Clinical trial NCT06288594: TraumaRelief App: A Pilot RCT Assessing Feasibility and Acceptability
Official title: Assessing the Feasibility, Acceptability, and Preliminary Efficacy of the 'TraumaRelief' App for PTSD Symptom Management in Turkey: A Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-Traumatic Stress Disorder (PTSD)
Keywords: Ptsd
Trauma
Mobile Application
Pilot study
Randomized Controlled Trial
Feasibility
Acceptability
Efficacy
E-health
Lead sponsor: Dokuz Eylul University
Sponsor class: OTHER
First posted: 2024-03-01
Enrollment: 107
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: PTSD Symptom Severity
timeFrame: 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:
measure: Depression Anxiety and Stress Symptom Severity
timeFrame: 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
measure: Quality of Life Improvement
timeFrame: 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
measure: Feasibility: Attrition Rate
timeFrame: Attrition rate will be measured from baseline, at 5 weeks post-intervention, 1 month post-intervention, and 3 months post-intervention.
measure: Feasibility: Recruitment Rate
timeFrame: Recruitment period will be calculated from the beginning of the enrollment process up to the start date of the intervention
measure: Feasibility: Retention Rate
timeFrame: Retention rate will be assessed from baseline, at 5 weeks, 1 month post-intervention, and 3 months post-intervention.
measure: Feasibility: Adherence Rate to the Mobile Application
timeFrame: Throughout the 5-week intervention period
measure: Feasibility: Consent Rate
timeFrame: Consent rate will be recorded from the onset of the recruitment period until the start date of the intervention.
measure: Feasibility: Fidelity of Intervention Delivery
timeFrame: Throughout the 5-week intervention period
measure: Acceptability: System Usability Scale (SUS) Score for Acceptability
timeFrame: End of the 5-week intervention period
measure: Acceptability: Preferred and Least Preferred Module Components
timeFrame: End of each module during the 5-week intervention period
measure: Acceptability: Application Utilization Frequency
timeFrame: Daily throughout the 5-week intervention period
measure: Acceptability: Likelihood to Recommend the Application
timeFrame: At the end of the 5-week intervention period
Other outcomes:
Locations:
city: Batman
country: Turkey
facility: Hasan arslan
Study officials:
affiliation: Dokuz Eylul University
name: Hasan ARSLAN, PHD. Cand.
role: PRINCIPAL_INVESTIGATOR
affiliation: Dokuz Eylul University
name: A. Esin YILMAZ SAMANCI, professor
role: STUDY_DIRECTOR
References:
citation: 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.