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Feasibility and Efficacy of Delivering Cognitive Behavioral Therapy Through an Online Psychotherapy Tool for Depression: Protocol for a Randomized Controlled Trial

机译:通过对抑郁症的在线心理治疗工具提供认知行为治疗的可行性和功效:随机对照试验的协议

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摘要

BackgroundMajor 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. ObjectiveThis 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. MethodsThis 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. ResultsEthics 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. ConclusionsThe 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. Trial RegistrationClinicalTrials.gov NCT04478058; http://clinicaltrials.gov/ct2/show/NCT04478058 International Registered Report Identifier (IRRID)DERR1-10.2196/27489
机译:BackgroundMajor抑郁症(MDD)是一种普遍和衰弱的心理健康障碍。中不同的治疗方法(例如,药物和心理),心理治疗认知行为疗法的形式(CBT)被认为是MDD治疗的金标准。然而,尽管有效,CBT是不是很多病人需要,因为障碍如柱头,漫长的等待时间,成本高,对医疗服务提供者的大的时间承诺,文化或地理障碍容易接近。电子方式提供认知行为疗法(E-CBT),可以有效地解决许多的这些辅助功能障碍。 ObjectiveThis研究旨在探讨在人的治疗MDD相比,实施电子CBT方案的可行性和有效性。据推测,在E-CBT程序将提供结果与那些在人的治疗方案相媲美,对于症状减轻和改善生活质量。 MethodsThis非随机对照试验的干预将通过网上心理工具,安全的,基于云的数字心理健康平台提供的e-CBT的MDD。参与者(年龄18-65岁)将提供针对MDD,以解决他们的抑郁症状的E-CBT计划的12次会议。参与者(N = 55),而接收个性化的反馈,并通过所述平台的治疗相互作用将完成预设计模块和家庭作业。使用临床验证症状问卷,则e-CBT程序的功效将与接收人CBT一组(n = 55)进行比较。问卷将在基线完成,6周和12周,并在6个月的随访。焦点小组将进行调查影响的获取和实现从病人和护理提供者角度来看,基于Web的工具心理治疗的可行性个人,文化和社会因素。入选标准包括MDD的诊断,有权同意参加,能力,说,读英语,到互联网的一致和可靠的访问。排除标准包括活性精神病,急性躁狂,严重酒精或物质使用障碍,和活性自杀或杀人观念。在2019年1月获得批准ResultsEthics,和参加者招募在2019年六月开始招聘已经通过社交媒体,基于Web的社区,和医生转介已经进行。迄今为止,52名学员已招募到E-CBT组,48例被招募到在人的CBT组。数据采集​​预计到2021年3月完成,并且预期分析在6月份2021完成,如线性回归(对于连续的结果)和二项式回归分析(对于分类结果)仍在进行。这项研究的ConclusionsThe结果可为增加护理能力MDD更方便和可扩展的精神卫生干预的发展有价值的信息,在不牺牲医疗质量。试用RegistrationClinicalTrials.gov NCT04478058; http://clinicaltrials.gov/ct2/show/NCT04478058国际注册报告标识符(IRRID)DERR1-10.2196 / 27489

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