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

Jungtae Leem,Eun Cho,Moon Joo Cheong,Hyeryun Lee,Hyung Won Kang,So Young Lee,Geun-Woo Kim

doi:10.3390/healthcare9101351

Jungtae Leem, Eun Cho + Show 5 more

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https://doi.org/10.3390/healthcare9101351

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Abstract

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.

Highlights

In the neurofeedback self-regulating training (NSRT) group, Post-traumatic stress disorder (PTSD) was caused by domestic violence in eight participants and traffic accidents in two participants
In the wait-control group, PTSD was caused by domestic violence in eight participants and school violence in one participant
We found that 16 sessions of NSRT over eight weeks effectively reduced the PCL-5-K symptom score in patients with PTSD

Summary

Introduction

Post-traumatic stress disorder (PTSD) is characterized by neurophysiological and psycho-emotional problems [1]. People with PTSD can present with specific symptoms such as hyperarousal, avoidance, and reexperiencing after exposure to trauma [2], such as a natural disaster, sexual assault, or military combat [3]. It is known that the rate of actual transition to PTSD after exposure to trauma is around 10% of all exposed patients [2]. PTSD leads to a decreased quality of life and an increased health-related resource consumption [4]

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