Madhusudhan DK, Glied KN, Nguyen E, Rose J, Bravata DM. Real-world JOURNAL OF MENTAL HEALTH Evaluation of a Novel Technology-enabled Capnometry-assisted Breathing AND CLINICAL PSYCHOLOGY Therapy for Panic Disorder. J Ment Health Clin Psychol; (2020). 4(4): 39-46 www.mentalhealthjournal.org Original Research Article Open Access Real-world Evaluation of a Novel Technology-enabled Capnometry- assisted Breathing Therapy for Panic Disorder Divya K. Madhusudhan1, Kore N. Glied1, Eugene Nguyen1, Jennifer Rose1, Dena M. Bravata1,2* 1Crossover Health, San Clemente, CA 2Center for Primary Care and Outcomes Research, Stanford University School of Medicine, Stanford, CA Article Info Abstract Article Notes Introduction: Anxiety disorders which include generalized anxiety disorder, Received: October 8, 2020 panic disorder (PD), post-traumatic stress disorder, and obsessive-compulsive Accepted: November 18, 2020 disorder are common psychiatric condition associated with significant social, *Correspondence: occupational, physical, and economic costs. Interventions that target the Dr. Dena M. Bravata, M.D., M.S., Crossover Health, San respiratory dysregulation associated with anxiety disorders have demonstrated Clemente, CA; Senior Affiliate, Center for Primary Care and considerable therapeutic benefit. However, no such intervention has been Outcomes Research, Stanford University School of Medicine; evaluated in among PD patients receiving care in an employer-sponsored 1840 Lexington Av, San Mateo CA; Telephone No: 415-706- health center. 5829; Email: [email protected]. Objective: To evaluate the use of a novel, capnometry-assisted breathing © 2020 Bravata DM. This article is distributed under the terms therapy on clinical outcomes, engagement, and satisfaction for patients with of the Creative Commons Attribution 4.0 International License. PD receiving care in an employer-sponsored health center. Keywords: Methods: Prospective analysis of participants using the program between Behavioral Health 1/1/2018 and 06/30/2020. Occupational Health Breathing Therapy Results: Twenty-two participants enrolled. Their average weekly usage Panic Disorder remained high throughout the 4-week treatment protocol of 17 minutes twice Post-traumatic Stress Disorder a day for 28 days (11.6 sessions (SD 3.1) in week one and 10.4 sessions (SD Real-world Evaluation 4.0) in week four). Their average Panic Disorder Severity Scale score decreased from 13.3 (SD ± 3.6) to 5.6 (SD ± 1.8), indicating that panic severity decreased from “moderately ill” to “slightly ill.” Use of the program was associated with clinically and statistically significant improvements in respiratory markers: average respiratory rate decreased from 14.9 (SD 3.6) to 11.9 (SD 4.7) breaths per minute (p<0.001) and end-tidal pCO2 increased from 37.2 mmHg (SD 4.2) to 39.1 mmHg (SD 3.6) (p<0.001). Engagement was associated with decline in utilizations of behavioral health services at employer-sponsored primary care center clinic after the intervention. Conclusion: The clinical improvements observed in this pilot suggest that capnometry-assisted breathing therapy is a valuable tool for patients suffering from panic-associated symptoms. Background / Introduction Anxiety disorders which include generalized anxiety disorder, PD, PTSD, and obsessive-compulsive disorder are common psychiatric and economic costs1,2. Approximately 27 million US adults experience panicconditions attacks associated annually with with significant over 6.7 million social, occupational,suffering from physical, PD and 8 million from PTSD3,4. Anxiety disorders are associated with poor workplace productivity and short and long term disabilities5,6 accounting for approximately $45 billion in annual health care spending7. While these conditions are commonly treated with pharmacotherapy and/or psychotherapy, not all patients respond or achieve full recovery with these modalities8. Page 39 of 46 Madhusudhan DK, Glied KN, Nguyen E, Rose J, Bravata DM. Real-world Evaluation of a Novel Technology-enabled Capnometry-assisted Breathing Journal of Mental Health & Clinical Psychology Therapy for Panic Disorder. J Ment Health Clin Psychol; (2020). 