TraumaRelief App: A Pilot RCT Assessing Feasibility and Acceptability

NCT ID: NCT06288594

Last Updated: 2025-05-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 107 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-01
• Study Completion Date: 2025-05-10

Brief 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.

Detailed Description

"TraumaRelief" consists of eight modules. These are:

1. Psychoeducation Module: This module addresses fundamental questions-What is trauma? What is PTSD? What are the symptoms of PTSD?-and elaborates on related problems such as sleep, nutrition, and anger. It is designed to provide comprehensive information and guidance on these issues and comprises 10,000 words and eight animated videos (approximately 40 minutes in total).

2. Coping with Symptoms Module: This module offers 10,000 words and six animations (around 40 minutes in total) featuring information and exercises tailored to manage PTSD and related issues.

3. Imaginary Exposure Module: The module including 4,000 words and two audio recordings details the concept of imaginary exposure. The elements of this exposure are the creation of a list of avoided and uncomfortable situations, and of an hierarchy of fear, alongside instructions for imaginary exposure to avoided objects and the traumatic event itself.

4. Daily Exercises: Featuring 14 distinct audio recordings-ranging from relaxation, body scanning, breathing exercises, positive visualization, thought awareness, to compassion (each recording varies between 5 and 17 minutes)-this module integrates exercises such as automatic thought questioning and reviews, daily activity forms, and an enjoyable activity list, as directed in the coping with symptoms module.

5. Online Meeting Module: Facilitates video calls with psychologists via phone or e mail, enhancing therapeutic engagement.

6. Messaging with the Therapist: This module enables participants to send messages to their therapists through the application in emergency situations, ensuring timely support.

7. Myself Module: Each time users access the psychoeducation and coping with symptoms modules, they assess their stress level, contributing to a personalized stress graph.

8. Emergency Module: Provides contact information for relevant institutions in high-risk scenarios, such as suicidal ideation, facilitating immediate assistance.

Application Usage Pattern: Post-registration, access to subsequent modules is contingent upon the completion of prior ones, ensuring a structured progression through the content. For instance, the Imaginary Exposure Module is unlocked only after completing at least eighty percent of the Psychoeducation Module, ensuring participants have a foundational understanding before proceeding.

This pilot randomized controlled study aims to evaluate the feasibility, acceptability, and preliminary efficacy of the "TraumaRelief" application for individuals who have experienced traumatic events. The research primarily focuses on measuring application compliance and user satisfaction through metrics such as attrition, recruitment, retention, consent, adherence rates, and usage frequency. It also seeks to gather initial data on the application's impact on clinical outcomes, including PTSD symptom severity, depressive symptoms, anxiety levels, and quality of life. The procured data will provide information for designing a larger-scale RCT (Randomized Controlled Trial) and underpin subsequent efforts to refine the "TraumaRelief" application.

Conditions

Post-Traumatic Stress Disorder (PTSD)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Application Plus Online Therapist Support Group

Participants in this arm will engage with the "TraumaRelief" mobile application while also receiving weekly online therapy sessions lasting 20 to 30 minutes for the duration of five weeks.

Group Type: EXPERIMENTAL

Application Plus Online Therapist Support Group

Intervention Type: BEHAVIORAL

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.

Application Only Group

Participants in this arm will utilize the "TraumaRelief" mobile application as the sole intervention over a period of five weeks. This group will not receive any therapist-led sessions or additional support outside of the application's features.

Group Type: EXPERIMENTAL

Application Only Group

Intervention Type: BEHAVIORAL

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.

Waitlist Control Group

Participants in this control group are placed on a waitlist and will not receive any intervention during the initial five-week active phase of the trial. They serve as a comparative benchmark against the experimental groups to assess the effectiveness of the interventions. Following the three-month follow-up period, participants in this group will be granted access to the "TraumaRelief" mobile application, allowing them to benefit from the application.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Minimum Education Level: Participants are required to have at least a primary school education to ensure comprehension of the study materials.
• Smartphone Ownership
• Regular Smartphone Access
• PTSD Diagnosis Risk: Participants must have a PCL-5 score at or above the diagnostic threshold of 31, indicative of PTSD.

Exclusion Criteria

• Risk of Suicide
• Neurological or Psychiatric Conditions: Participants should not have neurological or psychiatric conditions that would impede the use of the "TraumaRelief" mobile application.
• Current Medication Use: Participants who are on psychotropic medications that could influence the study's outcomes will be excluded to prevent interactions with the intervention.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dokuz Eylul University

OTHER

Sponsor Role: lead

Responsible Party

Hasan arslan

Research Assistant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hasan ARSLAN, PHD. Cand.

Role: PRINCIPAL_INVESTIGATOR

Dokuz Eylul University

A. Esin YILMAZ SAMANCI, professor

Role: STUDY_DIRECTOR

Dokuz Eylul University

Locations

Hasan arslan

Batman, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

Arslan H, Yilmaz AE. 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. Internet Interv. 2024 Nov 23;38:100793. doi: 10.1016/j.invent.2024.100793. eCollection 2024 Dec.

Reference Type: BACKGROUND

PMID: 39659870 (View on PubMed)

Other Identifiers

DEU-PSI-HA-001

Identifier Type: -

Identifier Source: org_study_id