Assessing the Feasibility, Acceptability, and Preliminary Efficacy of the 'TraumaRelief' App for PTSD Symptom Management in Turkey: A Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 107
- 试验地点
- 2
- 主要终点
- PTSD Symptom Severity
研究概览
简要总结
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.
详细描述
"TraumaRelief" consists of eight modules. These are:
- 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).
- 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.
- 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.
- 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.
- Online Meeting Module: Facilitates video calls with psychologists via phone or e mail, enhancing therapeutic engagement.
- Messaging with the Therapist: This module enables participants to send messages to their therapists through the application in emergency situations, ensuring timely support.
- Myself Module: Each time users access the psychoeducation and coping with symptoms modules, they assess their stress level, contributing to a personalized stress graph.
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
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.
干预措施: Application Plus Online Therapist Support Group (Behavioral)
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.
干预措施: Application Only Group (Behavioral)
结局指标
主要结局
PTSD Symptom Severity
时间窗: 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
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.
次要结局
- 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: Retention Rate(Retention rate will be assessed from baseline, at 5 weeks, 1 month post-intervention, and 3 months post-intervention.)
- 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: Consent Rate(Consent rate will be recorded from the onset of the recruitment period until the start date of the intervention.)
- Acceptability: Likelihood to Recommend the Application(At the end of the 5-week intervention period)
- Feasibility: Recruitment Rate(Recruitment period will be calculated from the beginning of the enrollment process up to the start date of the intervention)
- Feasibility: Adherence Rate to the Mobile Application(Throughout the 5-week intervention period)
- Acceptability: Preferred and Least Preferred Module Components(End of each module during the 5-week intervention period)
- 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)
- Feasibility: Fidelity of Intervention Delivery(Throughout the 5-week intervention period)
- Acceptability: System Usability Scale (SUS) Score for Acceptability(End of the 5-week intervention period)
- Acceptability: Application Utilization Frequency(Daily throughout the 5-week intervention period)
研究者
Hasan arslan
Research Assistant
Dokuz Eylul University