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.

创伤后应激障碍 (PTSD) 的循证治疗，包括心理治疗和药物治疗，辍学率和无反应率都很高，这表明需要更可接受和更有效的治疗方法来治疗 PTSD。Capnometry Guided Respiratory Intervention (CGRI) 是一种有效治疗恐慌症的数字疗法，可在结构化呼吸方案中实时测量和显示呼气末二氧化碳 (EtCO ₂ ) 和呼吸频率 (RR)，并可能通过以下方式对 PTSD 有益调节呼吸和 EtCO ₂水平。我们对 CGRI 系统 Freespira® 进行了一项单臂研究，以治疗 PTSD 症状。患有 PTSD 的参与者 (n = 55) 接受了为期 4 周的治疗，每天两次，每次 17 分钟的家庭 CGRI 会话，使用传感器和带有预加载软件的平板电脑。在基线、治疗结束、治疗后 2 个月和 6 个月评估 PTSD 和相关症状。主要疗效结果是 50% 的参与者在 2 个月的随访中临床医生管理的 PTSD 量表 (CAPS-5) 评分下降 ≥ 6 分。评估了耐受性、可用性、安全性、依从性和患者满意度。CGRI 耐受性良好，88% [95% CI 74–96%] 在治疗后 2 个月的随访中 CAPS-5 评分下降 ≥ 6 分。平均 CAPS-5 评分从基线时的 49.5 [sd = 9.2] 降至治疗后 2 个月的 27.1 [sd = 17.8]。₂级增加。相关的精神和身体健康症状也有所改善。这种 CGRI 干预在改善 PTSD 研究中的症状方面是安全的、可接受的和良好的耐受性。有必要针对适当的比较器进行进一步研究。

试验注册Clinicaltrials.gov NCT#03039231。