Background: Responders to the September 11, 2001, WTC attacks experience high rates of PTSD, and existing treatments often lead to high dropout and low care use. Objectives: This randomized, double-blind, sham-controlled trial assesses the feasibility and acceptability of transcutaneous auricular vagus nerve stimulation (taVNS) as a potential PTSD treatment for 9/11 responders. Methods: A total of 32 WTC responders aged 18+ with PTSD, recruited via the World Trade Center Health Program, participated; those with current psychosis, unstable medical conditions, or recent trial involvement were excluded. Participants were randomly assigned to taVNS or sham groups and asked to use the device for 15 min daily for 8 weeks, with staff and participants blinded. Primary outcomes included recruitment, adherence, retention, and feedback. Secondary outcomes examined changes in depression (PHQ-9), anxiety (GAD-7), and sleep (PSQI). Data were analyzed with mixed-effects models focusing on PTSD and mental health symptoms. Results: The taVNS group showed modest PTSD improvement, with a 10-point CAPS-5 reduction in 40% of stimulation participants versus 28.5% sham; no significant differences in self-reported symptoms were found. Discussion: Daily taVNS over eight weeks is feasible and acceptable, warranting larger studies to detect differences and identify subgroups with greater benefit. Trial registration: “taVNS to Reduce PTSD Symptoms in WTC Responders” (NCT05212714); registered 9 September 2021.
Debnath et al. (Sat,) studied this question.