• Sensate® is vibrotactile wellness device that offers a soothing mechanism known as Somacoustics

• ●  Somacoustics pairs infrasonic resonance with aural soundscapes, promoting relaxation and calmness

  Background

• ●  Before the pandemic, perceived stress levels, as determined by the perceived stress scale (PSS-10), were

  approximately 14-17 pts (0-40 pts)

• ●  Since the pandemic, average PSS-10 scores have increased to approximately 20 pts and have noted to be > 22

  pts in certain populations including those with anxiety disorders

• ●  Prolonged stress severity leads to the development of anxiety and depressive disorders and excess stress can

  lead to an anxiety disorder relapse

• ●  Those with anxiety or depressive disorders have lower levels of positive affect (e.g., enthusiasm, inspiration,

  and excitement) and higher levels of negative affect (e.g., fear, nervousness, and irritability)

0. BioSelf Technology sponsored this study. Scott McDoniel, Ph.D., is an independent research consultant for this research project and has 20 years of clinical research experience. Dr. McDoniel is not an employee of BioSelf Technology and owns no patents, stock, or equities in BioSelf Technology or Sensate.

A comparative design from a cross sectional survey of 227 adults usingSensate from February 2022-August 2022.

Perceived stress levels have increased from the COVID-19 pandemic (TMGH-Global COVID-19 Collaborative, 2021;). Before the pandemic, perceived stress levels, as determined by the perceived stress scale (PSS-10), were approximately 14-17 pts (TMGH-Global COVID-19 Collaborative, 2021; Cohen & Janicki-Deverts 2012; Andreou, et al., 2012;). Since the pandemic, average PSS-10 scores have increased to approximately 20 pts (Aly et al., 2021; Meaklim et al., 2021; TMGH-Global COVID-19 Collaborative, 2021; Agyapong et al., 2020), and those with anxiety disorders have higher stress scores compared to nonanxious individuals (TMGH-Global COVID-19 Collaborative, 2021; Agyapong et al., 2020; Cohen & Janicki-Deverts 2012; Andreou et al., 2012).

Prolonged stress severity can result in anxiety and depressive disorders (Khan and Khan, 2017). Moreover, excess stress can lead to an anxiety disorder relapse (Francis, Moitra, Dyck, & Keller, 2012). There are emotional differences between those with and without anxiety or depressive disorders. Individuals with anxiety and depressive disorder demonstrate cognitive and affective hyperactivity and describe feeling more threatened and less in control of their emotions when compared to nonanxious individuals (Llera & Newman, 2010).

Moreover, individuals with anxiety or depressive disorders have a lower positive affect and higher negative affect compared to individuals without these disorders (Díaz-García et al., 2021; Díaz-García et al., 2020, Serafini, Malin-Mayor, Nich, Hunkele, & Carroll, 2016; Watson, Clark, & Tellegen, 1988).

Emotion-focused coping is a component of stress management intended to lower perceived stress and negative affect. Emotion-focused coping includes soothing behaviors or mechanisms that provide extrinsic and intrinsic processes involved in monitoring, evaluating, and modifying emotional reactions (Gross, 1998; Lazarus, 1993). Soothing behaviors may include listening to music, taking a shower, massage, and meditation. ). Listening to music was one of the most effective coping strategies during the COVID-19 pandemic (Krause, Dimmock, Rebar, & Jackson, 2021; Ribeiro, Lessa, Delmolin, & Santos, 2021; Vidas, Larwood, Nelson, & Dingle, 2021 ). In addition, non-noxious sensory stimulation is a soothing mechanism that offers a pleasurable benefit (Sigurdardóttir et al., 2019; Uvnäs-Moberg, Handlin, & Petersson, 2015). Sensate® is a vibrotactile wellness device providing a non-noxious, somatosensory experience called Somacoustics (McDoniel & Chmelik, 2022). Somacoustics combines infrasonic resonance with aural soundscapes, which posits relaxation and calmness. However, it is unknown if there are differences in perceived stress or affects in adults with and without anxiety disorder using somacoustics for emotion-focused coping.

This study aimed to determine if there was a difference in perceived stress, positive affect, and negative affect in adults with and without anxiety or depression using Sensate for emotion-focused coping.

This study was a casual comparative analysis of current adult Sensate users. The research data set was obtained following Human Subject Regulations 45 CFR Part 46 and per the principles stated in the Declaration of Helsinki.

Inclusion for this study were adults who were consistent Sensate users (> 3 days per week) and had been using Sensate for 1-6 months (January-June 2022). Groups were assigned based on a self-reported diagnosis of a mental health disorder (Anxiety, Obsessive Compulsive Disorder, Post-Traumatic Stress Disorder, and Depression). Group 1 included adults reporting no prior mental health disorder diagnosis history.

