Discussion
PTSD, trauma
SECONDARY
The present paper describes the rationale, study design, and methods of the MARS-study: an RCT evaluating the effects of a phase-based treatment model compared to purely trauma-focused therapy in young individuals diagnosed with PTSD and on the possible symptoms of complex PTSD resulting from (repeated) sexual and/or physical abuse during childhood.This study had several strengths. First, it sought to assess the effectiveness and efficacy of two widely utilized treatment models in a group of patients who are often overlooked in research owing to their complex symptomatology. To the best of our knowledge, an efficacy study of adolescents who have experienced (repeated) sexual and/or physical abuse during childhood is unprecedented. Second, although a phase-based trauma-focused model has recently been studied in adults (15–17), no similar study has been conducted in adolescents. Research on the effectiveness of trauma treatment in adolescents (symptoms of complex) PTSD is limited [Although the proposed study has strengths, it is important to acknowledge several methodological issues that should be taken into consideration. First, the participants included in the study are those who have developed PTSD as a result of surviving (repeated) sexual and/or physical abuse during childhood. While our goal is to include individuals with Complex PTSD, the current study faces challenges due to the lack of reliable and validated instruments specifically designed to assess the complex manifestations of symptoms associated with complex trauma. Consequently, the study relies on trauma history as the primary criterion for inclusion rather than the comprehensive manifestation of complex trauma symptoms. However, as part of the secondary analyses, separate questionnaires are administered to assess domains related to Complex PTSD, including emotion regulation, interpersonal regulation, and negative self-image. Another important consideration pertains to the operationalization of the phase-based model. The concept of a 'phase-based model' can be interpreted differently, depending on various perspectives. In clinical settings, it encompasses more than one treatment protocol that focuses on skill development in regulation. For some clinicians, preparing patients for trauma-focused treatment requires a personalized approach that involves comprehensive psychoeducation, establishing a therapeutic alliance, and engaging with family members and trusted individuals. Training in regulation skills itself demands substantial time and effort from both the patient and therapist. However, it is crucial to note that the effectiveness of this approach has not been extensively studied, raising a limitation in our understanding of its impact and outcomes.Finally, this study implemented a non-inferiority trial. A non-inferiority trial is a type of clinical research study that aims to demonstrate that a new treatment is not worse than an existing treatment by a prespecified margin. One benefit of this type of trial is that it allows for the evaluation of new treatments that may have advantages over existing treatments, such as fewer side effects or lower costs, even if they are not necessarily more effective. However, non-inferiority trials have limitations. One limitation is that they require a well-defined and clinically meaningful non-inferiority margin, which is challenging to determine. In addition, non-inferiority trials may be less likely to detect small but clinically meaningful differences between treatments, which could limit their ability to provide definitive conclusions regarding the relative effectiveness of different treatments.