Neurofeedback self-regulating training in patients with Post traumatic stress disorder: A randomized controlled trial study protocol

Background: Post-traumatic stress disorder (PTSD) has become an important public health problem. However, the conventional therapeutic strategy, including pharmacotherapy and cognitive behavioral therapy, has limitations. Neurofeedback is a technique that utilizes electroencephalography (EEG) signal...

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Main Authors: Jungtae Leem, Moon Joo Cheong, Sang-hoon Yoon, Hyunho Kim, Hee-Geun Jo, Hyeryun Lee, Jeesu Kim, Hyang Yi Kim, Geun-Woo Kim, Hyung Won Kang
Format: Article
Language:English
Published: Elsevier 2020-12-01
Series:Integrative Medicine Research
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Online Access:http://www.sciencedirect.com/science/article/pii/S2213422020300962
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author Jungtae Leem
Moon Joo Cheong
Sang-hoon Yoon
Hyunho Kim
Hee-Geun Jo
Hyeryun Lee
Jeesu Kim
Hyang Yi Kim
Geun-Woo Kim
Hyung Won Kang
author_facet Jungtae Leem
Moon Joo Cheong
Sang-hoon Yoon
Hyunho Kim
Hee-Geun Jo
Hyeryun Lee
Jeesu Kim
Hyang Yi Kim
Geun-Woo Kim
Hyung Won Kang
author_sort Jungtae Leem
collection DOAJ
description Background: Post-traumatic stress disorder (PTSD) has become an important public health problem. However, the conventional therapeutic strategy, including pharmacotherapy and cognitive behavioral therapy, has limitations. Neurofeedback is a technique that utilizes electroencephalography (EEG) signaling to monitor human physiological functions and is widely used to treat patients with PTSD. The purpose of our study is to assess the efficacy and safety level of neurofeedback treatment in patients with PTSD using quantitative EEG. Methods: This is a randomized, waitlist-controlled, assessor-blinded, clinical trial. Forty-six patients with PTSD will be randomly assigned at a 1:1 ratio into two groups. The participants in the treatment group will receive neurofeedback treatment for 50 min, twice a week, for 8 weeks (16 sessions). Quantitative EEG will be utilized to monitor the physiological functions and brain waves of the participants. A four-week follow-up period is planned. The participants in the control group will wait for 12 weeks. The primary outcome is the Korean version of PTSD Checklist-5 (PCL-5-K) score. The PCL-5-K scores on week 8 will be compared between the two groups. Anxiety, depression, insomnia, emotions, EEG, quality-of-life, and safety level will be assessed as secondary outcomes. Discussion: This trial will describe a clinical research methodology for neurofeedback in patients with PTSD. The numerous subjective and objective secondary outcomes add to the value of this trial’s results. It will also suggest a therapeutic strategy for utilizing quantitative EEG in patients with PTSD. Our trial will provide basic evidence for the management of PTSD via an integrative treatment. Trial registration: Clinical Research Information Service (CRIS): KCT0003271.
