TraumaRelief App: A Pilot RCT Assessing Feasibility and Acceptability

NCT06288594 | Completed

• 1 other identifier: DEU-PSI-HA-001
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-Traumatic Stress Disorder (PTSD)

Keywords

Ptsd; Trauma; Mobile Application; Pilot study; Randomized Controlled Trial; Feasibility; Acceptability; Efficacy; E-health

Outcome Measures

Primary Outcomes (1)

• PTSD Symptom Severity

  This outcome measure will assess the change in severity of PTSD symptoms, utilizing the PTSD Checklist for DSM-5 (PCL-5). This self-report measure encompasses 20 items distributed across four domains: re-experiencing (comprising five items), avoidance (encompassing two items), negative alterations in cognition and mood (consisting of seven items), and hyperarousal (incorporating six items). The scoring spectrum extends from 0 to 80, with ascending scores indicative of augmented severity in PTSD symptoms. The threshold of concern has been established at 31 points. In the context of the Turkish adaptation study, the Cronbach's alpha reliability coefficient was ascertained to be .94. The instrument mandates participants to specify a particular traumatic event at the outset, thereby rendering the PCL-5 applicable for evaluating PTSD across diverse traumatic experiences.

  Change from baseline assessment, at 1 week post-intervention assessment (6-7 weeks after baseline), change from post-assessment at 1 month post-intervention assessment (2.5-3 months after baseline), and change from at 3 month post intervention assessment

Secondary Outcomes (12)

• Depression Anxiety and Stress Symptom Severity

  Change from baseline assessment, at 1 week post-intervention assessment (6-7 weeks after baseline), change from post-assessment at 1 month post-intervention assessment (2.5-3 months after baseline), and change from at 3 month post intervention assessment

• Quality of Life Improvement

  Change from baseline assessment, at 1 week post-intervention assessment (6-7 weeks after baseline), change from post-assessment at 1 month post-intervention assessment (2.5-3 months after baseline), and change from at 3 month post intervention assessment

• Feasibility: Attrition Rate

  Attrition rate will be measured from baseline, at 5 weeks post-intervention, 1 month post-intervention, and 3 months post-intervention.

• Feasibility: Recruitment Rate

  Recruitment period will be calculated from the beginning of the enrollment process up to the start date of the intervention

• Feasibility: Retention Rate

  Retention rate will be assessed from baseline, at 5 weeks, 1 month post-intervention, and 3 months post-intervention.

Study Arms (3)

Application Plus Online Therapist Support Group

EXPERIMENTAL

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.

Behavioral: Application Plus Online Therapist Support Group

Application Only Group

EXPERIMENTAL

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.

Behavioral: Application Only Group

Waitlist Control Group

NO INTERVENTION

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.

Interventions

Application Plus Online Therapist Support Group 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 Plus Online Therapist Support Group

Application Only Group 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.

Application Only Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Participants of any gender identity are eligible to enroll in this study, reflecting our commitment to inclusivity and recognition of the diversity of gender experiences.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dokuz Eylul University: lead

Study Sites (1)

Hasan arslan

Batman, 72100, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 39659870 BACKGROUND

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Wounds and Injuries

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Hasan ARSLAN, PHD. Cand.

  Dokuz Eylul University

  PRINCIPAL INVESTIGATOR

• A. Esin YILMAZ SAMANCI, professor

  Dokuz Eylul University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: In this pilot randomized controlled trial, no masking is applied, as the nature of the interventions makes it impractical. Participants are informed of their group assignment since those in the second group are aware of their additional video call sessions with psychotherapists. The therapists conducting the sessions also need to be aware of the intervention they are delivering to properly adhere to the treatment protocol. This open-label approach is necessary to facilitate the intended psychotherapeutic interactions and to ensure that the intervention is delivered with fidelity, as per the study design.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Model Details: This is a three-arm, parallel randomized controlled trial. Upon enrollment, participants are randomly assigned to one of three groups. The first group will use the "TraumaRelief" application in addition to weekly video calls with a psychologist. The second group will use the "TraumaRelief" mobile application exclusively. The third group will serve as a control and receive no intervention. The primary outcomes will be measured at baseline, five weeks, one month, and three months post-intervention to assess the efficacy and acceptability of the mobile application and the added benefit of psychological support.

Study Record Dates

• First Submitted: February 25, 2024
• First Posted: March 1, 2024
• Study Start: December 1, 2024
• Primary Completion: February 10, 2025
• Study Completion: May 10, 2025
• Last Updated: May 14, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)