4(4): 39-46 Growing evidence suggests that respiratory this intervention holds promise for reducing the morbidity dysregulation is a central feature of PD. Klein and and associated cost among employee populations. The colleagues’ ‘suffocation false alarm’ hypotheses regarding purpose of this pilot was to evaluate Freespira among a carbon dioxide hypersensitivity set the stage for the population of adult employees with PD receiving care in an examination of the respiratory irregularities associated with panic disorder and related conditions9,10. In the case to determine whether completing a 28-day intervention of panic disorder, chronic hyperventilation, lower end tidal withemployer-sponsored Freespira would: health 1) Reducecenter. Specifically,symptom severity we sought as CO2 levels, respiratory rate and tidal volume irregularities, sighing, and breath-holding are characteristic features11. Severity Scale (PDSS) for panic disorder, Post Traumatic The literature on respiratory dysregulation in PTSD is Stressmeasured Disorder by condition-specific checklist (PCL 5) scales for PTSD, (i.e., PanicPatient Disorder Health less extensive. However, a comparative analysis of PD and Questionnaire (PHQ-9) for depression, and Generalized PTSD found that subjects with PTSD also showed abnormal Anxiety Disorder questionnaire (GAD-7) for generalized breathing patterns (high sigh rate, more abdominal anxiety disorder; 2) Improve respiratory parameters breathing, and only slightly less hypocapnia than the as measured by end-tidal pCO2 and RR; and 3) Provide a PD group)12. Additional evidence linking underlying positive experience as measured by engagement rates. respiratory pathophysiology of PD and PTSD includes the Materials and Methods bidirectional relationship between the two disorders13 and reactivity to CO challenge testing14. Again, the literature for 2 Participants CO challenge is more substantial for PD, but an emerging 2 Eligible participants were adult Comcast employees body of evidence for PTSD points to CO2 reactivity as a risk factor for development of PTSD in military subjects15 and is with PD receiving care in an employer-sponsored Crossover characteristic in patients with PTSD16. In the trial of PTSD health center located in Midtown, New York City between by Kellner and colleagues, they found that patients with 1/1/2018 and 6/30/2020. Three training seminars PTSD were not reactive to placebo gas exposure whereas were conducted with primary care and behavioral health providers to provide education about the intervention, in addition to panic symptoms when exposed to a single inclusion criteria, and the referral process. These seminars inhalationsome subjects of 35% experienced CO 16. post-traumatic flashbacks were attended by more than 50 providers and clinic staff 2 who made 45 referrals. Patients who were referred to Freespira and expressed interest in the program were pathways have demonstrated considerable therapeutic sent an assessment packet via secure email and given the Interventions that specifically target these17-19 respiratory . Anxiety Freespira enrollment phone number. If a patient did not complete the assessment packet or call Freespira, there benefit among these patient populations stimulates the sympathetic nervous system to increase was no additional follow up. Participants were considered disorders can trigger the fight-or-flight response, which heart rate and blood pressure and leads to over-breathing ineligible for inclusion if they were pregnant or diagnosed among other stress reactions. Breathing exercises with obesity hyperventilation syndrome. Participants did can reduce the body’s reaction to stress and anxiety not incur incremental costs or receive any incentives for by mediating this relationship with the sympathetic study participation. associated with decreased heart rate, respiratory rate Intervention (RR),nervous and system. blood pressureSpecifically,20. Recognition breathing is exercisesgrowing thatare Freespira is a patented, FDA-cleared digital therapeutic treatments that effectively treat panic-related conditions solution for the treatment of PD, PTSD, agoraphobia, (psychopharmacological as well as psychotherapeutic) and other disorders where panic attacks are common. also reduce CO sensitivity11. Berenz and colleagues 2 The intervention trains patients, through physiological suggest treatment implications as follows: “Given the feedback, to increase their end-tidal pCO by reducing association between PTSD and subsequent PD, particularly 2 their RR and respiratory volume. The capnometry-assisted among men, clinicians may consider supplementing PTSD breathing treatment is delivered via a hand-held respiratory 13. sensor, nasal sampling cannula, and software that guides treatmentA novel with technology panic specific called interventions”Freespira was developed to the user through a structured training session, and a train participants to reduce their RR and increase their dedicated coach providing weekly support. The sensor exhaled end-tidal pCO levels through structured breathing 2 measures end-tidal pCO2 and RR. Data from this sensor are exercises. This technology has not been previously transmitted via Bluetooth to a tablet preloaded with the evaluated in an employer-sponsored setting. However, Freespira app. The app provides real-time feedback to the given