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spelling doaj-art-c72010c705ee4673b5c595fbad45f70c2025-08-20T03:10:36ZengElsevierIntegrative Medicine Research2213-42202020-12-019410046410.1016/j.imr.2020.100464Neurofeedback self-regulating training in patients with Post traumatic stress disorder: A randomized controlled trial study protocolJungtae Leem0Moon Joo Cheong1Sang-hoon Yoon2Hyunho Kim3Hee-Geun Jo4Hyeryun Lee5Jeesu Kim6Hyang Yi Kim7Geun-Woo Kim8Hyung Won Kang9Research and Development Institute, CY Pharma Co., Seoul, South Korea; Chung-Yeon Central Institute, Gwangju, South KoreaCollege of Education, Hanyang University, Seoul, South KoreaChung-Yeon Central Institute, Gwangju, South KoreaChung-Yeon Central Institute, Gwangju, South KoreaChung-Yeon Central Institute, Gwangju, South Korea; Chung-Yeon Korean Medicine Hospital, Gwangju, South KoreaDepartment of Korean Neuropsychiatry Medicine, Wonkwang University, Iksan, South KoreaDepartment of Korean Neuropsychiatry Medicine, Wonkwang University, Iksan, South KoreaDepartment of Nursing, Kyung-In Women's University, Incheon, South KoreaDepartment of Neuropsychiatry, Dongguk University Bundang Oriental Hospital, Seongnam, South Korea; Corresponding authors at: Department of Korean Neuropsychiatry Medicine, Wonkwang University, 460 Iksan-daero, Iksan-si, Jeollabuk-do, 54538, South KoreaDepartment of Korean Neuropsychiatry Medicine, Wonkwang University, Iksan, South Korea; Corresponding authors at: Department of Neuropsychiatry, Dongguk University Bundang Oriental Hospital, 268 Buljeong-ro, Bundang-gu, Seongnamsi, Gyeonggi-do, 13601, Republic of KoreaBackground: Post-traumatic stress disorder (PTSD) has become an important public health problem. However, the conventional therapeutic strategy, including pharmacotherapy and cognitive behavioral therapy, has limitations. Neurofeedback is a technique that utilizes electroencephalography (EEG) signaling to monitor human physiological functions and is widely used to treat patients with PTSD. The purpose of our study is to assess the efficacy and safety level of neurofeedback treatment in patients with PTSD using quantitative EEG. Methods: This is a randomized, waitlist-controlled, assessor-blinded, clinical trial. Forty-six patients with PTSD will be randomly assigned at a 1:1 ratio into two groups. The participants in the treatment group will receive neurofeedback treatment for 50 min, twice a week, for 8 weeks (16 sessions). Quantitative EEG will be utilized to monitor the physiological functions and brain waves of the participants. A four-week follow-up period is planned. The participants in the control group will wait for 12 weeks. The primary outcome is the Korean version of PTSD Checklist-5 (PCL-5-K) score. The PCL-5-K scores on week 8 will be compared between the two groups. Anxiety, depression, insomnia, emotions, EEG, quality-of-life, and safety level will be assessed as secondary outcomes. Discussion: This trial will describe a clinical research methodology for neurofeedback in patients with PTSD. The numerous subjective and objective secondary outcomes add to the value of this trial’s results. It will also suggest a therapeutic strategy for utilizing quantitative EEG in patients with PTSD. Our trial will provide basic evidence for the management of PTSD via an integrative treatment. Trial registration: Clinical Research Information Service (CRIS): KCT0003271.http://www.sciencedirect.com/science/article/pii/S2213422020300962Randomized controlled trialProtocolNeurofeedbackPost traumatic stress disorderQuantitative electroencephalography
spellingShingle Jungtae Leem
Moon Joo Cheong
Sang-hoon Yoon
Hyunho Kim
Hee-Geun Jo
Hyeryun Lee
Jeesu Kim
Hyang Yi Kim
Geun-Woo Kim
Hyung Won Kang
Neurofeedback self-regulating training in patients with Post traumatic stress disorder: A randomized controlled trial study protocol
Integrative Medicine Research
Randomized controlled trial
Protocol
Neurofeedback
Post traumatic stress disorder
Quantitative electroencephalography
title Neurofeedback self-regulating training in patients with Post traumatic stress disorder: A randomized controlled trial study protocol
title_full Neurofeedback self-regulating training in patients with Post traumatic stress disorder: A randomized controlled trial study protocol
title_fullStr Neurofeedback self-regulating training in patients with Post traumatic stress disorder: A randomized controlled trial study protocol
title_full_unstemmed Neurofeedback self-regulating training in patients with Post traumatic stress disorder: A randomized controlled trial study protocol
title_short Neurofeedback self-regulating training in patients with Post traumatic stress disorder: A randomized controlled trial study protocol
title_sort neurofeedback self regulating training in patients with post traumatic stress disorder a randomized controlled trial study protocol
topic Randomized controlled trial
Protocol
Neurofeedback
Post traumatic stress disorder
Quantitative electroencephalography
url http://www.sciencedirect.com/science/article/pii/S2213422020300962
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