[0001] BACKGROUND OF THE INVENTION

[0002] Field of the Invention

[0003] The invention relates generally to the fields of mental health assessment and treatment and the balance of physiological and mental states through the use of yoga. The invention employs a secure web-based communication platform for instantaneous and ongoing interaction.

[0004] Description of Background Art

[0005] Workout and fitness programs have become increasingly popular with the general public. Such programs can be designed for improving a user's condition as a result of excessive weight, physical injury or decreased range of motion, as well as psychological symptoms such as depression and anxiety.

[0006] Yoga is one of many practices designed to improve self-awareness, body relaxation and mental sharpness. There are several types of yoga, some emphasizing physiological benefits and others designed to improve brain functionality and mental health.

[0007] Anywhere from six to fourteen different styles or types of yoga are often described, including Anusara, Ashtanga, Bikram, Hatha, Iyengar, Jivamukti, Kripalu, Kundalini, Prenatal, Restorative, Sivananda, Viniyoga, Vinyasa/Power, and Yin. Each differs in types of poses, movement and relaxation, and meditation integration with some form of exercise.

[0008] An appealing aspect of yoga is that yoga has both physiological and mental benefits. Increased flexibility and decreased muscle stiffness are the most common reasons for practicing yoga, but there are significant mental benefits as well. These include improvements in psychological well-being, anxiety and depression, memory and concentration, and also as a preventive measure to avoid mental health conditions, particularly during adolescence.

[0009] Perhaps one of the most important benefits of yoga is reducing the effect of traumatic experiences. Clinical trials and various studies on patients suffering from post-traumatic stress disorder (PTSD) have found that those who completed a yoga program showed fewer or less intense PTSD symptoms compared to control participants in the same program who were provided with general health information.

[0010] Yoga has been scientifically and clinically determined to have several beneficial effects, including enhanced psychological and mental well-being, improvement of memory and concentration, diminishment of anxiety and depression, and prevention of some conditions common in adolescence. It is commonly accepted that yoga affects relaxation, meditation, socialization and body conditioning through physical exercise. While it is best recognized for clearing the mind and calming the senses, there is also the effect of lowering blood pressure and heart rate as well as improved respiration.

[0011] Increasingly, attention is being paid to the effect that yoga has on mindfulness. The practice of mindfulness is inherent in all forms of yoga practice. Mindfulness is the intentional awareness of one's own feelings, thoughts, and body sensations from moment to moment. The effectiveness of the practice of mindfulness as a therapeutic technique has been demonstrated in recent clinical trials, which have shown it to be successful in reducing the symptoms of mental health conditions such as anxiety and post-traumatic stress disorder. Several forms of yoga appear to promote a quality of elevated awareness of one's person. Promoting mindfulness can be used as part of a therapeutic technique.

[0012] Biofeedback is a method that is used to modify or ameliorate stress or other mental conditions by training the mind to focus on control of a physical process such as breathing or heart rate. Biofeedback has been developed over several decades and represents an interdisciplinary paradigm that unifies elements of psychology, neurophysiology, cybernetics and medicine. Feedback techniques have been developed utilizing operant conditioning to modify neurophysiological processes (Kamiya, 1969). Biofeedback is used to relay information and measurement of criteria back to a subject about his or her life processes and is a useful tool for self-mastery, research and clinical intervention.

[0013] A typical use of biofeedback is to employ sensitive electronic methods to provide meaningful information about a subject's physiological processes, such that the subject gains greater awareness and control over their physiology and can self-regulate more effectively.

[0014] It has long been accepted that a subject can learn through biofeedback to reliably discern between alpha and beta dominant cortical states (Kamiya, 1994) and can learn to voluntarily produce such states. Alpha brain states are associated with a receptive, meditative state that subjects can achieve through electronic monitoring without the use of drugs. Self- enhancement of alpha brain waves in some cases has been used to optimize physiological functioning and health (Fehmi and Fritz, 1980). The basic principle is that brain processes can be brought under voluntary control and that alpha dominant states of mind are conducive to some kind of mental attitude integration through EEG feedback or neurofeedback. The method has been used to treat alcoholism (Peniston and Kukolsi, 1989) and attention deficit disorder in children (Lubar, 1989, 1991). Operant conditioning of a variety of internal autonomically regulated physiological processes, including blood pressure, cardiac function, and intestinal activity (Miller and DeCara, 1967), has been demonstrated in animal experiments.

