Díaz-García Amanda, González-Robles Alberto, García-Palacios Azucena, Fernández-Felipe Isabel, Tur Cintia, Castilla Diana, Botella Cristina
Department of Psychology and Sociology, Universidad de Zaragoza (Campus de Teruel), Teruel, Spain.
Department of Basic and Clinical Psychology, and Psychobiology, Universitat Jaume I, Castellon, Spain.
Internet Interv. 2021 Jan 7;23:100363. doi: 10.1016/j.invent.2021.100363. eCollection 2021 Mar.
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.
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.
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.
ClinicalTrials.gov Identifier: NCT04008576. Registered 05 July 2019, https://clinicaltrials.gov/ct2/show/NCT04008576.
情绪障碍(焦虑症和抑郁症)是一个重要的公共卫生问题,其患病率高、成本高且导致严重残疾。因此,研究重点包括设计和测试具有成本效益的干预措施,以惠及所有有需要的人。通过互联网提供的情绪障碍干预措施是有效的,有助于传播和实施循证治疗。然而,尽管这些治疗方法总体上有效,但并非所有患者都能同等程度地从这种治疗形式中受益。混合治疗是一种新的干预形式,它结合了面对面治疗和互联网治疗方法的优点。然而,关于混合干预的研究主要集中在个体治疗上,而对在团体心理治疗中使用这种形式的潜力关注较少。本研究旨在分析针对情绪障碍的混合跨诊断团体认知行为疗法的可行性。本文描述了该试验的研究方案。
将进行一项单臂试点试验。参与者将是30名患有DSM-5焦虑症和/或抑郁症的成年人。治疗包括在24周内进行的混合跨诊断团体干预。每组6至10名患者将总共参加八次为时2小时的面对面会议,并与使用在线平台交替进行,他们将在该平台上找到治疗方案的内容。该干预有四个核心组成部分:关注当下的觉察、认知灵活性、识别和改变情绪回避的行为和认知模式,以及内感受和情境暴露。这些组成部分在16个模块中进行。评估将在基线、治疗期间、治疗后和3个月随访时进行。将纳入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)。
该试验已获得哈维尔一世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。本研究的结果将通过在会议上展示进行传播,并将提交至同行评审期刊发表。
ClinicalTrials.gov标识符:NCT04008576。于2019年7月5日注册,https://clinicaltrials.gov/ct2/show/NCT04008576 。