety signs in autism spectrum disorder: a pilot randomized controlled trial. Mol Autism. 2021; 12(1):72.
10. Yamane T, Nakadoi Y, Takagi M, Morita M. Simple wearable device to reduce stress when delivering a speech without pe-training. Healthc Inform Res. 2021 Jul;27(3):231-240.

Government Agency, Medical Society, and Other Authoritative Publications:

1. American Psychological Association. Stress in America: One Year Later, A New Wave of Pandemic Health Concerns. 2021. Available at: https://www.apa.org/news/press/releases/stress/2021/sia-pandemic-report.pdf. Accessed on October 14, 2024.

1. American Psychological Association. Wearable devices as therapy tools. 2021. Available at: https://www.apa.org/monitor/2021/09/sidebar-wearable-devices. Accessed on October 14, 2024.

Apollo Neuro
Apple Watch Series 6
Bellabeat Leaf Jewelry
BioHarness
Cove
Ember Wave 2
Empatica
Fitbit Sense
Flowtime
Mind Alive
MindWave Mobile
Muse 2 headband
Pip
Sensate 2
Thunc
TouchPoint
WHOOP
Withings ScanWatch2

The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

Applicable to Commercial HMO members in California: When a medical policy states a procedure or treatment is investigational, PMGs should not approve or deny the request. Instead, please fax the request to Anthem Blue Cross Grievance and Appeals at fax # 818-234-2767 or 818-234-3824. For questions, call G&A at 1-800-365-0609 and ask to speak with the Investigational Review Nurse.

Federal and State law, as well as contract language, including definitions and specific contract provisions/exclusions, take precedence over Medical Policy and must be considered first in determining eligibility for coverage. The member’s contract benefits in effect on the date that services are rendered must be used. Medical Policy, which addresses medical efficacy, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving, and we reserve the right to review and update Medical Policy periodically.

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