Ignite Creation Date:
2024-05-06 @ 8:10 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06288594
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-06
First Post:
2024-02-25
Brief Title:
TraumaRelief App A Pilot RCT Assessing Feasibility and Acceptability
Sponsor:
Dokuz Eylul University
Organization:
Dokuz Eylul University
Study Overview
Official Title:
Assessing the Feasibility Acceptability and Preliminary Efficacy of the TraumaRelief App for PTSD Symptom Management in Turkey A Pilot Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The world experiences a high rate of traumatic events Even if PTSD is not diagnosed traumatic events can significantly affect peoples 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 10000 words and eight animated videos approximately 40 minutes in total
2 Coping with Symptoms Module This module offers 10000 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 4000 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 applications 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
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 10000 words and eight animated videos approximately 40 minutes in total
2 Coping with Symptoms Module This module offers 10000 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 4000 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 applications 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None