Safety and effectiveness of transcutaneous auricular vagus nerve stimulation on patients with depersonalization-derealization disorder: study protocol for a randomized controlled trial
Abstract Background Depersonalization-derealization disorder (DPD) is a complex psychiatric condition marked by profound and often relentless feelings of detachment from one’s self and surroundings. Transcranial electrical stimulation (taVNS) holds promise as a potential therapeutic approach for DPD...
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| Language: | English |
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BMC
2024-12-01
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| Series: | Trials |
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| Online Access: | https://doi.org/10.1186/s13063-024-08658-w |
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| author | Yan Zhao Sisi Zheng Hong Zhu Dongqing Yin Meng Fang Hongxiao Jia |
| author_facet | Yan Zhao Sisi Zheng Hong Zhu Dongqing Yin Meng Fang Hongxiao Jia |
| author_sort | Yan Zhao |
| collection | DOAJ |
| description | Abstract Background Depersonalization-derealization disorder (DPD) is a complex psychiatric condition marked by profound and often relentless feelings of detachment from one’s self and surroundings. Transcranial electrical stimulation (taVNS) holds promise as a potential therapeutic approach for DPD. This study aims to investigate the safety and efficacy of taVNS in treating DPD. Methods DPD patients were recruited as research subjects and randomly allocated to the experimental and control groups, with the former receiving active-taVNS treatment and the latter receiving sham stimulation treatment for 6 weeks. The efficacy of taVNS in treating DPD was evaluated by comparing scores for DPD symptoms, depression and anxiety symptoms, cognitive function, and social function before and after treatment between the two groups. The safety of taVNS in treating DPD was assessed by comparing general safety assessment results between the two groups of DPD patients. Discussion This study will assess taVNS as a potential treatment for DPD, evaluating its safety, efficacy, and impact on patient outcomes and societal burden. Trial registration Chinese Clinical Trial Registry, ChiCTR2300078183, Registered on 30 November, 2023, https://www.chictr.org.cn/showproj.html?proj=206119 |
| format | Article |
| id | doaj-art-82c1bd4f677542328018adb5c4e8dd70 |
| institution | OA Journals |
| issn | 1745-6215 |
| language | English |
| publishDate | 2024-12-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj-art-82c1bd4f677542328018adb5c4e8dd702025-08-20T02:30:56ZengBMCTrials1745-62152024-12-0125111210.1186/s13063-024-08658-wSafety and effectiveness of transcutaneous auricular vagus nerve stimulation on patients with depersonalization-derealization disorder: study protocol for a randomized controlled trialYan Zhao0Sisi Zheng1Hong Zhu2Dongqing Yin3Meng Fang4Hongxiao Jia5Beijing Key Laboratory of Mental Disorders, National Clinical Research Center for Mental Disorders & National Center for Mental Disorders, Beijing Anding Hospital, Capital Medical UniversityBeijing Key Laboratory of Mental Disorders, National Clinical Research Center for Mental Disorders & National Center for Mental Disorders, Beijing Anding Hospital, Capital Medical UniversityBeijing Key Laboratory of Mental Disorders, National Clinical Research Center for Mental Disorders & National Center for Mental Disorders, Beijing Anding Hospital, Capital Medical UniversityBeijing Key Laboratory of Mental Disorders, National Clinical Research Center for Mental Disorders & National Center for Mental Disorders, Beijing Anding Hospital, Capital Medical UniversityBeijing Key Laboratory of Mental Disorders, National Clinical Research Center for Mental Disorders & National Center for Mental Disorders, Beijing Anding Hospital, Capital Medical UniversityBeijing Key Laboratory of Mental Disorders, National Clinical Research Center for Mental Disorders & National Center for Mental Disorders, Beijing Anding Hospital, Capital Medical UniversityAbstract Background Depersonalization-derealization disorder (DPD) is a complex psychiatric condition marked by profound and often relentless feelings of detachment from one’s self and surroundings. Transcranial electrical stimulation (taVNS) holds promise as a potential therapeutic approach for DPD. This study aims to investigate the safety and efficacy of taVNS in treating DPD. Methods DPD patients were recruited as research subjects and randomly allocated to the experimental and control groups, with the former receiving active-taVNS treatment and the latter receiving sham stimulation treatment for 6 weeks. The efficacy of taVNS in treating DPD was evaluated by comparing scores for DPD symptoms, depression and anxiety symptoms, cognitive function, and social function before and after treatment between the two groups. The safety of taVNS in treating DPD was assessed by comparing general safety assessment results between the two groups of DPD patients. Discussion This study will assess taVNS as a potential treatment for DPD, evaluating its safety, efficacy, and impact on patient outcomes and societal burden. Trial registration Chinese Clinical Trial Registry, ChiCTR2300078183, Registered on 30 November, 2023, https://www.chictr.org.cn/showproj.html?proj=206119https://doi.org/10.1186/s13063-024-08658-wTranscutaneous auricular vagus nerve stimulationDepersonalization-derealization disorderEffect |
| spellingShingle | Yan Zhao Sisi Zheng Hong Zhu Dongqing Yin Meng Fang Hongxiao Jia Safety and effectiveness of transcutaneous auricular vagus nerve stimulation on patients with depersonalization-derealization disorder: study protocol for a randomized controlled trial Trials Transcutaneous auricular vagus nerve stimulation Depersonalization-derealization disorder Effect |
| title | Safety and effectiveness of transcutaneous auricular vagus nerve stimulation on patients with depersonalization-derealization disorder: study protocol for a randomized controlled trial |
| title_full | Safety and effectiveness of transcutaneous auricular vagus nerve stimulation on patients with depersonalization-derealization disorder: study protocol for a randomized controlled trial |
| title_fullStr | Safety and effectiveness of transcutaneous auricular vagus nerve stimulation on patients with depersonalization-derealization disorder: study protocol for a randomized controlled trial |
| title_full_unstemmed | Safety and effectiveness of transcutaneous auricular vagus nerve stimulation on patients with depersonalization-derealization disorder: study protocol for a randomized controlled trial |
| title_short | Safety and effectiveness of transcutaneous auricular vagus nerve stimulation on patients with depersonalization-derealization disorder: study protocol for a randomized controlled trial |
| title_sort | safety and effectiveness of transcutaneous auricular vagus nerve stimulation on patients with depersonalization derealization disorder study protocol for a randomized controlled trial |
| topic | Transcutaneous auricular vagus nerve stimulation Depersonalization-derealization disorder Effect |
| url | https://doi.org/10.1186/s13063-024-08658-w |
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