Efficacy of a personalized, response-based transdiagnostic intervention for emotional disorders delivered via the Internet: a protocol for an adaptive randomized controlled trial

Abstract

One of the main challenges in clinical psychotherapy is disseminating effective psychological treatments to the millions who need them but lack access. Transdiagnostic interventions, particularly those delivered online, can help bridge this treatment gap. However, these interventions, often provided as a “one-size-fits-all” approach, do not tailor to individual patient needs. Therefore, it is essential to identify which patients benefit from these treatments and who require more intensive interventions. This randomized controlled trial (RCT) aims to evaluate the effects of an Internet-based transdiagnostic intervention (UJI Online Transdiagnostic Protocol/Transversal) for emotional disorders, adapted to patients’ response. Three hundred sixty-six adults with clinically significant symptoms of anxiety and depression (ODSIS ≥ 7 and/or OASIS ≥ 8) and without suicidal ideation or a severe mental disorder participated. After having completed the first three modules, patients will be randomized based on their symptomatic response. Early responders will either continue with the original intervention—12 self-administered modules—or discontinue treatment. Non-early responders will receive a blended format—including two therapist-led videoconference sessions—or continue with the original intervention. Multilevel models will be used to analyze the data. The primary expected result is that the blended format will improve treatment outcomes for non-early responders compared to the self-applied format. Moreover, it is expected that discontinuing treatment for early responders will be as effective as continuing it until completion. The findings are expected to inform clinical practice by highlighting the importance of assessing symptomatic response throughout treatment, especially in its early phases, to better tailor interventions to the needs of different patient groups. http://www.chictr.org.cn , identifier NCT07051148.