Effectiveness, Cost-Utility, and Safety of Neurofeedback Self-Regulating Training in Patients with Post-Traumatic Stress Disorder: A Randomized Controlled Trial.

Post-traumatic stress disorder (PTSD) is characterized by neurophysiological and psycho-emotional problems after exposure to trauma. Several pharmacological and psychotherapy limitations, such as adverse events and low adherence, increase the need for alternative therapeutic options. Neurofeedback is widely used for PTSD management. However, evidence of its clinical efficacy is lacking. We conducted a randomized, waitlist-controlled, assessor-blinded clinical trial to assess the effectiveness, cost-utility, and safety of 16 sessions of neurofeedback on people with PTSD for eight weeks. Eleven participants were allocated to each group. One and two subjects dropped out from the neurofeedback and control groups, respectively. The primary outcome was PTSD symptom change evaluated using the PTSD Checklist-5 (PCL-5-K). The PCL-5-K levels improved more in the neurofeedback group (44.3 ± 10.8 to 19.4 ± 7.75) than in the control group (35.1 ± 18.5 to 31.0 ± 14.92). The change value was significantly improved in the neurofeedback group (24.90 ± 13.13 vs. 4.11 ± 9.03). Secondary outcomes such as anxiety, depression, insomnia, and quality of life were also improved. In an economic analysis using EuroQol-5D, the incremental cost-per-quality-adjusted life-year was approximately $15,600, indicating acceptable cost-utility. There were no adverse events in either group. In conclusion, neurofeedback might be a useful, cost-effective, and safe intervention for PTSD management.