nctId: NCT06288594 id: DEU-PSI-HA-001 briefTitle: TraumaRelief App: A Pilot RCT Assessing Feasibility and Acceptability overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2024-09 date: 2024-12 date: 2024-03-01 date: 2024-03-06 name: Dokuz Eylul University class: OTHER 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. conditions: Post-Traumatic Stress Disorder (PTSD) studyType: INTERVENTIONAL phases: NA 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 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. count: 105 type: ESTIMATED name: Application Plus Online Therapist Support Group name: Application Only Group measure: PTSD Symptom Severity measure: Depression Anxiety and Stress Symptom Severity measure: Quality of Life Improvement measure: Feasibility: Attrition Rate measure: Feasibility: Recruitment Rate measure: Feasibility: Retention Rate measure: Feasibility: Adherence Rate to the Mobile Application measure: Feasibility: Consent Rate measure: Feasibility: Fidelity of Intervention Delivery measure: Acceptability: System Usability Scale (SUS) Score for Acceptability measure: Acceptability: Preferred and Least Preferred Module Components measure: Acceptability: Application Utilization Frequency measure: Acceptability: Likelihood to Recommend the Application sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False