Stephenson Callum, Malakouti Niloufar, Nashed Joseph Y, Salomons Tim, Cook Douglas J, Milev Roumen, Alavi Nazanin
Centre for Neuroscience Studies, Faculty of Health Sciences, Queen's University, Kingston, ON, Canada.
Department of Psychiatry, Faculty of Health Sciences, Queen's University, Kingston, ON, Canada.
JMIR Res Protoc. 2021 Sep 14;10(9):e30726. doi: 10.2196/30726.
Obsessive-compulsive disorder (OCD) is a debilitating and prevalent anxiety disorder. Although the basal ganglia and frontal cortex are the brain regions that are most commonly hypothesized to be involved in OCD, the exact pathophysiology is unknown. By observing the effects of proven treatments on brain activation levels, the cause of OCD can be better understood. Currently, the gold standard treatment for OCD is cognitive behavioral therapy (CBT) with exposure and response prevention. However, this is often temporally and geographically inaccessible, time consuming, and costly. Fortunately, CBT can be effectively delivered using the internet (electronically delivered CBT [e-CBT]) because of its structured nature, thus addressing these barriers.
The aims of this study are to implement an e-CBT program for OCD and to observe its effects on brain activation levels using functional magnetic resonance imaging (MRI). It is hypothesized that brain activation levels in the basal ganglia and frontal cortex will decrease after treatment.
Individuals with OCD will be offered a 16-week e-CBT program with exposure and response prevention mirroring in-person CBT content and administered through a secure web-based platform. The efficacy of the treatment will be evaluated using clinically validated symptomology questionnaires at baseline, at week 8, and after treatment (week 16). Using functional MRI at baseline and after treatment, brain activation levels will be assessed in the resting state and while exposed to anxiety-inducing images (eg, dirty dishes if cleanliness is an obsession). The effects of treatment on brain activation levels and the correlation between symptom changes and activation levels will be analyzed.
The study received initial ethics approval in December 2020, and participant recruitment began in January 2021. Participant recruitment has been conducted through social media advertisements, physical advertisements, and physician referrals. To date, 5 participants have been recruited. Data collection is expected to conclude by January 2022, and data analysis is expected to be completed by February 2022.
The findings from this study can further our understanding of the causation of OCD and help develop more effective treatments for this disorder.
ClinicalTrials.gov NCT04630197; https://clinicaltrials.gov/ct2/show/NCT04630197.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/30726.
强迫症(OCD)是一种使人衰弱且普遍存在的焦虑症。尽管基底神经节和额叶皮质是最常被假定与强迫症有关的脑区,但其确切的病理生理学尚不清楚。通过观察已证实的治疗方法对大脑激活水平的影响,可以更好地理解强迫症的病因。目前,强迫症的金标准治疗方法是认知行为疗法(CBT)结合暴露与反应阻止法。然而,这种治疗方法在时间和地理上往往难以获得,耗时且成本高昂。幸运的是,由于其结构化的性质,CBT可以通过互联网有效地提供(电子交付的CBT [e-CBT]),从而克服这些障碍。
本研究的目的是实施一项针对强迫症的e-CBT计划,并使用功能磁共振成像(MRI)观察其对大脑激活水平的影响。假设治疗后基底神经节和额叶皮质的大脑激活水平会降低。
患有强迫症的个体将接受为期16周的e-CBT计划,该计划具有与面对面CBT内容相似的暴露与反应阻止法,并通过一个安全的基于网络的平台进行管理。在基线、第8周和治疗后(第16周)使用经过临床验证的症状问卷评估治疗效果。在基线和治疗后使用功能MRI,将在静息状态下以及暴露于诱发焦虑的图像(例如,如果洁癖是一种强迫观念,则为脏盘子)时评估大脑激活水平。将分析治疗对大脑激活水平的影响以及症状变化与激活水平之间的相关性。
该研究于2020年12月获得初步伦理批准,并于2021年1月开始招募参与者。参与者招募通过社交媒体广告、实体广告和医生推荐进行。迄今为止,已招募了5名参与者。预计数据收集将于2022年1月结束,数据分析预计将于2022年2月完成。
本研究的结果可以加深我们对强迫症病因的理解,并有助于开发针对这种疾病更有效的治疗方法。
ClinicalTrials.gov NCT04630197;https://clinicaltrials.gov/ct2/show/NCT04630197。
国际注册报告识别码(IRRID):PRR1-10.2196/30726。