Perceived stress has increased due to the COVID-19 pandemic. In addition, those with diagnosed anxiety or depressive disorders note higher perceived stress ratings than those without these conditions. Moreover, those with anxiety and depression exhibit lower positive and more significant negative affect when compared to nonanxious or depressive individuals. Emotion-focused coping can be a practical adjunctive component with problem-based solutions during elevated stress. However, it is unknown if there are differences in perceived stress and cognitive affect in adults with and without anxiety or depression using a novel wellness device for emotion-focused coping. 

Ninety-seven adults using the novel wellness device completed an online version of the Perceived Stress Scale (PSS-10) and Positive and Negative Affect (PANAS). Group One (NANXD) included 34 individuals without a history of anxiety or depression; Group 2 had 58 individuals with an anxiety disorder and 5 with depressive disorder (ANXD). The average length of use of the wellness device was 3.5 months, with an average usage per week of 5-6 days. There was no significant difference in perceived stress between the NANXD (17.6 + 5.3) group and the ANXD (17.0 + 5.5). Over 70% of the study participants scored in the Low, Normal, or Mild stress classification per PSS-10. Moreover, there were no significant differences in positive or negative affect between groups. There was a meaningful relationship between perceived stress and positive affect (r= -.47, p<0.001) and perceived stress and negative affect (r= -.69, p<0.001). Therefore, individuals with lower perceived stress while using the wellness device were associated with higher positive and lower negative affect. A Chi-Square Goodness of Fit (GOF) test suggests the proportion of those with an anxiety disorder reported an improvement in their condition X2(1,n=58)= 6.90, p<0.01. Over 65% of the ANXD participants reported their anxiety as improved. There was no reported worsening of anxiety or depressive conditions in this population. Emotion-based coping with the novel wellness device appears to be a safe and viable strategy during stress in those with and without anxiety or depression. 

Two hundred and thirty-one (231) Individuals were evaluated for inclusion. Ninety-seven (97) individuals met the inclusion criteria. Group 1 included 34 individuals; Group 2 had 58 individuals with Anxiety Disorder and 5 with Depressive Disorder.

• ●  Sensate usage was similar between groups. The average use was five days per week, with the majority reporting using the 10 and 20-minute sensate sessions.

• ●  There was no significant difference in PSS levels between groups. The non-anxiety group had a mean PSS score of 17.6 (SD: 5.3; 95% CI: 15.6-19.2), and the anxiety group had a PSS score of 17.0 (SD: 5.5; 95% CI: 15.6-18.3). However, a large majority (> 70%) of users from both groups report PSS levels that would be low, normal, or mild levels of stress (Cohen & Janicki-Deverts, 2012; Andreou et al., 2012) (Figure 1).

• ●  Positive affect assesses emotional constructs related to determination, enthusiasm, inspiration, and excitement. There was no significant difference in positive affect between those with and without anxiety. However, a significant negative correlation between perceived stress and positive affect suggests that those with higher perceived stress scores have lower positive affect scores (r= -.47; 95% CI: -.61 to -.21; p<0.001) (Figure 2).

• ●  Negative affect assesses emotional constructs related to distress, fear, irritability, and nervousness and is correlated with the Beck Anxiety Inventory, State Anxiety, and Beck Depression Inventory (Díaz-García et al., 2021; Díaz-García et al., 2020, Serafini, Malin-Mayor, Nich, Hunkele, & Carroll, 2016; Watson, Clark, & Tellegen, 1988). There was a significant, positive correlation between perceived stress and negative affect, suggesting those with higher perceived stress scores had a higher negative affect score (r=.69; 95% CI; .56 to 78; p<.001) (Figure 3).

• ●  A Chi-Square Goodness of Fit (GOF) test was performed to determine whether the proportion of those with an anxiety disorder reported an improvement in their condition. The proportions significantly differed with a preference for improvement, X2(1,n=58)= 6.90, p<0.01. Approximately 41.4% of those with anxiety report an improvement, and 26% of the participants report their anxiety as greatly improved. There was no significant difference in perceived anxiety changes between types of anxiety (p=.07), as noted by a Pearson Chi-Square test (Figure 4).

• ●  Twelve individuals (55%) with a history of depression (n=20) reported an improvement in their depressive disorder. There was no reported response of worsening of depression, as eight reported no changes. Chi-Square GOF was performed to determine if there was a significant difference between responses, and the proportions did not differ, X2(1, n=18)=.80, p=.37.

• ●  Most adults with and without anxiety using Sensate for approximately five days per week between 1-6 months appear to obtain low to mild stress levels.

• ●  There is no difference in positive or negative affect between those with and without an anxiety disorder or depressive disorder that use Sensate. Lower stress levels are related to lower negative and higher positive affect scores among the study participants.

• ●  A large majority (>65%) of participants with anxiety disorder and over 50% with a depressive disorder reported an improvement in their condition while using Senate for emotion-based coping. There was no reported worsening of anxiety or depressive states.

• ●  Somacoustics appears to be a safe and viable emotion-based coping strategy during stress.

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Summary Report for BioSelf Technology, LTD 5 Scott McDoniel, PhD; Primary Investigator

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Summary Report for BioSelf Technology, LTD 6 Scott McDoniel, PhD; Primary Investigator

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