Investigation of a Capnometry Guided Respiratory Intervention in the Treatment of Posttraumatic Stress Disorder

Michael J Ostacher, Eileen Fischer, Ellie R Bowen, Jihun Lyu, Denishia J Robbins, Trisha Suppes, Michael J Ostacher, Eileen Fischer, Ellie R Bowen, Jihun Lyu, Denishia J Robbins, Trisha Suppes

Abstract

Evidence-based treatments for posttraumatic stress disorder (PTSD), including psychotherapies and medications, have high dropout and nonresponse rates, suggesting that more acceptable and effective treatments for PTSD are needed. Capnometry Guided Respiratory Intervention (CGRI) is a digital therapeutic effective in panic disorder that measures and displays end-tidal carbon dioxide (EtCO2) and respiratory rate (RR) in real-time within a structured breathing protocol and may have benefit in PTSD by moderating breathing and EtCO2 levels. We conducted a single-arm study of a CGRI system, Freespira®, to treat symptoms of PTSD. Participants with PTSD (n = 55) were treated for four weeks with twice-daily, 17-min at-home CGRI sessions using a sensor and tablet with pre-loaded software. PTSD and associated symptoms were assessed at baseline, end-of treatment, 2-months and 6-months post-treatment. Primary efficacy outcome was 50% of participants having ≥ 6-point decrease in Clinician Administered PTSD Scale (CAPS-5) score at 2-month follow up. Tolerability, usability, safety, adherence and patient satisfaction were assessed. CGRI was well tolerated, with 88% [95% CI 74-96%] having ≥ 6-point decrease in CAPS-5 scores at 2-months post-treatment follow up. Mean CAPS-5 scores decreased from 49.5 [s.d. = 9.2] at baseline to 27.1 [s.d. = 17.8] at 2-months post-treatment follow up. Respiratory rate decreased and EtCO2 levels increased. Associated mental and physical health symptoms also improved. This CGRI intervention was safe, acceptable, and well-tolerated in improving symptoms in this study in PTSD. Further study against an appropriate comparator is warranted.Trial registration Clinicaltrials.gov NCT#03039231.

Trial registration: ClinicalTrials.gov NCT03039231.

Keywords: Anxiety/anxiety disorders; Biofeedback; CGRI; Mindfulness/meditation; Posttraumatic stress disorder (PTSD).

Conflict of interest statement

Dr. Ostacher has received grant support from Palo Alto Health Sciences, Inc. and Otsuka America. In the past 36 months he has received personal fees for advisory board membership for Alkermes, Janssen (Johnson & Johnson), and Sage Therapeutics. Dr. Suppes, in the past 36 months, has received grants from Merck, National Institute on Drug Abuse, National Institute of Health, VA Cooperative Studies Program, and VA OR&D PRIME Care, Palo Alto Health Sciences Inc., Stanley Medical Research Institute, Pathways Genomics; consulting fees from Allergan, Inc., Intracellular Therapies, Sunovion Pharmaceuticals, Inc., and Impel NeuroPharma, Inc.; honoraria from CME Institute (Physicians Postgraduate Press, Inc.) and CMEology; and royalties from American Psychiatric Association Publishing, Hogrefe Publishing, Jones and Bartlett, and Wolters Kluwer Health (UpToDate). Ms. Fisher, Ms. Bowen, Mr. Lyu, and Ms. Robbins have no conflicts of interest to declare.

© 2021. This is a U.S. government work and not under copyright protection in the U.S.; foreign copyright protection may apply.

Figures

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Participant disposition

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