[0015] Basmajian (1967) tested the outer limits of voluntary control over skeletal muscles by utilizing surface electrodes over the muscles and visual (oscilloscope) and auditory feedback to the subject. It was demonstrated that almost any subject could establish conscious control and training of a single motor unit within a muscle, within a brief time. Biofeedback methods have been applied to a variety of medical and emotional disorders, including epileptic seizures, cardiac arrhythmia, and migraine and tension headaches. Use of both yoga and biofeedback in hypertension has been reported (Patel, 1975). Abundant empirical research has demonstrated biofeedback's efficacy for the following disorders: tension-type headache, migraine headache, Raynaud's syndrome, secondary Raynaud's symptoms, urinary and fecal incontinence, essential hypertension, nocturnal enuresis, and dyslexia. At least some research supports good outcomes with insomnia, anxiety disorders, chronic pain, ADD and ADHD, functional nausea and vomiting, irritable bowel syndrome, motion sickness, asthma, bruxism and TMD, tinnitus, and phantom limb pain. Additionally, there are case reports of positive outcomes for biofeedback with writer's cramp, esophageal spasm, occupational cramps, blepharospasm, dysmenorrhea, visual disorders, some dermatological disorders, diabetes mellitus, fibromyalgia, and menopausal hot flashes.

[0016] The majority of biofeedback practitioners are health care providers involved in a daily clinical practice; this includes physicians, psychologists, nurses, social workers, physical and occupational therapists, and several other disciplines. Clinical biofeedback today offers a diversity of clinical procedures and protocols, with applications to a wide range of disorders.

[0017] Yoga, mindfulness and biofeedback are each being used in various venues as ancillary or adjunctive techniques in treating or recognizing various mental conditions. PTSD, for example, is a chronic debilitating anxiety disorder found in a significant number of military veterans. Yoga has been used as an adjunctive treatment in specialized Veterans Administration PTSD treatment programs. While increasingly recognized as reducing stress for PTSD patients, there is little understanding of how selected yoga programs can define and distinguish yoga therapy as a therapeutic discipline. Connecting the physiological and mental effects of yoga with clinical feedback and intervention has yet to create care models to fulfill the unmet needs of individuals with mental health issues. [0018] SUMMARY OF THE INVENTION

[0019] The invention is the application of biofeedback coupled with a unique, effective and immediate communications tool to monitor, evaluate, and modify where necessary or desired and deliver a quality-driven service for yoga instruction and yoga-specific movements. Such instruction and movements aimed at specific client audiences can result in mental, behavioral and physical fitness improvements. Utilization of biofeedback analytical tools and online streaming yoga classes and instruction for specific client needs within a web-based planning and communications platform provides ongoing communication between the providers and participants.

[0020] By combining the known and widely accepted principles of biofeedback with an online website delivering yoga instruction and a library of yoga instruction classes designed for specific purposes, the yoga class subscriber is able to also avail himself of an opportunity to monitor and review their own individual application and learned yoga instructions and movements. Through the use of a unique and highly encrypted communications platform, clinical specialists as well as qualified yoga instructors are available for interactive communications.

[0021] The present invention includes a system for integrating real-time yoga class participation with interactive response evaluation by clinically trained personnel. Specific types of yoga programs are designed to be individually interactive with real-time monitored feedback based on medically vetted personal health information.

[0022] Content and live streaming capabilities are coordinated with research clinics to allow monitoring and tracking for fitness-related metrics. Optional links to sync with a research center for short- and long-term data tracking provide a care model to monitor and treat identified physical and mental conditions.

[0023] BRIEF DESCRIPTION OF THE FIGURE

[0024] FIG. 1 is a flow chart outlining the steps an individual may take to subscribe to a yoga-based program with choices for entering a clinical study and/or receiving biofeedback.

[0025] DETAILED DESCRIPTION OF THE INVENTION

[0026] The present invention provides a clinically useful process to monitor, evaluate and provide feedback to subjects who are actively participating in selected yoga programs. The type of yoga is based on recognized beneficial effects on mental health, particularly stress and most particularly for subjects suffering from PTSD. [0027] Selection of the type of yoga is matched to an individual's stress disorder, or, for healthy subjects, a type of yoga is selected that has physiological health effects as well as enhancement of well-being. The general types of yoga range from challenging poses to gentle stretching that has a relaxing effect.

[0028] Yoga can be based on several forms designed to address different physical and mental interests. Some forms emphasize postures while others are designed for relaxation. A number of different types such as Anusara, Ashtanga, Bikram, Hatha, Jivamukti and Kripalu, among others, concentrate on particular physical or mental improvements or well-being, although there is not universal agreement on what each type of yoga may include.

