Study protocol for pragmatic trials of Internet-delivered guided and unguided cognitive behavior therapy for treating depression and anxiety in university students of two Latin American countries: the Yo Puedo Sentirme Bien study.
Study protocol for pragmatic trials of Internet-delivered guided and unguided cognitive behavior therapy for treating depression and anxiety in university students of two Latin American countries: the Yo Puedo Sentirme Bien study.
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作者：
重度抑郁症（MDD）和广泛性焦虑症（GAD）在大学生中非常普遍，并预测大学表现和以后的生活角色功能受损。然而，大多数学生得不到治疗，特别是在中低收入国家。我们的目的是评估扩大治疗的影响，使用可扩展的和廉价的互联网提供的transdiagnosis认知行为疗法（iCBT）在大学生中的MDD和/或GAD的症状在两个LMIC在拉丁美洲（哥伦比亚和墨西哥），并调查创建一个精确的治疗规则（PTR）的可行性，以预测iCBT是最有效的。我们将首先进行一项多地点随机实用临床试验（N = 1500），学生在参与大学的学生心理健康诊所寻求治疗或回复提供服务的电子邮件。等待诊所服务的学生将被随机分配到无指导的iCBT（33%），指导的iCBT（33%）和常规治疗（TAU）（33%）。iCBT将立即提供，而TAU将在诊所预约可用时提供。将在随机化后90天评估短期总体效应，并在12个月后评估长期效应。我们将使用集成机器学习来预测无指导iCBT与有指导iCBT与TAU的治疗效果的异质性，并开发精确治疗规则（PTR）以优化个体学生的结果。然后我们将进行第二次和第三次试验，分别使用不同的样本（每组n = 500例），但两组分配不均：25%将分配给根据第一项试验中制定的PTR确定的产生最佳结局的治疗（PTR用于试验2的最佳短期结局和试验3的12个月结局），而其余75%将在所有三个治疗组中平均分配。通过收集全面的基线特征来评估治疗效果的异质性，我们将为优化治疗效果和指导大学心理健康治疗计划提供有价值的创新信息。这一努力可以扩大治疗范围，减少未满足的需求和诊所等待时间，并作为循证干预规划和实施的模式，从而对该区域产生巨大的公共卫生影响。IRB批准方案版本1.0; 2020年6月3日。招募工作于2021年3月1日开始。招募工作暂定于2024年5月30日完成。ClinicalTrials.govNCT04780542.首次提交日期：2021年2月28日。
Major depressive disorder (MDD) and generalized anxiety disorder (GAD) are highly prevalent among university students and predict impaired college performance and later life role functioning. Yet most students do not receive treatment, especially in low-middle-income countries (LMICs). We aim to evaluate the effects of expanding treatment using scalable and inexpensive Internet-delivered transdiagnostic cognitive behavioral therapy (iCBT) among college students with symptoms of MDD and/or GAD in two LMICs in Latin America (Colombia and Mexico) and to investigate the feasibility of creating a precision treatment rule (PTR) to predict for whom iCBT is most effective. We will first carry out a multi-site randomized pragmatic clinical trial (N = 1500) of students seeking treatment at student mental health clinics in participating universities or responding to an email offering services. Students on wait lists for clinic services will be randomized to unguided iCBT (33%), guided iCBT (33%), and treatment as usual (TAU) (33%). iCBT will be provided immediately whereas TAU will be whenever a clinic appointment is available. Short-term aggregate effects will be assessed at 90 days and longer-term effects 12 months after randomization. We will use ensemble machine learning to predict heterogeneity of treatment effects of unguided versus guided iCBT versus TAU and develop a precision treatment rule (PTR) to optimize individual student outcome. We will then conduct a second and third trial with separate samples (n = 500 per arm), but with unequal allocation across two arms: 25% will be assigned to the treatment determined to yield optimal outcomes based on the PTR developed in the first trial (PTR for optimal short-term outcomes for Trial 2 and 12-month outcomes for Trial 3), whereas the remaining 75% will be assigned with equal allocation across all three treatment arms. By collecting comprehensive baseline characteristics to evaluate heterogeneity of treatment effects, we will provide valuable and innovative information to optimize treatment effects and guide university mental health treatment planning. Such an effort could have enormous public-health implications for the region by increasing the reach of treatment, decreasing unmet need and clinic wait times, and serving as a model of evidence-based intervention planning and implementation. IRB Approval of Protocol Version 1.0; June 3, 2020. Recruitment began on March 1, 2021. Recruitment is tentatively scheduled to be completed on May 30, 2024. ClinicalTrials.govNCT04780542. First submission date: February 28, 2021.
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影响因子：
7.4
作者：
Alonso J;Liu Z;Evans-Lacko S;Sadikova E;Sampson N;Chatterji S;Abdulmalik J;Aguilar-Gaxiola S;Al-Hamzawi A;Andrade LH;Bruffaerts R;Cardoso G;Cia A;Florescu S;de Girolamo G;Gureje O;Haro JM;He Y;de Jonge P;Karam EG;Kawakami N;Kovess-Masfety V;Lee S;Levinson D;Medina-Mora ME;Navarro-Mateu F;Pennell BE;Piazza M;Posada-Villa J;Ten Have M;Zarkov Z;Kessler RC;Thornicroft G;WHO World Mental Health Survey Collaborators
通讯作者：
WHO World Mental Health Survey Collaborators
DOI：
10.1080/01621459.2012.734171
发表时间：
2012-12-01
影响因子：
3.7
作者：
Clarke, Paul S.;Windmeijer, Frank
通讯作者：
Windmeijer, Frank
影响因子：
6
作者：
Brosnan, Caragh;Southgate, Erica;Kelly, Brian
通讯作者：
Kelly, Brian
影响因子：
3.7
作者：
Angrist, JD;Imbens, GW;Rubin, DB
通讯作者：
Rubin, DB
影响因子：
1.9
作者：
Daniels, Michael J.;Jackson, Dan;White, Ian R.
通讯作者：
White, Ian R.