Fernández-Buendía Sara, Cuijpers Pim, Grimaldos Jorge, Díaz-García Amanda, Palau-Batet María, Quero Soledad
Department of Basic, Clinical Psychology and Psychobiology, Universitat Jaume I, Castellón, Spain.
Department of Clinical, Neuro and Developmental Psychology, Amsterdam Public Health Research Institute, Vrije Universiteit Amsterdam, the Netherlands.
Internet Interv. 2024 Jan 22;35:100715. doi: 10.1016/j.invent.2024.100715. eCollection 2024 Mar.
Adjustment disorder (AjD) is a maladaptive response to one or more psychosocial stressors. In many cases, the symptomatology of this disorder disappears once the stressor or its consequences are no longer present. However, in some cases, if left untreated, the symptoms may worsen and develop into a more severe mental disorder. In this regard, different authors propose that a low-intensity intervention may be suitable for this disorder. Previous studies with other mental disorders and with patients with AjD found that blended interventions can be a viable and effective option. The aim of this study is to analyze the feasibility (the participants' expectations and preferences, the satisfaction and acceptance, the appropriateness of different methods of recruitment and data collection, and the reasons for dropping out) of a blended cognitive-behavioral intervention (CBT) for AjD that combines the use of a self-applied Internet-based program with videoconference sessions with a therapist. As a secondary objective, the potential efficacy of this intervention will be tested.
A feasibility trial with a single-group and open-trial design will be conducted. A total of 41 participants will be assigned to the single treatment group. All the participants will be assessed for eligibility and respond at four measurement points: pre-treatment, post-treatment, and 3- and 12-month follow-ups. The treatment combines the use of an Internet-based intervention through a web platform with videoconference sessions with a therapist every 10-12 days. The intervention contains seven modules and is based on CBT. The main outcome measures are related to the feasibility of the intervention (adherence, treatment satisfaction and expectations, participants' opinions, preferences, therapeutic alliance, and usability). Clinical measures will also be assessed.
To the best of our knowledge, this is the first study to test a blended intervention for AjD in the Spanish language. We expect this intervention to be feasible, and that a future Randomized Controlled Trial will be able to show its efficacy. Potential limitations include difficulties in recruiting the sample, failures in the computer systems, or a high dropout rate. Measures have been taken to try to reduce the impact of these limitations. This study received the approval of the Ethics committee of Universitat Jaume I in March 2022 (CD/42/2022).
ClinicalTrials.gov Identifier: NCT05464121. Registered 19 July 2022, https://clinicaltrials.gov/ct2/show/NCT05464121.
适应障碍（AjD）是对一个或多个心理社会应激源的适应不良反应。在许多情况下，一旦应激源或其后果不再存在，这种障碍的症状就会消失。然而，在某些情况下，如果不进行治疗，症状可能会恶化并发展成更严重的精神障碍。在这方面，不同的作者提出低强度干预可能适用于这种障碍。先前针对其他精神障碍以及AjD患者的研究发现，混合干预可能是一种可行且有效的选择。本研究的目的是分析一种针对AjD的混合认知行为干预（CBT）的可行性（参与者的期望和偏好、满意度和接受度、不同招募和数据收集方法的适当性以及退出原因），该干预将基于互联网的自我应用程序与与治疗师的视频会议相结合。作为次要目标，将测试这种干预的潜在疗效。
将进行一项单组开放试验设计的可行性试验。总共41名参与者将被分配到单一治疗组。所有参与者将接受资格评估，并在四个测量点进行回应：治疗前、治疗后以及3个月和12个月随访。治疗将通过网络平台使用基于互联网的干预，并每10 - 12天与治疗师进行一次视频会议。该干预包含七个模块，基于认知行为疗法。主要结局指标与干预的可行性（依从性、治疗满意度和期望、参与者的意见、偏好、治疗联盟和可用性）相关。还将评估临床指标。
据我们所知，这是第一项以西班牙语测试针对AjD的混合干预的研究。我们预计这种干预是可行的，并且未来的随机对照试验将能够证明其疗效。潜在的局限性包括招募样本困难、计算机系统故障或高退出率。已采取措施试图减少这些局限性的影响。本研究于2022年3月获得了哈维尔一世大学伦理委员会的批准（CD/42/2022）。
ClinicalTrials.gov标识符：NCT05464121。于2022年7月19日注册，https://clinicaltrials.gov/ct2/show/NCT05464121。