[0029] An important aspect of the invention is a yoga program designed for one or more groups of individuals with special psychological or mental health needs. One group in particular need is U.S. military veterans who often suffer from chronic and debilitating anxiety or fear disorders. Other types of patients include those dealing with overwhelming stress or depression. In some instances, yoga may be helpful for cancer patients who face mental challenges in accepting what may not be a positive outcome. A program can be selected by the individual or recommended by a patient's health care provider and can be changed depending on progress or lack thereof.

[0030] A unique feature of the yoga program is to connect the participants with the availability of specialized clothing designed particularly for different physiques with the purpose of enhancing the experience and effectiveness of the workout, for instance the Yoga for Men Bhujang Style line, which is designed particularly for the male physique.

[0031] The invention includes a process for gathering data from specialized devices and clothing capable of measuring physiological parameters during workouts. The output will be interfaced with a variety of different clothing types and brands and existing and future transmitting or recording devices. In a similar manner, the system will receive data from specialized clothing with integrated sensors that report various bodily metrics. The unique system employed will allow analysis of these values and will enable feedback to the individual and to the individual's team members. Supplemental treatment plans can be initiated by using, for example, biofeedback techniques, changing to a different yoga program more focused on destressing, and then monitoring changes or improvements in the individual's stress levels. In addition, the data can be used to measure the effectiveness of the programs in which the subjects are participating, and these programs can be evaluated and improved based on the data collected and analyzed. [0032] Alternatively or in addition to biofeedback of physiological parameters, subjects participating in the online yoga-based programs can provide feedback from survey forms prepared from questionnaires completed before and after a yoga session. This can provide subjective feedback to clinicians to monitor attitude and frame of mind pre- and post-session. Optionally, additional questionnaires and surveys may be sent online during a test period to measure or monitor other aspects of the subject's progress. Responses transmitted with encrypted, Health Insurance Portability and Accountability Act (HIPAA)-compliant voice, video, or text can be used to further enhance communication between study clinicians and participants.

[0033] Survey forms can be customized and developed for several types of clinical conditions based on input from clinicians. The forms will not include personally identifiable information and will be identified only by an identifying code. For forms to be completed and transmitted by the subjects, a link will be sent to each subject so that he/she can use the secure link to view and complete the form on a secure site. The subject can then electronically submit the information which can be stored on a secure server with access only by authorized clinicians or medical personnel.

[0034] Another novel feature of the invention is the level of interaction an individual maintains during the program, with a rolling evaluation and consultation available throughout the subscription period. Progress in normalizing mental state can be based on professional input to the individual over the subscription period. The effect of yoga over a time period can be compared with mental state and quality of life as determined by conventional psychological interventions. Psychological and physiological data can be stored in an archive for the individual, who can access this information at any time. The data archive will typically be available to a treating physician and/or other clinicians including clinical team members.

[0035] MATERIALS AND METHODS

[0036] Web-based platform: ReadyOp (Tampa, FL)

[0037] Devices for reporting and/or transmitting information: Microsoft Band, FITBIT and APPLE WATCH.

[0038] Clothing source modified for transmission of physiological data: ATHOS and iOS BioMan.

[0039] EXAMPLES [0040] The following examples are provided as illustrations of the invention and are in no way to be considered limiting.

[0041] Example 1

[0042] A war veteran is diagnosed with PTSD after seeking treatment at a VA hospital. The subject is suffering mentally with intrusive memories and increasing depression. His or her family has noticed personality changes and a possible tendency toward suicide. In addition to drugs traditionally used to treat this condition, a course in yoga is recommended to assist in moving the subject away from negative thoughts.

[0043] The subject is subscribed to a series of yoga classes customized to increase their ability to focus on breathing and to promote observation and understanding of internal states in order to control them or recognize them as temporal and passing. The subject logs into a special site for collecting and assessing individual patient information to be used as feedback to the medical staff and the subject for monitoring the subject's mental state. Prior to each class, the subject responds to and transmits answers to a series of health questions. At the end of each class the subject fills out answers to a second series of health questions.

[0044] One or more of a team of clinical neurologists, clinical social workers, nurse practitioners, psychologists, psychiatrists or other clinical specialists analyzes the two responses filed by the subject before and after each class. Based on the analysis, the subject receives feedback on changes in physical perceptions of wellness, sense of relaxation, and well-being. The results are used to adjust any medication or to recommend changes in the type of yoga and other treatment care plans that might further enhance progress.

