TraumaRelief App: A Pilot RCT Assessing Feasibility and Acceptability

Summary

The world experiences a high rate of traumatic events. Even if PTSD is not diagnosed, traumatic events can significantly affect people's lives. Traditional face-to-face therapies often face challenges, such as financial constraints, expensive therapy sessions, time restrictions, fear of stigma, and difficulties in accessing clinical psychologists. These challenges motivated us to develop new methods. Particularly in Turkey, there is neither sufficient infrastructure nor existing applications dedicated to addressing trauma-related complications. The development of the 'TraumaRelief' app is a pioneering initiative aimed at bridging this gap, targeting the resolution of these prevalent issues by introducing an accessible, innovative solution. The newly developed "TraumaRelief" app aims to provide solutions to these issues. This app contains eight modules: online video talks, psychoeducation, coping with symptoms, mindfulness-based relaxation exercises, imagery exposure, CBT (Cognitive Behavioral Therapy)-based daily exercises, therapist messaging, emergency contact access. The purpose of this study is to test the feasibility and acceptability of this newly developed application through a pilot randomized controlled trial.

Conditions

• Post-Traumatic Stress Disorder (PTSD)

Interventions

BEHAVIORAL

Application Plus Online Therapist Support Group

Participants in the therapist-supported group will receive weekly 20-30 minute online sessions for five weeks, with content based on a semi-structured manual. After 80% completion of the psychoeducation module, the coping module becomes available, and similarly, the exposure module follows. These sessions will be conducted in adherence to a structured manual, with the therapist introducing the module of the week, guiding through exercises, assigning homework, and reviewing the previous assignments. Sessions include module introductions, exercises, homework assignments, and application use review. Feedback and PCL-5 scores guide post-session recommendations. A random 40% of sessions will undergo fidelity checks by doctoral-level psychologists.

BEHAVIORAL

Application Only Group

Participants allocated to this group will have access to the "TraumaRelief" mobile application over a five-week period, with the exception of the online module component. The application's deployment strategy ensures a structured progression through its features: participants will gain access to the subsequent modules only after completing 80% of the preceding module. Initially, they will engage with the psychoeducation module; upon completion of at least 80% of this module, the coping with symptoms module will become available. Similarly, successful engagement with 80% of the coping module will unlock the imaginary exposure module. This sequential module access is designed to reinforce the acquisition of knowledge and skills in a stepwise manner, paralleling the structure provided to the "TraumaRelief Mobile Application with Therapist Support" group, yet without the additional therapist interaction.

Sponsors & Collaborators

• Dokuz Eylul University

  lead OTHER

Principal Investigators

• Hasan ARSLAN, PHD. Cand. · Dokuz Eylul University

• A. Esin YILMAZ SAMANCI, professor · Dokuz Eylul University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-12-01

Primary Completion

2025-02-10

Completion

2025-05-10

Countries

• Turkey (Türkiye)

Study Locations