Real-world outcomes of an innovative digital therapeutic for treatment of panic disorder and PTSD: A 1,500 patient effectiveness study

OBJECTIVE: Prior clinical trials have shown consistent clinical benefit for Capnometry Guided Respiratory Intervention (CGRI), a prescription digital therapeutic for the treatment of panic disorder (PD) and post-traumatic stress disorder (PTSD). The purpose of this study is to report real-world outcomes in a series of patients treated with the intervention in clinical practice. DESIGN: This paper reports pre- and post-treatment self-reported symptom reduction, measures of respiratory rate and end-tidal carbon dioxide levels, drop-out and adherence rates drawn from an automatic data repository in a large real-world series of patients receiving CGRI for panic disorder and PTSD. SETTING: Patients used the intervention in their homes, supported by telehealth coaching. PARTICIPANTS: Patients meeting symptom criteria for panic disorder (n = 1,395) or posttraumatic stress disorder (n = 174) were treated following assessment by a healthcare professional. INTERVENTION: Capnometry Guided Respiratory Intervention is a 28-day home-based treatment that provides breath-to-breath feedback of respiratory rate and exhaled carbon dioxide levels, aimed at normalizing respiratory style and increasing patients’ mastery for coping with symptoms of stress, anxiety, and panic. Health coaches provide initial training with weekly follow up during the treatment episode. Remote data upload and monitoring facilitates individualized coaching and aggregate outcomes analysis. MAIN OUTCOME MEASURES: Self-reported Panic Disorder Severity Scale (PDSS) and the Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) scores were obtained at pre-treatment and post-treatment. RESULTS: Panic disorder (PD) patients showed a mean pre-to-post-treatment reduction in total PDSS scores of 50.2% (P < 0.001, d = 1.31). Treatment response rates for PD (defined as a 40% or greater reduction in PDSS total scores) were observed in 65.3% of the PD patients. PTSD patients showed a pre-to-post-treatment reduction in total PCL-5 scores of 41.1% (P < 0.001, d = 1.16). The treatment response rate for PTSD (defined as a ≥10-point reduction in PCL-5 scores) was 72.4%. In an additional analysis of response at the individual level, 55.7% of panic disorder patients and 53.5% of PTSD patients were classified as treatment responders using the Reliable Change Index. Patients with both normal and below-normal baseline exhaled CO(2) levels experienced comparable benefit. Across the 28-day treatment period, mean adherence rates of 74.8% (PD) and 74.9% (PTSD) were recorded during the 28-day treatment. Dropout rates were 10% (PD) and 11% (PTSD) respectively. CONCLUSIONS: The results from this cohort of 1,569 patients treated with the CGRI intervention demonstrate significant rates of symptom reduction and adherence consistent with prior published clinical trials. The brief duration of treatment, high adherence rates, and clinical benefit suggests that CGRI provides an important addition to treatment options for panic disorder and PTSD.