Arslan Hasan, Yilmaz A Esin
Department of Psychology, Dokuz Eylül University, Tınaztepe Campus, Buca 35390, İzmir, Turkey.
Internet Interv. 2024 Nov 23;38:100793. doi: 10.1016/j.invent.2024.100793. eCollection 2024 Dec.
The rate of exposure to traumatic events is high globally, and post-traumatic stress disorder (PTSD) is one of the most serious consequences. It was reported that approximately 14 million people were affected by earthquakes in Turkey in February 2023. Cognitive Behavioral Therapy (CBT) is a therapeutic approach to treating PTSD and has a proven efficacy. However, access to face-to-face therapies such as CBT is limited and there is a high dropout rate. Technology-based interventions can offer new solutions to make CBT more accessible and integrated into daily life. In this study, we will develop an application called TraumaRelief, which aims to relieve PTSD symptoms. We will test the feasibility, acceptability, and efficacy of this application through a pilot randomized controlled study conducted in Turkey, with 105 participants aged between 18 and 65 years who have experienced a traumatic event. Participants will be randomly assigned to the Application Plus Online Therapist Support Group (AT + OT Group), Application Only Group (Group A), and Waitlist Control Group (WLC Group). This study aims to evaluate symptoms of PTSD, depression, and anxiety, as well as their effects on quality of life. In addition, the feasibility and acceptability of the study; the attrition, consent, recruitment, and adherence rate to the application; fidelity of intervention delivery; system usability score; preferred and least preferred module components; app utilization frequency; and likelihood to recommend the application will be examined. Application efficacy will be monitored with follow-ups at one and three months. The results could provide important information on the integration of technology-based treatments with psychotherapy. In addition, it could allow the evaluation of potential mobile applications in the field of psychotherapy and represents an important step in the development and evaluation of a customized mobile application for a society with unique cultural and social dynamics, such as Turkey. It could also be an important resource for increasing the capacity to cope with the effects of traumatic events that have occurred in Turkey or future events.
ClinicalTrials.gov Identifier NCT06288594. Unique Protocol ID: DEU-PSI-HA-001.
全球范围内创伤性事件的暴露率很高，创伤后应激障碍（PTSD）是最严重的后果之一。据报道，2023年2月土耳其约1400万人受到地震影响。认知行为疗法（CBT）是一种治疗PTSD的治疗方法，且已证实有效。然而，获得诸如CBT等面对面治疗的机会有限，且退出率很高。基于技术的干预措施可以提供新的解决方案，使CBT更容易获得并融入日常生活。在本研究中，我们将开发一款名为TraumaRelief的应用程序，旨在缓解PTSD症状。我们将通过在土耳其进行的一项试点随机对照研究来测试该应用程序的可行性、可接受性和有效性，该研究有105名年龄在18至65岁之间经历过创伤性事件的参与者。参与者将被随机分配到应用程序加在线治疗师支持组（AT + OT组）、仅应用程序组（A组）和等待列表对照组（WLC组）。本研究旨在评估PTSD、抑郁和焦虑症状，以及它们对生活质量的影响。此外，还将考察研究的可行性和可接受性；应用程序的损耗、同意、招募和依从率；干预实施的保真度；系统可用性评分；最喜欢和最不喜欢的模块组件；应用程序使用频率；以及推荐该应用程序的可能性。将在1个月和3个月时进行随访以监测应用程序的疗效。研究结果可为基于技术的治疗与心理治疗的整合提供重要信息。此外，它可以评估心理治疗领域潜在的移动应用程序，并代表着为具有独特文化和社会动态的社会（如土耳其）开发和评估定制移动应用程序的重要一步。它也可能是提高应对土耳其已发生的创伤性事件或未来事件影响能力的重要资源。
ClinicalTrials.gov标识符NCT06288594。独特方案标识符：DEU-PSI-HA-001。