[0045] Example 2

[0046] A female cancer patient is not responding well to treatment, in part because of severe depression. The patient is 37 years old and until beginning chemotherapy and drugs for her cancer was athletic and in excellent physical condition. This patient initially chose to subscribe to a yoga program designed for relaxation and mindfulness, and then later decided to introduce components of a more physical practice as she became more comfortable and gained the ability to do so. The subject signed on to a web-based platform that allowed interactive participation with study clinicians. Feedback to the subject was provided from survey forms filled out and submitted online before and after each yoga class using an identifying code and an encrypted HTPAA-compliant file transfer of the communications. Access to the responses is only available to selected clinicians and persons authorized by the patient. Reports and evaluations for self-monitoring of progress in alleviating depression are provided to the patient and are recommendations for optionally selecting new or replacement yoga programs. The reporting system and databases can be handled by a web-based platform such as ReadyOp (Tampa, FL).

[0047] Example 3

[0048] This example provides a description of how the disclosed system can be accessed and used by the general public or in a format designed particularly for veterans.

[0049] A subject can use a system such as "TouchPoint" (Tampa, FL) (FIG. 1), which provides a simple entry point for both the general public and active military personnel, including veterans of government military service, to locate an Internet website which opens a series of options for those interested. Veterans may enter through a specialized targeted web portal as well as the general entry point for all interested persons. Veterans who enter the web portal through the general information access point are also provided the option of being directed to a specific Veteran's Landing Page and are given the option to choose if they wish to participate in a clinical trial focused on PTSD. This option, if the veteran is eligible, may allow the veteran's first year subscription to be waived as a clinical trial participant. Alternatively, if the veteran so chooses, he or she may choose not to participate, and is thereby directed to the option to subscribe to or choose free classes and free videos which are held in an archive based, on a variety of levels such as Beginner, Intermediate, Experienced, etc. Also, the archive will contain specific types of classes depending upon the interest of the individual.

[0050] If the subscription option is selected, the subscriber is encouraged to complete a questionnaire which provides basic contact information and the option to have individual biofeedback information collected and transmitted, along with the option to connect a series of wearable biophysical sensors to be included in the biofeedback connection. Each subscriber, by entering basic and, if chosen, additional information regarding biofeedback options and reporting details, allows the TouchPoint system to gather yoga-centric details and to provide class and/or instruction modifications requested by the subscriber. Alternatively, TouchPoint may recommend certain challenges and/or alternatives.

[0051] For subscribers in a clinical study, the biofeedback materials are integral and pertinent to the study. With the TouchPoint system, announcements regarding upcoming classes, reminders, available classes, and unique classes as well as archived materials and product enhancements are provided, along with immediate responses relating to subscriber satisfaction and/or reactions to all of the products and services provided by and through the invention.

[0052] REFERENCES

[0053] Libby, D.J., Reddy, F., Pilver, C.E., and Desai, R.A. (2012). "The use of yoga in specialized VA PTSD treatment programs, " Int. J. Yoga Therap., v. 22, 79-87.

[0054] Basmajian, J. V. (1967). Muscles Alive: Their Functions Revealed by Electromyography. Baltimore: Williams and Wilkins.

[0055] Pate I, C. (1975). "12 Month Follow -Up of Yoga and Biofeedback in the Management of Hypertension, " Lancet 1, 62-65.

[0056] Fehmi, L.G. and Fritz, G. (1980). "Open Focus: The attentional foundation of health and well being, " Somatics, Spring, 24-30.

[0057] Kamiya, J. (1969). "Operant control of the EEG alpha rhythm, " in Altered States of Consciousness, C. Tart (ed.), Wiley, N. Y.

[0058] Lubar, J.F. (1991). "Discourse on the Development of EEG Diagnostics and Biofeedback Treatment for Attention-Deficit Hyperactivity Disorders, " Biofeedback and Self- regulation, 16, 201-225.

[0059] Miller, N.E. and DiCara, L. (1967). "Instrumental Learning of Heart Rate Changes in Curarized Rats: Shaping and Specificity to Discriminative Stimulus, " Journal of Comparative and Physiological Psychology, 63, 12-19.

[0060] Peniston, E.G. and Kukolski, P.J. (1989). "Alpha-theta Brainwave Training and Beta- endorphin Levels in Alcoholics, " Alcoholism: Clinical and Experimental Research, 13, 271- 279.