Assessing the feasibility, acceptability, and preliminary efficacy of the ‘TraumaRelief’ app for PTSD symptom management in Turkey: Study protocol for a pilot randomized controlled trial

IF 3.6 2区医学 Q1 HEALTH CARE SCIENCES & SERVICES

Internet Interventions-The Application of Information Technology in Mental and Behavioural Health Pub Date : 2024-11-23 DOI:10.1016/j.invent.2024.100793

Hasan Arslan, A. Esin Yilmaz

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引用次数: 0

Abstract

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.

Clinical Trial Registration

ClinicalTrials.gov Identifier NCT06288594. Unique Protocol ID: DEU-PSI-HA-001.

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评估 "TraumaRelief "应用程序在土耳其用于创伤后应激障碍症状管理的可行性、可接受性和初步疗效：随机对照试验研究方案

全球遭受创伤事件的比例很高，而创伤后应激障碍（PTSD）是最严重的后果之一。据报道，2023 年 2 月，土耳其约有 1400 万人受到地震影响。认知行为疗法（CBT）是治疗创伤后应激障碍的一种治疗方法，其疗效已得到证实。然而，获得 CBT 等面对面疗法的机会有限，而且辍学率很高。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。在这项研究中，我们将开发一款名为 TraumaRelief 的应用程序，旨在缓解创伤后应激障碍症状。我们将在土耳其开展一项试验性随机对照研究，对该应用程序的可行性、可接受性和疗效进行测试，研究对象为 105 名年龄在 18 岁至 65 岁之间、经历过创伤事件的参与者。参与者将被随机分配到应用加在线治疗师支持组（AT + OT 组）、仅应用组（A 组）和候补对照组（WLC 组）。本研究旨在评估创伤后应激障碍、抑郁和焦虑症状及其对生活质量的影响。此外，还将考察研究的可行性和可接受性；应用程序的流失率、同意率、招募率和坚持率；干预实施的忠实度；系统可用性评分；首选和最不首选的模块组件；应用程序的使用频率；以及推荐应用程序的可能性。将在一个月和三个月时进行随访，监测应用程序的功效。研究结果将为技术治疗与心理治疗的整合提供重要信息。此外，它还能对心理治疗领域潜在的移动应用程序进行评估，是为土耳其这样一个具有独特文化和社会动态的社会开发和评估定制移动应用程序的重要一步。它还可以成为一种重要资源，提高人们应对土耳其已发生的创伤事件或未来事件影响的能力。临床试验注册ClinicalTrials.gov Identifier NCT06288594。唯一协议 ID：DEU-PSI-HA-001。

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来源期刊

Internet Interventions-The Application of Information Technology in Mental and Behavioural Health Medicine-Health Informatics

CiteScore

6.50

自引率

9.30%

发文量

审稿时长

6 weeks

期刊介绍： Official Journal of the European Society for Research on Internet Interventions (ESRII) and the International Society for Research on Internet Interventions (ISRII). The aim of Internet Interventions is to publish scientific, peer-reviewed, high-impact research on Internet interventions and related areas. Internet Interventions welcomes papers on the following subjects: • Intervention studies targeting the promotion of mental health and featuring the Internet and/or technologies using the Internet as an underlying technology, e.g. computers, smartphone devices, tablets, sensors • Implementation and dissemination of Internet interventions • Integration of Internet interventions into existing systems of care • Descriptions of development and deployment infrastructures • Internet intervention methodology and theory papers • Internet-based epidemiology • Descriptions of new Internet-based technologies and experiments with clinical applications • Economics of internet interventions (cost-effectiveness) • Health care policy and Internet interventions • The role of culture in Internet intervention • Internet psychometrics • Ethical issues pertaining to Internet interventions and measurements • Human-computer interaction and usability research with clinical implications • Systematic reviews and meta-analysis on Internet interventions