Alavi Nazanin, Stephenson Callum, Yang Megan, Kumar Anchan, Shao Yijia, Miller Shadé, Yee Caitlin S, Stefatos Anthi, Gholamzadehmir Maedeh, Abbaspour Zara, Jagayat Jasleen, Shirazi Amirhossein, Omrani Mohsen, Patel Archana, Patel Charmy, Groll Dianne
Department of Psychiatry, Queen's University, Kingston, ON, Canada.
Centre for Neuroscience Studies, Queen's University, Kingston, ON, Canada.
JMIR Res Protoc. 2021 Jun 16;10(6):e27489. doi: 10.2196/27489.
Major depressive disorder (MDD) is a prevalent and debilitating mental health disorder. Among different therapeutic approaches (eg, medication and psychotherapy), psychotherapy in the form of cognitive behavioral therapy (CBT) is considered the gold standard treatment for MDD. However, although efficacious, CBT is not readily accessible to many patients in need because of hurdles such as stigma, long wait times, high cost, the large time commitment for health care providers, and cultural or geographic barriers. Electronically delivered cognitive behavioral therapy (e-CBT) can effectively address many of these accessibility barriers.
This study aims to investigate the efficacy and feasibility of implementing an e-CBT program compared with in-person treatment for MDD. It is hypothesized that the e-CBT program will offer results comparable with those of the in-person treatment program, regarding symptom reduction and quality of life improvement.
This nonrandomized controlled trial intervention will provide e-CBT for MDD through the Online Psychotherapy Tool, a secure, cloud-based, digital mental health platform. Participants (aged 18-65 years) will be offered 12 weekly sessions of an e-CBT program tailored to MDD to address their depressive symptoms. Participants (n=55) will complete predesigned modules and homework assignments while receiving personalized feedback and interacting with a therapist through the platform. Using clinically validated symptomology questionnaires, the efficacy of the e-CBT program will be compared with that of a group (n=55) receiving in-person CBT. Questionnaires will be completed at baseline, at week 6 and week 12, and at a 6-month follow-up. Focus groups will be conducted to investigate personal, cultural, and social factors impacting the accessibility and feasibility of implementing a web-based psychotherapy tool from a patient and care provider perspective. Inclusion criteria include diagnosis of MDD, competence to consent to participate, ability to speak and read English, and consistent and reliable access to the internet. Exclusion criteria include active psychosis, acute mania, severe alcohol or substance use disorder, and active suicidal or homicidal ideation.
Ethics approval was obtained in January 2019, and recruitment of participants began in June 2019. Recruitment has been conducted via social media, web-based communities, and physician referrals. To date, 52 participants have been recruited to the e-CBT group, and 48 patients have been recruited to the in-person CBT group. Data collection is expected to be completed by March 2021, and analyses are expected to be completed by June 2021, as linear regression (for continuous outcomes) and binomial regression analysis (for categorical outcomes) are still being conducted.
The results of this study can provide valuable information for the development of more accessible and scalable mental health interventions with increased care capacity for MDD, without sacrificing the quality of care.
ClinicalTrials.gov NCT04478058; http://clinicaltrials.gov/ct2/show/NCT04478058.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/27489.
重度抑郁症（MDD）是一种常见且使人衰弱的心理健康障碍。在不同的治疗方法（如药物治疗和心理治疗）中，认知行为疗法（CBT）形式的心理治疗被认为是MDD的金标准治疗方法。然而，尽管CBT有效，但由于耻辱感、等待时间长、成本高、医疗服务提供者所需的大量时间投入以及文化或地理障碍等问题，许多有需要的患者难以获得CBT治疗。电子交付的认知行为疗法（e-CBT）可以有效解决其中许多可及性障碍。
本研究旨在调查与面对面治疗MDD相比，实施e-CBT项目的疗效和可行性。假设e-CBT项目在减轻症状和改善生活质量方面将提供与面对面治疗项目相当的结果。
这项非随机对照试验干预将通过在线心理治疗工具（一个安全的、基于云的数字心理健康平台）为MDD患者提供e-CBT。参与者（年龄在18至65岁之间）将接受为期12周、针对MDD量身定制的e-CBT项目，以解决他们的抑郁症状。参与者（n = 55）将完成预先设计的模块和家庭作业任务，同时通过该平台接受个性化反馈并与治疗师互动。使用经过临床验证的症状问卷，将e-CBT项目的疗效与接受面对面CBT的一组患者（n = 55）进行比较。问卷将在基线、第6周、第12周以及6个月随访时完成。将进行焦点小组讨论，从患者和医疗服务提供者的角度调查影响实施基于网络的心理治疗工具的可及性和可行性的个人、文化和社会因素。纳入标准包括MDD诊断、同意参与的能力、说英语和读英语的能力以及持续可靠的互联网接入。排除标准包括活动性精神病、急性躁狂症、严重酒精或物质使用障碍以及活动性自杀或杀人意念。
2019年1月获得伦理批准，2019年6月开始招募参与者。招募通过社交媒体、网络社区和医生推荐进行。迄今为止，e-CBT组已招募52名参与者，面对面CBT组已招募48名患者。数据收集预计于2021年3月完成，分析预计于2021年6月完成，因为线性回归（用于连续结果）和二项式回归分析（用于分类结果）仍在进行中。
本研究结果可为开发更易获得且可扩展的心理健康干预措施提供有价值的信息，在不牺牲护理质量的情况下提高MDD的护理能力。
ClinicalTrials.gov NCT04478058；http://clinicaltrials.gov/ct2/show/NCT04478058。
国际注册报告识别码（IRRID）：DERR1-10.2196/27489。
