protocolSection identificationModule nctId: NCT06288594, orgStudyIdInfo id: DEU-PSI-HA-001, briefTitle: TraumaRelief App: A Pilot RCT Assessing Feasibility and Acceptability, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2024-09, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Dokuz Eylul University, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Post-Traumatic Stress Disorder (PTSD), designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: 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., primaryPurpose: TREATMENT, maskingInfo masking: NONE, maskingDescription: 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., enrollmentInfo count: 105, type: ESTIMATED, armsInterventionsModule interventions name: Application Plus Online Therapist Support Group, interventions name: Application Only Group, outcomesModule primaryOutcomes measure: PTSD Symptom Severity, secondaryOutcomes measure: Depression Anxiety and Stress Symptom Severity, secondaryOutcomes measure: Quality of Life Improvement, secondaryOutcomes measure: Feasibility: Attrition Rate, secondaryOutcomes measure: Feasibility: Recruitment Rate, secondaryOutcomes measure: Feasibility: Retention Rate, secondaryOutcomes measure: Feasibility: Adherence Rate to the Mobile Application, secondaryOutcomes measure: Feasibility: Consent Rate, secondaryOutcomes measure: Feasibility: Fidelity of Intervention Delivery, secondaryOutcomes measure: Acceptability: System Usability Scale (SUS) Score for Acceptability, secondaryOutcomes measure: Acceptability: Preferred and Least Preferred Module Components, secondaryOutcomes measure: Acceptability: Application Utilization Frequency, secondaryOutcomes measure: Acceptability: Likelihood to Recommend the Application, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False