一项随机临床试验，用于评估 COVID-19 大流行期间基于试验的认知疗法、基于正念的健康促进和积极心理疗法对创伤后应激障碍的在线治疗效果：研究方案

A Randomized Clinical Trial to Assess the Efficacy of Online-Treatment with Trial-Based Cognitive Therapy, Mindfulness-Based Health Promotion and Positive Psychotherapy for Post-Traumatic Stress Disorder during the COVID-19 Pandemic: A Study Protocol

原载《国际环境研究与公共卫生杂志》2022年第19卷第2期

<International Journal of Environmental Research and Public Health>, 2022, 19 (2)

【摘要】背景：研究表明，在治疗创伤后应激障碍 (PTSD) 时，可以使用不同形式的治疗来降低流失率。本研究将评估的心理疗法是基于试验的认知疗法（TBCT）、基于正念的健康促进（MBHP）和积极心理疗法（PPT）。目的：(1) 与MBHP和PPT相比，评估TBCT在2019年冠状病毒病 (COVID-19) 大流行背景下减轻PTSD症状的在线疗效；(2) 比较这些心理疗法在改善焦虑、抑郁、内疚和促进幸福感方面的功效；(3) 描述专业人士如何看待在线治疗。方法：将进行一项随机、多中心、单盲的临床试验，包括三个独立的组。估计有135名患者的样本将接受 TBCT、MBHP或 PPT，并将通过在线、个人、每周访问的方式进行治疗，总共14个疗程。主要结果将是CAPS-5，次要结果将是HADS和WHO-5。用于调节这些结果的变量将是创伤相关内疚量表 (TRGI)、消极核心信念量表 (NCBI) 和加州心理治疗联盟量表 (CALPAS-P)。预期结果：预期在TBCT、MBHP和PPT后PTSD症状会减轻。预计这三者之间没有统计学差异。讨论：本研究将评估并有助于为PTSD患者开发新的心理治疗选择。这项研究的结果将有助于为PTSD患者传递新的有效且适应性强的干预措施。

【关键词】创伤后应激障碍；基于试验的认知疗法；积极的心理治疗；基于正念的健康促进；新冠病毒病

[Abstract]Background: Research suggests the use of different forms of therapy as a way of decreasing dropout rates in the treatment of post-traumatic stress disorder (PTSD). The psychotherapies to be assessed in this study are trial-based cognitive therapy (TBCT), mindfulness-based health promotion (MBHP)and positive psychotherapy (PPT). Objectives: (1) to assess the online efficacy of TBCT compared to MBHP and PPT to reduce the symptoms of PTSD in the context of the Coronavirus Disease 2019 (COVID-19) pandemic; (2) to compare the efficacy of these psychotherapies in improving anxiety, depression, guilt and in promoting well-being; and (3) to describe how professionals perceive online treatment. Methods: A randomized, multicenter, single-blind clinical trial will be conducted, with three separate arms. An estimated sample of 135 patients will receive either TBCT, MBHP or PPT and will be treated through online, individual, weekly visits, totaling 14 sessions. The primary outcome will be CAPS-5 and secondary outcomes will be HADS and WHO-5.The variables used to mediate these outcomes will be the Trauma-Related Guilt Inventory (TRGI), Negative Core Beliefs Inventory (NCBI) and the California Psychotherapy Alliance Scale (CALPAS-P). Expected results: PTSD symptoms are expected to be reduced after TBCT, MBHP and PPT. No statistical difference is expected to be found among the three. Discussion: The present study will evaluate and contribute towards the development of new psychotherapeutic options for patients with PTSD. The results of this study will allow the dissemination of new effective and adaptable interventions for patients with PTSD.

[Keywords] post-traumatic stress disorder; trial-based cognitive therapy; positive psychotherapy; mindfulness-based health promotion; COVID-19 

论文原文：ÉricaPanzani Duran, Curt Hemanny, Renata Vieira, Orlando Nascimento, Leonardo Machado, Irismar Reis de Oliveira and Marcelo Demarzo (2022). A Randomized Clinical Trial to Assess the Efficacy of Online-Treatment with Trial-Based Cognitive Therapy, Mindfulness-Based Health Promotion and Positive Psychotherapy for Post-Traumatic Stress Disorder during the COVID-19 Pandemic: A Study Protocol. International Journal of Environmental Research and Public Health. 19 (2): 819;

https://doi.org/10.3390/ijerph19020819

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