Increasing the Effectiveness of Psychotherapy in Routine Care through Blended Therapy with Transdiagnostic Online Modules (PsyTOM): Study Protocol for a Randomized Controlled Trial

Background: In blended therapy, face-to-face psychotherapy and Internet-based interventionsare combined. Blended therapy may be advantageous for patients and psychotherapists.However, most blended interventions focus on cognitive behavioral therapy or single disorders,making them less suitable for routine care settings. Methods: In a randomized controlled trial, we will compare blended therapy and face-to-facetherapy in routine care. We intend to randomize 1152 patients nested in 231 psychotherapistsin a 1:1 ratio. Patients in the blended therapy group will receive access to TONI (therapeuticonline intervention). TONI contains 12 transdiagnostic online modules suited forpsychodynamic, cognitive behavioral, and systemic therapy. Psychotherapists decide whichmodules to assign and how to integrate TONI components into the psychotherapeutic processto tailor treatment to their patients’ specific needs. We will assess patients at baseline, 6weeks, 12 weeks, and 6 months. Patients enrolled early in the trial will also completeassessments at 12 months. The primary outcomes are depression and anxiety at 6-monthpost-randomization, as measured by PHQ-8 and GAD-7. Secondary outcomes includesatisfaction with life, level of functioning, personality traits and functioning, eating pathology,sexual problems, alcohol/drug use, satisfaction with treatment, negative effects, and mentalhealth care utilization. In addition, we will collect several potential moderators and mediators,including therapeutic alliance, agency, and self-efficacy. Psychotherapists will also report onchanges in symptom severity and therapeutic alliance. Qualitative interviews withpsychotherapists and patients will shed light on the barriers and benefits of the blendedintervention. Furthermore, we will assess significant others of enrolled patients in a sub-study. Discussion: The integration of online modules which use a common therapeutic language andaddress therapeutic principles shared across therapeutic approaches into regularpsychotherapy has the potential to improve the effectiveness of psychotherapy and transferinto everyday life as well help save therapists' resources and close treatment gaps. A modularand transdiagnostic setup of the blended intervention also enables psychotherapists to tailortheir treatment optimally to the needs of their patients.