Introduction

Emotional disorders (anxiety and depressive disorders) are a relevant public health concern associated with high prevalence, high costs, and important disability. Therefore, research priorities include designing and testing cost-effective interventions to reach everyone in need. Internet-delivered interventions for emotional disorders are effective and can help to disseminate and implement evidence-based treatments. However, although these treatments are generally effective, not all patients benefit from this treatment format equally. Blended treatments are a new form of intervention that combines the strengths of face-to-face and Internet approaches. Nevertheless, research on blended interventions has focused primarily on individual therapy, and less attention has been paid to the potential of using this format in group psychotherapy. This study aims to analyze the feasibility of blended transdiagnostic group CBT for emotional disorders. The current article describes the study protocol for this trial.

Method and analysis

A one-armed pilot trial will be conducted. Participants will be 30 adults suffering from DSM-5 anxiety and/or depressive disorders. The treatment consists of a blended transdiagnostic group intervention delivered during a period of 24 weeks. Groups of 6 to 10 patients will attend a total of eight 2-hour, face-to-face sessions, alternated with the use of an online platform where they will find the contents of the treatment protocol. The intervention has four core components: present-focused awareness, cognitive flexibility, identification and modification of behavioral and cognitive patterns of emotional avoidance, and interoceptive and situational exposure. These components are delivered in 16 modules. Assessments will be performed at baseline, during the treatment, at post-treatment, and at 3-month follow-up. Clinical and treatment acceptability outcomes will be included. Quantitative and qualitative data (participants’ views about blended group psychotherapy) will be analyzed.

Ethics and dissemination

The trial has received ethical approval from the Ethics Committee of Universitat Jaume I (September 2019) and will be conducted in accordance with the study protocol, the Declaration of Helsinki, and good clinical practice. The results of this study will be disseminated by presentation at conferences and will be submitted for publication in a peer-reviewed journal.

Trial registration

ClinicalTrials.gov Identifier: NCT04008576. Registered 05 July 2019, https://clinicaltrials.gov/ct2/show/NCT04008576

中文翻译：

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混合跨诊断团体 CBT 治疗情绪障碍：可行性试验方案

介绍

情绪障碍（焦虑症和抑郁症）是一个相关的公共卫生问题，与高患病率、高费用和严重残疾有关。因此，研究重点包括设计和测试具有成本效益的干预措施，以惠及每个有需要的人。互联网提供的情绪障碍干预措施是有效的，可以帮助传播和实施循证治疗。然而，尽管这些治疗通常有效，但并非所有患者都能平等地受益于这种治疗方式。混合治疗是一种新的干预形式，结合了面对面和互联网方法的优势。然而，混合干预的研究主要集中在个体治疗上，而很少关注在团体心理治疗中使用这种形式的潜力。本研究旨在分析混合跨诊断团体 CBT 治疗情绪障碍的可行性。当前的文章描述了该试验的研究方案。

方法与分析

将进行单臂试点试验。参与者将是 30 名患有 DSM-5 焦虑症和/或抑郁症的成年人。该治疗包括为期 24 周的混合跨诊断小组干预。6 至 10 名患者组成的小组将参加总共 8 次时长 2 小时的面对面会议，期间交替使用在线平台，在该平台上他们可以找到治疗方案的内容。干预措施有四个核心组成部分：关注当下的意识、认知灵活性、情绪回避的行为和认知模式的识别和修改，以及内感受和情境暴露。这些组件以 16 个模块的形式提供。评估将在基线、治疗期间、治疗后和 3 个月随访时进行。将包括临床和治疗可接受性结果。将分析定量和定性数据（参与者对混合团体心理治疗的看法）。

道德与传播

该试验已获得 Jaume I 大学伦理委员会的伦理批准（2019 年 9 月），并将按照研究方案、赫尔辛基宣言和良好临床实践进行。这项研究的结果将通过在会议上演讲的方式传播，并将提交在同行评审的期刊上发表。

试用注册

ClinicalTrials.gov 标识符：NCT04008576。注册日期：2019 年 7 月 5 日，https://clinicaltrials.gov/ct2/show/NCT04008576