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.

Unlabelled: 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.