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Somryst is a prescription-only digital therapeutic intended to provide a neurobehavioral intervention (Cognitive Behavioral Therapy for Insomnia - CBT-I) in patients 22 years of age and older with chromic insomnia. Somryst treats chronic insomnia by improving a patient's insomnia symptoms.

Somryst is a 9-week prescription digital therapeutic (computerized behavioral therapy) used in the treatment of chronic insomnia. Somryst is based on principles of Cognitive Behavioral Therapy (CBT) for Insomnia, Sleep Restriction, and other proven psychosocial treatment elements, which are delivered in a sequence of "cores" of patient education, training and skill building. The therapy is delivered via a mobile application intended to be used on a patient's mobile device and consists of text, video, animation and graphics. Clinicians, as part of a patient's general treatment program, have access to a clinician dashboard that shows patient utilization and engagement with the application.

reSET-O™ is intended to increase retention of patients with opioid use disorder (OUD) in outpatient treatment by providing cognitive behavioral therapy, as an adjunct to outpatient that includes transmucosal buprenorphine and contingency management, for patients 18 years or older who are currently under the supervision of a clinician. reSET-O is indicated as a prescription-only digital therapeutic.

reSET-O™ is a 12-week interval prescription digital therapeutic for Opioid Use Disorder (OUD). reSET-O™ is modeled on the Community Reinforcement Approach (CRA) and engineered to deliver behavioral therapy for patients with OUD. reSET-O™ delivers CRA therapy as a series of interactive therapy lessons. Each therapy lesson is comprised of a cognitive behavioral therapy component and skill building exercises. Therapy lesson content is delivered primarily via text or audio, and may include videos, animations and graphics. reSET-O™ is intended as an adjunct to standard of care for patients with OUD. It is limited to persons with a valid prescription from their licensed provider. reSET-O™ supports clinician-patient communication between visits, by providing a means for patients to self-report cravings and triggers, and buprenorphine use/non-use. reSET-O™ reinforces the importance of using buprenorphine for treatment of OUD.

reSET is intended to provide cognitive behavioral therapy, as an adjunct to a contingency management system, for patients 18 years of age and older who are currently enrolled in outpatient treatment under the supervision of a clinician. reSET is indicated as a 12 week (90 days) prescription-only treatment for patients with substance use disorder (SUD), who are not currently on opioid replacement therapy, who do not abuse alcohol solely, or who do not abuse opioids as their primary substance of abuse. It is intended to: - increase abstinence from a patient's substances of abuse during treatment, and ● - increase retention in the outpatient treatment program.

reSET™ is a digital therapy comprised of a patient application and clinician dashboard intended to deliver cognitive behavioral therapy (CBT) to patients with SUD to increase abstinence from substance use and increase retention in outpatient therapy programs. CBT is a psychosocial intervention that aims to change a patient's thinking and behavior, and it has been studied in psychiatric disorders such as major depressive disorder (Psychiatr Clin North Am. 2010; 33: 537-55). reSET is based on a specialized version of CBT known as the community reinforcement approach (CRA). which was originally developed for alcohol dependence and cocaine use (Behav Res Ther. 1973; 11:91-104; Exp. Clin. Psychopharmacol 2000; 3:205–2). The community reinforcement incorporates a range of therapeutic modalities including CBT to make substance-free lifestyle rewarding, skill building to promote behavioral change, and contingency management to reward and incentivize abstinence and replace the satisfaction obtained from substance abuse. CBT and CRA are considered valid models for substance abuse therapy and other psychiatric disorders. reSET consists of several therapy lessons (modules) that are intended to teach the user the following skills to aid in the treatment of substance use disorder: - Identifying situations and triggers that make substance use more likely ● - . Avoiding substance use. - . Coping with thoughts about substance use, - . Recognizing negative thinking and identifying techniques to move to positive thinking - Making decisions about substance use - Taking responsibility for choices made and evaluating the consequences of those choices ● Each therapy lesson is comprised of a cognitive behavioral therapy component and skill building exercises related to the above areas. The content of the therapy lessons is delivered primarily via text, and may include videos, animations and graphics. All text and video within reSET is narrated in English. Following most therapy lessons, the patient undergoes fluency learning, a method of questioning that intended to promote learning and improve both short-term and long-term retention of material. Within the fluency learning section of reSET, patients are asked between 4-10 multiple choice and fill-in-the-blank questions about the key concepts presented in the lesson. An example of screenshots from the device is provided in the figure below. When a question is answered incorrectly, the patient is presented with the correct response and the question is recycled back into the queue and asked again. In order to successfully complete the fluency learning section, patients must answer each question correctly three times, providing a repetitive component that reinforces concept mastery. If the patient completes the lesson and demonstrates proficiency, they can "spin the wheel" for virtual rewards that may be incorporated into a contingency management program at the treating physician's clinic. reSET is comprised of 62 lessons, including one on-screen User Guide that explains how to use the reSET app and 61 therapy lessons. When a patient uses reSET for the very first time, he or she must step through the User Guide session to ensure they understand how to use the app. The 61 therapy lessons are split into 31 core therapy lessons and 30 supplemental therapy lessons. The therapy lessons include categories related to life skills, treatment, mood matters, social connections, sexual health, and hepatitis C and HIV. The therapy lessons in the core therapy lesson group are focused on building basic cognitive behavioral and relapse prevention skills (e.g., functional analysis of drug use and selfmanagement planning, drug refusal skills). The therapy lessons in the supplemental group cover a range of topics that can be relevant for patients with SUD such as managing relationships, building communication skills, and time management. They also provide more in-depth training on HIV, hepatitis and STI prevention as well as support for those patients living with HIV and Hepatitis C. Once the initial User Guide lesson has been completed, the patient gains access to the next core therapy lesson. In the core therapy lessons, a patient can only advance to the next lesson after successfully completing the prior lesson. At any time, patients can choose to review a completed lesson. Once a patient successfully completes all the core therapy lessons, they gain access to all the supplemental therapy lessons. These lessons do not have a set order of completion, and patients can choose lessons that are relevant to managing their disease or as recommended by their clinician. reSET recommends that patients should complete 4 lessons per week. Each lesson is intended to take between 10-20 minutes to complete. Therapy lesson lengths vary, as do the number of fluency assessment questions the patient must take at the end of a lesson. Some therapy lessons have optional worksheets for the patient to complete that are intended to help the patient understand the key concepts taught in the therapy lesson. The reSET application allows patients to track their own progress on the device's therapy modules. The device additionally has a Patient Self Report interface that allows for patients to track their cravings and substance use. This information is available to the patient's treating physician through the device. The clinician dashboard for reSET displays the patient's progress. The clinician can view which therapy lessons the patient has completed, as well as view patient-reported substance use, cravings and triggers. The reSET app automatically pushes an assessment every four days to ask if the patient has taken any drugs or alcohol in the past 4 days, and if so, on which days. The patient is also asked to report whether they have had any cravings for drugs and alcohol and if so, to rate the intensity of the cravings. This reSET initiated, self-report data will display on the clinician's dashboard. Patients may also log their drug and alcohol use at any time into reSET along with tracking their cravings and distinct triggers. These use, craving and trigger data are presented to the clinician. The clinician can also enter in-clinic data inputs such as urine drug screens and appointment attendance. reSET is intended be used in conjunction with a contingency management incentives system. reSET provides virtual "rewards" when the patient completes a lesson successfully as well as when their urine drug screen, or other objective test, is negative for substances. Clinics mav convert the virtual "rewards" into tangible rewards according to their own procedures.